Phase 3, Sciatic Nerve Block With EXPAREL for Subjects Undergoing Bunionectomy

Phase 3 Completed 185 enrolled Pacira Pharmaceuticals, Inc

RandomizedSequentialTriple-blindTreatment

Summary

The study is conducted sequentially in two parts. Part A: The purpose is to obtain information on pharmacokinetic (PK) profile, pharmacodynamics (PD), efficacy, safety, and to assess the performance of 266 mg EXPAREL vs 133 mg EXPAREL. Part B: The purpose is to evaluate the efficacy and safety of the preferred dosage of EXPAREL from Part A compared with bupivacaine HCl.

Timeline

Start: 2022-02-15
Primary completion: 2022-08-17
Completion: 2022-08-17

Publications

Schwartz G, Gadsden JC, Gonzales J, Hutchins J, Song J, Brady O, DiGiorgi M, Winston R. A phase 3 active-controlled trial of liposomal bupivacaine via sciatic nerve block in the popliteal fossa after bunionectomy. J Clin Anesth. 2024 Jun;94:111402. doi: 10.1016/j.jclinane.2024.111402. Epub 2024 Feb 9.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Bupivacaine	Other / unclassified	50 mg	Other
Comparator	Bupivacaine	Other / unclassified	133 mg	Other
Comparator	Bupivacaine	Other / unclassified	266 mg	Other

Indications

No indication recorded.