Surgical Treatment of Proximal Femoral Fractures Under Peripheral Regional Anesthesia. A Prospective Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Success Rate (Conversion to General Anesthesia)
研究概览
简要总结
The study investigates whether treatment of proximal femoral fractures is possible using a peripheral regional anesthesia technique.
详细描述
The study investigates whether treatment of proximal femoral fractures is possible using a peripheral regional anesthesia technique.
After positioning on the non-fractured side, a double injection technique is used (dual guidance concept: nerve stimulation and sonography).
The injections are performed parasacrally (blockade of the sacral plexus under the piriformis muscle) and lumbar paravertebrally (psoas compartment block and transmuscular quadratus lumborum block). Per block 20 ml ropivacaine 0.375% is administered (total dose: 225mg ropivacaine).
The study examines the success rate (rate of successfully performed nerve blockade; need for supplemental medication: sufentanil and/or propofol; conversion rate to general anesthesia), circulatory stability (need for application of ephedrine or norepinephrine) and side effects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- •proximal femoral fracture
- •older then 18 years
- •written informed consent
排除标准
- •local or systematic inflammation
- •allergy to ropivacaine
- •participate in other studies
- •body mass index over 35
- •periprosthetic fractures
研究组 & 干预措施
intertrochanteric femoral fractures
geriatric patients with intertrochanteric femoral fracture who have consented to the study intervention
干预措施: Ropivacaine (sciatic nerve block) (Drug)
intertrochanteric femoral fractures
geriatric patients with intertrochanteric femoral fracture who have consented to the study intervention
干预措施: Ropivacaine (lumbar plexus block L2-L4) (Drug)
intertrochanteric femoral fractures
geriatric patients with intertrochanteric femoral fracture who have consented to the study intervention
干预措施: Ropivacaine (lumbar plexus block Th12-L1) (Drug)
neck femur fractures
geriatric patients with neck of femur fracture who have consented to the study intervention
干预措施: Ropivacaine (sciatic nerve block) (Drug)
neck femur fractures
geriatric patients with neck of femur fracture who have consented to the study intervention
干预措施: Ropivacaine (lumbar plexus block L2-L4) (Drug)
neck femur fractures
geriatric patients with neck of femur fracture who have consented to the study intervention
干预措施: Ropivacaine (lumbar plexus block Th12-L1) (Drug)
subtrochanteric femoral fractures
geriatric patients with subtrochanteric femoral fracture who have consented to the study intervention
干预措施: Ropivacaine (sciatic nerve block) (Drug)
subtrochanteric femoral fractures
geriatric patients with subtrochanteric femoral fracture who have consented to the study intervention
干预措施: Ropivacaine (lumbar plexus block L2-L4) (Drug)
subtrochanteric femoral fractures
geriatric patients with subtrochanteric femoral fracture who have consented to the study intervention
干预措施: Ropivacaine (lumbar plexus block Th12-L1) (Drug)
结局指标
主要结局
Success Rate (Conversion to General Anesthesia)
时间窗: during surgery
number of participants with need for conversion to general anesthesia
Success Rate (Supplemental Medication)
时间窗: during surgery
number of participants with need for supplemental analgesic medication (sufentanil)
次要结局
- Circulation Stability(during surgery)
研究者
Dr.med.Ronald Seidel
Principal Investigator
Helios Research Center