NCT03954639

Phase 3, Randomized, Double Blinded, Active Controlled, Multicenter Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of EXPAREL Admixed With Bupi vs. Bupi Only Administered as Combined Sciatic and Adductor Canal Nerve Block for Postsurgical Analgesia in Lower Extremity Surgeries

A Phase 3, Randomized, Double Blinded, Active Controlled, Multicenter Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of EXPAREL Admixed With Bupivacaine vs. Bupivacaine Only Administered as Combined Sciatic (in Popliteal Fossa) and Adductor Canal Nerve Block for Postsurgical Analgesia in Subjects Undergoing Lower Extremity Surgeries

• Status: Withdrawn
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Pacira Pharmaceuticals, Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 3, multicenter, randomized, double blinded, active controlled study in approximately 81 subjects undergoing lower extremity surgeries with combined sciatic and adductor canal nerve block.

Conditions

• Bunion
• Metatarsophalangeal Fusion
• Midfoot Fusion
• Hindfoot Fusion
• Total Ankle Arthroplasty
• Forefoot Surgery

Interventions

Type	Name	Description
DRUG	EXPAREL 13.3Mg/mL Suspension for Injection	Combined Sciatic and Adductor Canal Nerve Block with EXPAREL mixed with Bupivacaine (Single Dose)
DRUG	Bupivacaine Hydrochloride	Combined Sciatic and Adductor Canal Nerve Block with Bupivacaine HCL

Timeline

• Start date: 2020-06-15
• Primary completion: 2020-09-01
• Completion: 2020-09-01
• First posted: 2019-05-17
• Last updated: 2020-08-13

Regulatory

• FDA-regulated drug study