Analgesia For Positioning Patient With Femur Fracture For Spinal Anaesthesia : Ultrasound-Guided Fascia Iliaca Compartment Block Versus Intravenous Fentanyl
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Pain score during positioning
研究概览
简要总结
This study is performed to determine the efficacy of ultrasound-guided fascia iliaca compartment block during positioning for spinal anaesthesia in patient undergoing repair of proximal femur fracture surgery comparing with intravenous fentanyl.
详细描述
This a prospective, single-blind, randomized control study that compare the efficacy of ultrasound-guided fascia iliaca compartment block with intravenous fentanyl in positioning patient with femur fracture for spinal anaesthesia.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •American Society of Anaesthesiologists (ASA) score I and II
- •Elective surgery of repair of unilateral, single femoral fracture under spinal anaesthesia performed in General Operation Theatre, Hospital Kuala Lumpur. The fracture may involve femoral neck or femoral shaft.
排除标准
- •Patient with contraindication for spinal anaesthesia
- •Known hypersensitivity or contraindication to medication used in this study
- •Morbid obesity (body mass index (BMI) > 35 kg/m2)
- •Infection at the intended site of administration of fascia iliaca compartment block
- •Patient with impaired cognitive function
研究组 & 干预措施
fascia iliaca compartment block
Patient will receive 40ml of ropivacaine 0.375% at the fascia iliaca compartment under the guidance of ultrasound. It will be given 20 minutes before patient is positioned for spinal anaesthesia
干预措施: Ropivacaine (Drug)
fascia iliaca compartment block
Patient will receive 40ml of ropivacaine 0.375% at the fascia iliaca compartment under the guidance of ultrasound. It will be given 20 minutes before patient is positioned for spinal anaesthesia
干预措施: Ultrasound (Device)
intravenous fentanyl
Patient will receive 0.5 mcg/kg of intravenous fentanyl. It will be given 5 minutes before patient is positioned for spinal anaesthesia
干预措施: Fentanyl (Drug)
结局指标
主要结局
Pain score during positioning
时间窗: Group 1: 20 minutes after intervention (block), Group 2: 5 minutes after intervention (fentanyl)
Pain score is assessed using Visual Analogue Scale (VAS) score
次要结局
- Ease of positioning for spinal anaesthesia(Group 1: 20 minutes after intervention (block), Group 2: 5 minutes after intervention (fentanyl))
- Adverse effects(Up to 24 hours of intervention)
- Patient satisfaction(24 hours after intervention)
研究者
Dr Aida Mastura Mohd Shah
Principle Investigator
Kuala Lumpur General Hospital