Liposomal Bupivacaine Versus Interscalene Nerve Block

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

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.

Study Overview

• Status: Completed
• Conditions: Pain, Postoperative
• Intervention / Treatment: Drug: Exparel; Procedure: Interscalene Nerve Block

• Study Type: Interventional
• Enrollment (Actual): 76
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Adam Schumaier, MD; Phone Number: 513-558-4516; Email: adam.schumaier@uc.edu
• Study Contact Backup: Name: Brian Grawe, MD; Phone Number: 513-558-4516; Email: brian.grawe@uc.edu

Study Locations

• United States
  • Ohio
    • Cincinnati, Ohio, United States, 45267
      • University of Cincinnati Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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).	Drug: Exparel; Patients will receive a local injection of liposomal bupivacaine near the end of their shoulder arthroplasty operation.
Other: 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.	Procedure: Interscalene Nerve Block; Patients will undergo a pre-operative interscalene nerve block performed by the anesthesiology team.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Opioid Consumption	Post-operative use of opioid pain medications, measured in morphine equivalents (higher scores are worse)	72 hours post-operatively
Visual Analog Scale Pain Scores	Post-operative level of pain measured from 0 (no pain) to 10 (worst pain)	72 hours post-operatively
Patient Satisfaction: Rating	Rating of satisfaction with post-operative pain management from 0 (least satisfied) to 10 (most satisfied)	72 hours post-operatively
Relationship between catastrophizing, pain, and patient satisfaction	The effect of patient catastrophizing (measured using the Pain Catastrophizing Scale) on post-operative pain control and satisfaction. The Pain Catastrophizing Scale measures how individuals psychologically respond to pain and hardship, and it ranges from a minimum score of 0 to a maximum score of 52. Higher scores on the Pain Catastrophizing Scale indicate more catastrophic thinking. The patients' catastrophizing scores will be correlated with their post-operative pain scores and their satisfaction scores. A correlation closer to -1 or 1 (correlations range from -1 to 1) indicates a stronger relationship between catastrophizing with pain control and satisfaction.	Catastrophizing will be measured pre-operatively
Relationship between resilience, pain, and patient satisfaction	The effect of patient resilience (measured using the Brief Resilience Scale) on post-operative pain control and satisfaction. The Brief Resilience Scale measures how individuals psychologically respond to pain and hardship, and it ranges from a minimum score of 1 to a maximum score of 5. Higher scores on the Brief Resilience Scale indicate greater resilience. The patients' resilience scores will be correlated with their post-operative pain scores and their satisfaction scores. A correlation closer to -1 or 1 (correlations range from -1 to 1) indicates a stronger relationship between resilience with pain control and satisfaction.	Resilience will be measured pre-operatively

Collaborators and Investigators

• Sponsor: University of Cincinnati
• Investigators: Principal Investigator: Adam Schumaier, MD, University of Cincinnati, Department of Orthopaedics and Sports Medicine

Study record dates

Study Major Dates

• Study Start (Actual): February 5, 2019
• Primary Completion (Actual): November 1, 2022
• Study Completion (Actual): November 1, 2022

Study Registration Dates

• First Submitted: April 15, 2019
• First Submitted That Met QC Criteria: April 23, 2019
• First Posted (Actual): April 26, 2019

Study Record Updates

• Last Update Posted (Actual): May 10, 2023
• Last Update Submitted That Met QC Criteria: May 8, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: 2017-7698

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No