Creating a Regional Anasthesia CPG to Manage Postoperative Pain in Eligible NICU Patients: A Quality Improvement Project

Over 4000 neonates require surgery annually in the United States. The use of opioids for postoperative pain control and sedation during a lengthy stay in the NICU can result in increased cumulative doses, leading to adverse effects in the neonatal patient. Opioid administration may have adverse clinical side effects, including respiratory suppression, delayed bowel motility, and possible neurodevelopmental issues during childhood. Few studies in the surgical neonatal population exist regarding the reduction of opioid use through different analgesic strategies, such as regional anesthesia. Utilizing regional anesthesia has the potential to reduce opioid use, yet there is a knowledge gap regarding the efficacy and use of regional anesthesia in the NICU population. While the use of regional anesthesia is commonplace for pain control in other patient populations, there is no clinical practice guideline for regional anesthesia to treat postoperative pain in neonates. Without a standardized guideline for regional anesthesia, this pain treatment modality is underutilized. This project aims to develop a clinical practice guideline to provide regional anesthesia to eligible patients in the NICU. This project utilized a literature review, stakeholder meetings, clinician surveys, and a chart review to understand attitudes and education regarding regional anesthesia and to guide the creation of a CPG. Data was presented to a multidisciplinary team and used to define the population and parameters of the process change. The designed educational processes in conjunction with the unit education team to ensure the project's sustainability. Unit resources were assessed to create an integrative implementation plan. The project lead surveyed providers regarding the use of regional anesthesia in the NICU. Using the information from the survey, the QI team created and implemented an education plan for bedside nursing about regional anesthesia and its utility in the neonatal population. Stakeholders, including the NICU medical director, surgery, and anesthesia, created and approved the clinical practice guideline. The project lead designed and implemented a sustainability plan to ensure the success of the CPG. The chart review showed that patients received between 0.6-30.77 OME/kg of opioids with a mean of 7.49 OME/kg (SD 8.56) in the first 72 hours postoperatively. NICU providers indicated their openness to utilizing regional anesthesia as a pain relief modality in the NICU, with the majority indicating a CPG would increase their likelihood of implementing the use of regional anesthesia (n=59, 82%). The qualitative analysis identified two overarching categories: barriers to implementing the CPG and facilitators for implementation which varied based on role in the NICU. Based on our data collection, the QI team created a CPG with defined inclusion and exclusion criteria, streamlined necessary communication, and outlined roles for every provider involved. Educational needs were identified and addressed through educational offerings and documents. The project lead created and implemented a sustainability plan, including PDSA cycles, an electronic medical record trigger, and ongoing education to ensure the uptake of the practice change. Adopting this guideline as the standard of care would likely improve patient outcomes. Data collection must continue through sustained PDSA cycles to determine the benefits of this practice change and assess the intervention's feasibility, usability, and satisfaction.

1 Creating a Regional Anesthesia CPG to Manage Postoperative Pain in Eligible NICU Patients: A Quality Improvement Project Samantha C. Keirsey and Kelly Mansfield College of Nursing: The University of Utah NURS 7702: DNP Scholarly Project II Spring 2024 2 Abstract Background: Over 4000 neonates require surgery annually in the United States. The use of opioids for postoperative pain control and sedation during a lengthy stay in the NICU can result in increased cumulative doses, leading to adverse effects in the neonatal patient. Opioid administration may have adverse clinical side effects, including respiratory suppression, delayed bowel motility, and possible neurodevelopmental issues during childhood. Few studies in the surgical neonatal population exist regarding the reduction of opioid use through different analgesic strategies, such as regional anesthesia. Utilizing regional anesthesia has the potential to reduce opioid use, yet there is a knowledge gap regarding the efficacy and use of regional anesthesia in the NICU population. Local Problem: While the use of regional anesthesia is commonplace for pain control in other patient populations, there is no clinical practice guideline for regional anesthesia to treat postoperative pain in neonates. Without a standardized guideline for regional anesthesia, this pain treatment modality is underutilized. This project aims to develop a clinical practice guideline to provide regional anesthesia to eligible patients in the NICU. Methods: This project utilized a literature review, stakeholder meetings, clinician surveys, and a chart review to understand attitudes and education regarding regional anesthesia and to guide the creation of a CPG. Data was presented to a multidisciplinary team and used to define the population and parameters of the process change. The designed educational processes in conjunction with the unit education team to ensure the project's sustainability. Unit resources were assessed to create an integrative implementation plan. Interventions: The project lead surveyed providers regarding the use of regional anesthesia in the NICU. Using the information from the survey, the QI team created and implemented an education plan for bedside nursing about regional anesthesia and its utility in the neonatal 3 population. Stakeholders, including the NICU medical director, surgery, and anesthesia, created and approved the clinical practice guideline. The project lead designed and implemented a sustainability plan to ensure the success of the CPG. Results: The chart review showed that patients received between 0.6-30.77 OME/kg of opioids with a mean of 7.49 OME/kg (SD 8.56) in the first 72 hours postoperatively. NICU providers indicated their openness to utilizing regional anesthesia as a pain relief modality in the NICU, with the majority indicating a CPG would increase their likelihood of implementing the use of regional anesthesia (n=59, 82%). The qualitative analysis identified two overarching categories: barriers to implementing the CPG and facilitators for implementation which varied based on role in the NICU. Based on our data collection, the QI team created a CPG with defined inclusion and exclusion criteria, streamlined necessary communication, and outlined roles for every provider involved. Educational needs were identified and addressed through educational offerings and documents. The project lead created and implemented a sustainability plan, including PDSA cycles, an electronic medical record trigger, and ongoing education to ensure the uptake of the practice change. Conclusion: Adopting this guideline as the standard of care would likely improve patient outcomes. Data collection must continue through sustained PDSA cycles to determine the benefits of this practice change and assess the intervention's feasibility, usability, and satisfaction. Keywords: regional anesthesia, epidural, postoperative pain, clinical practice guideline, opioid, Neonatal Intensive Care Unit 4 Creating a Regional Anesthesia CPG to Manage Postoperative Pain in Eligible NICU Patients: A Quality Improvement Project Problem Description Profound progress in perinatal care has significantly improved neonatal outcomes in the last several decades (Khasawneh et al., 2020). Advances in care led to significant changes, including decreases in the viable gestational age and improved mortality for preterm neonates (Wingert et al., 2023). While these advancements are an incredible feat for neonatology, increased survival has also shown an increase in the number and acuity of neonates admitted to the NICU (Wingert et al., 2023). With enhanced care and increased neonatal hospitalizations, more NICU patients undergo invasive procedures and surgical interventions (Puthoff et al., 2021; Wingert et al., 2023). Neonates receive more opioids for pain control than in the past (Puthoff et al., 2021). In addition, improved care in extremely low birth weight (ELBW) infants includes options for surgical intervention at lower weights and lower gestational ages (Visoiu, 2022 & Wingert et al., 2023). Providing sufficient pain control for procedures is a central focus of neonatal care as it supports the overarching goal of improved outcomes for the neonatal population (Puthoff et al., 2022; Visoiu, 2022; Wingert et al., 2023). In the past, overlooked and undertreated pain led to poor patient healing and outcomes. More recent research indicates that nerve endings and spinal cord projections fully mature by 2325 weeks’ gestation, suggesting that pain sensation and perception are possible for very premature neonates (Duran et al., 2015 & Visoiu, 2022). Early pain experiences contribute to long-term behavioral changes and have shown neuroanatomic changes in infant animal models (Visoiu, 2022). Noxious events endured in early life, when the nervous system is most vulnerable, can lead to long-term and short-term detrimental effects. There is resounding 5 evidence that failure to treat pain in infants can cause attention-deficit/hyperactivity disorder, impaired visual-perceptual ability or visual-motor integration, poor executive function, lower body weight, and decreased head circumference independent of other medical confounders (Duran et al., 2015; Visoiu, 2022; Wingert et al., 2023). Traditionally, opioids have been the standard of care for pain management in the NICU despite their known unfavorable side effects (Duran et al., 2015; Puthoff et al., 2021; Visoiu, 2022). The most common opioids used in the NICU are morphine and fentanyl, which are available via intermittent IV bolus doses, continuous infusions, and nurse-controlled analgesia (Visoiu, 2022). It is important to note that these medications require administration by nurses, which can lead to inconsistency of the actual dose administered and may lead to unrelieved pain. Although opioids contribute to improved outcomes related to pain management, they are not benign and may cause prolonged hospitalization due to side effects, which can lead to postoperative complications and opioid dependence (Duran et al., 2015; Puthoff et al., 2021; Visoiu, 2022). Common opioid side effects include respiratory depression, prolonged intubation and ventilation, ileus, and decreased gut motility (Grabski et al., 2020; Visoiu, 2022). Postoperatively, neonatal patients often experience increased pain requiring analgesia via opioid administration; in some cases, this leads to iatrogenic drug withdrawal (Duran et al., 2015; Puthoff et al., 2021; Visoiu et al., 2022; Wingert et al., 2023). Currently, there is little information identifying which procedures and surgeries lead to higher opioid use (Grabski et al., 2020; Visoiu, 2022; Wingert et al., 2023). Neonatal surgery is associated with alteration in future pain responses, increased perioperative analgesic requirement for future surgical procedures, and difficulty managing postoperative pain (Visoiu, 2022). Opioid use in neonates could lead to complications for the infant; morphine exposure specifically has been associated with impaired 6 cerebellar growth and poorer neurodevelopmental outcomes (Duran et al., 2015; Wingert et al., 2023; Zwicker et al., 2015). With the known detrimental effects of opioids in the NICU population, maximizing the use of adjunctive therapies to decrease cumulative opioids is a logical next step in improving neonatal outcomes. In the pediatric population, regional anesthesia (RA) is widely accepted as a safe and effective pain control modality (Johr, 2015; Wingert et al., 2023). This method provides consistent anesthetic dosing without the concern of human error for each dose administration. Studies have shown that regional anesthesia can decrease overall opioid use by blocking the transmission of nerve signals at the level of the central and peripheral nervous systems without the systemic side effects seen with opioids (Wingert et al., 2023). Available Knowledge Until as recently as the 1980s, it was an accepted misconception that neonates could not feel pain. Thus, the priority of pain management did not exist, and infants lived without appropriate analgesia (Gibbs et al., 2022; Puthoff et al., 2021; Wingert et al., 2023). In preterm infants, painful procedures led to reduced white matter integrity and neuronal loss (Attarian et al., 2014; Visoiu, 2022). Within the hospital, long-term use of opioids in neonates causes complications, including prolonged mechanical ventilation, urine retention, respiratory depression, delayed return of intestinal function, and carries an inherent risk of tolerance leading to further prolonged use and complicated tapering procedures (Kinoshita et al., 2023; Rana et al., 2017; Stetson et al., 2020). There is mounting evidence showing a relationship between opioid exposure and neurodevelopmental impairments. Anesthetics, benzodiazepines, and opiates all act on the Nmethyl-D-aspartate receptor antagonism and the y-aminobutyric acid antagonism (Creely, 2016). 7 Animal studies have demonstrated neuroapoptosis and cognitive impairments related to these drug-receptor interactions (Creely, 2016; Wingert et al., 2023). Using adjunctive medications and alternative therapies may help negate the unfavorable side effects associated with excessive opioid exposure and lead to better pain control. Interventions that reduce neonatal pain and stress are associated with improved clinical outcomes. Examples of this include nonpharmacologic treatments such as non-nutritive sucking, breast milk, music therapy, skin-to-skin contact, and swaddling (McPherson et al., 2020). Alternatively, pharmacologic measures include careful use of opioids, benzodiazepines, and alternate pharmaceutical therapies (McPherson et al., 2020; Visoiu, 2022; Wingert et al., 2023; Zwicker et al., 2015). Considered a safe adjunct therapy for postoperative pain control, regional anesthesia offers an option for decreasing opioid use while providing pain control through the integration of continuous infusions of anesthesia via epidural catheters. This therapy may offer more pain control than relying on opioids and acetaminophen alone (Duran et al., 2015; Johr, 2015; Puthoff et al., 2021; Wingert et al., 2023). Regional anesthesia is a safe adjunctive therapy for postoperative pain management. In 2016 and again in 2018, the Pediatric Regional Anesthetic Network (PRAN) published data on more than 100,000 nerve blocks, including continuous epidurals and one-time dose blocks; they reported the level of safety in pediatric regional anesthesia comparable to adult practice and confirmed the safety of placing blocks under general anesthesia in the pediatric population (Long et al., 2016; Vargas et al., 2019; Walker et al., 2018). In addition, PRAN reviewed the insertion and use of 307 neonatal epidural catheters and found there were no permanent neurologic sequelae or confirmed local anesthetic systemic toxicity (Long et al., 2016). 8 Other comparable NICUs have implemented regional anesthesia in neonates after abdominal surgery (Duran et al., 2015; Puthoff et al., 2021; Relland et al., 2022; Sandoval et al., 2020). Their guidelines included a variety of surgical modalities, including thoracoabdominal procedures and genitourinary. Additionally, their guideline implementation relied upon process maps and pain management protocols, which were managed in coordination with a specialized pain management team (Duran et al., 2015; Puthoff et al., 2021; Relland et al., 2022; Sandoval et al., 2020). After adopting regional anesthesia, the average postoperative opioid dose decreased, the time to extubation decreased, and postoperative pain scores decreased (Puthoff et al., 2021; Relland et al., 2022). Limiting cumulative opioid exposure in the neonatal population may decrease adverse side effects associated with opioid use and lead to the use of new pain control initiatives intended to decrease neonatal postoperative pain. More data and research could lead to alternatives in pain management and a change in standard practice that could improve individualized patient care. Rationale This project's theoretical framework is the Johns Hopkins Evidence-Based Practice Model (JHNEBP). The JHNEBP utilizes a problem-solving approach to clinical decision-making and provides user-friendly tools to assist users through the evidence-based process. This model uses a three-step PET process: practice question, evidence, and translation. The first phase is to develop a practice question based on the PICO model—the second phase reviews existing literature, including appraisal and synthesis of the findings. The third phase is translating the evidence into practice by developing a clinical practice guideline and then implementing the guideline into practice. Per JHNEBP recommendations, this project will also utilize a multidisciplinary quality improvement team (NICU nurses, Advanced Practice Providers, 9 neonatologists, pediatric surgeons, and anesthesia) to contribute their clinical expertise to developing the CPG. Once the PET process reaches completion, best practices will undergo continuous assessment through plan-do-study-act (PDSA) cycles. The QI team will analyze data, including CPG utilization, evaluate the need for improvement, assess barriers to change weekly, and implement practice changes by adjusting the guideline to ensure the project's success. The JHNEBP enhances team collaboration and allows the QI multidisciplinary team to disseminate information, incorporate real-time evidence-based suggestions, and translate it into project development and implementation. Because of this fluidity, the success of the CPG is sustainable and can continue to be improved well after the initial execution of this project. Specific Aims The purpose of this Doctor of Nursing Practice (DNP) project is to understand the current process of postoperative pain management, create a CPG regarding the use of regional anesthesia in the NICU population, and design an implementation and sustainability plan for the CPG. There were four specific aims for this project: 1) assess the current neonatal postoperative pain management processes, 2) develop an evidence-based CPG for postoperative-epidural management 3) educate the clinical staff on the use of epidural catheters and implement the CPG, and 4) develop an implementation and sustainability plan for the CPG. Methods Context A 51-bed, all-referral level IV newborn intensive care unit in the urban, intermountain west harbored this project. This NICU serves newborns in a 400,000-square-mile area, including Utah, Wyoming, Montana, Idaho, Nevada, and Alaska, with an average of about 35 monthly 10 admissions, all requiring specialist or surgical services and neonatal care. It employs about 200 registered nurses, 65 advanced practice practitioners, 28 attending neonatologists, 9 pediatric surgeons, and 20 pediatric anesthesiologists. Social determinants of health shape many aspects affecting the care of the NICU patient. Infants born prematurely or requiring high acuity interdisciplinary care in the NICU represent a highly vulnerable population with tremendous medical and social risk. During prolonged hospitalizations often seen in level III and IV NICUs, families travel to and from the hospital and incur unforeseen costs from transportation and childcare in conjunction with forgone income from lost time at work (Adappa & Barr, 2023 & Parker et al., 2020). These stressors to NICU infants' parents can impact bonding with their child, household income and financial stability, and coping mechanisms (Adappa & Barr, 2023). Neonates experience extended hospital stays and often undergo more painful procedures requiring analgesia; incorporating regional anesthesia may decrease the morbidities related to pain and poorly controlled pain, which may facilitate the ability to be discharged home sooner than those who do not undergo regional anesthesia (Puthoff et al., 2021; Relland et al., 2022; Wingert et al., 2023). Greater pain control may also offer improved parental mental health and bonding, as they would not have to endure seeing their child struggle with pain management and adequate pain control may facilitate improved bonding, such as holding the infant skin-to-skin sooner postoperatively (Relland et al., 2022). A related quality improvement project addressing standardized postoperative adjunctive pain management for postoperative surgical patients is underway in this NICU. This project is complementary as it has the same goals of reducing opioid use and improving postoperative pain management in surgical patients. 11 Interventions This project comprises of four phases designed to understand the need for change and address barriers and sustainability of the new practice. First Phase The focus of the first phase was to assess current neonatal postoperative pain management processes and to understand the educational basis of regional anesthesia. The project lead assembled a multidisciplinary quality improvement team comprised of individuals who recognized the need for improved adjunctive postoperative pain control. This QI team included the project lead, NICU practitioners and nurses, anesthesia, pain management, and pediatric surgery. Next, to better understand the current processes and opioid use, the project lead conducted a chart review of past surgical procedures of NICU patients and their cumulative opioid consumption. This review included all patients undergoing abdominal surgery in from January to December 2022. Postoperative opioid use was defined as total opioid exposure, continuous infusions, and doses as needed in the initial 72-hour postoperative period. 72 hours was chosen as it is the most common timeline used in comparative literature (Kinoshita et al., 2023). The calculation of oral morphine equivalents (OME) per kilogram defined the amount of postoperative opioid use to allow for a standard comparison using a conversion factor of 30 mg oral:10 mg parenteral. Morphine is considered the gold standard of pain relief in literature; therefore, all calculations were done using OME (Bhatnagar & Pruskowski, 2022). This review excluded adjunct therapies that were used, such as acetaminophen, ibuprofen, or other sedatives. A pre-intervention survey was created and disseminated via REDCap, an encrypted webbased application designed to manage web-based surveys, see Appendix A (REDCap, nd). The 12 survey included Likert-based questions and short answer questions designed to assess the stakeholders' knowledge of, barriers to, and facilitators of using postoperative epidural infusions as an adjunctive therapy to the postoperative pain protocol. The survey was distributed to nurses, advanced practice practitioners, physicians, fellows, and neonatal therapists via e-mail. To further understand the impact of the practice change, the project lead conducted a cost analysis to share with the QI team. Through this analysis, the team considered the cost/benefit of utilizing regional anesthesia compared to the current standard opioid administration. This analysis compared costs associated with the Current Procedural Terminology (CPT) codes necessary for regional anesthesia insertion, maintenance, and removal to the costs associated with postoperative opioid use. Second Phase The second phase of the project was to create the CPG. Using the initial survey results and stakeholder feedback, the QI team met several times to discuss best practices to be included in the CPG and to assess the need for specific education regarding the care of the infant with an epidural in place and gaps in education for postoperative patients. The QI team addressed questions and concerns about the CPG in real time, taking feedback back to team meetings to tailor education and clarify the CPG. Using feedback from stakeholder meetings, a key driver diagram was introduced to the QI team to explain the planned steps and goal to create the CPG (see Figure 1). The diagram assisted the team in identifying, characterizing, and addressing potential barriers, including when to identify eligible patients, ensuring buy-in from anesthesia, and logistics in managing patients in the immediate postoperative pain period. Inclusion criteria included infants who were undergoing a laparotomy and had opioid exposure. Exclusion criteria included infants less than 2.5 kg, emergent cases, patients on vasopressors, coagulopathy or 13 thrombocytopenia within the 7 days before surgery, patients undergoing treatment for a presumed infection, patients who had surgery within 7 days of this surgery, significant blood loss during surgery, parent or guardian refusal, increased intracranial pressure, and spinal abnormalities. The QI team met often to discuss the CPG verbiage, inclusion criteria, and process. We employed a mix of team member meetings to accommodate the team’s schedules. Scheduling comprehensive, collaborative meetings, including NICU, surgery, and anesthesia proved challenging and time-consuming. Time constraints necessitated several separate meetings between the NICU QI, surgical, and anesthesia teams. The project lead created several CPG drafts discussed and edited by the QI team, including the NICU medical director. Once the NICU team approved the document, it was submitted to surgery and anesthesia. The final document included feedback from the full multidisciplinary group and was finalized by NICU, surgery, and anesthesia. The team passed this version to the hospital’s chief nursing officer for publishing approval. Third Phase Staff received multiple modalities of education regarding the intervention. Nursing and provider buy-in was crucial to the success of this project; because of this, several approaches to education were used, including in-person, one-on-one, or small-group educational in-services provided for nursing and providers. First situation-background-assessment-recommendation (SBAR) descriptions of the CPG were discussed in a monthly educational meeting, emailed in electronic newsletters, and sent to nurses and providers (Appendix B). The NICU quality improvement and pediatric surgery teams received a brief presentation in their meetings. During these meetings, the organizers actively encouraged attendees to ask questions and voice 14 concerns, addressing them in real time. Educational in-services were performed on shift and consisted of a verbal explanation of the CPG, distribution of educational materials regarding the CPG, and opportunities to voice questions and concerns regarding the CPG. The project lead was available to all providers with questions regarding epidural anesthesia, and contact information was provided to the bedside caregivers if their patient returned from the OR with an epidural in place. The tele-critical care nurses for the NICU were also educated and supplied with educational documents to provide nurses with necessary just-in-time education. Lastly, the QI team created an online quick guide for patient management, which included information regarding rounding with pain services and communicating with the APP regarding epidural management, and infusion pump directions and troubleshooting, which was available via a shared folder to all nursing staff. See Appendices C and D. Fourth Phase The final phase consisted of the creation of an implementation and sustainability plan. The sustainability plan defined who would be involved in adopting and using the CPG, data collection, and ongoing education. The QI team assessed the current NICU resources to determine which resources could be used to implement the CPG and assess uptake using the PDSA cycle. Based on survey responses, we included continued education to ensure that nurses and providers received updates and access to current education to enhance sustainability. Study of the Intervention The project lead explored the staff's current clinical knowledge and attitudes regarding regional anesthesia through a pre-intervention electronic survey conducted in the Research Electronic Database Capture (REDCap) tool hosted at the University of Utah. The survey was emailed to neonatal nurses, advanced practice providers, attending neonatologists, and neonatal 15 fellows participating in the unit. The QI team gathered pre-intervention pain management information from a neonatal postoperative pain dashboard, focusing on the total oral morphine equivalent per kilogram consumption in the initial 72 postoperative hours. We then imported data from REDCap for analysis. The project lead created a draft CPG, and several QI team meetings occurred to discuss the feasibility of the draft CPG and how it would work in real time. Subsequently, an analysis of the data from RedCap identified common themes that different clinicians wanted to increase buy-in for the CPG. While holding QI team meetings and editing the CPG, the project lead hosted educational meetings and generated educational materials for bedside nurses to learn more about caring for an epidural. During these sessions, the project lead addressed specific areas of concern gathered via the pre-survey. The pediatric surgeons and anesthesiologists reviewed and edited the CPG per NICU request. The NICU medical director approved the finalization of the CPG and forwarded it to the hospital's chief nursing officer for hospital-wide approval. The success of the interventions in creating change in postoperative pain management will depend upon the success and attention to the approved sustainability plan. Pending approval, the team created a hospital-wide sustainability plan to ease and organize the roll-out of the CPG. Measures The project lead distributed a pre-intervention survey to help understand facilitators and barriers to the CPG and to obtain a baseline need for education. The first two questions were to establish demographic information, asking about unit roles and years of experience. The survey included nine pre-intervention questions. The survey asked respondents whether they had cared for an infant with an epidural in place. If they had, a follow-up question would populate about 16 receiving education on appropriate patient care and whether that information proved helpful. Participants were also asked via Likert scale their thoughts about whether utilizing continuous epidural infusions in postoperative NICU patients can decrease postop opioid usage and if it would be helpful to have a standardized CPG regarding epidural use. On the scale, a 1 correlated with "strongly disagree," and a 5 correlated with "strongly agree." Participants also answered two short answer questions: What are the barriers to using epidural infusions as an adjunctive pain relief modality in the NICU, and what would make you more inclined to use epidural infusions as a pain relief modality? Analysis Chart Data The project lead and QI team members completed a pre-intervention retrospective chart review regarding the oral morphine equivalent (OME) per kilogram consumption in the initial 72 hours postop for infants identified as epidural candidates in 2022. We used descriptive statistics to summarize the data. Survey Data The survey data was summarized using appropriate summary statistics. Participant roles and years of experience were summarized using frequency counts by category. The mean and standard deviation for each question by provider role were calculated for Likert scale questions. Open-ended questions were analyzed using qualitative methods. First, the coding team (SK and KJM) reviewed the data. One coder (SK) inductively coded the data. The coding team met to review and discuss the codes. Categories and all discrepancies were discussed by the team and determined with a team consensus. For sample codes and definitions, see Table 1. 17 Ethical Considerations This project was deemed quality improvement and thus was not subject to Institutional Review Board (IRB) oversight. The QI team selected patients for this project solely based on inclusion/exclusion criteria. There were no conflicts of interest concerning this project. The team lead collected surveys anonymously through REDCap, and the survey results were downloaded to Ubox, which is hosted on a secure server. Results Phase 1 Approximately 400 healthcare providers received the pre-intervention survey via email. Of those providers, 70 (17.5%) completed the questionnaire. Respondents consisted of registered nurses (n=42, 60%), Neonatal APPs (n=19, 27%), Neonatal Therapy (n=1, 1%), Neonatal fellow (n=1, 1%), and Attending Neonatologists (n=7, 10%). APPs had the highest number of years of experience (16+ years, 42.1%); see Table 2. Thirty (43%) respondents reported they had taken care of a patient with an epidural in place in their practice, including 18 (43%) nurses, 6 (32%) APPs, and 6 (86%) attendings. Of this pool of respondents, 17 (57%) reported receiving some education regarding managing the patient and epidural. See Table 3. Overall, no matter what role responders fulfilled in the NICU, the results indicated agreement with the need for an RAspecific CPG. See Table 4. In the qualitative data, the coding team identified two overarching categories of responses: barriers to implementing the CPG and facilitators to the CPG. Participants identified barriers to implementation of the CPG as lack of education around epidural use and care, support for caregivers, and concerns that it aligned with current evidence-based practice. A primary focus was the importance of patient safety. 18 The coding team found that nurses, physicians, and APPs indicated different concerns surrounding implementing the practice change. Nurses overwhelmingly described the need for additional education regarding epidural management and patient care specific to epidurals within this population. Nurses noted they would be more inclined to advocate for epidural use if provided bedside educational tools and multiple methods of training. APPs' comments centered on advocacy for patients by focusing on the educational needs for providing patient care and clear guidelines for coordinating care with surgical partners. One APP participant with less than five years of experience summed this up by saying, "There is a lack of education surrounding how to care for epidurals, what medications to infuse through the epidurals, complications of epidurals, etc. Need more education." For attending neonatologists, primary concerns included engaging stakeholders and understanding the evidence surrounding the practice change, noting that a clear protocol and evidence-based examples would influence their support of the practice change. See Table 4. Chart Review Patients received between 0.6-30.77 OME/kg with a mean of 7.49 OME/ kg (SD 8.56). Of the two patients who only received 0.6 OME/kg, one had an epidural in place for the first 72 hours postoperatively (Figure 2). Most of the surgeries reviewed involved intestinal reanastomosis and other intraabdominal interventions. Cost Analysis Based on the current hospital standard charge, the cost of regional anesthesia for surgery alone is $2,531.32 (Intermountain Healthcare, 2024). The base cost for systemic opioid administration is $704.47 (Intermountain Healthcare, 2024). Additional NICU days are $11,295.00 per day (Intermountain Healthcare, 2024). See Table 5. 19 Second Phase To develop the CPG, the QI team first defined the modalities of RA to be used and defined the surgical population eligible for regional anesthesia and exclusion criteria. Next, the team developed a plan for RA use activation, which triggers communication between specialties (NICU, pain service, anesthesia, and surgery). See Figure 1. The final CPG outlined information regarding the management of any epidurals, necessary steps that must occur if an epidural is used, contact information for issues or concerns that require the pain team, transitional information from epidural to other medication modalities, what to do with increased pain scores and options of care plan if pain becomes problematic, and a discussion regarding the local anesthetic systemic toxicity (LAST) protocol in the unlikely event that systemic toxicity occurs. See Appendix E for the full CPG. Third Phase Based on survey feedback, a unit-wide postoperative pain education overhaul ensued. Working with the unit educators, the project lead created an educational program that used multiple educational methods to address various learning needs. During a NICU-specific shared leadership meeting, open to any NICU employee for attendance, the project lead introduced educational materials (refer to Appendices C and D). First, the QI established an epidural champion team. Bedside nurses could volunteer to become more familiar with the epidural pump and provide education and support to nurses caring for a patient with an epidural. Epidural champions received additional education and materials regarding epidurals and the chain of command for issues that may arise with an epidural (see Appendices D, E, and F). APPs received a quick reference sheet regarding streamlined communication for RA (Appendix G). 20 The next level of support includes charge nurses and tele-critical care (TCC) nurses. These groups received education about the CPG's intended use, exclusion criteria, ideal patient candidacy, and overall epidural education, including medication pump instructions, how to access the necessary equipment for an epidural, and troubleshooting information filed in their offices. Charge nurses and tele-critical care nurses are available 24 hours a day to provide justin-time education for nurses caring for a patient with an epidural and to help troubleshoot issues. The next step was to provide bedside nurses with educational materials and opportunities. The QI team added a tab to the nurses' bedside reference binders. This tab consists of an epidural just-in-time training aid for bedside nurses caring for an infant with an epidural. The epidural section includes examples of the appropriate order set in iCentra, charting tips and tricks, epidural troubleshooting, and contact information for the pain service team. Led by the NICU educators, nurses participated in an epidural set-up and use scenario in the annual skill day for bedside nurses, which utilized a short reference sheet (see Appendix F). During this hands-on session, nurses visualized the necessary equipment, including the medication pump, appropriate epidural tubing, protective sheet for the epidural site, bedside signage, and charting instructions. Fourth Phase This project's fourth and final phase was to create a clear sustainability plan for the CPG. Central to the plan is a trigger for epidural use based on patient candidacy, ongoing audits of CPG uptake, continued identification of barriers, and adaptations to ensure uptake relying on the PDSA cycle. The sustainability plan relies on resources from multiple groups within the NICU. The QI team will utilize two resources to identify epidural candidates and missed opportunities. First, the iCentra nursing team will create a trigger that pops up when the surgeon or surgical fellow schedules a procedure meeting the epidural guidelines. This alert will prompt 21 the surgeon to determine if epidural use is appropriate. If the surgeon deems epidural use appropriate, an order set automatically generates to consult pain services and flag the neonatal team. If the surgeon selects no, follow-up is not necessary. Secondly, tele-critical care nurses will monitor infants' planned surgeries and their RA candidacy. Tele-critical care nurses will actively review the Kardex to identify RA candidates. Upon identifying a candidate, they will flag the patient's profile, and the day shift tele-critical care nurse will actively identify the candidates in the NICU safety and census once surgery is scheduled. Additionally, tele-critical care nurses will audit for opportunities. A file tab will appear in their tasks folder for every shift. This tab asks if surgical infants were discussed in safety and census, if RA was approved, and if an epidural was placed during surgery. The tele-critical care nurses will also document why RA was not approved for the candidates that meet the guidelines for RA. See Figure 3. Tele-critical care audits will be used to evaluate barriers to CPG implementation. Audits will be compiled and sent to the QI team biweekly to determine the cause of missed opportunities. This team will try to identify any common issues that may be a barrier to using epidurals. The QI team will meet monthly to discuss the CPG's feasibility, usability, and satisfaction. The QI team will evaluate PDSA cycles, and appropriate changes to the CPG or process of enacting the CPG will occur. If more rapid changes are necessary, identified members of the QI team may adjust accordingly with approval from the medical director. An executive summary was created and presented to the QI team so that the unit could share results and ongoing efforts to support the initiation and adoption of the CPG (Appendix H). 22 Discussion Summary Despite the overall inclination of NICU clinicians to adopt an RA guideline and studies outlining the benefit of an RA guideline, necessary education and obtaining collaborative approval created challenges to implementing the CPG. Retrospective chart reviews of infants that would have been regional anesthesia candidates showed opioid use with a wide range of OME/kg for postoperative pain management. Pre-implementation findings indicated that most NICU caregivers agreed that using regional anesthesia may decrease the overall consumption of opioids in the postoperative period and that they would benefit from a regional anesthesia CPG. Time constraints prevented the results of the guideline implementation from being followed. Interpretation The current literature provides evidence that using RA to help control postoperative pain in the NICU is a safe and feasible alternative to this facility's current standard of care of using opioids for pain control. RA popularity has increased as a part of postoperative pain management in pediatrics, and its use has demonstrated opioid-sparing, effective analgesia with additional benefits (Puthoff et al., 2020). Encouragingly, RA has not been associated with any evidence of long-term neurocognitive deficits in newborn animal models or human infants (Puthoff et al., 2020). The methods implemented by this project are in line with other studies done by Duran et al. (2015), Puthoff et al. (2020), Relland et al. (2021). Their results indicated that implementing an RA guideline leads to less postoperative opioid consumption, among other benefits. In previous studies, authors described excellent uptake, feasibility, and usability of an RA guideline once the guideline achieved acceptance in the pediatric population (Duran et al., 2015; Puthoff et 23 al., 2020). The acceptance and use of their guidelines led to standard of care practice changes and increased the utilization of RA (Duran et al., 2015; Puthoff et al., 2020). With awareness of the cost of medical care and the economics of medicine, the project lead completed a cost analysis. The analysis compared costs associated with the accepted standard of care for postoperative pain treatment and the proposed practice change associated with the CPG. Upon initial inspection, the cost of regional anesthesia will come under scrutiny as the base price of RA use is $2,531.32. While the associated costs with epidural anesthesia are more than systemic opioid administration, with a base of about $704.47, in terms of overall charges, the risk of having an infant endure iatrogenic opioid withdrawal not only adds more stress to the infant and family but increases the cost and length of stay exponentially. One night's stay in the NICU in which this project was completed is $11,295.00. If an infant suffers from iatrogenic opioid withdrawal, their stay is typically extended by 16 days (Sutter et al., 2022). At the base iatrogenic withdrawal, with an uncomplicated opioid weaning protocol in place, adds $185,255.00 to their overall stay. Families in the NICU experience profound stress while their child is hospitalized. Increasing the length of stay, infant distress, and rising costs could have a significant impact on families. Out-of-pocket costs and financial stressors can act as a barrier to care both during their infant’s hospitalization and after discharge (King et al., 2021). Studies have shown that on the upper end of costs, families may face costs 300% higher than their annual income, creating insurmountable strain on their day-to-day lives and the care of their children (King et al, 2021). Parental stress is directly linked to concerns regarding their infant’s health, outcomes, changes in the parental role, unexpected situations regarding their infant, and disruptions in the parent-infant bond (Hendy et al., 2024). Introducing an RA guideline may offer parents a reprieve from their 24 stress by alleviating infant discomfort, avoiding prolonged stays related to iatrogenic withdrawal, and improving overall outcomes. Limitations This project presented several limitations. First, only 70 out of over 400 clinicians responded to the pre-intervention survey, a sample size of about 18% of the neonatal caregiver population. Even with a lower-than-anticipated response rate, the survey still received close to the average response rate for e-mailed surveys, which is approximately 25%-30% (Menon & Muraleedharan, 2020). Secondly, finding a time when all constituents of the QI team and the multidisciplinary team could meet proved challenging; this led to constraints on decisions necessary for meetings with stakeholders. While workarounds such as e-mail communication and smaller meetings for each specialty helped overcome these barriers, they also caused unnecessary delays that could have been avoided by in-person multidisciplinary meetings. While much time went into creating the CPG, the usability, feasibility, and satisfaction remain to be seen as the implementation is still pending. Pre-implementation data support the willingness of this NICU to utilize the CPG; education was done and is planned for future dissemination as educational opportunities arise. A sustainability team has been built and is ready to follow the implementation of the guideline and assist the QI team in making the CPG as successful as possible in becoming the new standard of care in adjunctive postoperative pain management. With the support surrounding this project and a sustainability plan in place, this project could decrease the overall opioid consumption in postoperative infants undergoing approved surgical interventions. With this outcome in mind, this project may lead this NICU into 25 a new standard of care that could decrease these patient's lengths of stay, intubated days, and days to full enteral feedings. Conclusions The field of neonatology continues to rapidly expand and progress as the knowledge, technology, and equipment available to care for ill and premature infants increasingly grows. Medical innovation allows the NICU to care for sicker and more premature patients and opens the door for more surgical interventions for these patients. Because of the increased ability to help these patients, more patients are surviving and requiring surgeries to live their healthiest lives. Comparing this institution's postoperative pain to other leading NICUs in the nation revealed a gap in care; this was attributed to increased surgical intervention leading to more postoperative pain. To address the gap in postoperative pain control, the QI team created and implemented a CPG focusing on utilizing regional anesthesia in infants undergoing abdominal surgeries. Per the pre-implementation survey results and after the unit-wide educational overhaul was completed this NICU is prepared for the implementation of the guideline and amenable to a practice change. Adopting this guideline as the standard of care would likely improve patient outcomes. Data collection must continue through sustained PDSA cycles to determine the benefits of this practice change and assess the intervention's feasibility, usability, and satisfaction. 26 Acknowledgments I want to acknowledge the efforts of Giovana King, DNP, NNP-BC, C-ONQS; Con Yee Ling, MD; Kelly Mansfield, RN, Ph.D.; and Kim Friddle, Ph.D., APRN, NNP-BC. As a content expert, project chair, and program director, they provided invaluable guidance, constant support, and mentorship. Thank you for your advice, expertise, and understanding as I navigated the elaborate steps of this project. I am beyond thankful for your input and unwavering support. Thank you to the Neonatal DNP faculty for providing a supportive learning and personal growth environment. Thank you to my cohort and school family for enduring this unique experience with me. We made it through every trial and tribulation together; I could not have asked for a better group of people to learn and grow with Thank you to my family and friends who supported me in every phase of this journey. Thank you to those who edited papers, acted as a sounding board, and encouraged me to embark on this adventure. I am forever grateful for the love and grace you've given me over the past three years. 27 References Adappa, R., & Barr, S. (2023). Social determinants of health and the neonate in the neonatal intensive care. Paediatrics and Child Health, 33(6), 154–157. https://doi.org/10.1016/j.paed.2023.03.002 Attarian, S., Tran, L. C., Moore, A., Stanton, G., Meyer, E. G., & Moore, R. P. (2014). The neurodevelopmental impact of neonatal morphine Administration. 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Anesthesia & Analgesia, 122(6), 1965–1970. https://doi.org/10.1213/ane.0000000000001322 29 Menon, V., & Muraleedharan, A. (2020). Internet-based surveys: relevance, methodological considerations and troubleshooting strategies. General Psychiatry, 33(5), e100264. https://doi.org/10.1136/gpsych-2020-100264 Parker, M. G., Garg, A., Brochier, A., Rhein, L., Forbes, E. S., Klawetter, S., & Drainoni, M. (2020). Approaches to addressing social determinants of health in the NICU: a mixed methods study. Journal of Perinatology, 41(8), 1983–1991. https://doi.org/10.1038/s41372-020-00867-w Puthoff, T. D., Veneziano, G., Kulaylat, A. N., Seabrook, R., Diefenbach, K. A., Ryshen, G., Hastie, S., Lane, A., Renner, L., & Bapat, R. (2021). Development of a structured regional analgesia program for postoperative pain management. Pediatrics, 147(3). https://doi.org/10.1542/peds.2020-0138 Rana, D., Bellflower, B., Sahni, J., Kaplan, A., Owens, N., Arrindell, E. L., Talati, A. J., & Dhanireddy, R. (2017). Reduced narcotic and sedative utilization in a NICU after implementation of pain management guidelines. Journal of Perinatology, 37(9), 1038– 1042. https://doi.org/10.1038/jp.2017.88 REDCap. (n.d.). https://www.project-redcap.org/ Relland, L. M., Beltran, R. J., Kim, S. S., Bapat, R., Shafy, S. Z., Uffman, J. C., Maitre, N. L., Tobias, J. D., & Veneziano, G. (2022). Continuous epidural chloroprocaine after abdominal surgery is associated with lower postoperative opioid exposure in NICU infants. Journal of Pediatric Surgery, 57(4), 683–689. https://doi.org/10.1016/j.jpedsurg.2021.05.015 Sandoval, N., Holland, T., Daughtery, L., & Cheng, S. (2020). Epidural Catheter Management Protocol [Protocol]. UCSF Benioff Children’s Hospital. 30 Stetson, R. C., Smith, B. N., Sanders, N., Misgen, M. A., Ferrie, L. J., Schuning, V. S., Schuh, A. R., Fang, J. L., & Brumbaugh, J. E. (2020). Reducing opioid exposure in a level IV neonatal intensive care unit. Pediatric Quality & Safety, 5(4), e312. https://doi.org/10.1097/pq9.0000000000000312 Sutter, M. B., Watson, H., Yonke, N., Weitzen, S., & Leeman, L. (2022). Morphine versus methadone for neonatal opioid withdrawal syndrome: a randomized controlled pilot study. BMC Pediatrics, 22(1). https://doi.org/10.1186/s12887-022-03401-3 Vargas, A. A., Sawardekar, A., & Suresh, S. (2019). Updates on pediatric regional anesthesia safety data. Current Opinion in Anesthesiology, 32(5), 649–652. https://doi.org/10.1097/aco.0000000000000768 Visoiu, M. (2022). Evolving approaches in neonatal postoperative pain management. Seminars in Pediatric Surgery, 31(4), 151203. https://doi.org/10.1016/j.sempedsurg.2022.151203 Walker, B., Long, J., Sathyamoorthy, M., Birstler, J., Wolf, C., Bösenberg, A., Flack, S. H., Krane, E. J., Sethna, N. F., Suresh, S., Taenzer, A. H., Polaner, D. M., Martin, L. D., Anderson, C., Sunder, R., Adams, T., Martin, L. D., Pankovich, M., Sawardekar, A., . . . Anderson, T. (2018). Complications in pediatric regional anesthesia. Anesthesiology, 129(4), 721–732. https://doi.org/10.1097/aln.0000000000002372 Wingert, T., Hekmat, D., & Ayad, I. (2023). Regional anesthesia for neonates. Neoreviews, 24(10), e626–e641. https://doi.org/10.1542/neo.24-10-e626 Zwicker, J. G., Miller, S. P., Grunau, R. E., Chau, V., Brant, R., Studholme, C., Liu, M., Synnes, A., Poskitt, K. J., Stiver, M. L., & Tam, E. (2016). Smaller cerebellar growth and poorer neurodevelopmental outcomes in very preterm infants exposed to neonatal morphine. The Journal of Pediatrics, 172, 81-87.e2. https://doi.org/10.1016/j.jpeds.2015.12.024 31 Tables and Figures Table 1 Codebook Category Barriers Definition Perceived barriers to the use of RA in the NICU Facilitators Perceived facilitators to the use of RA in the NICU Example “Nurses wouldn't know how to manage it since we don't use epidurals often. infection risk? Also, how would it impact baby's anxiety/agitation in the post op period if they had full range of motion above the level of epidural- would they still require sedation to keep them calm/still?” “I think it's a great idea to utilize. I feel like we have a lot of issues regarding pain relief, and an epidural would help mitigate these issues.” 32 Table 2 Demographics Role Nurse (N=41) APP (N=19) Attending (N=7) Fellow (N=1) PT (N=1) Years of Experience Less than 5 years 6-10 years 11-15 years 16+ years Less than 5 years 6-10 years 11-15 years 16+ years Less than 5 years 6-10 years 11-15 years 16+ years Less than 5 years 16+ years n (%) 20 (48.8%) 11 (26.8 %) 3 (7.3%) 7 (17.1%) 6 (31.6%) 4 (21.1%) 1 (5.3%) 8 (42.1%) -5 (71.4%) -2 (28.6%) 1 (100%) 1 (100%) 33 Table 3 Epidural Education Role Registered Nurse Cared for a patient with an epidural 18 (60%) Did you receive education 13 (72%) APP 6 (20%) 3 (50%) Attending 6 (20%) 1 (17%) Example “How to use the pump. Get the key and manage pump, etc. It was just passed along in report” “Bedside in the moment training” “General education re: pain and sedation and need for foley” 34 Table 4 Survey Results Item Nurse APP Attending Fellow PT/OT n=41 n=19 n=7 n=1 n=1 Mean (SD) Mean (SD) Mean (SD) Mean (SD) Mean (SD) Need for an epidural standard guideline 4.49 (0.75) 4.68 (0.58) 4.57 (0.53) 4 5 Use of epidural to decrease opioid use 3.95 (0.59) 4.43 (0.77) 4.29 (0.76) 4 4 35 Table 1 Cost Analysis Cost per patient Avg cost of level IV NICU stay/night ($11,295) Fluoroscopic guidance and localization of needle for epidural placement Infusion epidural placement Ropivicaine infusion Removal of epidural Morphine bolus per dose Morphine drip per syringe Oral morphine per dose IV push single IV infusion Total Base Cost Cost of RA Cost of systemic morphine with no complications Cost of Iatrogenic withdrawal (avg 16 nights) $180,720 $20.77 $39.90 $5.80 $254.97 $383.03 $704.47 $332.32 $788.80 $794.54 $181.37 $766.61 $2,531.32 $92.80 $4,079.52 $185,225 36 Figure 1 Key Driver Barriers to Obtaining Anticipatory Guidance (N=11) (n=2), 18% (n=5), 46% (n=4), 36% Limited Time with Provider Limited AG Information Unknown Expectations 37 Figure 2 Postoperative Morphine OME/kg Postoperative Morphine OME/kg 35 30 25 20 15 10 5 0 30.77 25.2 0.6 0.6 1.8 2.28 2.68 2.85 3.87 4.81 4.84 5 6.9 8.57 9.45 9.67 38 Figure 3 Sustainability Plan 39 Appendix A Pre-implementation survey What is your role within the NICU? a. Bedside RN b. APP c. Attending Neonatologist d. PT/OT e. Other; if other, please explain How many years of experience in the NICU do you have? a. Less than 5 years b. 6-10 years c. 11-15 years d. More than 16 years Have you ever cared for an infant in the NICU with an epidural? Yes No If the answer is yes—Did you receive education of how to manage this patient? Yes No If yes—What education did you receive, and was it helpful? What are your thoughts about the following statement: Utilizing a continuous epidural infusion in eligible postoperative NICU patients can decrease postop opioid usage: a. Strongly disagree b. Disagree c. Neither agree or disagree d. Agree 40 e. Strongly Agree What are your thoughts about the following statement: It will be helpful to have a standardized clinical practice guideline regarding the use of epidurals in the NICU: a. Strongly disagree b. Disagree c. Neither agree or disagree d. Agree e. Strongly Agree Open Ended: What are the barriers to using epidural infusions as an adjunctive pain relief modality? What would make you more likely to use epidural infusions as a pain relief modality? 41 Appendix B SBAR for Nursing Situation: Over 4000 neonates require surgery annually in the United States (Grabski et al., 2020). The use of opioids for postop pain control and sedation during a lengthy stay in the NICU can result in increased cumulative doses, leading to adverse effects in the neonatal patient. Opioid administration may have negative clinical effects, including respiratory suppression, delayed bowel motility, and possibly diminished neurodevelopmental scores later in childhood (Grabski et al., 2020). Few studies in the surgical neonatal population exist regarding the reduction of opioids through different analgesic strategies, and those that are published have mixed results (Grabski et al., 2020). There is a knowledge gap regarding objective pain assessment, the most effective way to prevent and relieve pain, and the long-term effects of drug therapy (Kinoshita et al., 2021). Background: Interventions that can reduce neonatal pain and stress are associated with improved clinical outcomes. Examples of this include nonpharmacologic treatments such as non-nutritive sucking, breast milk, music therapy, skin-to-skin contact, and swaddling (McPherson et al., 2020). Alternatively, pharmacologic measures include careful use of opioids, benzodiazepines, and alternate pharmaceutical therapies (McPherson et al., 2020; Visoiu, 2022; Wingert et al., 2023; Zwicker et al., 2015). An adjunct therapy to typical postoperative pain control, regional anesthesia, specifically using continuous infusions of analgesia or anesthesia via epidural catheters, offers more pain control than relying on opioids and Acetaminophen alone (Duran et al., 2015; Johr, 2015; Puthoff et al., 2021; Visoiu, 2022; Wingert et al., 2023).. In 2016, and 42 again in 2018 the Pediatric Regional Anesthetic Network (PRAN) published data of more than 100,000 blocks; they reported the level of safety in pediatric regional anesthesia comparable to adult practice and confirms the safety in placing blocks under general anesthesia in the pediatric population (Long et al., 2016; Walker et al., 2018 & Vargas et al., 2019). In addition, PRAN reviewed the insertion and use of 307 neonatal epidural catheters and use and found there was no permanent neurologic sequelae or confirmed local anesthetic systemic toxicity (Long et al., 2016). Assessment: Regional anesthesia is a safe adjunctive therapy to postoperative pain management that offers more pain control than relying on opioids and Acetaminophen alone, use of regional anesthesia may help decrease overall opioid consumption postoperatively. Recommendation: Establish a clinical practice guideline outlining regional anesthesia in the NICU focusing on using epidurals in infants who require abdominal surgery. This will include collaborative care between NICU, surgery, and anesthesia. Education will be done to ensure bedside caregivers are familiar with the necessary equipment and feel comfortable caring for patients with epidurals in place. All necessary teams will collaborate to create a comprehensive guideline outlining eligibility criteria, communication, and roles of team members. 43 Appendix C NICU Shared Leadership Presentation 44 45 46 Appendix D Educational Document for RNs Epidural: A catheter is inserted in the caudal space just above the coccyx to provide spinal anesthesia. Epidurals are typically in place for five days or less. The infant will arrive from the OR with the epidural catheter in place with a tegaderm dressing covering the epidural insertion site and securing the catheter. Anesthesia orders the PCA/Epidural while the infant is in the OR. Pharmacy fills the order and delivers the medication to the NICU prior to the infant’s return from the OR. The NICU RN will set up the infusion pump so that it is ready at the bedside when the infant returns to the NICU. The TCC, Charge Nurse, Charge 2 can assist with the epidural pump initiation and required EMR charting. Accessing and Returning the PCA Key in the automated dispensing cabinet • Key is kept in the main hall Accudose • Log into Accudose • Select “med management” • Select “inventory” • Select “generic” • Type in “p” and select “KEYS-PCA” • Type in “1” for the count Refer to the Lippincott document for more information (Epidural analgesia administration, pediatric) Epidural analgesia administration, peds Refer to wiki article: PCA Charting in Powerchart 47 Bedside RN: 1. Place “Epidural” sign at the head of the bed and on patient’s blue chart 2. Place an “Epidural Catheter” label on the epidural catheter if not already in place 3. Review orders for the epidural in the EMR-PED Analgesia Management a. Double-check orders and settings with a 2nd RN, follow laminated double check tool b. Scan medication 4. Our 0.0625% Ropivacaine should be available in the medication library 5. Initiate documentation in the EMR. Create a new dynamic group in Pediatric Lines-Devices-Advanced Pain Management 6. Please see the wiki article: PCA Charting in PowerChart a. Document baseline NPASS score b. Chart Dermatome level as “NA” for neonates 7. The CN/CN 2 will assist with the epidural pump initiation 8. Begin the infusion and monitor infant’s response a. Local anesthetic toxicity i. Naloxone is available in the Accudose using “Override” function b. Infection i. Maintain sterile technique when changing medication ii. Maintain dressing integrity (RN DOES NOT CHANGE DRESSING) iii. Do not use antiseptic containing alcohol to disinfect the epidural catheter hub, these agents can cause neurotoxic effects. Instead use Povidone-iodine or chlorhexidine c. Hematoma in the epidural space can push on the spinal cord i. Frequently assess motor function of the legs and feet. If movement decreases, notify APP & Pain Services 9. Epidural dressing considerations a. To secure the epidural beyond the dressing run the catheter up the infant’s back with tegaderm. b. Prevent stool from coming into contact with the epidural dressing i. Place a mud flap (Steri-Drape) just below the dressing. Change mudflap as needed. ii. A small amount of drainage may be noted at the insertion site. The dressing does not need to be changed if the rest of the dressing is intact. iii. Dressing changes are NOT to be done by the RN 1. If the dressing comes loose, reinforce it with tegaderm until a pain service team member can come and change the dressing 10. Defer holding or getting the patient out of bed while the epidural catheter is in place to mitigate safety concerns and risk of dislodgement 48 Infusion Maintenance 1. Review orders against pump settings and medications at shift change and with medication or pump changes 2. Assess and document catheter site, pump/tubing/connection and dressing every 12 hours 3. If you change the dose (THIS WOULD BE RARE) you may be asked to enter a security code, the code is 4265. 4. To order replacement medication, use Med Request in the MAR a. Medication should be changed every 24 hours b. Ask the CN/CN 2 to help when changing this medication out. The box on the pump will require the key to unlock it which is found in the main hall Accudose 5. Pain Service is the only team that can prescribe modifications to the epidural pump. a. Per anesthesia, adjunctive pain medications will be managed by the NICU team b. Please call your APP whenever pain services is bedside to discuss pain management c. Adequate pain management should be obtained prior to removal of epidural 6. Reportable conditions: a. Failure to achieve adequate pain control b. Persistent hypotension c. Change in neurological status d. Over sedation (-6 to -10 on NPASS) e. Decreased movement of the legs/feet f. Urinary retention g. Disconnection or dislodgement of the catheter h. Respiratory complications. Increased oxygen or flow needs, or apnea i. Redness, swelling, or tenderness at catheter insertion site Equipment 49 When you have a patient with an epidural infusion, use the ICU Medical standard IV syringe tubing set IH# 32008803 - 72” Syringe Set w/0.2 Micron Filter & Bonded Clear MicroClave, ICU Medical # MC33904 (Already has the filter in line so does NOT need any other filter added). The IV tubing does not have a colored stripe so additional EPIDURAL stickers must be placed to identify the tubing. This will require the bedside nurse to mark the tubing with Epidural labels on the proximal, medical, and distal ends. 50 51 52 Appendix E NICU Regional Anesthesia Clinical Practice Guideline Purpose Establish a process for regional anesthesia use in newborn intensive care unit (NICU) surgical patients. Scope Primary Children’s Hospital Salt Lake City & Lehi NICUs Patient Population Patients who would benefit from caudal/spinal injections or continuous infusions: Not addressed in this guideline • • • Neurosurgery surgeries (reservoirs, shunts) Head and Neck surgeries (tracheostomy, mandibular distractors, reconstruction) Thoracic surgeries (CPAM, BPS, cardiac surgeries) Background Historically, opioids have been the standard of care for pain management in the NICU despite their known detrimental side effects (Visoiu, 2022). Common opioid side effects include respiratory depression, prolonged intubation and ventilation, ileus, and decreased gut motility (Visoiu, 2022). Animal studies have shown that commonly used anesthetics can cause neurological changes in the developing brain and result in long-lasting behavioral and cognitive changes (Kil, 2018). Regional anesthesia (RA) performed for neonates is a desirable, well-tolerated, and effective intervention (Visoiu, 2022). This method of analgesia can decrease inhaled and intravenous anesthetic exposure and provides opioid-sparing benefits to the infant (Visoiu, 2022). Pediatric Regional Anesthesia Network (PRAN) studies have demonstrated a lack of significant 53 complications and a general overall safety profile with pediatric nerve blocks (Kaye et al., 2019). The use of continuous epidural anesthesia in a newborn undergoing major abdominal surgery offers the advantage of good perioperative analgesia while reducing the neurotoxic risks associated with systemic analgesia (Joe & Long, 2018). Additional benefits include improved respiratory function leading to earlier extubation, earlier return of bowel function, attenuation of postoperative stress response, and reduction in postoperative apnea episodes (Joe & Long, 2018). Caudal blocks provide a feasible alternative to general anesthesia in the infant undergoing hernia repair as it allows for the avoidance of intubation (Bong et al., 2019). Epidural analgesia can be used as a monotherapy or combined with other continuous analgesia or sedative infusions. Patients who receive spinal anesthesia have fewer apneic episodes and a decreased need for mechanical ventilation than those who receive general anesthesia (GA). Definition Spinal Anesthesia - A neuraxial anesthesia technique where local anesthetic is placed directly in the intrathecal (subarachnoid) space, a single injection, or a continuous infusion. Caudal Anesthesia - A neuraxial anesthesia technique in which local anesthetic is placed in the epidural space, a single injection, or a continuous infusion. 54 Guideline Patients undergoing the following procedures are candidates for RA: Caudal Epidural & Spinal Intrathecal single injections • • • Inguinal hernia repair Duodenal atresia Urological Surgeries Caudal Epidural Continuous Infusion • • • • • • • Consider for laparotomy. This may include ostomy reversal, adhesive bowel obstruction, or other pathologies. Exclusion criteria Infants < 2.5 Kg Emergent cases (level I or level II) Unstable patients (e.g., vasopressors, coagulopathy (INR > 1.2), thrombocytopenia (platelets <100k) presumed/suspected infection) Parental/guardian refusal Increased intracranial pressure Spinal abnormalities or high risk of anomalies (e.g., pathology with known VACTERL association where the spine has not been assessed, spinal stenosis, sacral anomalies, pilonidal cysts, anorectal malformations) Communication process to order RA 1. When the pediatric surgery team requests the scheduler to book surgery in iCentra, the surgical team will add under comments: "Evaluate regional anesthesia candidacy.” This will flag anesthesia to evaluate the patient for regional anesthesia. 2. Pediatric surgery and anesthesia will discuss the best RA modality for the patient. 3. 1-2 days before surgery for patients that the NICU team suspects pain will be difficult to control postoperatively e.g., infants with prolonged opioid exposure, the NICU providers (Neonatologist or APP) can: 3.1 Contact the OR scheduling office at 22757 and ask them to write “REGIONAL ANESTHESIA CANDIDATE, pls contact NICU Neo or APP” (include name and number to facilitate further discussion with anesthesia.) 3.2 Consider consulting Pain Service via SmartWeb (SPOK) paging system. 4. The full name of the APP responsible for the patient on the day of surgery and contact information should be on the front page of the green sheet. If issues are encountered, please 55 call the NICU front desk at 801-662-4000 (24000) to request the provider or call the provider directly via Vocera at 801-662-6677 (26677). Upon return from the OR 1. Anesthesia will report the RA modality used for the patient to the NICU team. Pain Services (PS) will manage any continuous RA. 2. If a caudal epidural continuous infusion is used 2.1 PS consults and manages epidural. 2.2 PS team rounds twice each day - once in the morning AM and one time in the afternoon PM. The PS physician does sedation procedures from 9 am to 4 pm, but the PS RN is readily available during that time if concerns arise. 2.2.2 The PS provider carries a pager 24/7 via SmartWeb (SPOK) paging system. 2.3 Plan to transition to PO/IV meds within 4-5 days, as epidural catheters are typically removed after 4-5 days due to the risk of infection. 2.4 Typically, low-concentration Ropivacaine (0.0625%) is used without narcotics. 2.4.1 If there are increased pain scores with this type of epidural, options are to adjust adjunct meds or adjust the epidural infusion rate in collaboration with the APS team. 2.4.2 Adjusting the infusion rate is a limited option in the NICU population due to the weight-dosing limits of local anesthetic. 3. Local Anesthetic Systemic Toxicity (LAST) Protocol 3.1 For use if signs and symptoms of anesthetic toxicity are observed 3.1.1 Seizures 3.1.2 Tachycardia/tachydysrhythmias 3.1.3 Conduction block 3.1.4 Hypertension/hypotension 56 Disclosure This clinical RA guideline was developed for informational, educational, and internal clinical use purposes only. The data provided is based on the most current evidence-based publications, internal data, clinical medical knowledge, and expert opinion. These guidelines are subject to review on a regular basis to align with current best practices. Creation Date: 01/2024 Subsequent Revision Dates: NCID: Name and Title of Author: Giovana King, DNP, NNP-BC, C-ONQS, Samantha Keirsey RN, NNPS Content Reviewers: NICU PCH Surgical Working Group, NICU, Surgery, Anesthesia, Pain Service Approved By: This is CNO for clinical documents. Keywords: Epidural, Post-op, Pain, Regional Anesthesia 57 References Bong, C., et al. (2019). Randomized control trial of dexmedetomidine sedation vs general anaesthesia for inguinal hernia surgery on perioperative outcomes in infants. British Journal of Anaesthesia, 122 (5): 662-670. Dohms, K., et al. (2019). Inguinal hernia repair in preterm neonates is there evidence that spinal or general anesthesia is the better option regarding intraoperative and postoperative complications? A systematic review and meta-analysis. BMJ Open. Heydinger, G., et al. (2021). Fundamentals and innovations in regional anesthesia for infants and children. Anaesthesia, 76 (suppl 1), 74-88. Jones, L., Craven, P., Lakkundi, A., Foster, J., Badawi, N. (2015). Regional (spinal, epidural, caudal) versus general anaesthesia in preterm infants undergoing inguinal herniorrhaphy in early infancy. Cochrane Database Syst Rev. 2015 (6). Jöhr, M. (2015). Regional anaesthesia in neonates, infants and children: an educational review. European Journal of Anaesthesiology, 32(5):289-97. Kaye, A. D. et al. (2019). Newer nerve blocks in pediatric surgery. Best Practices & Research Clinical Anesthesiology 33; 447-463. Kil, H. (2018). Caudal and epidural blocks in infants and small children: historical perspective and ultrasound-guided approaches. Korean Journal of Anesthesiology. Polaner, D., Taenzer, A. Walker, B., Bosenberg, A., Krane, E., Suresh, S., Wolf, C., Martin, L. (2012). Pediatric Regional Anesthesia Network (PRAN): A Multi-Institutional Study of the Use and Incidence of Complications of Pediatric Regional Anesthesia. Anesthesia & Analgesia 115(6):p 1353-1364. 58 Shirmohammadie, M., Ebrahim, A., Arbabi, S., Nasseri, K. (2015). A randomized-controlled, double-blind study to evaluate the efficacy of caudal midazolam, ketamine, and neostigmine as adjuvants to bupivacaine on postoperative analgesic in children undergoing lower abdominal surgery. Acta Biomedica 89(4):513-518. Webb, L. M. W., & Peterson, M. B. (2023). Regional Anesthesia Techniques for Circumcision and Congenital Inguinal Hernia repair. Regional Anesthesia and Acute Pain Medicine: A Problem-Based Learning Approach, 423. Wingert, T., Hekmat, D., & Ayad, I. (2023). Regional anesthesia for neonates. Neoreviews, 24(10), e626–e641. https://doi.org/10.1542/neo.24-10-e626 Visoiu, M. (2022). Evolving approaches in neonatal postoperative pain management. Seminars in Pediatric Surgery, 31(4), 151203. https://doi.org/10.1016/j.sempedsurg.2022.151203 Xiong, C. et al. (2022). Comparison of adjuvant pharmaceuticals for caudal block in pediatric lower abdominal and urological surgeries: A network meta-analysis. Journal of Clinical Anesthesia, 81, 59 Appendix F Skills Day Reference Sheet Bedside RN Quick Reference Sheet Accessing and Returning the PCA Key in the automated dispensing cabinet • Key is kept in the main hall Accudose • Log into Accudose • Select “med management” • Select “inventory” • Select “generic” • Type in “p” and select “KEYS-PCA” • Type in “1” for the count Refer to the Lippincott document for more information (Epidural analgesia administration, pediatric) Epidural analgesia administration, peds Refer to wiki article: PCA Charting in Powerchart Infusion Maintenance 7. Review orders against pump settings and medications at shift change and with medication or pump changes 8. Assess and document catheter site, pump/tubing/connection and dressing every 12 hours 9. If you change the dose (THIS WOULD BE RARE) you may be asked to enter a security code, the code is 4265. 10. To order replacement medication, use Med Request in the MAR a. Medication should be changed every 24 hours b. Ask the CN/CN 2 to help when changing this medication out. The box on the pump will require the key to unlock it which is found in the main hall Accudose 11. Pain Service is the only team that can prescribe modifications to the epidural pump. a. Per anesthesia, adjunctive pain medications will be managed by the NICU team b. Please call your APP whenever pain services is bedside to discuss pain management c. Adequate pain management should be obtained prior to removal of epidural 12. Reportable conditions: a. Failure to achieve adequate pain control b. Persistent hypotension c. Change in neurological status d. Over sedation (-6 to -10 on NPASS) e. Decreased movement of the legs/feet f. Urinary retention g. Disconnection or dislodgement of the catheter 60 h. Respiratory complications. Increased oxygen or flow needs, or apnea i. Redness, swelling, or tenderness at catheter insertion site 13. Epidural dressing considerations a. To secure the epidural beyond the dressing run the catheter up the infant’s back with tegaderm. b. Prevent stool from coming into contact with the epidural dressing i. Place a mud flap (Steri-Drape) just below the dressing. Change mudflap as needed. ii. A small amount of drainage may be noted at the insertion site. The dressing does not need to be changed if the rest of the dressing is intact. iii. Dressing changes are NOT to be done by the RN 1. If the dressing comes loose, reinforce it with tegaderm until a pain service team member can come and change the dressing 14. Defer holding or getting the patient out of bed while the epidural catheter is in place to mitigate safety concerns and risk of dislodgement Communication • • • Pain service rounds twice a day, once in the morning and once in the evening. The pain service physician does sedation procedures 9 AM-4 PM, but the pain service RN is readily available during this time. Contact them under Pain Service via SmartWeb SPOK paging system 2.4.1 If there are increased pain scores with this type of epidural, options are to adjust adjunct meds or adjust the epidural infusion rate in collaboration with the APS team. 2.4.2 Adjusting the infusion rate is a limited option in the NICU population due to the weight dosing limits of local anesthetic. 4. Local Anesthetic Systemic Toxicity (LAST) Protocol 3.2 For use if signs and symptoms of anesthetic toxicity are observed 3.2.1 Seizures, tachycardia/tachydysrhythmias, conduction block, hypertension/hypotension 61 Appendix G Regional Anesthesia Reference Sheet for Providers Regional Anesthesia Reference Sheet Exclusion criteria • • • • • • Infants < 2.5 Kg Emergent cases (level I or level II) Unstable patients (e.g., vasopressors, coagulopathy, thrombocytopenia, infection) Parental/guardian refusal Increased intracranial pressure. Spinal abnormalities or high risk of anomalies Communication process to order RA 5. When the pediatric surgery team requests the scheduler to book surgery in iCentra, the surgical team will add under comments: "Evaluate regional anesthesia candidacy.” This will flag anesthesia to evaluate the patient for regional anesthesia. 6. Pediatric surgery and anesthesia will discuss the best RA modality for the patient. 7. 1-2 days before surgery for patients that the NICU team suspects pain will be difficult to control postoperatively, e.g., infants with prolonged opioid exposure, the NICU providers (Neonatologist or APP) can: 3.1 Contact the OR scheduling office at 22757 and ask them to write “REGIONAL ANESTHESIA CANDIDATE, pls contact NICU Neo or APP” (include name and number to facilitate further discussion with anesthesia.) 3.2 Consider consulting Pain Service (PS) via SmartWeb (SPOK) paging system. 8. The full name of the APP responsible for the patient on the day of surgery and contact information should be on the front page of the green sheet. If issues are encountered, please call the NICU front desk at 801-662-4000 (24000) to request the provider or call the provider directly via Vocera at 801-662-6677 (26677). Upon return from the OR 5. Anesthesia will report the RA modality used for the patient to the NICU team. PS will manage any continuous RA. 6. If a caudal epidural continuous infusion is used 2.1 PS consults and manages epidural. 62 2.2 PS team rounds twice each day - once in the morning AM and one time in the afternoon PM. The PS physician does sedation procedures from 9 am to 4 pm, but the PS RN is readily available during that time if concerns arise. 2.2.2 The PS provider carries a pager 24/7 via SmartWeb (SPOK) paging system. 2.3 Plan to transition to PO/IV meds within 4-5 days, as epidural catheters are typically removed after 4-5 days due to the risk of infection. 2.4 Typically, low-concentration Ropivacaine (0.0625%) is used without narcotics. 63 Appendix H Executive Summary Executive Summary Creating a Postoperative Epidural Use to Manage Pain in Eligible NICU Patients: A Quality Improvement Project Situation: Patients in the Neonatal Intensive Care Unit (NICU) who undergo abdominal surgeries are at high risk for increased pain postoperatively which can lead to negative clinical side effects and a high dose of opioid consumption. Currently, opioid administration is the standard of care in the NICU, which can lead to iatrogenic drug withdrawal, increased length of stay, and detrimental long-term side effects. This summary intends to present the creation and sustainability plan for a clinical practice guideline outlining the use of regional anesthesia for postoperative pain control. Background: Interventions that reduce neonatal pain and stress are associated with improved clinical outcomes. Pharmacologic measures to address pain include careful use of opioids, benzodiazepines, and alternate pharmaceutical therapies. These therapies are successful in decreasing pain. However, they do not come without adverse effects on children’s development and without risk of opioid dependence leading to withdrawal. An adjunct therapy to this center’s standard of care that has been rising in utility in the pediatric population is regional anesthesia. The Pediatric Regional Anesthetic Network (PRAN) has reported a favorable safety profile in pediatric regional anesthesia with no neurologic sequelae or toxicity. Financials: Literature shows that the average patient affected by opioid withdrawal remains in the hospital for 11 extra days. Based on current hospital standard charges, the cost for regional anesthesia for surgery alone is $2,531.32. The base cost for systemic opioid administration is $704.47. Additional level IV NICU days are $11,295.00. On average, infants who suffer from iatrogenic drug withdrawal endure 16 more days in the NICU. Using RA can potentially decrease the overall cost by decreasing the length of stay, saving about $180,720. 64 Cost per patient Avg cost of level IV NICU stay/night ($11,295) Fluoroscopic guidance and localization of needle for epidural placement Infusion epidural placement Ropivacaine infusion Removal of epidural Morphine bolus per dose Morphine drip per syringe Oral morphine per dose IV push single IV infusion Total Base Cost Cost of RA Cost of systemic morphine with no complications Cost of Iatrogenic withdrawal (avg 16 nights) $180,720 $788.80 $794.54 $181.37 $766.61 $2,531.32 $20.77 $39.90 $5.80 $254.97 $383.03 $704.47 $332.32 $92.80 $4,079.52 $185,225 Results: A pre-implementation survey was completed to determine NICU clinicians' willingness to utilize regional anesthesia for postoperative pain management and to gather clinicians’ insight into barriers and facilitators to a new CPG. The need for education was determined via the survey results, and an educational overhaul was initiated regarding postoperative pain with a focus on utilizing and caring for the infant returning from the OR with regional anesthesia in place. A multidisciplinary clinical practice guideline was created and signed off on by neonatology, surgery, and anesthesia. Pre-implementation data support the willingness of this NICU to utilize the CPG; education was done and is planned for future dissemination as educational opportunities arise. A sustainability team has been built and are ready to follow the implementation of the guideline and assist the QI team in making the CPG as successful as possible in becoming the new standard of care in adjunctive postoperative pain management. Recommendation: As a leading level IV NICU, this NICU should embrace the evidence behind regional anesthesia and utilize the CPG to assist in a practice change. The sustainability plan should be utilized and another DNP student should consider following this project and assessing the implementation data. It is strongly recommended that this NICU utilize the CPG and follow the post-implementation data to determine the efficacy of this new pain management modality.