Preoperative Gabapentine for Carpal Tunnel

NCT ID: NCT01632215

Last Updated: 2019-03-05

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Study Completion Date

2012-03-31

Brief Summary

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

Detailed Description

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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

Conditions

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Carpal Tunnel Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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preoperative gabapentine,

Gabapentine

Group Type EXPERIMENTAL

Gabapentine

Intervention Type DRUG

Gabapentine 600 mg 01 dose

sugar pill

Placebo group

Group Type PLACEBO_COMPARATOR

Sugar pill

Intervention Type OTHER

Sugar pill 01 dose

Interventions

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Gabapentine

Gabapentine 600 mg 01 dose

Intervention Type DRUG

Sugar pill

Sugar pill 01 dose

Intervention Type OTHER

Other Intervention Names

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Anticonvulsant

Eligibility Criteria

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Inclusion Criteria

* carpal tunnel syndrome

Exclusion Criteria

* disorientation, psychiatric disease, myocardial ischemia, hypertension, arrhythmia, another pain syndrome, drug user, and pregnant
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Federal University of São Paulo

OTHER

Sponsor Role lead

Responsible Party

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Rioko Kimiko Sakata

Pain Clinic Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Rioko K Sakata, PhD

Role: STUDY_DIRECTOR

Universidade Federal de São Paulo

Other Identifiers

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CEP 0223/09

Identifier Type: -

Identifier Source: org_study_id

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