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

February 15, 2024 updated by: University of North Carolina, Chapel Hill

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Supraclavicular Liposomal Bupivacaine group
This group will receive the liposomal bupivacaine
Drug: 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
Other Names:
  • Exparel
Active Comparator: Supraclavicular Plain Bupivacaine group
This group will receive the plain bupivacaine
Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pre-operative and 48-hour Post-operative Quality of Recovery 15 survey score
Time Frame: Pre-operative and at 24 hours and 48 hours post-operative
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
Time Frame: Post-operative period up to 48 hours after surgery
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
Time Frame: Post-operative period up to 48 hours after surgery
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
Time Frame: Post-operative period up to 48 hours after surgery
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of North Carolina, Chapel Hill

Investigators

  • Principal Investigator: Jay Schoenherr, MD, University of North Carolina, Chapel Hill

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 1, 2024

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

December 11, 2023

First Submitted That Met QC Criteria

December 11, 2023

First Posted (Actual)

December 21, 2023

Study Record Updates

Last Update Posted (Actual)

February 20, 2024

Last Update Submitted That Met QC Criteria

February 15, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 23-1116

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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