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

No AccessJournal of UrologyOriginal Research Articles1 Jan 2024Effectiveness 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 TrialThis article is commented on by the following:Editorial CommentEditorial CommentEditorial Comment Andrew T. Gabrielson, Logan Galansky, Tamir Sholklapper, Chad Crigger, Hiten D. Patel, Kelly Harris, Nora Haney, Yuezhou Jing, Ming-Hsien Wang, Charlotte Wu, John P. Gearhart, and Heather N. Di Carlo Andrew T. GabrielsonAndrew T. Gabrielson *Corresponding Author: Andrew T. Gabrielson, MD, The James Buchanan Brady Urological Institute, The Johns Hopkins University School of Medicine, 1800 Orleans St, Baltimore, MD 21287 ( E-mail Address: [email protected] https://orcid.org/0000-0001-9971-9813 James Buchanan Brady Urological Institute, Johns Hopkins University School of Medicine, Baltimore, Maryland More articles by this author , Logan GalanskyLogan Galansky James Buchanan Brady Urological Institute, Johns Hopkins University School of Medicine, Baltimore, Maryland More articles by this author , Tamir SholklapperTamir Sholklapper Department of Urology, Albert Einstein Medical Center, Philadelphia, Pennsylvania More articles by this author , Chad CriggerChad Crigger James Buchanan Brady Urological Institute, Johns Hopkins University School of Medicine, Baltimore, Maryland More articles by this author , Hiten D. PatelHiten D. Patel Department of Urology, Feinberg School of Medicine, Northwestern University, Chicago, Illinois More articles by this author , Kelly HarrisKelly Harris Department of Urology, University of Colorado School of Medicine, Aurora, Colorado More articles by this author , Nora HaneyNora Haney James Buchanan Brady Urological Institute, Johns Hopkins University School of Medicine, Baltimore, Maryland More articles by this author , Yuezhou JingYuezhou Jing James Buchanan Brady Urological Institute, Johns Hopkins University School of Medicine, Baltimore, Maryland More articles by this author , Ming-Hsien WangMing-Hsien Wang James Buchanan Brady Urological Institute, Johns Hopkins University School of Medicine, Baltimore, Maryland More articles by this author , Charlotte WuCharlotte Wu James Buchanan Brady Urological Institute, Johns Hopkins University School of Medicine, Baltimore, Maryland More articles by this author , John P. GearhartJohn P. Gearhart James Buchanan Brady Urological Institute, Johns Hopkins University School of Medicine, Baltimore, Maryland More articles by this author , and Heather N. Di CarloHeather N. Di Carlo James Buchanan Brady Urological Institute, Johns Hopkins University School of Medicine, Baltimore, Maryland More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000003764AboutFull TextPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract Purpose: We sought to determine if the addition of liposomal bupivacaine to bupivacaine hydrochloride improves opioid-free rate and postoperative pain scores among children undergoing ambulatory urologic surgery. Materials and Methods: A prospective, phase 3, single-blinded, single-center randomized trial with superiority design was conducted in children 6 to 18 years undergoing ambulatory urologic procedures between October 2021 and April 2023. Patients were randomized 1:1 to receive dorsal penile nerve block (penile procedures) or incisional infiltration with spermatic cord block (inguinal/scrotal procedures) with weight-based liposomal bupivacaine plus bupivacaine hydrochloride or bupivacaine hydrochloride alone. The primary outcome was opioid-free rate at 48 hours. Secondary outcomes included parents’ postoperative pain measure scores, numerical pain scale scores, and weight-based opioid utilization at 48 hours and 10 to 14 days. Results: We randomized 104 participants, with > 98% (102/104) 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%-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. Conclusions: 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. REFERENCES 1. . Inconsistent and excessive opioid prescribing after common pediatric surgical operations. J Pediatr Surg. 2019; 54(7):1427-1431. Crossref, Medline, Google Scholar 2. . Opioid use after pediatric urologic surgery: is it really needed?. Urology. 2021; 158:184-188. 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Editor's Note: This article is the first of 5 published in this issue for which Category 1 CME credits can be earned. Instructions for obtaining credits are given with the questions on pages 201 and 202. © 2023 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetailsCited bySiemens D and Wan J (2023) Editor's Choice: January 2024Journal of Urology, VOL. 211, NO. 1, (1-2), Online publication date: 1-Jan-2024.Gabrielson A, Galansky L, Sholklapper T, Crigger C, Patel H, Harris K, Haney N, Jing Y, Wang M, Wu C, Gearhart J and Di Carlo H (2024) Reply by AuthorsJournal of Urology, VOL. 211, NO. 1, (47-47), Online publication date: 1-Jan-2024.Trask D and Swords K (2023) Editorial CommentJournal of Urology, VOL. 211, NO. 1, (46-46), Online publication date: 1-Jan-2024.Shukla A (2023) Editorial CommentJournal of Urology, VOL. 211, NO. 1, (45-46), Online publication date: 1-Jan-2024.Lorenzo A (2023) Editorial CommentJournal of Urology, VOL. 211, NO. 1, (45-45), Online publication date: 1-Jan-2024.Related articlesJournal of Urology10 Nov 2023Editorial CommentJournal of Urology10 Nov 2023Editorial CommentJournal of Urology10 Nov 2023Editorial Comment Volume 211Issue 1January 2024Page: 37-47Supplementary Materials Peer Review Report January 2024 JU PRR/JU-23-992 PRR Patient Summary Open Patient Summary Advertisement Copyright & Permissions© 2023 by American Urological Association Education and Research, Inc.Keywordslocal anestheticsambulatory surgical proceduresMetrics Author Information Andrew T. Gabrielson James Buchanan Brady Urological Institute, Johns Hopkins University School of Medicine, Baltimore, Maryland *Corresponding Author: Andrew T. Gabrielson, MD, The James Buchanan Brady Urological Institute, The Johns Hopkins University School of Medicine, 1800 Orleans St, Baltimore, MD 21287 ( E-mail Address: [email protected] More articles by this author Logan Galansky James Buchanan Brady Urological Institute, Johns Hopkins University School of Medicine, Baltimore, Maryland More articles by this author Tamir Sholklapper Department of Urology, Albert Einstein Medical Center, Philadelphia, Pennsylvania More articles by this author Chad Crigger James Buchanan Brady Urological Institute, Johns Hopkins University School of Medicine, Baltimore, Maryland More articles by this author Hiten D. Patel Department of Urology, Feinberg School of Medicine, Northwestern University, Chicago, Illinois More articles by this author Kelly Harris Department of Urology, University of Colorado School of Medicine, Aurora, Colorado More articles by this author Nora Haney James Buchanan Brady Urological Institute, Johns Hopkins University School of Medicine, Baltimore, Maryland More articles by this author Yuezhou Jing James Buchanan Brady Urological Institute, Johns Hopkins University School of Medicine, Baltimore, Maryland More articles by this author Ming-Hsien Wang James Buchanan Brady Urological Institute, Johns Hopkins University School of Medicine, Baltimore, Maryland More articles by this author Charlotte Wu James Buchanan Brady Urological Institute, Johns Hopkins University School of Medicine, Baltimore, Maryland More articles by this author John P. Gearhart James Buchanan Brady Urological Institute, Johns Hopkins University School of Medicine, Baltimore, Maryland More articles by this author Heather N. Di Carlo James Buchanan Brady Urological Institute, Johns Hopkins University School of Medicine, Baltimore, Maryland More articles by this author Expand All Support: This study was internally funded by the Robert Jeffs, MD, Department of Pediatric Urology at Johns Hopkins Hospital. Conflict of Interest Disclosures: The Authors have no conflicts of interest to disclose. Ethics Statement: This study received Institutional Review Board approval (IRB No. IRB00284462). Trial Registration: ClinicalTrials.gov identifier: NCT04826484. Editor's Note: This article is the first of 5 published in this issue for which Category 1 CME credits can be earned. Instructions for obtaining credits are given with the questions on pages 201 and 202. Advertisement PDF downloadLoading ...