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Liposomal Bupivacaine Versus Interscalene Nerve Block

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ClinicalTrials.gov Identifier: NCT03929146
Recruitment Status : Recruiting
First Posted : April 26, 2019
Last Update Posted : April 26, 2019
Sponsor:
Information provided by (Responsible Party):
Adam Schumaier, University of Cincinnati

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 Intervention/treatment Phase
Pain, Postoperative Drug: Exparel Procedure: Interscalene Nerve Block Phase 4

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Study Type : Interventional  (Clinical Trial)
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 5, 2019
Estimated Primary Completion Date : December 1, 2021
Estimated Study Completion Date : December 1, 2021

Resource links provided by the National Library of Medicine


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.

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.




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.



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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
  • patients undergoing primary shoulder replacement secondary to a traumatic fracture
  • those who have an allergy to the study medications (ropivicaine, bupivicaine) or have clinically significant hepatic disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03929146


Contacts
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Contact: Adam Schumaier, MD 513-558-4516 adam.schumaier@uc.edu
Contact: Brian Grawe, MD 513-558-4516 brian.grawe@uc.edu

Locations
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United States, Ohio
University of Cincinnati Medical Center Recruiting
Cincinnati, Ohio, United States, 45267
Contact: Adam Schumaier    513-558-1109    adam.schumaier@uc.edu   
Contact: Brian Grawe    5135581109    grawebn@ucmail.uc.edu   
Sponsors and Collaborators
University of Cincinnati
Investigators
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Principal Investigator: Adam Schumaier, MD University of Cincinnati, Department of Orthopaedics and Sports Medicine

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Responsible Party: Adam Schumaier, Principal Investigator, 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 26, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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

Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents