Efficacy, Safety, and Pharmacokinetics of Brachial Plexus Block With EXPAREL in Shoulder Surgery

Phase 3 Completed 156 enrolled Pacira Pharmaceuticals, Inc

RandomizedParallel-groupTriple-blindTreatment

Summary

This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study in 155 adult subjects undergoing primary unilateral total shoulder arthroplasty or rotator cuff repair with general anesthesia

Timeline

Start: 2016-05-09
Primary completion: 2017-07-07
Completion: 2017-07-07

Publications

Patel MA, Gadsden JC, Nedeljkovic SS, Bao X, Zeballos JL, Yu V, Ayad SS, Bendtsen TF. Brachial Plexus Block with Liposomal Bupivacaine for Shoulder Surgery Improves Analgesia and Reduces Opioid Consumption: Results from a Multicenter, Randomized, Double-Blind, Controlled Trial. Pain Med. 2020 Feb 1;21(2):387-400. doi: 10.1093/pm/pnz103.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Bupivacaine	Other / unclassified	133 mg	Other
Comparator	Bupivacaine	Other / unclassified	266 mg	Other

Indications

No indication recorded.