Epidurals? We Don’t Need No Stinkin' Epidurals: Convincing the NICU why they do.
Rita Agarwal MD and Lynne G; Maxwell MD
Regional anesthesia increasingly has become an essential component of most ERAS and/or multi-modal analgesia protocols…except perhaps in the NICU. Admittedly, the NICU, like the Marine Corps, is a world unto itself, with its own culture, protocols and often even its own monitoring and oxygen delivery systems. As anesthesiologists we enter this alternate universe with the knowledge that we are barely tolerated and couldn’t possibly know what we are doing (“you gave how much fluid?”, “you brought the baby back too cold or too hot!”, “you didn’t tape the tube with our special tape or use our approved taping technique”). Further as an anesthesiologist can you (or the pain team) even write orders on NICU babies for the epidural and adjuvant drugs and will the nursing staff acknowledge them and carry out the orders?
Like many of you, I have struggled mightily over the years trying to provide superior post-operative analgesia to NICU babies using epidural catheters ever since reading the landmark paper by Dr. Adrian Bosenberg in the 1980s,1 but admittedly with mixed results. In the NICU, I have experienced regional analgesia deniers (“this doesn’t work, this never works”), agnostics (“well maybe it works, but we use it so rarely we don’t feel comfortable”), as well as regional analgesia supporters (“why doesn’t this baby have an epidural, how will we manage pain without one?”). The main difference in success or failure has been the support or lack of it by the neonatologists and NICU nursing leadership. When neonatology team leaders embraced regional analgesia most of the epidurals worked well. When we had a skeptical or sometimes even hostile team, not surprisingly, the epidural didn’t seem to work as well or at all. What to do… What to do?
Today’s PAAD written primarily by Rita Agarwal, the PAAD’s primary pain reviewer, reveals how one institution (Nationwide Children’s Hospital) increased epidural use and acceptance in the NICU. Be aware that once again, this article, like many others we’ve recently reviewed in the PAAD, used quality improvement methodology rather than an investigational review board (IRB) approved research protocol for their study. Admittedly, as Lynn Martin of the Seattle Children’s Hospital repeatedly points out, there is much to gain from QI methodology as a research tool. However, I am increasingly uneasy about this and am afraid that using this methodology, even for a medical protocol that is extremely safe,2 is a back door method to skirt the research protections that an IRB provides. Collectively we need to think if this is an ethical way to approach research. Let me know what you think and I’ll post as a reader’s response. Myron Yaster MD
Original article
Puthoff TD, Veneziano G, Kulaylat AN, Seabrook RB, Diefenbach KA, Ryshen G, Hastie S, Lane A, Renner L, Bapat R. Development of a Structured Regional Analgesia Program for Postoperative Pain Management. Pediatrics. 2021 Mar;147(3):e20200138. doi: 10.1542/peds.2020-0138. PMID: 33602800
Today’s article reveals the results of an effort by a multidisciplinary team at Nationwide Children’s Hospital to develop a structured postoperative regional analgesia program using QI methodology. The goal was to increase the use of regional analgesia and decrease the use of opioids in neonates after surgery. “Eligible babies were defined as infants with a weight of ≥ 2 kg, undergoing open thoracoabdominal, genitourinary, or extremity procedures, which were scheduled > 24 hours in advance and with parental consent. Patients with planned laparoscopic or thoracoscopic operations, known coagulopathies and thrombocytopenia, suspected infections, known spinal anomalies, intraventricular hemorrhage or a ventricular access device, or known neurologic disorders were not considered eligible.”3 Interestingly, the senior author on the article is a neonatologist and the first author is a pharmacist, with anesthesiologists and nurse practitioners among the other coauthors.
There are some very unusual aspects to the protocol. Regional anesthesia was the default analgesic preference for all eligible procedures. The postoperative pain plan for NICU babies was written by the pharmacist in the medical record so that all the medications could be ordered ahead of time and IV lines primed and ready for the patient on arrival to the NICU. The standard plan consisted of multimodal analgesia with around the clock acetaminophen or ketorolac, and a continuous infusion of either morphine or fentanyl. The use of around the clock ketorolac in the neonate is quite unusual, and there is only one safety study of repeated doses in neonates/young infants (0.5 mg/kg q6h x 8-9 doses4,which was associated with a high incidence of bleeding and had no control group, and another pK study of single dose ketorolac. 5 The authors do not specify how many patients received acetaminophen or ketorolac. It is also unstated whether the patients in the pre-intervention period received these adjuvants. Finally, the use of continuous opioid infusions required “role clarification”. The pain team would manage opioid infusions when used for analgesia while the epidural was in place. The neonatology team would resume management of the systemic infusion if used for sedation”.3 Interestingly, the authors have very recently presented results of a similar quality improvement initiative in 20 patients in whom they substituted nurse controlled analgesia (NCA) for the continuous opioid infusion in the same patient population, which resulted in a reduction in opioid administration from 5 mg/kg to 1.78 mg/kg.[ref[LM1] Epidurals were caudal catheters threaded to the desired level, with tip location confirmed by ultrasound (not as accurate as epidurogram, but better than nothing). Chloroprocaine 1.5% + clonidine was used for the epidural infusion.
What is not unusual is that to be effective, the authors assembled a collaborative, multidisciplinary team, developed standardized indications for regional anesthesia, a process map, and did what sounds like a lot of ongoing education with the surgeons, nurses, NPs and neonatologists on the safety and benefits of RA. The pain team helped the nursing staff in the NICU set up epidural infusions and document in the medical record. A CPT code for epidural insertion was added to the OR schedule so that the surgeons would not get penalized for having longer OR times. The pain service would be consulted 1-2 days prior to the surgery and were responsible for final approval and getting parental consent for epidural placement. The average time for catheter insertion was ~21 minutes and all the catheters were tunneled away from the insertion site to minimize contamination.6
As expected, the use of RA increased dramatically after the start of this project with 88% of eligible infants getting an epidural (30/34). They were unable to successfully place an epidural in 2 and not able to get epidural placement consent in 2 others. Opioid usage was substantially lower in the RA group and length of post-operative intubation was shorter compared to their baseline group, with 75% of patients getting extubated in the OR compared to 10.5% pre-intervention. They reported no major complications, but had 4/30 (13.33%) who required early removal of the catheter (2 stooled on the dressing, 1 had leakage and 1 was not thought to be working)
The authors of this QI initiative and paper are to be commended. It is apparent that they spent a great deal of time and effort creating and refining the process map which was critical to the success of the project. We would love to know how many person hours were spent educating the nurses, NPs surgeons and neonatologists and if they found some materials and approaches (flash cards versus videos, websites versus printed materials etc.) more useful than others. The team succeeded in providing safe, effective and superior analgesia to the most vulnerable patients and quite frankly we are in awe of their success. Since there is no real control group and this is a QI initiative and not a formal, IRB approved, double blind RCT, it raises many questions (ideal dosing, duration of epidural, types of surgery, and more) Still, I (RA) inspired to throw myself into the fray to develop together with my NICU colleagues, policies and procedures to make regional anesthesia common in my hospital’s NICU again. In addition, further pK and safety study is required for repeated dose ketorolac in this age group.
Rita Agarwal MD and Lynne Maxwell
PS: From Myron: Ostensibly the rationale for this study was to decrease opioid use postoperatively. Why? Even if you are a believer that anesthetic drugs may cause neuroapoptosis in the newborn (I do not) which was the rationale for the study, the safest drugs appear to be dexmedetomidine, opioids, and regional anesthetics. Thus, like Rita, I applaud the increased use of epidurals for post operative pain management in the NICU, However, I think the rationale is that it provides fantastic analgesia not because I fear the use of opioids in this population will cause neuroapoptosis. Again, I’d like to hear your thoughts on this as well. MY
References
1. Bosenberg AT, Bland BA, Schulte-Steinberg O, Downing JW: Thoracic epidural anesthesia via caudal route in infants. Anesthesiology 1988; 69: 265-269
2. Long JB, Joselyn AS, Bhalla T, Tobias JD, De Oliveira GS, Jr., Suresh S: The Use of Neuraxial Catheters for Postoperative Analgesia in Neonates: A Multicenter Safety Analysis from the Pediatric Regional Anesthesia Network. Anesth Analg 2016; 122: 1965-70
3. Puthoff TD, Veneziano G, Kulaylat AN, Seabrook RB, Diefenbach KA, Ryshen G, Hastie S, Lane A, Renner L, Bapat R: Development of a Structured Regional Analgesia Program for Postoperative Pain Management. Pediatrics 2021; 147
4. Aldrink JH, Ma M, Wang W, Caniano DA, Wispe J, Puthoff T: Safety of ketorolac in surgical neonates and infants 0 to 3 months old. J Pediatr Surg 2011; 46: 1081-5
5. Zuppa AF, Mondick JT, Davis L, Cohen D: Population pharmacokinetics of ketorolac in neonates and young infants. Am J Ther 2009; 16: 143-6
6. Kost-Byerly S, Jackson EV, Yaster M, Kozlowski LJ, Mathews RI, Gearhart JP: Perioperative anesthetic and analgesic management of newborn bladder exstrophy repair. J.Pediatr.Urol. 2008; 4: 280-285
7. Puthoff TD, Beltran R, Ryshen G, Lane A, Six A, Strohl K, Giles L, Easatep J, Diefenbach KA, Bapat R. NCA for post-operative analgesia and opioid reduction in the NICU. Pediatrics 2022; 149(1): 696 (Meeting abstracts)