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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
June 28, 2012
July 2, 2012
February 24, 2014
June 4, 2014
June 4, 2014
March 2010
August 2011   (Final data collection date for primary outcome measure)
Pain Intensity [ Time Frame: 6 months ]
Numerical score from 0 to 10; zero means no pain and 10 is the more intense pain
Pain Intensity [ Time Frame: 3 months ]
Complete list of historical versions of study NCT01632215 on ClinicalTrials.gov Archive Site
Chronic Pain [ Time Frame: 6 months ]
Number of neuropathic pain and complex regional syndrome pain after 6 months
Not Provided
Not Provided
Not Provided
 
Preoperative Gabapentine for Carpal Tunnel
Effect of Preoperative Gabapentine for Carpal Tunnel Syndrome
The purpose of this study was to evaluate the postoperative analgesic effect of preoperative gabapentine for carpal tunnel syndrome surgery.

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

Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Carpal Tunnel Syndrome
  • Drug: Gabapentine
    Gabapentine 600 mg 01 dose
    Other Name: Anticonvulsant
  • Other: Sugar pill
    Sugar pill 01 dose
  • Experimental: preoperative gabapentine,
    Gabapentine
    Intervention: Drug: Gabapentine
  • Placebo Comparator: sugar pill
    Placebo group
    Intervention: Other: Sugar pill
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
March 2012
August 2011   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • carpal tunnel syndrome

Exclusion Criteria:

  • disorientation, psychiatric disease, myocardial ischemia, hypertension, arrhythmia, another pain syndrome, drug user, and pregnant
Sexes Eligible for Study: All
18 Years to 60 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT01632215
CEP 0223/09
No
Not Provided
Not Provided
Rioko Kimiko Sakata, Federal University of São Paulo
Federal University of São Paulo
Not Provided
Study Director: Rioko K Sakata, PhD Universidade Federal de São Paulo
Federal University of São Paulo
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP