Preoperative Gabapentine for Carpal Tunnel

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Rioko Kimiko Sakata, Federal University of São Paulo
ClinicalTrials.gov Identifier:
NCT01632215
First received: June 28, 2012
Last updated: May 19, 2014
Last verified: May 2014
  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: Double Blind (Subject, 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 Federal University of São Paulo:

Primary Outcome Measures:
  • Pain Intensity [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01632215

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

No publications provided

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
Study First Received: June 28, 2012
Results First Received: February 24, 2014
Last Updated: May 19, 2014
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Federal University of São Paulo:
gabapentine
postoperative pain

Additional relevant MeSH terms:
Cumulative Trauma Disorders
Carpal Tunnel Syndrome
Median Neuropathy
Mononeuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Nerve Compression Syndromes
Sprains and Strains
Wounds and Injuries
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 24, 2014