Efficacy of EXPAREL vs. Bupivacaine

The goal of this clinical study is to learn about pain management strategies in subjects undergoing total ankle replacement. arthroplasty surgery The primary objective is to compare the magnitude of the analgesic effect following a single dose injection of EXPAREL vs. 0.25% bupivacaine (HCl). Secondary objectives are to: Compare the total opioid consumption (in oral morphine equivalents) from 0 to 96 hours following a single dose injection of EXPAREL vs. 0.25% bupivacaine HCl * Compare the time to first opioid consumption following a single dose injection of EXPAREL vs. 0.25% bupivacaine HCl * Assess the safety of EXPAREL vs. 0.25% bupivacaine HCl * Evaluate subject satisfaction with pain management following a single-dose injection of EXPAREL vs. 0.25% bupivacaine hydrochloride (HCl) * Compare clinical performance from Preoperative status to 3- and 12- months postoperatively

NCT Number	NCT07212114
Lead Sponsor	Emory University Collaborators: Pacira Pharmaceuticals, Inc
Conditions	Total Ankle Arthroplasty, Postsurgical Analgesia
Enrollment	104 participants
Start Date	2025-11-17
Primary Completion	2029-08 (estimated)
Study Completion	2029-08 (estimated)
Updated on ClinicalTrials.gov	2026-02-23