EXPAREL versus bupivacaine for pain control after total ankle replacement

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Adults undergoing unilateral total ankle arthroplasty will receive a single local injection of either EXPAREL or 0.25% bupivacaine during their procedure. The primary comparison is the magnitude of postoperative analgesia, with secondary measures including total opioid consumption (oral morphine equivalents) and time to first opioid use over the first 96 hours. Safety, patient satisfaction with pain management, and clinical function versus preoperative status will be tracked at 3 and 12 months postoperatively. The Phase 3 interventional comparison is conducted at Emory University in collaboration with Pacira Pharmaceuticals.

Why it matters

Who can join: the full rules

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

Exclusion Criteria:

* 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's running

• Emory University Orthopaedic Hospital Musculoskeletal Institute (MSK)
  Atlanta, Georgia, United States Recruiting

Study contacts

• Principal investigator: Sameh Labib, MD, FAOA — Emory University
• Study coordinator: Sameh Labib, MD, FAOA
• Email: slabib@emory.edu
• Phone: 404-778-4398

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.