NCT06179004

Supraclavicular Bupivacaine Vs. Supraclavicular Liposomal Bupivacaine for Orthopedic Wrist Surgery

Randomized Controlled Trial of Supraclavicular Bupivacaine Vs. Supraclavicular Liposomal Bupivacaine for Orthopedic Wrist Surgery

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: University of North Carolina, Chapel Hill · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed description

Purpose: 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 shoulder 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 the investigators prior standard practice of using 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. Participants: Adult participants age \> 18 undergoing orthopedic wrist surgery at the University of North Carolina ambulatory surgery center and University of North Carolina Hillsborough campus Exclusion Criteria: the below are simply contraindications to regional anesthesia in general, this is a pragmatic study to evaluate the quality of care for these subjects with no additional exclusion criteria.- Contraindications to regional anesthesia- Significant peripheral neuropathy or neurological disorder affecting the upper extremity- Pregnancy- Cognitive or psychiatric condition that might affect patient assessment and/or inability to provide informed consent. Procedures (methods): This is a prospective, randomized comparison of participants undergoing orthopedic wrist procedures that receive one of two types of supraclavicular nerve block. Group 1 will be comprised of patients with a preoperative supraclavicular nerve block placed with 20 mL 0.5% bupivacaine. Group 2 will be comprised of participants with a preoperative supraclavicular nerve block placed with 10 mL 0.5% bupivacaine and 10 mL 1.3% Liposomal Bupivacaine (Exparel). All subjects in both groups will have a similar intraoperative general anesthetic with multimodal analgesic pre-op oral medications. Outcomes measured by Post anesthesia care unit assessment and telephone follow up: see uploaded data collection form.

Conditions

• Distal Radius Fractures
• Wrist Fractures

Interventions

Type	Name	Description
DRUG	Liposomal bupivacaine	133mg Liposomal bupivacaine plus 10mL 0.5% bupivacaine administered in a supraclavicular single shot perineural injection
DRUG	Bupivacaine Hydrochloride	20mL 0.25% bupivacaine administered in a supraclavicular single shot perineural injection

Timeline

• Start date: 2024-04-10
• Primary completion: 2026-10-01
• Completion: 2026-10-01
• First posted: 2023-12-21
• Last updated: 2025-10-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study