Efficacy of Gabapentin in Prevention of Tourniquet Pain and Hypertension During Orif of Tibia Fracture Under General Anesthesia
试验速览
- 阶段
- 早期 1 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Incidence of tourniquet-induced hypertension
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient ages 18-64
- •ASA physical status 1-3
- •Schedule for orif tibia fracture with use of pneumatic tourniquet
排除标准
- •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
研究组 & 干预措施
Gabapentin
Gabapentin 600 mg po given 1 hour before surgery
干预措施: gabapentin 600 mg po (Drug)
Placebo sugar pill
干预措施: Placebo pill given one hour before surgery (Drug)
结局指标
主要结局
Incidence of tourniquet-induced hypertension
时间窗: 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.
次要结局
- Postoperative pain(24 hours)
- Narcotic use(24 hours)
研究者
Jaime Ortiz
Assistant Professor of Anesthesiology
Baylor College of Medicine