Liposome Bupivacaine Interscalene Total Shoulder

Phase 2

Completed

• Conditions: Acute Pain
• Interventions: Drug: liposome bupivacaine; Drug: Bupivacaine

• Registration Number: NCT03587636
• Lead Sponsor: University of Minnesota

Brief 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.

Study Timeline

• Study First Submitted: 2018-06-20
• Study First Submitted QC: 2018-07-13
• Study First Posted: 2018-07-16
• Study Start: 2018-09-17
• Primary Completion: 2021-03-15
• Study Completion: 2021-03-17
• Results First Submitted: 2022-03-21
• Status Verified: 2022-04
• Results First Submitted QC: 2022-04-28
• Last Update Submitted: 2022-04-28
• Results First Posted: 2022-05-02
• Last Update Posted: 2022-05-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 77

Inclusion Criteria

• All adult patients aged greater than 18 years of age that are undergoing total or reverse total shoulder arthroplasty

Exclusion Criteria

• Patients with allergy to local anesthetics, daily use of opioids for more than 3 weeks prior to surgery, patient refusal, patient with coagulopathy, non-english speaking patients, and those who do not have access to a telephone.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Liposome bupivacaine interscalene block	liposome bupivacaine	10 mL of liposome bupivacaine and 10 mL of 0.5% bupivacaine will be injected at the interscalene brachial plexus under ultrasound guidance
bupivacaine interscalene block	Bupivacaine	20 mL of 0.5% bupivacaine will be injected at the interscalene brachial plexus under ultrasound guidance.

Primary Outcome Measures

Name	Time	Method
Total Opioid Use	From end of surgery through 72 hours after end of surgery	total amount of opioid use from after surgery through 72 hours. Opioids normalized to morphine equivalents

Secondary Outcome Measures

Name	Time	Method
Total Maximum Pain Scores f	time from end of surgery through 72 hours after end of surgery	Sum total of maximal pain scores through 72 horus after surgery. Pain scores reported on a numerical rating scale from 0-10. 10 is worse and 0 is best

Trial Locations

Locations (1)

University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States