Efficacy of Gabapentin in Prevention of Tourniquet Pain and Hypertension

Efficacy of Gabapentin in Prevention of Tourniquet Pain and Hypertension During Orif of Tibia Fracture Under General Anesthesia

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.

Study Overview

• Status: Withdrawn
• Conditions: Tourniquet-induced Pain; Tourniquet-induced Hypertension
• Intervention / Treatment: Drug: gabapentin 600 mg po; Drug: Placebo pill given one hour before surgery

• Study Type: Interventional
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Ben Taub General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 64 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of tourniquet-induced hypertension	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.	During the tourniquet inflation time period

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative pain	Postoperative pain scores for 24 hours after surgery	24 hours
Narcotic use	Total use of morphine, vicodin during 24 hours after surgery	24 hours

Collaborators and Investigators

• Sponsor: Baylor College of Medicine

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (ACTUAL): June 1, 2014
• Study Completion (ACTUAL): June 1, 2014

Study Registration Dates

• First Submitted: September 21, 2011
• First Submitted That Met QC Criteria: September 26, 2011
• First Posted (ESTIMATE): September 27, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): March 17, 2015
• Last Update Submitted That Met QC Criteria: March 13, 2015
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Keywords: narcotic use; Other Acute Pain
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Tranquilizing Agents; Psychotropic Drugs; Anti-Anxiety Agents; Anticonvulsants; Antimanic Agents; Gabapentin
• Other Study ID Numbers: H-28860