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

June 28, 2012
May 19, 2014
March 2010
August 2011   (final data collection date for primary outcome measure)
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
Pain intensity [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01632215 on ClinicalTrials.gov Archive Site
Chronic Pain [ Time Frame: 6 months ] [ Designated as safety issue: No ]
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: Double Blind (Subject, 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
Both
18 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01632215
CEP 0223/09
No
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