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Liposomal Bupivacaine Versus Interscalene Nerve Block

NCT03929146 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 76

Last updated 2023-05-10

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • University of Cincinnati

    lead OTHER

Principal Investigators

  • Adam Schumaier, MD · University of Cincinnati, Department of Orthopaedics and Sports Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-02-05
Primary Completion
2022-11-01
Completion
2022-11-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03929146 on ClinicalTrials.gov