We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

  Participant Flow
  Hide Participant Flow

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
  Hide Baseline Characteristics

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 
Overall Participants Analyzed 
[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) 
[1] gabapentine 51,5 (41 - 59) Sugar pill 52,1 (35 - 70)
Gender 
[Units: Participants]
     
Female   20   20   40 
Male   0   0   0 


  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.  


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

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
No text entered.


  More Information
  Hide More Information

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



Responsible Party: Rioko Kimiko Sakata, 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