WithdrawnEarly Phase 1

Efficacy of Gabapentin in Prevention of Tourniquet Pain and Hypertension

Stopped: Unable to recruit patient due to surgical case type. Not worth continuing study.

United States0Started 2012-01

Plain-language 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.

Who can participate

Age range18 Years – 64 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Incidence of tourniquet-induced hypertension

Timeframe: During the tourniquet inflation time period

Trial details

NCT IDNCT01441531

SponsorBaylor College of Medicine

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2014-06

View on ClinicalTrials.gov More Tourniquet-induced Pain trials