Liposomal Bupivacaine Versus Interscalene Nerve Block

NCT ID: NCT03929146

Last Updated: 2023-05-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 76 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-02-05
• Study Completion Date: 2022-11-01

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Liposomal Bupivacaine

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).

Group Type: EXPERIMENTAL

Exparel

Intervention Type: DRUG

Patients will receive a local injection of liposomal bupivacaine near the end of their shoulder arthroplasty operation.

Interscalene Nerve Block

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

Group Type: OTHER

Interscalene Nerve Block

Intervention Type: PROCEDURE

Patients will undergo a pre-operative interscalene nerve block performed by the anesthesiology team.

Interventions

Exparel

Patients will receive a local injection of liposomal bupivacaine near the end of their shoulder arthroplasty operation.

Intervention Type: DRUG

Interscalene Nerve Block

Patients will undergo a pre-operative interscalene nerve block performed by the anesthesiology team.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Cincinnati

OTHER

Sponsor Role: lead

Responsible Party

Adam Schumaier

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Adam Schumaier, MD

Role: PRINCIPAL_INVESTIGATOR

University of Cincinnati, Department of Orthopaedics and Sports Medicine

Locations

University of Cincinnati Medical Center

Cincinnati, Ohio, United States

Countries

United States

Other Identifiers

2017-7698

Identifier Type: -

Identifier Source: org_study_id