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Preoperative Gabapentine for Carpal Tunnel

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. Read our disclaimer for details. Identifier: NCT01632215
Recruitment Status : Completed
First Posted : July 2, 2012
Results First Posted : June 4, 2014
Last Update Posted : March 5, 2019
Information provided by (Responsible Party):
Rioko Kimiko Sakata, Federal University of São Paulo

Brief Summary:
The purpose of this study was to evaluate the postoperative analgesic effect of preoperative gabapentine for carpal tunnel syndrome surgery.

Condition or disease Intervention/treatment Phase
Carpal Tunnel Syndrome Drug: Gabapentine Other: Sugar pill Phase 3

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Preoperative Gabapentine for Carpal Tunnel Syndrome
Actual Study Start Date : March 2010
Actual Primary Completion Date : August 2011
Actual Study Completion Date : March 2012

Arm Intervention/treatment
Experimental: preoperative gabapentine,
Drug: Gabapentine
Gabapentine 600 mg 01 dose
Other Name: Anticonvulsant

Placebo Comparator: sugar pill
Placebo group
Other: Sugar pill
Sugar pill 01 dose

Primary Outcome Measures :
  1. Pain Intensity [ Time Frame: 6 months ]
    Numerical score from 0 to 10; zero means no pain and 10 is the more intense pain

Secondary Outcome Measures :
  1. Chronic Pain [ Time Frame: 6 months ]

    Numerical score from 0 to 10 scale:

    Minimum value= zero (means no pain) and Maximum value= 10 (more intense pain)

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • carpal tunnel syndrome

Exclusion Criteria:

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

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 identifier (NCT number): NCT01632215

Sponsors and Collaborators
Federal University of São Paulo
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Study Director: Rioko K Sakata, PhD Universidade Federal de São Paulo

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Responsible Party: Rioko Kimiko Sakata, Pain Clinic Director, Federal University of São Paulo Identifier: NCT01632215    
Other Study ID Numbers: CEP 0223/09
First Posted: July 2, 2012    Key Record Dates
Results First Posted: June 4, 2014
Last Update Posted: March 5, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Rioko Kimiko Sakata, Federal University of São Paulo:
postoperative pain
Additional relevant MeSH terms:
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Carpal Tunnel Syndrome
Pathologic Processes
Median Neuropathy
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Nerve Compression Syndromes
Cumulative Trauma Disorders
Sprains and Strains
Wounds and Injuries