drugset / Trial / NCT04974385

Liposomal Bupivacaine Versus Non-liposomal Bupivacaine for Total Shoulder Arthroplasty

NCT04974385

Phase 3 Completed 80 enrolled University of Virginia
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The objective of this study is to validate the analgesic efficacy of admixed Liposomal bupivacaine (LB) + bupivacaine compared with plain bupivacaine when injected for interscalene nerve block (ISNB) for total shoulder arthroplasty (TSA). We hypothesize that admixed LB will be non-inferior to plain bupivacaine in terms of postoperative opioid consumption following TSA. The primary outcome of this study will be opioid consumption over the first 72 hours following surgery. Secondary outcomes will include: pain scores, opioid-related adverse events, block related adverse events, pain related phone calls, pain related ED visits and patient satisfaction.

Timeline

Start
2021-08-04
Primary completion
2022-04-30
Completion
2022-05-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Bupivacaine Other / unclassified 10 ml Other
Subject Bupivacaine Other / unclassified 20 ml Other

Indications

No indication recorded.