Efficacy of Gabapentin in Prevention of Tourniquet Pain and Hypertension

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

EARLY_PHASE1

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2014-06-30

Brief Summary

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The purpose of the study is to find out if taking a dose of gabapentin 600 mg by mouth (po) before surgery will help prevent the development of tourniquet pain and hypertension while the tourniquet is inflated during orif of tibia fracture.

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Detailed Description

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Conditions

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Tourniquet-induced Pain Tourniquet-induced Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Gabapentin

Gabapentin 600 mg po given 1 hour before surgery

Group Type EXPERIMENTAL

gabapentin 600 mg po

Intervention Type DRUG

Given one hour before surgery

Placebo sugar pill

Group Type PLACEBO_COMPARATOR

Placebo pill given one hour before surgery

Intervention Type DRUG

Placebo pill given

Interventions

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gabapentin 600 mg po

Given one hour before surgery

Intervention Type DRUG

Placebo pill given one hour before surgery

Placebo pill given

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patient ages 18-64
* ASA physical status 1-3
* Schedule for orif tibia fracture with use of pneumatic tourniquet

Exclusion Criteria

* Allergy to study medications
* polytrauma
* lower extremity crush injury
* chronic opioid use
* sickle cell disease or trait
* peripheral vascular disease
* poorly controlled hypertension
* history of DVT/PE
* morbid obesity (BMI \> 35)
* patient or surgeon refusal
* patient inability to properly describe postoperative pain to investigators

Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No