Tourniquet-induced Hypertension Clinical Trial
Official title:
Efficacy of Gabapentin in Prevention of Tourniquet Pain and Hypertension During Orif of Tibia Fracture Under General Anesthesia
| Verified date | March 2015 |
| Source | Baylor College of Medicine |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Institutional Review Board |
| Study type | Interventional |
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.
| Status | Withdrawn |
| Enrollment | 0 |
| Est. completion date | June 2014 |
| Est. primary completion date | June 2014 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 64 Years |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | Ben Taub General Hospital | Houston | Texas |
| Lead Sponsor | Collaborator |
|---|---|
| Baylor College of Medicine |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | Yes |
| Secondary | Postoperative pain | Postoperative pain scores for 24 hours after surgery | 24 hours | No |
| Secondary | Narcotic use | Total use of morphine, vicodin during 24 hours after surgery | 24 hours | No |