Opioid Reduction Initiative During Outpatient Pediatric Urologic Procedures Using Exparel

Phase 3 Terminated 104 enrolled Johns Hopkins University

RandomizedParallel-groupSingle-blindTreatment

Summary

This study aims to evaluate the utility of long-acting liposomal bupivacaine (Exparel®) in improving pain scores and reducing narcotic pain requirements in pediatric patients following minor urologic procedures.

Timeline

Start: 2021-10-01
Primary completion: 2023-04-26
Completion: 2023-04-26

Outcome

Missed primary endpoint

Stopped: “Met futility threshold at interim analysis”

paper At interim analysis, there was no significant difference in opioid-free rate at 48 hours between arms PMID 37871332 ↗

Publications

Gabrielson AT, Galansky L, Sholklapper T, Crigger C, Patel HD, Harris K, Haney N, Jing Y, Wang MH, Wu C, Gearhart JP, Di Carlo HN. 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 Jan;211(1):37-47. doi: 10.1097/JU.0000000000003764. Epub 2023 Oct 23.

Drugs

Evaluation	Drug	Modality	Dose	Route
Background	Bupivacaine	Other / unclassified	133 mg	Other
Background	Bupivacaine	Other / unclassified	0.25 %	Other