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
Results First Received: February 24, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Carpal Tunnel Syndrome
Interventions: Drug: Gabapentine
Other: Sugar pill

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Preoperative Gabapentine,

Gabapentine

Gabapentine: Gabapentine 600 mg 01 dose

Sugar Pill

Placebo group

Sugar pill: Sugar pill 01 dose


Participant Flow:   Overall Study
    Preoperative Gabapentine,     Sugar Pill  
STARTED     20     20  
COMPLETED     18     19  
NOT COMPLETED     2     1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Preoperative Gabapentine,

Gabapentine

Gabapentine: Gabapentine 600 mg 01 dose

Sugar Pill

Placebo group

Sugar pill: Sugar pill 01 dose

Total Total of all reporting groups

Baseline Measures
    Preoperative Gabapentine,     Sugar Pill     Total  
Number of Participants  
[units: participants]
  20     20     40  
Age [1]
[units: years]
Median ( Full Range )
  51.5  
  ( 41 to 59 )  
  52.1  
  ( 35 to 70 )  
  51.8  
  ( 35 to 70 )  
Gender  
[units: participants]
     
Female     20     20     40  
Male     0     0     0  
[1] gabapentine 51,5 (41 - 59) Sugar pill 52,1 (35 - 70)



  Outcome Measures

1.  Primary:   Pain Intensity   [ Time Frame: 6 months ]

2.  Secondary:   Chronic Pain   [ Time Frame: 6 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Rioko K. Sakata
Organization: Federal University of São Paulo
phone: 055 11 5084 7463
e-mail: riokoks.dcir@epm.br


No publications provided


Responsible Party: Rioko Kimiko Sakata, 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