EXPAREL versus bupivacaine for pain control after total ankle replacement
A Randomized, Double-blind, Active Controlled, Single-center Study to Evaluate the Efficacy of EXPAREL vs. Bupivacaine HCl Administered as Combined Sciatic (in the Popliteal Fossa) and Saphenous (in the Adductor Canal) Nerve Blocks for Postsurgical Analgesia in Subjects Undergoing Total Ankle Arthroplasty
This trial will try a single injection of EXPAREL to see if it controls pain better than 0.25% bupivacaine in adults having unilateral total ankle replacement.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 104 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Emory University Academic / other |
| Locations | 1 site (Atlanta, Georgia) |
| Trial ID | NCT07212114 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults scheduled for unilateral total ankle arthroplasty who are ASA physical status 1–3, have a BMI between 18 and 40 kg/m2, and can provide informed consent and comply with study visits are ideal candidates.
Not a fit: Patients with allergy or intolerance to amide local anesthetics, those on chronic opioid therapy or with concurrent painful conditions requiring ongoing analgesics, recent substance abuse, or uncontrolled psychiatric disorders are unlikely to benefit or would be excluded.
Why it matters
Potential benefit: If successful, EXPAREL could provide longer-lasting pain relief after ankle replacement and reduce the need for opioid pain medicines.
How similar studies have performed: Previous trials of EXPAREL and other long-acting bupivacaine formulations have shown reduced early opioid use and longer analgesia for some surgeries, although effectiveness can vary by procedure.
Eligibility criteria
Show full inclusion / exclusion 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 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 this trial is running
Atlanta, Georgia
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.