Liposomal Bupivacaine Versus Interscalene Nerve Block

University of Cincinnati

Status and phase: Completed; Phase 4

Conditions: Pain, Postoperative

Treatments: Procedure: Interscalene Nerve Block; Drug: Exparel

Study type: Interventional

Funder types: Other

Identifiers

NCT03929146

2017-7698

Details and patient eligibility

About

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.

Enrollment: 76 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• patients who are older than 18 years
• patients undergoing reverse total shoulder arthroplasty

Exclusion criteria

• pregnancy
• inability to provide informed consent
• deemed unreliable for follow-up survey completion
• individuals who do not speak English
• those who have an allergy to the study medications (ropivicaine, bupivicaine) or have clinically significant hepatic disease

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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76 participants in 2 patient groups

Liposomal Bupivacaine

Experimental group

Description:

Patients in this group will receive a single intra-operative injection of liposomal bupivacaine near the surgical site (40 ml total: consisting of 20 ml 1.3% liposomal bupivacaine and 20 ml normal saline).

Treatment:

Drug: Exparel

Interscalene Nerve Block

Other group

Description:

Patients in this group will receive a single pre-operative interscalene nerve block in the neck/shoulder consisting of 30 ml 0.5% ropivacaine.

Treatment:

Procedure: Interscalene Nerve Block