Clinical trial

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

Name
23-1116
Description
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.
Trial arms
Trial start
2024-02-01
Estimated PCD
2024-12-01
Trial end
2024-12-01
Status
Not yet recruiting
Phase
Early phase I
Treatment
Liposomal bupivacaine
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
Arms:
Supraclavicular Liposomal Bupivacaine group
Other names:
Exparel
Bupivacaine Hydrochloride
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.
Arms:
Supraclavicular Plain Bupivacaine group
Size
100
Primary endpoint
Pre-operative and 48-hour Post-operative Quality of Recovery 15 survey score
Pre-operative and at 24 hours and 48 hours post-operative
Eligibility criteria
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'maskingDescription': 'As participants are enrolled in this study, a study identification will be created as their basic demographic information is entered into the secure RedCap database. At this time, the RedCap randomization tool will randomize the subject to either group 1 or 2.', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 100, 'type': 'ESTIMATED'}}
Updated at
2024-02-20

1 organization

2 products

1 indication

Indication
Wrist Fractures