Efficacy of Gabapentin in Prevention of Tourniquet Pain and Hypertension During Orif of Tibia Fracture Under General Anesthesia
Overview
- Phase
- Early Phase 1
- Status
- Withdrawn
- Sponsor
- Baylor College of Medicine
- Locations
- 1
- Primary Endpoint
- Incidence of tourniquet-induced hypertension
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 64 Years (Adult)
- Sex
- 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
Arms & Interventions
Gabapentin
Gabapentin 600 mg po given 1 hour before surgery
Intervention: gabapentin 600 mg po (Drug)
Placebo sugar pill
Intervention: Placebo pill given one hour before surgery (Drug)
Outcomes
Primary Outcomes
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 Outcomes
- Postoperative pain(24 hours)
- Narcotic use(24 hours)
Investigators
Jaime Ortiz
Assistant Professor of Anesthesiology
Baylor College of Medicine