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

Distal Radius Fractures Clinical Trial

— Vs  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06179004
• Other study ID #: 23-1116
• Status: Recruiting
• Phase: Phase 3
• Start date: April 10, 2024
• Est. completion date: May 2025

Study information

• Verified date: June 2024
• Source: University of North Carolina, Chapel Hill
• Contact: Jay Schoenherr, MD
• Phone: 9199515062
• Email: jay_schoenherr[@]med.unc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: May 2025
• Est. primary completion date: May 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Distal Radius Fractures
• Fractures, Bone
• Radius Fractures
• Wrist Fractures

Intervention

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
• 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.

Locations

Country	Name	City	State
United States	UNC Chapel Hill	Chapel Hill	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill

Country where clinical trial is conducted

United States, 

References & Publications (9)

Abell DJ, Barrington MJ. Pneumothorax after ultrasound-guided supraclavicular block: presenting features, risk, and related training. Reg Anesth Pain Med. 2014 Mar-Apr;39(2):164-7. doi: 10.1097/AAP.0000000000000045. — View Citation

Brown CA, Ghanouni A, Williams R, Payne SH, Ghareeb PA. Safety and Efficacy of Liposomal Bupivacaine Supraclavicular Nerve Blocks in Open Treatment of Distal Radius Fractures: A Perioperative Pain Management Protocol. Ann Plast Surg. 2023 Jun 1;90(6S Supp — View Citation

Chazapis M, Walker EM, Rooms MA, Kamming D, Moonesinghe SR. Measuring quality of recovery-15 after day case surgery. Br J Anaesth. 2016 Feb;116(2):241-8. doi: 10.1093/bja/aev413. — View Citation

D'Souza RS, Johnson RL. Supraclavicular Block. [Updated 2023 Jan 8]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2023 Jan-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK519056/

Hussain N, Brull R, Sheehy B, Essandoh MK, Stahl DL, Weaver TE, Abdallah FW. Perineural Liposomal Bupivacaine Is Not Superior to Nonliposomal Bupivacaine for Peripheral Nerve Block Analgesia. Anesthesiology. 2021 Feb 1;134(2):147-164. doi: 10.1097/ALN.000 — View Citation

Myles PS, Myles DB, Galagher W, Chew C, MacDonald N, Dennis A. Minimal Clinically Important Difference for Three Quality of Recovery Scales. Anesthesiology. 2016 Jul;125(1):39-45. doi: 10.1097/ALN.0000000000001158. — View Citation

Myles PS, Shulman MA, Reilly J, Kasza J, Romero L. Measurement of quality of recovery after surgery using the 15-item quality of recovery scale: a systematic review and meta-analysis. Br J Anaesth. 2022 Jun;128(6):1029-1039. doi: 10.1016/j.bja.2022.03.009 — View Citation

Rundgren J, Mellstrand Navarro C, Ponzer S, Regberg A, Serenius S, Enocson A. Regional or General Anesthesia in the Surgical Treatment of Distal Radial Fractures: A Randomized Clinical Trial. J Bone Joint Surg Am. 2019 Jul 3;101(13):1168-1176. doi: 10.210 — View Citation

Schoenherr JW, Gonzalez M, Serrano R, Park M, Lee Z, Cobb K, Howard C, Flynn D, Li Q, Grant S, Bullard T. Quality of Recovery After Rotator Cuff Repair With Interscalene Liposomal Bupivacaine Versus Interscalene Nerve Catheter. Orthop J Sports Med. 2022 N — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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