Supraclavicular Bupivacaine Vs. Supraclavicular Liposomal Bupivacaine for Orthopedic Wrist Surgery

NCT ID: NCT06179004

Last Updated: 2025-10-24

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-10
• Study Completion Date: 2026-10-31

Brief Summary

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.

Detailed Description

Purpose: 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 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 orthopedic wrist surgery 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 orthopedic wrist procedures 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.

Conditions

Distal Radius Fractures; Wrist Fractures

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Supraclavicular Liposomal Bupivacaine group

This group will receive the liposomal bupivacaine

Group Type: EXPERIMENTAL

Liposomal bupivacaine

Intervention Type: DRUG

133mg Liposomal bupivacaine plus 10mL 0.5% bupivacaine administered in a supraclavicular single shot perineural injection

Supraclavicular Plain Bupivacaine group

This group will receive the plain bupivacaine

Group Type: ACTIVE_COMPARATOR

Bupivacaine Hydrochloride

Intervention Type: DRUG

20mL 0.25% bupivacaine administered in a supraclavicular single shot perineural injection

Interventions

Liposomal bupivacaine

133mg Liposomal bupivacaine plus 10mL 0.5% bupivacaine administered in a supraclavicular single shot perineural injection

Intervention Type: DRUG

Bupivacaine Hydrochloride

20mL 0.25% bupivacaine administered in a supraclavicular single shot perineural injection

Intervention Type: DRUG

Other Intervention Names

Exparel

Eligibility Criteria

Inclusion Criteria

• Age greater than or equal to 18
• Scheduled for orthopedic wrist surgery 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of North Carolina, Chapel Hill

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jay Schoenherr, MD

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina, Chapel Hill

Locations

UNC Chapel Hill

Chapel Hill, North Carolina, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Jay Schoenherr, MD

Role: CONTACT

jay_schoenherr@med.unc.edu

9199515062

Facility Contacts

Jay Schoenherr, MD

Role: primary

Jay_Schoenherr@med.unc.edu

919-951-5062

References

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.

Reference Type: RESULT

PMID: 24496168 (View on PubMed)

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 Suppl 4):S332-S336. doi: 10.1097/SAP.0000000000003464. Epub 2023 Jan 31.

Reference Type: RESULT

PMID: 36752544 (View on PubMed)

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.0000000000003651.

Reference Type: RESULT

PMID: 33372953 (View on PubMed)

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. Epub 2022 Apr 14.

Reference Type: RESULT

PMID: 35430086 (View on PubMed)

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: 10.2106/JBJS.18.00984.

Reference Type: RESULT

PMID: 31274718 (View on PubMed)

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 Nov 22;10(11):23259671221134819. doi: 10.1177/23259671221134819. eCollection 2022 Nov.

Reference Type: RESULT

PMID: 36458106 (View on PubMed)

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.

Reference Type: RESULT

PMID: 26787793 (View on PubMed)

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/

Reference Type: RESULT

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.

Reference Type: RESULT

PMID: 27159009 (View on PubMed)

Other Identifiers

23-1116

Identifier Type: -

Identifier Source: org_study_id