Efficacy of Gabapentin in Prevention of Tourniquet Pain and Hypertension

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01441531
Recruitment Status : Withdrawn (Unable to recruit patient due to surgical case type. Not worth continuing study.)
First Posted : September 27, 2011
Last Update Posted : March 17, 2015
Information provided by (Responsible Party):
Jaime Ortiz, 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.

Condition or disease Intervention/treatment Phase
Tourniquet-induced Pain Tourniquet-induced Hypertension Drug: gabapentin 600 mg po Drug: Placebo pill given one hour before surgery Early Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of Gabapentin in Prevention of Tourniquet Pain and Hypertension During Orif of Tibia Fracture Under General Anesthesia
Study Start Date : January 2012
Actual Primary Completion Date : June 2014
Actual Study Completion Date : June 2014

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Gabapentin
Gabapentin 600 mg po given 1 hour before surgery
Drug: gabapentin 600 mg po
Given one hour before surgery

Placebo Comparator: Placebo sugar pill Drug: Placebo pill given one hour before surgery
Placebo pill given

Primary Outcome Measures :
  1. Incidence of tourniquet-induced hypertension [ Time Frame: 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 :
  1. Postoperative pain [ Time Frame: 24 hours ]
    Postoperative pain scores for 24 hours after surgery

  2. Narcotic use [ Time Frame: 24 hours ]
    Total use of morphine, vicodin during 24 hours after surgery

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01441531

United States, Texas
Ben Taub General Hospital
Houston, Texas, United States, 77030
Sponsors and Collaborators
Baylor College of Medicine
Principal Investigator: Jaime Ortiz, MD Baylor College of Medicine

Responsible Party: Jaime Ortiz, Assistant Professor of Anesthesiology, Baylor College of Medicine Identifier: NCT01441531     History of Changes
Other Study ID Numbers: H-28860
First Posted: September 27, 2011    Key Record Dates
Last Update Posted: March 17, 2015
Last Verified: March 2015

Keywords provided by Jaime Ortiz, Baylor College of Medicine:
narcotic use
Other Acute Pain

Additional relevant MeSH terms:
Vascular Diseases
Cardiovascular Diseases
gamma-Aminobutyric Acid
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Antimanic Agents
GABA Agents