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Liposomal Bupivacaine in Rotator Cuff Repair

Sponsor
University of Alabama at Birmingham (Other)
Overall Status
Recruiting
CT.gov ID
NCT03738696
Collaborator
Pacira Pharmaceuticals, Inc (Industry)
80
Enrollment
1
Location
2
Arms
35.5
Anticipated Duration (Months)
2.3
Patients Per Site Per Month

Study Details

Study Description

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
Phase 4

Study Design

Study Type:
Interventional
Anticipated 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 :
Dec 15, 2019
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

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 Names:
  • 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

    Primary Outcome Measures

    1. Postoperative pain scores [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 [0-96 hrs postoperative]

      oral morphine equivalents of all opioid-containing medications received

    2. Analgesia Satisfaction [0-96 hrs postoperative]

      Likert scale of analgesia satisfaction [0-5, with 5 being the most satisfied]

    3. Analgesia Complications [0-96 hrs postoperative]

      Complications resulting from the method of analgesia utilized

    4. Sleep quality [0-96 hrs postoperative]

      Likert scale of sleep quality [0-5, with 5 being the most satisfied]

    5. Hours of painless sleep [0-96 hrs postoperative]

      Hours of sleep uninterrupted by pain [numerical, hours]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 UAB Hospital-Highlands Birmingham Alabama United States 35205

    Sponsors and Collaborators

    • University of Alabama at Birmingham
    • Pacira Pharmaceuticals, Inc

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    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:
    Nov 13, 2018
    Last Update Posted:
    Nov 16, 2021
    Last Verified:
    Nov 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    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:
    Rotator Cuff Injuries
    Bupivacaine
    Ropivacaine

    Study Results

    No Results Posted as of Nov 16, 2021