At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 3, Randomized, Double-Blind, Active-Controlled, Multicenter Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of EXPAREL vs. Bupivacaine Hydrochloric Acid (HCl) Administered as a Sciatic (in the Popliteal Fossa) Nerve Block for Postsurgical Analgesia in Subjects Undergoing Bunionectomy
In Brief
A Phase 3 clinical trial evaluating Bupivacaine liposome injectable suspension 266 mg, Bupivacaine HCl, and 1 other intervention for Bunionectomy and Hallux Valgus. Completed, enrolled 185 participants across 7 sites.
Detailed 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.
Study Details
Timeline
Interventions
Sciatic nerve block in the popliteal fossa with EXPAREL 266 mg
Sciatic nerve block in the popliteal fossa with Bupivacaine HCl
Sciatic nerve block in the popliteal fossa with EXPAREL 133 mg