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Completed

NCT Number: NCT03929146

Liposomal Bupivacaine Versus Interscalene Nerve Block

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Cincinnati Medical Center

Cincinnati, Ohio, 45267, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exparel

Drug

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

Interscalene nerve block

Procedure

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

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Cincinnati

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Apr 26, 2019
Registry last updated
May 10, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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