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Preoperative Gabapentine for Carpal Tunnel

Primary Purpose

Carpal Tunnel Syndrome

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Gabapentine
Sugar pill
Sponsored by
Federal University of São Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carpal Tunnel Syndrome focused on measuring gabapentine, postoperative pain

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • carpal tunnel syndrome

Exclusion Criteria:

  • disorientation, psychiatric disease, myocardial ischemia, hypertension, arrhythmia, another pain syndrome, drug user, and pregnant

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    preoperative gabapentine,

    sugar pill

    Arm Description

    Gabapentine

    Placebo group

    Outcomes

    Primary Outcome Measures

    Pain Intensity
    Numerical score from 0 to 10; zero means no pain and 10 is the more intense pain

    Secondary Outcome Measures

    Chronic Pain
    Numerical score from 0 to 10 scale: Minimum value= zero (means no pain) and Maximum value= 10 (more intense pain)

    Full Information

    First Posted
    June 28, 2012
    Last Updated
    February 12, 2019
    Sponsor
    Federal University of São Paulo
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01632215
    Brief Title
    Preoperative Gabapentine for Carpal Tunnel
    Official Title
    Effect of Preoperative Gabapentine for Carpal Tunnel Syndrome
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    March 2010 (Actual)
    Primary Completion Date
    August 2011 (Actual)
    Study Completion Date
    March 2012 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Federal University of São Paulo

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The purpose of this study was to evaluate the postoperative analgesic effect of preoperative gabapentine for carpal tunnel syndrome surgery.
    Detailed Description
    There was studied 40 patients. Group 1 patients received 600 mg of gabapentin 1 hour before surgery; G2 received placebo 1 hour before surgery. Anesthesia was regional intravenous block. Postoperative analgesia when needed was with acetaminophen. If needed was administered codeine. The evaluation of neuropathic pain was made by DN4 questionnaire. Pain intensity was assessed by numeric scale at block and after 30min, 1h, 2h, 2wk, 4wk, 6m. It was noted the duration of analgesia, and the amount of acetaminophen and codeine. The statistical program used for analysis of the results was the Instat Graph

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Carpal Tunnel Syndrome
    Keywords
    gabapentine, postoperative pain

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    40 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    preoperative gabapentine,
    Arm Type
    Experimental
    Arm Description
    Gabapentine
    Arm Title
    sugar pill
    Arm Type
    Placebo Comparator
    Arm Description
    Placebo group
    Intervention Type
    Drug
    Intervention Name(s)
    Gabapentine
    Other Intervention Name(s)
    Anticonvulsant
    Intervention Description
    Gabapentine 600 mg 01 dose
    Intervention Type
    Other
    Intervention Name(s)
    Sugar pill
    Intervention Description
    Sugar pill 01 dose
    Primary Outcome Measure Information:
    Title
    Pain Intensity
    Description
    Numerical score from 0 to 10; zero means no pain and 10 is the more intense pain
    Time Frame
    6 months
    Secondary Outcome Measure Information:
    Title
    Chronic Pain
    Description
    Numerical score from 0 to 10 scale: Minimum value= zero (means no pain) and Maximum value= 10 (more intense pain)
    Time Frame
    6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: carpal tunnel syndrome Exclusion Criteria: disorientation, psychiatric disease, myocardial ischemia, hypertension, arrhythmia, another pain syndrome, drug user, and pregnant
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Rioko K Sakata, PhD
    Organizational Affiliation
    Universidade Federal de São Paulo
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Preoperative Gabapentine for Carpal Tunnel

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