NCT05068960

Postoperative Pain Control in Total Shoulder Arthroplasty

A Prospective Randomized Controlled Trial to Evaluate the Efficacy of an Interscalene Brachial Plexus Block and Multimodal Analgesia With and Without Liposomal Bupivacaine for Postoperative Pain Control in Total Shoulder Arthroplasty

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Scripps Clinic · Academic / Other
• Sex: All
• Age: 50 Years – 85 Years
• Healthy volunteers: Accepted

Summary

A double blind, prospective, randomized trial to evaluate postoperative pain, narcotic use, patient satisfaction, and function among shoulder arthroplasty patients receiving interscalene block with and without the addition of liposomal bupivacaine.

Detailed description

In order to reduce narcotic abuse potential, orthopaedic surgeons have explored multimodal pain regimens in addition to regional anesthesia to improve postoperative pain control. One commonly used intervention to reduce postoperative shoulder pain has been the interscalene brachial plexus block. This block provides significant pain relief for shoulder procedures, but has been limited to less than 24 hours even with long acting anesthetics. In the setting of shoulder arthroplasty, this short-term pain control often leads to the need for increased narcotic pain medication. Since shoulder arthroplasty has been steadily increasing in the United States with an annual growth rate of 10.6%, it is imperative to control patients' postoperative pain without increasing their risk for opiate abuse. A potential method for achieving this is by using liposomal bupivacaine in the interscalene blocks. This study is a double blind, prospective, randomized trial to evaluate the postoperative pain profiles among shoulder arthroplasty patients receiving interscalene block with and without the addition of liposomal bupivacaine. The purpose of this study is to determine if patients undergoing shoulder arthroplasty with an interscalene brachial plexus block with liposomal bupivacaine (study group) or without liposomal bupivacaine (control group) will have differences in postoperative opiate consumption, patient-reported pain, satisfaction with surgery, and shoulder function.

Conditions

• Total Shoulder Arthroplasty

Interventions

Type	Name	Description
DRUG	Liposomal bupivacaine	Addition of liposomal bupivacaine to the interscalene block for extended pain control following total shoulder arthroplasty
DRUG	Bupivacaine	Interscalene block with bupivacaine for pain control following total shoulder arthroplasty

Timeline

• Start date: 2021-03-01
• Primary completion: 2025-02-01
• Completion: 2025-02-01
• First posted: 2021-10-06
• Last updated: 2025-03-21

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study