Efficacy of EXPAREL vs. Bupivacaine
Recruiting now · Phase 3
Conditions studied: Total Ankle Arthroplasty, Postsurgical Analgesia
In brief
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
Key facts
- Study ID
- NCT07212114
- Run by
- Emory University
- People needed
- 104
- Starts
- 2025-11-17
- Expected to finish
- 2029-08-01
- Last updated by the study team
- 2026-02-23
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- Allergy, hypersensitivity, intolerance, or contraindication to any of the study medications for which an alternative is not named in the protocol (e.g., amide-type local anesthetics, opioids, bupivacaine HCl, NSAIDs)
- Concurrent painful physical condition that may require analgesic treatment (such as long-term, consistent use of opioids) in the post-dosing period for pain, and which, in the Investigator's opinion, may confound the post-dosing assessments
- History of, suspected, or known addiction to or abuse of illicit drug(s), prescription medicine(s), or alcohol within the past 2 years
- Uncontrolled anxiety, schizophrenia, or other psychiatric disorder that, in the opinion of the Investigator, could interfere with study assessments or compliance
- Currently pregnant, nursing, or planning to become pregnant during the study
- History of contralateral ankle arthroplasty within 1 year
- Subjects that require ankle arthroplasty due to failed prior ankle arthrodesis
- Subjects with avascular necrosis of the talus
- Subjects undergoing revision total ankle arthroplasty
- Clinically significant medical disease that, in the opinion of the Investigator, would make participation in a clinical study inappropriate. This includes diabetic neuropathy, coagulation or bleeding disorders, severe peripheral vascular disease, renal insufficiency, hepatic dysfunction or other conditions that would constitute a contraindication to participation in the study
- Chronic opioid use within 30 days before randomization (average ≥30 oral morphine equivalents/day
- Prisoners
- Cognitive impairment or impaired decision-making capacity
- Inability to communicate in English
Where it is running
- Emory University Orthopaedic Hospital Musculoskeletal Institute (MSK) — Atlanta, Georgia, United States (enrolling)
Full record on ClinicalTrials.gov
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