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Liposomal Bupivacaine in Rotator Cuff Repair

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03738696
Recruitment Status : Recruiting
First Posted : November 13, 2018
Last Update Posted : November 16, 2021
Sponsor:
Collaborator:
Pacira Pharmaceuticals, Inc
Information provided by (Responsible Party):
Amit Momaya, University of Alabama at Birmingham

Study Description
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Brief Summary:
To assess the efficacy of interscalene liposomal bupivacaine in controlling postoperative pain scores, oral morphine equivalents and sleep quality after arthroscopic rotator cuff repair surgery as compared to interscalene catheter.

Condition or disease Intervention/treatment Phase
Rotator Cuff Injury Drug: Exparel Drug: Ropivacaine Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy of Liposomal Bupivacaine in Arthroscopic Rotator Cuff Repair
Actual Study Start Date : December 15, 2019
Estimated Primary Completion Date : December 1, 2022
Estimated Study Completion Date : December 1, 2022

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Liposomal bupivacaine Interscalene Block

Interscalene block:

  • 10cc (133mg) liposomal bupivacaine;PLUS
  • 10cc 0.25% bupivacaine
 Drug: Exparel
A long-acting injectable sodium channel blocker bound to lipid that is indicated in controlling postoperative pain
Other Name: liposomal bupivacaine
Active Comparator: Ropivacaine Interscalene Catheter
  • 20cc 0.25% bupivacaine interscalene block; PLUS
  • Ropivacaine 0.25% interscalene catheter (6ml/hr for 48hrs)
 Drug: Ropivacaine
A short-acting injectable sodium channel blocker bound to lipid that is indicated in controlling postoperative pain


Outcome Measures
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Primary Outcome Measures :
  1. Postoperative pain scores [ Time Frame: 0-96 hrs postoperative ]
    Visual analog pain scores after operation [0-10, with 10 being the worst pain]


Secondary Outcome Measures :
  1. Postoperative oral morphine equivalents [ Time Frame: 0-96 hrs postoperative ]
    oral morphine equivalents of all opioid-containing medications received

  2. Analgesia Satisfaction [ Time Frame: 0-96 hrs postoperative ]
    Likert scale of analgesia satisfaction [0-5, with 5 being the most satisfied]

  3. Analgesia Complications [ Time Frame: 0-96 hrs postoperative ]
    Complications resulting from the method of analgesia utilized

  4. Sleep quality [ Time Frame: 0-96 hrs postoperative ]
    Likert scale of sleep quality [0-5, with 5 being the most satisfied]

  5. Hours of painless sleep [ Time Frame: 0-96 hrs postoperative ]
    Hours of sleep uninterrupted by pain [numerical, hours]


Eligibility Criteria
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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Undergoing outpatient arthroscopic rotator cuff repair
  • Greater than or equal to 19 years of age at the time of surgery

Exclusion Criteria:

  • Planned operative fixation of the biceps tendon or acromioclavicular joint
  • Opioid use 6 weeks before surgery
  • Gabapentin use 6 weeks before surgery
  • History of prior shoulder surgery on the operative limb
  • Severe pulmonary dysfunction
  • Diagnosis of chronic pain, fibromyalgia or other somatosensory disorder(s)
  • History of radicular pain or neuropathy in the operative limb
  • Patients who are currently incapacitated for medical decision making
Contacts and Locations
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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): NCT03738696


Contacts
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Contact: Alexandra M Arguello, BS 7023754975 aarguello@uabmc.edu
Contact: Jun Kit He, BA jkhe@uabmc.edu

Locations
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United States, Alabama
UAB Hospital-Highlands Recruiting
Birmingham, Alabama, United States, 35205
Contact: Christy Acton    205-996-6781    christyacton@uabmc.edu   
Sponsors and Collaborators
University of Alabama at Birmingham
Pacira Pharmaceuticals, Inc
More Information
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Responsible Party: Amit Momaya, Associate Professor, Orthopaedic Surgery, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT03738696    
Other Study ID Numbers: IRB-300002544
First Posted: November 13, 2018    Key Record Dates
Last Update Posted: November 16, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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.: Yes
Additional relevant MeSH terms:
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Rotator Cuff Injuries
Rupture
Wounds and Injuries
Shoulder Injuries
Tendon Injuries
Bupivacaine
Ropivacaine
 Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents