Supraclavicular Bupivacaine Vs. Supraclavicular Liposomal Bupivacaine for Orthopedic Wrist Surgery
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of North Carolina, Chapel Hill
About this trial
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
This trial accepts healthy volunteersQualifiers
Age greater than or equal to 18
Scheduled for orthopedic wrist surgery at University of North Carolina at Chapel Hill.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Liposomal bupivacaine
Drug133mg Liposomal bupivacaine plus 10mL 0.5% bupivacaine administered in a supraclavicular single shot perineural injection
Bupivacaine Hydrochloride
Drug20mL 0.25% bupivacaine administered in a supraclavicular single shot perineural injection
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Supraclavicular Liposomal Bupivacaine groupExperimental treatment 1 intervention
Group B: Supraclavicular Plain Bupivacaine groupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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
Time frame
Pre-operative and at 24 hours and 48 hours post-operativeSecondary outcomes
1
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.
Time frame
Post-operative period up to 48 hours after surgery2
Time to First Dose of Opioid Medication
Investigate opioid medication consumption by recording time to first opioid medication administered.
Time frame
Post-operative period up to 48 hours after surgery3
Total opioid dose through Post-op Day 2
Investigate opioid medication consumption by recording total opioid dose for each group through postoperative day 2.
Time frame
Post-operative period up to 48 hours after surgerySponsors and contacts
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Source ClinicalTrials.gov