Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of EXPAREL, EXPAREL Admixed With Bupivacaine HCl vs. Bupivacaine HCl Administered as Combined Sciatic and Saphenous Nerve Blocks for Postsurgical Analgesia in Subjects Undergoing Lower Extremity Surgeries

Phase 3 Completed 121 enrolled Pacira Pharmaceuticals, Inc

RandomizedParallel-groupQuadruple-blindTreatment

Summary

This is a Phase 3, multicenter, randomized, double blinded, active controlled study in approximately 120 subjects undergoing lower extremity surgeries.

Timeline

Start: 2020-10-20
Primary completion: 2021-04-05
Completion: 2021-04-05

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Bupivacaine	Other / unclassified	20 ml	Other
Subject	Bupivacaine	Other / unclassified	40 ml	Other
Subject	Bupivacaine	Other / unclassified	50 mg	Other
Subject	Bupivacaine	Other / unclassified	100 mg	Other
Subject	Bupivacaine	Other / unclassified	266 mg	Other

Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of EXPAREL, EXPAREL Admixed With Bupivacaine HCl vs. Bupivacaine HCl Administered as Combined Sciatic and Saphenous Nerve Blocks for Postsurgical Analgesia in Subjects Undergoing Lower Extremity Surgeries

Summary

Timeline

Drugs

Indications