NCT03587636

Liposome Bupivacaine Interscalene Total Shoulder

Prospective Randomized Controlled Trial Comparing Liposomal Bupivacaine to Bupivacaine Interscalene Blocks for Total Shoulder Arthroplasty Surgery; a Pilot Study

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 77 (actual)
• Sponsor: University of Minnesota · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This is a randomized prospective outcomes study comparing two groups of patients. One group will receive liposomal bupivacaine plus bupivacaine and the other will receive bupivacaine alone in interscalene blocks when undergoing total shoulder arthroplasty. The purpose of the study is to determine if LB plus bupivacaine provides superior pain control compared to bupivacaine alone when injected in an interscalene block for patients undergoing total shoulder arthroplasty surgery.

Detailed description

Liposomal bupivacaine (LB) is a long acting local anesthetic. It is liposome encapsulated bupivacaine which allows for prolonged release of bupivacaine over a 72-hour period. Bupivacaine is a medium acting local anesthetic which provides between 6 and 24 hours of analgesia when used in a peripheral nerve block. Both medications are standard of care for use in interscalene blocks here at the U of MN. LB has not been adequately studied in peripheral nerve blocks and has yet to be studied for use in interscalene blocks for Total Shoulder Arthroplasty (TSA) patients. It has been studied in Rotator Cuff Repairs (RCR) surgery and showed superior analgesia compared to bupivacaine. The purpose of the study is to determine if LB plus bupivacaine provides superior pain control compared to bupivacaine alone when injected in an interscalene block for patients undergoing total shoulder arthroplasty surgery.

Conditions

• Acute Pain

Interventions

Type	Name	Description
DRUG	liposome bupivacaine	interscalene block with liposomal bupivacaine plus bupivacaine
DRUG	Bupivacaine	interscalene block with bupivacaine

Timeline

• Start date: 2018-09-17
• Primary completion: 2021-03-15
• Completion: 2021-03-17
• First posted: 2018-07-16
• Last updated: 2022-05-02
• Results posted: 2022-05-02

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study