Review Article: Epidurals? We Don’t Need No Stinkin’ Epidurals: Convincing the NICU why they do. Rita Agarwal MD and Lynne G. Maxwell MD
From Giorgio Veneziano MD
To have this article posted as the PAAD is a gratifying acknowledgment of the importance of addressing the last bastion (the NICU) in the children’s hospital that has not experienced the regional anesthesia surge of the past 15 years. Bringing this quality improvement initiative to fruition required substantial collective efforts of dedicated individuals at NCH due to the reasons well-articulated by Dr. Yaster. The success of the project, I believe, hinged on the ability to create many multidisciplinary stakeholders while extricating oneself from true ownership (avoiding “this is my procedure” or “this is solely my patient” thinking).
This quality improvement project was just that, an attempt at improvement in patient care, and not research. The project sought to take what is demonstrated in multiple large databases to be a safe procedure in neonates (epidural analgesia) and increase the application in the NICU population. The evidence of efficacy of RA in this population is more limited, largely due to the challenges of a randomized controlled trial in newborns for an “elective” procedure, but our improving understanding of neonatal pain physiology and the effectiveness of RA in slightly older populations makes avoiding RA in neonates difficult to defend (although many try!). We did not conduct this project to answer any question (which would make it research) but to achieve a goal, as mentioned earlier. We had outcome measures, opioid consumption and time-to-extubation, which is a well-recognized mechanism to demonstrate the continued value of a quality improvement initiative. If we had not shown any improvement in those outcome measures the project would have been unsustainable.
Due to the large improvement in our outcome measures, to confirm the outcomes were not a product of confounding or bias (as many naysayers would inevitably indicate), our group decided to follow this initiative with a retrospective matched cohort study1. The results of the with-and-without RA comparison confirmed large benefits in postop opioid consumption and timing of tracheal extubation. The study was submitted to a surgical journal, as we believe our surgical colleagues are most likely to benefit from witnessing these data.
Opioid consumption in our quality improvement initiative is a proxy for demonstrating superior analgesia, in which superior is having clinically equivalent pain scores with reduced opioid consumption (these babies are very comfortable with high-dose Morphine infusions!). The avoidance of the numerous adverse effects of opioids of which we are all familiar is the key here. Personally, I think direct neurotoxicity is not the primary concern with long-term opioid infusions in neonates. However, there is evidence to suggest that the sedation with opioid infusions and corresponding reduction in somatosensory inputs may have deleterious effects on neurodevelopment2.
1.Relland LM, Beltran R, Kim SS, Bapat R, Shafy S, Uffman J, Maitre NL, Tobias JD, Veneziano G. Continuous epidural chloroprocaine after abdominal surgery is associated with lower postoperative opioid exposure in NICU infants. J Pediatr Surg. 2022 Apr;57(4):683-689.
2.Maitre NL, Key AP, Chorna OD, Slaughter JC, Matusz PJ, Wallace MT, Murray MM. The Dual Nature of Early-Life Experience on Somatosensory Processing in the Human Infant Brain. Curr Biol. 2017 Apr 3;27(7):1048-1054.
From Lynn Martin MD
I read with interest the PAAD review article by Drs. Agarwal and Maxwell and the associated opinion by Dr. Yaster. I applaud the authors for their efforts to improve pain treatment to one of our most vulnerable pediatric patient populations (neonates). I also commend the reviewers for their objective and insightful review of this QI project. My reasoning for this reply comes from the always entertaining comments of Dr. Yaster (my friend and mentor). This time he called me out by name in a positive manner, but stated a common misperception (“there is much to be gained from QI methodology as a research tool”). Hence my reply for clarification.
Before diving deep into my clarifications, allow me to provide some personal context. Likely similar to most readers, I have had a passion for improving the health of children throughout my career. As taught to me by my mentor, I monitored my patient’s outcomes and modified my practices based on my daily observations. As new evidence emerged in the literature, I again would modify my practice and appropriately monitor the outcomes. However, perhaps my personal practices to improve care delivery are not as common as I hoped. There is universal agreement that knowledge and evidence derived from robust scholarly methods should drive our clinical practice, decisions and improve the way we provide care. Furthermore, translating research evidence into clinical practice is essential to safe, transparent, efficient and effective healthcare provision and meeting the expectations of our patients, families, and society at large. Despite this obvious importance, translating research into clinical practice is always challenging and painfully slow. Research shows that the delay in translation from research into clinical practice is an amazing 17 years.1 Quality Improvement is nothing more than taking the principles I described for my individual practice and making it a group effort, typically with more objectivity and real data.
As a pediatric intensivist (retired) and anesthesiologist, I am fundamentally inpatient and have a desire to make a decision and move forward quickly. This character trait (some say flaw) took on much more importance for me when I became a leader of the anesthesia department in Seattle. I was routinely frustrated by the glacially slow and always complex efforts needed to make even the smallest improvements in group clinical practice. I realized that I needed to stop thinking of myself as a researcher and recognize that I needed to be a quality improvement leader, coach and cheerleader. Having now been on that never-ending QI journey for over 20 years, one fundamental understanding that is necessary to successfully proceed down this path is the differences between research and quality improvement. One must realize and accept that quality improvement work is NOT research. I refer the readers to an excellent website that explains these differences.2 The table below from this site stolen shamelessly (a common trait of many true QI leaders) describes these major differences. I have added some highlights to the table to emphasize what I believe are the critical differences.
Dr. Yaster states his unease and concern that QI methodology is used to circumvent research protections and questions the ethics to this approach. In reply, let me take you back to the turn of this century when it was estimated that we suffered from 80,000 catheter-associated blood stream infections each year, causing as many as 28,000 unnecessary deaths. Surely if there were processes known to reduce this complication, we wound want hospitals to adopt these processes. A colleague of Dr. Yaster’s, Peter Pronovost, introduced highly effective infection-prevent processes in many hospitals in Michigan,3 only to run into major problems with federal regulators at the Office for Human Research Protection for failure to obtain informed consents for his “research”.4 I refer the readers to an editorial describing the conundrum and controversy that ensued and ultimately brought forth the more nuanced understanding of the variances between research and quality improvement we have today.5 In my view, this example points to key differences between research and quality improvement work; (1) risks, (2) participate obligation, and (3) adoption results. In Dr. Pronovost’s work there was no additional patient risk, participation was built into routine clinical care, and the changes in clinical practice (and benefits) were immediate.
Let me further illustrate with a more recent example from Seattle. In 2018 we launched a QI effort in our ambulatory surgery center (ASC) to add value in our anesthesia care process by reducing our anesthetic medication costs. Through an iterative number of steps this morphed into an opioid-free anesthetic driven by evidence from a RCT of the effectiveness of our proposal alterative (dexmedetomidine) through still not routinely in clinical practice eight years later6 and a national shortage in intravenous opioid supplies present at that time. To our surprise we found that patients receiving our opioid-free anesthetics had lower pain scores, reduced need for rescue opioid in the PACU and virtual elimination of PONV. Based on these positive findings, we quickly replicated this new (better) practice iteratively to all of our ASC procedures. Wanting to share our insights, we published our results after undergoing IRB review and receiving approval.7,8 Not surprisingly we subsequently received many inquiries from colleagues about these opioid-free methods. One institution even decided to replicate our results in a randomized, blinded clinical trial. As is often the case, these laudable research efforts ran into many anticipated and unanticipated obstacles. Three years later this center has yet to recruit the necessary number of research subjects into the study to test their hypothesis while we have treated in excess 18,000 opioid-free anesthetic patients at our ASC. We now are modifying this practice for the hospital patient and have over 20,000 additional patients who received an opioid-free anesthetics. In the hospital setting we have noted shorter lengths of stay for select procedures and no worsening of post-operative pain scores or need for rescue opioids. Furthermore, parents commonly express their relief regarding our efforts to reduce and/or eliminate the previously universal use of perioperative opioids. Lastly, we have not stopped as we are CONTINUOUSLY adapting and improving.
In closing, let me state that I am fortunate to practice at an organization that has embraced and invested significantly in quality improvement to enhance the care provided to our patients and families. We have institutional safeguards in place to assure appropriate protections for patients and families. If we want practices to evolve and improve, then we need to be leveraging the real-world data that is generated for every patient encounter and use each patient’s data to make the system smarter and better. The institution has given me necessary the training and tools (the intersection of QI method, technology and data) to confidently improve clinical care for our patients TODAY, not 17 years down the road. Dr Yaster did get one thing right. I have been and will continue to be a strong and vocal advocate for quality improvement efforts. I now believe this is the primary way we will enhance the clinical care we provide to our patients and families.
References
1. Morris ZS, Wooding S, and Grant J. The answer is 17 years, what is the question: understanding the time lags in translation research. J R Soc Med 2011 Dec;104(2):510-20. doi: 10.1258/jrsm.2011.110180. PMID: 22179294.
2. Children’s Hospital of Philadelphia Research Institute, Institutional Review Board. (accessed on 5/19/22 at https://irb.research.chop.edu/quality-improvement-vs-research).
3. Pronovost P, Needham D, Berenholtz S, et al. An intervention to decrease catheter-related bloodstream infections in the ICU. N Engl J Med 2006;355:2725-32.
4. Office for Human Research Protections, U.S. Department of Health and Human Services. Human subject regulations decision charts, September 24, 2004. (Accessed 5/19/22 at http://www.hhs.gov/ohrp/humansubjects/guidance/decisioncharts.htm.)
5. Baily MA. Harming through Protection? N Engl J Med 2008:358:768-9.
6. Olutoye OA, Glover CD, Diefenderfer JW, et al. The effect of intraoperative dexmedetomidine on postoperative analgesia and sedation in pediatric patients undergoing tonsillectomy and adenoidectomy. Anesth Analg 2010;111(2):490-5.
7. Franz AM, Dahl JP, Huang H, et al. The Development of an Opioid Sparing Anesthesia Protocol for Pediatric Ambulatory Tonsillectomy and Adenotonsillectomy Surgery - A Quality Improvement Project. Pediatric Anesthesia 2019; 29: 682-9. PMID: 31077491.
8. Franz AM, Martin LD, Liston D, et al. In pursuit of an Opioid-Free Pediatric Ambulatory Surgery Center – A Quality Improvement Initiative. Anesth Analg 2021; 132:788-97. PMID: 32282383.