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Preoperative Gabapentine for Carpal Tunnel

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01632215
First Posted: July 2, 2012
Last Update Posted: June 4, 2014
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.
Information provided by (Responsible Party):
Rioko Kimiko Sakata, Federal University of São Paulo
  Purpose
The purpose of this study was to evaluate the postoperative analgesic effect of preoperative gabapentine for carpal tunnel syndrome surgery.

Condition Intervention Phase
Carpal Tunnel Syndrome Drug: Gabapentine Other: Sugar pill Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Rioko Kimiko Sakata, Federal University of São Paulo:

Primary Outcome Measures:
  • 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:
  • Chronic Pain [ Time Frame: 6 months ]
    Number of neuropathic pain and complex regional syndrome pain after 6 months


Enrollment: 40
Study Start Date: March 2010
Study Completion Date: March 2012
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: preoperative gabapentine,
Gabapentine
Drug: Gabapentine
Gabapentine 600 mg 01 dose
Other Name: Anticonvulsant
Placebo Comparator: sugar pill
Placebo group
Other: Sugar pill
Sugar pill 01 dose

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

  Eligibility

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
Criteria

Inclusion Criteria:

  • carpal tunnel syndrome

Exclusion Criteria:

  • disorientation, psychiatric disease, myocardial ischemia, hypertension, arrhythmia, another pain syndrome, drug user, and pregnant
  Contacts and Locations
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
Investigators
Study Director: Rioko K Sakata, PhD Universidade Federal de São Paulo
  More Information

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 Submitted: June 28, 2012
First Posted: July 2, 2012
Results First Submitted: February 24, 2014
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:
gabapentine
postoperative pain

Additional relevant MeSH terms:
Cumulative Trauma Disorders
Syndrome
Carpal Tunnel Syndrome
Disease
Pathologic Processes
Median Neuropathy
Mononeuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Nerve Compression Syndromes
Sprains and Strains
Wounds and Injuries
Gabapentin
Anticonvulsants
gamma-Aminobutyric Acid
Analgesics
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