We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu

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.
ClinicalTrials.gov Identifier: NCT01632215
Recruitment Status : Completed
First Posted : July 2, 2012
Results First Posted : June 4, 2014
Last Update Posted : June 4, 2014
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

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
Study Start Date : March 2010
Primary Completion Date : August 2011
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 ]
    Number of neuropathic pain and complex regional syndrome pain after 6 months

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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 ClinicalTrials.gov identifier (NCT number): NCT01632215

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

Responsible Party: Rioko Kimiko Sakata, Pain Clinic Director, Federal University of São Paulo
ClinicalTrials.gov Identifier: NCT01632215     History of Changes
Other Study ID Numbers: CEP 0223/09
First Posted: July 2, 2012    Key Record Dates
Results First Posted: June 4, 2014
Last Update Posted: June 4, 2014
Last Verified: May 2014

Keywords provided by Rioko Kimiko Sakata, Federal University of São Paulo:
postoperative pain

Additional relevant MeSH terms:
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
gamma-Aminobutyric Acid
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Excitatory Amino Acid Antagonists