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JU INSIGHT A Randomized Trial Evaluating Liposomal Bupivacaine as a Local Anesthetic in Pediatric Urologic Surgery
By: Andrew T. Gabrielson, MD, James Buchanan Brady Urological Institute, Johns Hopkins University School of Medicine, Baltimore, Maryland; Logan Galansky, MD, James Buchanan Brady Urological Institute, Johns Hopkins University School of Medicine, Baltimore, Maryland; Tamir Sholklapper, MD, Albert Einstein Medical Center, Philadelphia, Pennsylvania; Chad Crigger, MD, James Buchanan Brady Urological Institute, Johns Hopkins University School of Medicine, Baltimore, Maryland; Hiten D. Patel, MD, MPH, Feinberg School of Medicine, Northwestern University, Chicago, Illinois; Kelly Harris, MD, University of Colorado School of Medicine, Aurora; Nora Haney, MD, MBA, James Buchanan Brady Urological Institute, Johns Hopkins University School of Medicine, Baltimore, Maryland; Yuezhou Jing, MS, James Buchanan Brady Urological Institute, Johns Hopkins University School of Medicine, Baltimore, Maryland; Ming-Hsien Wang, MD, James Buchanan Brady Urological Institute, Johns Hopkins University School of Medicine, Baltimore, Maryland; Charlotte Wu, MD, James Buchanan Brady Urological Institute, Johns Hopkins University School of Medicine, Baltimore, Maryland; John P. Gearhart, MD, James Buchanan Brady Urological Institute, Johns Hopkins University School of Medicine, Baltimore, Maryland; Heather N. Di Carlo, MD, James Buchanan Brady Urological Institute, Johns Hopkins University School of Medicine, Baltimore, Maryland | Posted on: 19 Jan 2024
Gabrielson AT, Galansky L, Sholklapper T, et al. Effectiveness of liposomal bupivacaine with bupivacaine hydrochloride vs bupivacaine hydrochloride alone as a local anesthetic for children undergoing ambulatory urologic surgery: the Baby ORIOLES randomized clinical trial. J Urol. 2024;211(1):37-47.
Study Need and Importance
Based on results of the PLAY phase 3 trial, the US Food and Drug Administration approved a long-acting liposomal formulation of bupivacaine for use as a local anesthetic in children ≥ 6 years. However, the PLAY trial was based on safety and pharmacokinetics without attention to comparative clinical efficacy. No level 1 evidence exists to support the use of liposomal bupivacaine over other local anesthetics in children undergoing urologic surgery. We conducted a randomized trial to evaluate whether liposomal bupivacaine plus bupivacaine hydrochloride administered by dorsal penile nerve block (penile procedures) or spermatic cord block with incisional infiltration (inguinal/scrotal procedures) improves opioid-free rate or validated pain metrics (parents’ postoperative pain measure, numerical pain scale) compared to bupivacaine hydrochloride alone in children undergoing ambulatory urologic surgery (Figure).
What We Found
We randomized 104 participants, with > 98% with complete follow-up data at 48 hours and 10 to 14 days. At interim analysis, there was no significant difference in opioid-free rate at 48 hours between arms (60% in the intervention vs 62% in the control group; estimated difference in proportion −1.9% [95% CI, −20% to 16%]; P = .8). We observed no increased odds of patients being opioid-free at 48 hours with the intervention compared to the control group (OR 0.96 [95% CI 0.41-2.3]; P = .9). The trial met the predetermined futility threshold for early stopping. There was no difference in parents’ postoperative pain measure scores, numerical pain scale scores, or opioid utilization at 48 hours or 10 to 14 days. No difference in adverse events was observed.
Limitations
This study was single center, used a single-blinded design, lacked a cost-effectiveness analysis, and included mostly low-morbidity procedures which might have reduced differences in outcomes between groups.
Interpretation for Patient Care
The addition of liposomal bupivacaine to bupivacaine hydrochloride did not significantly improve opioid-sparing effect or postoperative pain compared with bupivacaine hydrochloride alone among children ≥ 6 years undergoing ambulatory urologic surgery.
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