Liposomal Bupivacaine Versus Interscalene Nerve Block

NCT03929146 | Completed Phase 4 FDA Drug

• 1 other identifier: 2017-7698
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (5)

• 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

Study Arms (2)

Liposomal Bupivacaine

EXPERIMENTAL

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

Interscalene Nerve Block

OTHER

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

Interventions

Exparel DRUG

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

Liposomal Bupivacaine

Interscalene Nerve Block PROCEDURE

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

Interscalene Nerve Block

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Cincinnati: lead

Study Sites (1)

University of Cincinnati Medical Center

Cincinnati, Ohio, 45267, United States

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Adam Schumaier, MD

  University of Cincinnati, Department of Orthopaedics and Sports Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 15, 2019
• First Posted: April 26, 2019
• Study Start: February 5, 2019
• Primary Completion: November 1, 2022
• Study Completion: November 1, 2022
• Last Updated: May 10, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)