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Liposomal Bupivacaine Versus Interscalene Nerve Block

  • Clinicaltrials.gov identifier

    NCT03929146

  • Recruitment Status

    Recruiting

  • First Posted

    April 26, 2019

  • Last update posted

    April 28, 2021

Study Description

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.

  • Condition or Disease:Pain, Postoperative
  • Intervention/Treatment: Drug: Exparel
    Procedure: Interscalene Nerve Block
  • Phase: Phase 4

Detailed Description

N/A

Study Design

  • Study Type: Interventional
  • Estimated Enrollment: 76 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: None (Open Label) ()
  • Primary Purpose: Treatment
  • Official Title: Randomized Trial Comparing Interscalene Nerve Block to Liposomal Bupivacaine For Pain Management Following Reverse Total Shoulder Arthroplasty (RTSA)
  • Actual Study Start Date: February 2019
  • Estimated Primary Completion Date: December 2021
  • Estimated Study Completion Date: December 2021

Arms and interventions

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.

Outcome Measures

  • Primary Outcome Measures: 1. Opioid Consumption [ Time Frame: 72 hours post-operatively ]
    Post-operative use of opioid pain medications, measured in morphine equivalents (higher scores are worse)
  • 2. Visual Analog Scale Pain Scores [ Time Frame: 72 hours post-operatively ]
    Post-operative level of pain measured from 0 (no pain) to 10 (worst pain)
  • 3. Patient Satisfaction: Rating [ Time Frame: 72 hours post-operatively ]
    Rating of satisfaction with post-operative pain management from 0 (least satisfied) to 10 (most satisfied)
  • 4. Relationship between catastrophizing, pain, and patient satisfaction [ Time Frame: Catastrophizing will be measured pre-operatively ]
    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.
  • 5. Relationship between resilience, pain, and patient satisfaction [ Time Frame: Resilience will be measured pre-operatively ]
    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.

Eligibility Criteria

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

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

Contacts and Locations

Contacts

Contact: Adam Schumaier, MD 513-558-4516 adam.schumaier@uc.edu

Contact: Brian Grawe, MD 513-558-4516 brian.grawe@uc.edu

Locations

United States, Ohio
University of Cincinnati Medical Center
Cincinnati

Sponsors and Collaborators

University of Cincinnati

Investigators

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

More Information

  • Responsible Party: University of Cincinnati
  • ClinicalTrials.gov Identifier: NCT03929146 History of Changes
  • Other Study ID Numbers: 2017-7698
  • First Posted: April 26, 2019 Key Record Dates
  • Last Update Posted: April 28, 2021
  • Last Verified: April 2021
  • Individual Participant
    Data (IPD) Sharing
    Statement:

  • Plan to Share IPD: No
  • 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.: Yes
  • Additional relevant MeSH terms: Pain, Postoperative