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

PHASE3WithdrawnINTERVENTIONAL
0
Timeline

Start Date

June 15, 2020

Primary Completion Date

September 30, 2020

Study Completion Date

September 30, 2020

Conditions
BunionMetatarsophalangeal FusionMidfoot FusionHindfoot FusionTotal Ankle ArthroplastyForefoot Surgery
Interventions
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

Sponsors
All Listed Sponsors
lead

Pacira Pharmaceuticals, Inc

INDUSTRY

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 | Biotech Hunter | Biotech Hunter