Efficacy of Gabapentin in Prevention of Tourniquet Pain and Hypertension | RxWiki

Efficacy of Gabapentin in Prevention of Tourniquet Pain and Hypertension

Overview[ - collapse ][ - ]

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	Tourniquet-induced Pain Tourniquet-induced Hypertension
Intervention	Drug: gabapentin 600 mg po Drug: Placebo pill given one hour before surgery
Phase	Phase 0
Sponsor	Baylor College of Medicine
Responsible Party	Baylor College of Medicine
ClinicalTrials.gov Identifier	NCT01441531
First Received	September 21, 2011
Last Updated	January 25, 2014
Last verified	January 2014

Tracking Information[ + expand ][ + ]

First Received Date	September 21, 2011
Last Updated Date	January 25, 2014
Start Date	January 2012
Estimated Primary Completion Date	February 2015
Current 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.
Current 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

Descriptive Information[ + expand ][ + ]

Brief Title	Efficacy of Gabapentin in Prevention of Tourniquet Pain and Hypertension
Official Title	Efficacy of Gabapentin in Prevention of Tourniquet Pain and Hypertension During Orif of Tibia Fracture Under General Anesthesia
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.
Detailed Description	Not Provided
Study Type	Interventional
Study Phase	Phase 0
Study Design	Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Condition	Tourniquet-induced Pain Tourniquet-induced Hypertension
Intervention	Drug: gabapentin 600 mg po Given one hour before surgery Drug: Placebo pill given one hour before surgery Placebo pill given
Study Arm (s)	Experimental: Gabapentin Gabapentin 600 mg po given 1 hour before surgery Placebo Comparator: Placebo sugar pill

Recruitment Information[ + expand ][ + ]

Recruitment Status	Recruiting
Estimated Enrollment	90
Estimated Completion Date	February 2015
Estimated Primary Completion Date	December 2014
Eligibility 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
Gender	Both
Ages	18 Years
Accepts Healthy Volunteers	No
Contacts	Contact: Jaime Ortiz, MD 713-873-950 jaimeo@bcm.edu
Location Countries	United States

Administrative Information[ + expand ][ + ]

NCT Number	NCT01441531
Other Study ID Numbers	H-28860
Has Data Monitoring Committee	No
Information Provided By	Baylor College of Medicine
Study Sponsor	Baylor College of Medicine
Collaborators	Not Provided
Investigators	Principal Investigator: Jaime Ortiz, MD Baylor College of Medicine
Verification Date	January 2014

Locations[ + expand ][ + ]