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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

September 21, 2011
January 25, 2014
January 2012
December 2014   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01441531 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
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.

Not Provided
Interventional
Phase 0
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Tourniquet-induced Pain
  • Tourniquet-induced Hypertension
  • Drug: gabapentin 600 mg po
    Given one hour before surgery
  • Drug: Placebo pill given one hour before surgery
    Placebo pill given
  • Experimental: Gabapentin
    Gabapentin 600 mg po given 1 hour before surgery
    Intervention: Drug: gabapentin 600 mg po
  • Placebo Comparator: Placebo sugar pill
    Intervention: Drug: Placebo pill given one hour before surgery
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
90
February 2015
December 2014   (final data collection date for primary outcome measure)

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
Both
18 Years to 64 Years
No
Contact: Jaime Ortiz, MD 713-873-950 jaimeo@bcm.edu
Contact: Cealy Browder 713-873-2860
United States
 
NCT01441531
H-28860
No
Jaime Ortiz, Baylor College of Medicine
Baylor College of Medicine
Not Provided
Principal Investigator: Jaime Ortiz, MD Baylor College of Medicine
Baylor College of Medicine
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP