NCT05005260

Liposomal Bupivacaine Single-Injection Interscalene Block vs. Continuous Interscalene Block for Primary Total Shoulder Arthroplasty

Prospective, Randomized Clinical Trial Comparing Analgesic Efficacy of Liposomal Bupivacaine Single-Injection Interscalene Blockade to Continuous Interscalene Blockade for Patients Undergoing Primary Total Shoulder Arthroplasty

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 88 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study aims to assess analgesia efficacy between liposomal bupivacaine single injection interscalene blockade vs. continuous interscalene nerve block for patients undergoing primary total shoulder arthroplasty.

Conditions

• Pain, Postoperative
• Brachial Plexus Block

Interventions

Type	Name	Description
DRUG	Bupivacaine HCl	Subjects randomized to the continuous interscalene nerve block group will receive a loading dose of 15-20 mL bupivacaine HCl 0.5% followed by a continuous catheter infusion of bupivacaine 0.2% at 8 mL per hour for 72 hours.
DRUG	Liposomal bupivacaine + Bupivacaine Hcl 0.5% Inj	Subjects will receive a one-time interscalene nerve block injection of 5 mL of bupivacaine 0.5% (25 mg) admixed with 10 mL of liposomal bupivacaine (133 mg).

Timeline

• Start date: 2021-10-14
• Primary completion: 2023-03-18
• Completion: 2023-03-18
• First posted: 2021-08-13
• Last updated: 2024-05-07
• Results posted: 2023-12-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study