Supraclavicular Bupivacaine Vs. Supraclavicular Liposomal Bupivacaine for Distal Radius Fracture Repair

Study Overview
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Brief Summary
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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 Description
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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.

Official Title
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Randomized Controlled Trial of Supraclavicular Bupivacaine Vs. Supraclavicular Liposomal Bupivacaine for Distal Radius Fracture Repair

Conditions
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Distal Radius Fractures

Intervention / Treatment
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* Drug: Liposomal bupivacaine
* Drug: Bupivacaine Hydrochloride


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age greater than or equal to 18 Scheduled for distal radius fracture repair 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Supraclavicular Liposomal Bupivacaine group<br>This group will receive the liposomal bupivacaine | Drug: Liposomal bupivacaine<br>* The medication liposomal bupivacaine of the dose of 133 mg in the form of a supraclavicular single shot injection perineural as a one-time administration<br>* Other names: Exparel;|
| Active Comparator: Supraclavicular Plain Bupivacaine group<br>This group will receive the plain bupivacaine | Drug: Bupivacaine Hydrochloride<br>* The medication plain bupivacaine of the concentration of 0.25% will be administered as a perineural injection in the form of a one-time supraclavicular single shot injection.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pre-operative and 48-hour Post-operative Quality of Recovery 15 survey score | 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 | Pre-operative and at 24 hours and 48 hours post-operative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in Participant Reported Pain Scores | These pain scores will be collected immediately after surgery in the recovery room, and on postoperative days 1 and 2 during follow up telephone encounters. The estimate of interest is the difference in patient reported pain scores (numeric 0-10) between groups at these points in time. | Post-operative period up to 48 hours after surgery | 
| Time to First Dose of Opioid Medication | Investigate opioid medication consumption by recording time to first opioid medication administered. | Post-operative period up to 48 hours after surgery | 
| Total opioid dose through Post-op Day 2 | Investigate opioid medication consumption by recording total opioid dose for each group through postoperative day 2. | Post-operative period up to 48 hours after surgery |