Supraclavicular Bupivacaine Vs. Supraclavicular Liposomal Bupivacaine for Orthopedic Wrist Surgery
Part of paid clinical trials in Chapel Hill, North Carolina.
- Sponsor
- University of North Carolina, Chapel Hill
- Study ID
- NCT06179004
- Phase
- PHASE3
- Status
- Recruiting
Conditions
- Distal Radius Fractures
- Wrist Fractures
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Accepted
Interventions
- Liposomal bupivacaine — DRUG133mg Liposomal bupivacaine plus 10mL 0.5% bupivacaine administered in a supraclavicular single shot perineural injection
- Bupivacaine Hydrochloride — DRUG20mL 0.25% bupivacaine administered in a supraclavicular single shot perineural injection
Study Details
Orthopedic wrist procedures often cause significant postoperative pain. A supraclavicular nerve block is an effective and proven method to help reduce postoperative pain and decrease opioid use around the time of upper extremity surgery. Liposomal bupivacaine (Exparel) has been approved for use around the brachial plexus, but its analgesic efficacy has limited data. The investigators' goal is to evaluate the effectiveness of Exparel as compared to plain bupivacaine. The investigators hope to ensure the quality of pain control around the time of distal radius fracture repair and reduce the variability of care at the investigators institution by prospectively and rigorously collecting perioperative data during this study.
Key Dates
- Start date
- Apr 10, 2024
- Status verified
- Oct 2025
- Primary completion
- Oct 31, 2026
- Completion
- Oct 31, 2026
Study Design
- Enrollment
- 100 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Supraclavicular Liposomal Bupivacaine groupThis group will receive the liposomal bupivacaine
- Active Comparator: Supraclavicular Plain Bupivacaine groupThis group will receive the plain bupivacaine
Primary Outcome Measure
Pre-operative and 48-hour Post-operative Quality of Recovery 15 survey score [ Time Frame: Pre-operative and at 24 hours and 48 hours post-operative ]
Central Contacts
- Jay Schoenherr, MD9199515062
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| UNC Chapel Hill | Chapel Hill | North Carolina | 27514 |
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