Clinical trial

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

Name

2017-7698

Description

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.

Trial arms

Trial start

2019-02-05

Estimated PCD

2022-11-01

Trial end

2022-11-01

Status

Completed

Phase

Early phase I

Treatment

Exparel

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

Arms:

Liposomal Bupivacaine

Interscalene Nerve Block

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

Arms:

Interscalene Nerve Block

Size

Primary endpoint

Opioid Consumption

72 hours post-operatively

Visual Analog Scale Pain Scores

72 hours post-operatively

Patient Satisfaction: Rating

72 hours post-operatively

Relationship between catastrophizing, pain, and patient satisfaction

Catastrophizing will be measured pre-operatively

Relationship between resilience, pain, and patient satisfaction

Resilience will be measured pre-operatively

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 76, 'type': 'ACTUAL'}}

Updated at

2023-05-10

1 organization

1 product

2 indications

Organization

University of Cincinnati

Product

Exparel

Indication

Pain

Indication

Postoperative