Recruiting
Phase 3

Bupivacaine vs. Liposomal Bupivacaine

Sponsor:

University of North Carolina, Chapel Hill

Code:

NCT06179004

Conditions

Distal Radius Fractures

Wrist Fractures

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Liposomal bupivacaine

Bupivacaine Hydrochloride

Study Details

Brief summary:

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.

Conditions

Distal Radius Fractures

Wrist Fractures

Study ID

NCT06179004

Start date

Apr 10, 2024

Status verified date

Oct, 2025

Completion date

Oct, 2026

Anticipated

Primary completion date

Oct, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Age greater than or equal to 18
  • Scheduled for orthopedic wrist surgery at University of North Carolina at Chapel Hill.

Exclusion Criteria:

  • Contraindications to regional anesthesia
  • Emergent surgery Open fractures will be treated emergently and will not allow adequate lead time for enrollment in this study. Also, open fractures are usually accompanied by other traumatic injuries that would confound the pain related outcomes in this study.
  • Significant peripheral neuropathy or neurological disorder affecting the upper extremity
  • Pregnancy Pregnant women have physiologic changes that make them more sensitive to local anesthetics. That would introduce a confounding element in interpreting the effectiveness of the peripheral nerve blocks being studied.
  • Cognitive or psychiatric condition that might affect patient assessment and/or inability to provide informed consent.

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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

Interventions

Liposomal bupivacaine

133mg Liposomal bupivacaine plus 10mL 0.5% bupivacaine administered in a supraclavicular single shot perineural injection

Bupivacaine Hydrochloride

20mL 0.25% bupivacaine administered in a supraclavicular single shot perineural injection

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 and Locations

Central contacts

Jay Schoenherr, MD

9199515062jay_schoenherr@med.unc.edu

Locations

UNC Chapel Hill

Recruiting

Chapel Hill, North Carolina, United States, 27514

Contacts

Jay Schoenherr, MD

919-951-5062Jay_Schoenherr@med.unc.edu

More Information

Sponsor

University of North Carolina, Chapel Hill

Last update posted

Oct 24, 2025

Last verified

Oct, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of North Carolina, Chapel Hill on 2025-10-24.