Status:
NOT_YET_RECRUITING
Efficacy of EXPAREL vs. Bupivacaine
Lead Sponsor:
Emory University
Collaborating Sponsors:
Pacira Pharmaceuticals, Inc
Conditions:
Total Ankle Arthroplasty
Postsurgical Analgesia
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 t...
Detailed Description
EXPAREL® is a long-acting local anesthetic specifically developed to provide extended postsurgical pain relief from a single-dose administration, thereby reducing or eliminating the need for indwellin...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2029
Estimated Enrollment :
104 Patients enrolled
Trial Details
Trial ID
NCT07212114
Start Date
October 1 2025
End Date
August 1 2029
Last Update
October 8 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Emory University Orthopaedic Hospital Musculoskeletal Institute (MSK)
Atlanta, Georgia, United States, 30329