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NCT01632215 Clinical Trial

Preoperative Gabapentine for Carpal Tunnel

Carpal Tunnel Syndrome Clinical Trial

Official title:
Effect of Preoperative Gabapentine for Carpal Tunnel Syndrome

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01632215
Other study ID # CEP 0223/09
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date March 2010
Est. completion date March 2012

Study information
Verified date February 2019
Source Federal University of São Paulo
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study was to evaluate the postoperative analgesic effect of preoperative gabapentine for carpal tunnel syndrome surgery.

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

Recruitment information / eligibility
Status Completed
Enrollment 40
Est. completion date March 2012
Est. primary completion date August 2011
Accepts healthy volunteers No
Gender All
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria:

- carpal tunnel syndrome

Exclusion Criteria:

- disorientation, psychiatric disease, myocardial ischemia, hypertension, arrhythmia, another pain syndrome, drug user, and pregnant

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Gabapentine
Gabapentine 600 mg 01 dose
Other:
• Sugar pill
Sugar pill 01 dose

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Federal University of São Paulo

Outcome
Type Measure Description Time frame Safety issue
Primary Pain Intensity Numerical score from 0 to 10; zero means no pain and 10 is the more intense pain 6 months
Secondary Chronic Pain Numerical score from 0 to 10 scale:
Minimum value= zero (means no pain) and Maximum value= 10 (more intense pain)		 6 months
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