Preoperative Gabapentine for Carpal Tunnel

Phase 3

Completed

• Conditions: Carpal Tunnel Syndrome
• Interventions: Other: Sugar pill; Drug: Gabapentine

• Registration Number: NCT01632215
• Lead Sponsor: Federal University of São Paulo

Brief Summary

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

Detailed 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

Study Timeline

• Study Start: 2010-03
• Primary Completion: 2011-08
• Study Completion: 2012-03
• Study First Submitted: 2012-06-28
• Study First Submitted QC: 2012-06-29
• Study First Posted: 2012-07-02
• Results First Submitted: 2014-02-24
• Results First Submitted QC: 2014-05-19
• Results First Posted: 2014-06-04
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-12
• Last Update Posted: 2019-03-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• carpal tunnel syndrome

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
sugar pill	Sugar pill	Placebo group
preoperative gabapentine,	Gabapentine	Gabapentine

Primary Outcome Measures

Name	Time	Method
Pain Intensity	6 months	Numerical score from 0 to 10; zero means no pain and 10 is the more intense pain

Secondary Outcome Measures

Name	Time	Method
Chronic Pain	6 months	Numerical score from 0 to 10 scale: Minimum value= zero (means no pain) and Maximum value= 10 (more intense pain)