Efficacy of Gabapentin in Prevention of Tourniquet Pain and Hypertension

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Baylor College of Medicine
Sponsor:
Information provided by (Responsible Party):
Jaime Ortiz, Baylor College of Medicine
ClinicalTrials.gov Identifier:
NCT01441531
First received: September 21, 2011
Last updated: January 25, 2014
Last verified: January 2014
  Purpose

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 Intervention Phase
Tourniquet-induced Pain
Tourniquet-induced Hypertension
Drug: gabapentin 600 mg po
Drug: Placebo pill given one hour before surgery
Phase 0

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Baylor College of Medicine:

Primary Outcome Measures:
  • Incidence of tourniquet-induced hypertension [ Time Frame: During the tourniquet inflation time period ] [ Designated as safety issue: Yes ]
    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:
  • Postoperative pain [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    Postoperative pain scores for 24 hours after surgery

  • Narcotic use [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    Total use of morphine, vicodin during 24 hours after surgery


Estimated Enrollment: 90
Study Start Date: January 2012
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01441531

Contacts
Contact: Jaime Ortiz, MD 713-873-950 jaimeo@bcm.edu
Contact: Cealy Browder 713-873-2860

Locations
United States, Texas
Ben Taub General Hospital Recruiting
Houston, Texas, United States, 77030
Contact: Jaime Ortiz, MD       jaimeo@bcm.edu   
Principal Investigator: Jaime Ortiz, MD         
Sub-Investigator: Neil S Bailard, MD         
Sub-Investigator: Lee C Chang, MD         
Sub-Investigator: Sonal Zambare, MD         
Sub-Investigator: Suman Rajagopalan, MD         
Sub-Investigator: Roland Flores, MD         
Sponsors and Collaborators
Baylor College of Medicine
Investigators
Principal Investigator: Jaime Ortiz, MD Baylor College of Medicine
  More Information

No publications provided

Responsible Party: Jaime Ortiz, Assistant Professor of Anesthesiology, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT01441531     History of Changes
Other Study ID Numbers: H-28860
Study First Received: September 21, 2011
Last Updated: January 25, 2014
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Gabapentin
Gamma-Aminobutyric Acid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anticonvulsants
Antiparkinson Agents
Anti-Dyskinesia Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
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

ClinicalTrials.gov processed this record on August 28, 2014