Efficacy of Gabapentin in Prevention of Tourniquet Pain and Hypertension

Early Phase 1

Withdrawn

• Conditions: Tourniquet-induced Hypertension; Tourniquet-induced Pain
• Interventions: Drug: Placebo pill given one hour before surgery; Drug: gabapentin 600 mg po

• Registration Number: NCT01441531
• Lead Sponsor: Baylor College of Medicine

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2011-09-21
• Study First Submitted QC: 2011-09-26
• Study First Posted: 2011-09-27
• Study Start: 2012-01
• Primary Completion: 2014-06
• Study Completion: 2014-06
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-13
• Last Update Posted: 2015-03-17

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo sugar pill	Placebo pill given one hour before surgery	-
Gabapentin	gabapentin 600 mg po	Gabapentin 600 mg po given 1 hour before surgery

Primary Outcome Measures

Name	Time	Method
Incidence of tourniquet-induced hypertension	During the tourniquet inflation time period	Primary outcome is incidence of tourniquet-induced hypertension, which is defined as an increase of systolic or diastolic blood pressure \> 30% from baseline. This will be looked at during the time of tourniquet inflation (from inflation to deflation) during the actual surgical procedure. Usual maximum inflation time is 120 minutes.

Secondary Outcome Measures

Name	Time	Method
Postoperative pain	24 hours	Postoperative pain scores for 24 hours after surgery
Narcotic use	24 hours	Total use of morphine, vicodin during 24 hours after surgery

Trial Locations

Locations (1)

Ben Taub General Hospital; 🇺🇸 Houston, Texas, United States