NCT03929146

Liposomal Bupivacaine Versus Interscalene Nerve Block

Randomized Trial Comparing Interscalene Nerve Block to Liposomal Bupivacaine For Pain Management Following Reverse Total Shoulder Arthroplasty (RTSA)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 76 (actual)
• Sponsor: University of Cincinnati · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The aim of this study is to compare two different pain management interventions in patients undergoing reverse total shoulder arthroplasty. The two interventions are 1) pre-operative interscalene nerve block and 2) intraoperative injection of liposomal bupivacaine (Exparel, Pacira Pharmaceuticals, Parsippany NJ). Specifically, the primary aims of this study are to compare these two interventions on the following: post-operative opioid consumption, pain scores, and patient satisfaction. Additionally, the investigators want to determine if psychological factors, catastrophizing and resilience, are associated with post-operative pain control and satisfaction. The investigators' hypothesis is that the two interventions will have similar pain control efficacy and that the liposomal bupivacaine group will experience faster post-operative recovery, earlier discharge, and improved satisfaction. The investigators also expect patient catastrophizing and resilience to significantly predict the degree of post-operative pain and level of patient satisfaction.

Conditions

• Pain, Postoperative

Interventions

Type	Name	Description
DRUG	Exparel	Patients will receive a local injection of liposomal bupivacaine near the end of their shoulder arthroplasty operation.
PROCEDURE	Interscalene Nerve Block	Patients will undergo a pre-operative interscalene nerve block performed by the anesthesiology team.

Timeline

• Start date: 2019-02-05
• Primary completion: 2022-11-01
• Completion: 2022-11-01
• First posted: 2019-04-26
• Last updated: 2023-05-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study