Clinical Trial: Supraclavicular Bupivacaine Vs. Supraclavicular Liposomal Bupivacaine for Distal Radius Fracture Repair
Study Status: NOT_YET_RECRUITING
Recruit Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Official Title: Randomized Controlled Trial of Supraclavicular Bupivacaine Vs. Supraclavicular Liposomal Bupivacaine for Distal Radius Fracture Repair
Brief Summary: Distal radius fracture repair often causes 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 Summary:
Purpose: Distal radius fracture repair often causes 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 distal radius fracture repair 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 distal radius fracture repair 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.
Sponsor: University of North Carolina, Chapel Hill
Current Primary Outcome: The quality of recovery-15 (QoR-15) is a validated questionnaire to assess postoperative recovery.
Scale is based on 15 questions, each question score range is 0-10 (0 being poor and 10 being excellent) The survey will be conducted at 24 hours intervals after surgery up to 48 hours total after surgery.
The total score range is 0-150, where a score of 0 would be the worst possible score, and 150 would be the best possible score
Original Primary Outcome: The quality of recovery-15 (QoR-15) is a validated questionnaire to assess postoperative recovery.
Scale is based on 15 questions, each question score range is 0-10 (0 being poor and 10 being excellent) The survey will be conducted at 24 hours intervals after surgery up to 48 hours total after surgery.
The total score range is 0-150, where a score of 0 would be the worst possible score, and 150 would be the best possible score
Current Secondary Outcome:
Original Secondary Outcome:
Information By: University of North Carolina, Chapel Hill
Dates:
Date Received: December 11, 2023
Date Started: December 01, 2023
Date Completion: December 01, 2023
Last Updated: December 11, 2023
Last Verified: December 01, 2023
