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Effect of Gabapentin on Sleep and Opioid Use Following Rotator Cuff Repair

Primary Purpose

Rotator Cuff Tears

Status
Not yet recruiting
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Gabapentin
Placebo
Sponsored by
Hughston Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Rotator Cuff Tears focused on measuring Rotator Cuff Repair, Gabapentin, Opioid Use

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: diagnosed traumatic or degenerative rotator cuff tear undergoing primary arthroscopic repair between the ages of 18 and 65 years old Exclusion Criteria: chronic pre-operative narcotic pain medication use undergoing superior capsular reconstruction / balloon interposition etc < 18 y/o or > 65 y/o bilateral rotator cuff tear currently taking prescribed sleep-aid medications history of fibromyalgia or chronic pain syndrome pain management patient narcolepsy diagnosis diagnosis of cervical radiculopathy reported non-shoulder pain interfering with sleep

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Placebo Comparator

    Experimental

    Arm Label

    Control

    Gabapentin

    Arm Description

    Patients in this arm will be receiving 100 mg placebo q8h for 2 days followed by 300 mg placebo q8h for 12 days. Patients will also receive 30 pills of hydrocodone-acetaminophen 5-325 mg q4-6h as needed.

    Patients in this arm will be receiving 100 mg gabapentin q8h for 2 days followed by 300 mg gabapentin q8h for 12 days. Patients will also receive 30 pills of hydrocodone-acetaminophen 5-325 mg q4-6h as needed.

    Outcomes

    Primary Outcome Measures

    Usage of Opioids for Pain Control
    Determined based on morphine milligram equivalents
    Change in Sleep Quality
    Determined with Patient-Reported Outcomes Measurement Information System Sleep Disturbance Scale (min: 8, max: 40, higher score represents worse sleep)

    Secondary Outcome Measures

    Change in Pain
    Determined with Visual Analog Scale (min: 0, max: 10, higher score represents more pain)
    Change in Functional Outcome (Based on Prior Baseline)
    Determined with Single Assessment Numerical Evaluation (min: 0, max: 100, higher score represents better outcome)
    Change in Functional Outcome (Based on Survey)
    Determined with American Shoulder and Elbow Surgeons Scores (min: 0, max: 100, higher score represents better outcome)

    Full Information

    First Posted
    March 21, 2023
    Last Updated
    April 4, 2023
    Sponsor
    Hughston Clinic
    Collaborators
    University of Alabama at Birmingham
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05800847
    Brief Title
    Effect of Gabapentin on Sleep and Opioid Use Following Rotator Cuff Repair
    Official Title
    Gabapentin Following Arthroscopic Rotator Cuff Repair: Evaluation of Postoperative Opioid Use and Sleep Quality
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    April 2023 (Anticipated)
    Primary Completion Date
    April 2024 (Anticipated)
    Study Completion Date
    July 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Hughston Clinic
    Collaborators
    University of Alabama at Birmingham

    4. Oversight

    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

    5. Study Description

    Brief Summary
    The goal of this clinical trial is to compare the effects of gabapentin in patients undergoing rotator cuff repair surgery. The main question it aims to answer is whether gabapentin can improve postoperative pain and sleep quality. Participants in this study will be randomized to either take gabapentin after surgery or a placebo after surgery.
    Detailed Description
    Perioperative gabapentin use has been established in prior literature to decrease postoperative opioid use; however, all of these studies have evaluated gabapentin given by an anesthesia team in the immediate pre- or intraoperative period. No known literature exists regarding scheduled post-operative oral gabapentin use in regards to pain control and opioid use. Sleep quality still tends to be a frequent concern associated with rotator cuff injury and shoulder surgery in general. The added known benefit of somnolence or drowsiness, in addition to aid in sleep, with use of gabapentin may also contribute to improved sleep quality following rotator cuff repair.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Rotator Cuff Tears
    Keywords
    Rotator Cuff Repair, Gabapentin, Opioid Use

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    130 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Control
    Arm Type
    Placebo Comparator
    Arm Description
    Patients in this arm will be receiving 100 mg placebo q8h for 2 days followed by 300 mg placebo q8h for 12 days. Patients will also receive 30 pills of hydrocodone-acetaminophen 5-325 mg q4-6h as needed.
    Arm Title
    Gabapentin
    Arm Type
    Experimental
    Arm Description
    Patients in this arm will be receiving 100 mg gabapentin q8h for 2 days followed by 300 mg gabapentin q8h for 12 days. Patients will also receive 30 pills of hydrocodone-acetaminophen 5-325 mg q4-6h as needed.
    Intervention Type
    Drug
    Intervention Name(s)
    Gabapentin
    Intervention Description
    Gabapentin will be administered for 2 days at 100 mg q8h for titration to avoid side effects. The next 12 days, gabapentin will be taken at 300 mg q8h.
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    Placebo will follow the same dosing pattern as gabapentin to allow for blinding. Placebo will be encapsulated with a gelatin capsule to mimic the look of gabapentin.
    Primary Outcome Measure Information:
    Title
    Usage of Opioids for Pain Control
    Description
    Determined based on morphine milligram equivalents
    Time Frame
    Up to 12 weeks postoperatively
    Title
    Change in Sleep Quality
    Description
    Determined with Patient-Reported Outcomes Measurement Information System Sleep Disturbance Scale (min: 8, max: 40, higher score represents worse sleep)
    Time Frame
    Up to 12 weeks postoperatively
    Secondary Outcome Measure Information:
    Title
    Change in Pain
    Description
    Determined with Visual Analog Scale (min: 0, max: 10, higher score represents more pain)
    Time Frame
    Up to 12 weeks postoperatively
    Title
    Change in Functional Outcome (Based on Prior Baseline)
    Description
    Determined with Single Assessment Numerical Evaluation (min: 0, max: 100, higher score represents better outcome)
    Time Frame
    Up to 12 weeks postoperatively
    Title
    Change in Functional Outcome (Based on Survey)
    Description
    Determined with American Shoulder and Elbow Surgeons Scores (min: 0, max: 100, higher score represents better outcome)
    Time Frame
    Up to 12 weeks postoperatively

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: diagnosed traumatic or degenerative rotator cuff tear undergoing primary arthroscopic repair between the ages of 18 and 65 years old Exclusion Criteria: chronic pre-operative narcotic pain medication use undergoing superior capsular reconstruction / balloon interposition etc < 18 y/o or > 65 y/o bilateral rotator cuff tear currently taking prescribed sleep-aid medications history of fibromyalgia or chronic pain syndrome pain management patient narcolepsy diagnosis diagnosis of cervical radiculopathy reported non-shoulder pain interfering with sleep
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Brent A Ponce, MD
    Phone
    2059306722
    Email
    bponce@hughston.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Cholly Minton
    Phone
    7063246661
    Email
    cminton@hughston.com

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Effect of Gabapentin on Sleep and Opioid Use Following Rotator Cuff Repair

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