NCT06179004 Supraclavicular Bupivacaine Vs. Supraclavicular Liposomal Bupivacaine for Orthopedic Wrist Surgery
| NCT ID | NCT06179004 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | University of North Carolina, Chapel Hill |
| Condition | Distal Radius Fractures |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2024-04-10 |
| Primary Completion | 2026-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 100 participants in total. It began in 2024-04-10 with a primary completion date of 2026-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Jay Schoenherr, MD
PRINCIPAL INVESTIGATOR
University of North Carolina, Chapel Hill
Frequently Asked Questions
Who can join the NCT06179004 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Distal Radius Fractures. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06179004 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 100 participants.
Is NCT06179004 currently recruiting?
Yes, NCT06179004 is actively recruiting participants. Contact the research team at jay_schoenherr@med.unc.edu for enrollment information.
Where is the NCT06179004 trial being conducted?
This trial is being conducted at Chapel Hill, United States.
Who is sponsoring the NCT06179004 clinical trial?
NCT06179004 is sponsored by University of North Carolina, Chapel Hill. The principal investigator is Jay Schoenherr, MD at University of North Carolina, Chapel Hill. The trial plans to enroll 100 participants.