Efficacy of EXPAREL vs. Bupivacaine
Recruiting
Phase 3
Interventional Study
Total Ankle Arthroplasty
Postsurgical Analgesia
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 104 (estimated)
- Sponsor
- Emory University · Other
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About This Trial
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 …
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Indicated to undergo unilateral total ankle arthroplasty
* American Society of Anesthesiologists (ASA) physical status 1, 2, or 3
* Able to provide informed consent, adhere to the study schedule, and complete all study assessments
* Body Mass Index (BMI) ≥18 and ≤40 kg/m2
Exc…
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