drugset / Trial / NCT05374499

Double-Blinded Randomized Controlled Study Investigating the Efficacy of Exparel (Liposomal Bupivacaine) for Postoperative Pain Relief in Mandibular Third Molar Extractions

NCT05374499 ↗

Phase 4 Completed 85 enrolled University of Southern California
RandomizedSingle-groupQuadruple-blindPrevention

Summary

The most prevalent complaint after third molar extractions is pain. There have been many modalities and regimens developed to manage post-operative pain, such as modifications in surgical techniques, locally-applied medicaments, and oral analgesics. Recently, liposomal bupivacaine (Exparel) has been FDA approved for single-dose infiltration in the oral cavity in adults and children (6 years or older) to produce extended postsurgical local anesthesia. We hypothesize that the administration of liposomal bupivacaine (Exparel) at the end of third molar extractions will decrease postoperative pain and decrease narcotic use for pain management.

Timeline

Start
2022-09-01
Primary completion
2023-12-01
Completion
2024-05-01

Outcome

Met primary endpoint

paper Pain was lower in the LB versus SB group on surgery day (NRS difference -0.75; P = .002) PMID 39900116 ↗

paper AUC analysis showed cumulative pain reduction for the LB group in comparison to the SB group through all 4 postoperative days for the overall cohort (average AUC0-96 difference 93.5, P = .005) PMID 39900116 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Bupivacaine Other / unclassified 3 ml Other
Comparator Epinephrine Other / unclassified — Other

Indications

No indication recorded.