Fascia Iliaca Block in the Emergency Department for Analgesia After Femoral Neck Fracture
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Pain scores at rest
研究概览
简要总结
Femoral neck fracture is very common in the elderly and can produce severe to moderate pain. As this pathology is not life-threatening, waiting time in the emergency department may be prolonged due to the high number of unforeseen cases with patients remaining in pain.
Fascia iliaca block consists of injecting local anaesthetics below the fascia iliaca, resulting in the anaesthesia of the femoral, the lateral cutaneous and the obturator nerves, with effective analgesia.
详细描述
The objective of this trial is to compare the fascia iliaca block with a sham injection on patients arriving in the emergency department with a femoral neck fracture.
The fascia iliaca block will be performed with an anatomical landmark technique and a volume of 30 mLs of bupivacaine 0.5% with epinephrine 5 mcg/mL will be injected.
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
- Triple (Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with femoral neck fracture in the emergency department
排除标准
- •presence of demencia
- •body weight less than 40kg
- •presence of a cancer or patients receiving chemotherapy
- •allergy to local anaesthetics
研究组 & 干预措施
Fascia iliaca block
Fascia iliaca block (Injection of 30 mLs of bupivacaine 0.5% with epinephrine 5 mcg/mL below the fascia iliaca, Carbostesin®)
干预措施: Fascia iliaca block (Procedure)
Sham injection
No fascia iliaca block (Sham injection = Subcutaneous injection of 5 cc of normal saline, no intervention)
干预措施: Sham injection (Procedure)
结局指标
主要结局
Pain scores at rest
时间窗: 45 minutes after the injection
次要结局
- Pain scores at rest(60 min, 4h, 8h, 12h, 24h after the injection)
- Pain scores on movement(60 min, 4h, 8h, 12h, 24h after the injection)
- Length of stay(up to 3 weeks)
- Morphine consumption(60 min, 4h, 8h, 12h, 24h after the injection)
研究者
Eric Albrecht
PD Dr Eric Albrecht, MD, MER, DESA, Program Director, Regional Anaesthesia
Centre Hospitalier Universitaire Vaudois