Femoral Nerve Block Together With Lateral Femoral Cutaneous Nerve Block and Sedation as Anesthesia Among High Risk Patients With Intertrochanteric Fracture Repair Surgery
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Percentage of patients suffering from major cardiovascular event during 30 days after the surgery.
研究概览
简要总结
This single-center open label study compares the outcomes of surgical repair of intratrochanteric fracture under general anesthetic or peripheral nerve blocks.
详细描述
This single-center open label study compares the outcomes of surgical repair of intratrochanteric fracture under general anesthetic or peripheral nerve blocks.
Patients are high risk individuals scheduled for intratrochanteric fracture repair, with contraindications to spinal anesthesia. One group will receive general endotracheal anesthetic, the other femoral and lateral femoral cutaneous nerve with deep sedation.
Mortality, morbidity (major cardiovascular incidents,delirium, pneumonia), pain scores and opioid consumption will be recorded.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •intratrochanteric fracture
- •need for surgery
- •contraindications for spinal anesthesia
排除标准
- •allergy to local anesthetics
结局指标
主要结局
Percentage of patients suffering from major cardiovascular event during 30 days after the surgery.
时间窗: 30 days from the day of the surgery.
Occurence of stroke or acute coronary syndrome will be assessed during period of 30 postoperative days. The result will be displayed as a percentage of examined group.
Percentage of patients suffering from postoperative delirium during 7 days after the surgery.
时间窗: 7 days after the surgery.
Occurence of postoperative delirium will be assessed during 7 days after the surgery. The result will be displayed as a percentage of examined group.
Percentage of patients surviving 30 days after the surgery.
时间窗: 30 days from the day of the surgery.
Numbers of survivors will be assessed on 30th day after the surgery. The result will be displayed as a percentage of examined group.
次要结局
- Opioid consumption(first 24 hours after surgery)
- Pain score after surgery(first 24 hours after surgery)
研究者
Jakub Klimkiewicz
Principal Investigator
Military Institute od Medicine National Research Institute