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 — DRUG
    133mg Liposomal bupivacaine plus 10mL 0.5% bupivacaine administered in a supraclavicular single shot perineural injection
  • Bupivacaine Hydrochloride — DRUG
    20mL 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 group
    This group will receive the liposomal bupivacaine
  • Active Comparator: Supraclavicular Plain Bupivacaine group
    This 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

Locations (1)

FacilityCityStateZIPSite coordinators
UNC Chapel HillChapel HillNorth Carolina27514
Jay Schoenherr, MD
919-951-5062

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