Efficacy of EXPAREL vs. Bupivacaine
Summary
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
Timeline
- Start
- 2025-11-17
- Primary completion
- 2029-08
- Completion
- 2029-08
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bupivacaine | Other / unclassified | 75 mg | Other |
| Subject | Bupivacaine | Other / unclassified | 100 mg | Other |
| Subject | Bupivacaine | Other / unclassified | 266 mg | Other |
Indications
No indication recorded.