Comparison the Efficacy as Analgesia Between Ultrasound Guided Femoral 3 in 1 Block Versus Blind Fascia Iliaca Block for Positioning Prior Spinal Anaesthesia in Femur Fracture Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- The percentage of success rate between ultrasound guided femoral 3 in 1 block versus single shot blind fascia iliaca compartment block as analgesic method for positioning prior spinal anaesthesia in femur fracture surgery
研究概览
简要总结
This study aimed to evaluate the efficacy of ultrasound guided femoral 3 in 1 block versus the blind technique single shot fascia iliaca compartment block as an analgesia method in patients prior positioning for spinal anaesthesia in femur fracture surgery. A total of 60 patients were enrolled and divided equally into 2 groups.
详细描述
This study is to evaluate the efficacy of fascia iliaca compartment block comparing to femoral nerve block. If it is proven effective, this technique should be implemented as a method of analgesia (pain relief) prior positioning for spinal anaesthesia. As fascia iliaca compartment block is relatively easy to be done without the need of advanced equipment, it has the potential role for good pain management in patient with femur fracture. Thus this will reduce the need of intravenous or oral analgesic such as opioid or nonsteroidal anti-inflammatory drugs and side effects that comes with it.
This is a prospective single blind randomized study of a total of 60 patients ASA I - III who were scheduled to undergo fixation of femur fractures. Patients who fulfilled the criteria were recruited after informed consent was taken. This study was conducted in the operation theatres of the Hospital Universiti Sains Malaysia, Kubang Kerian, Kelantan.
Hypothesis
- There is no difference in term of success rate between ultrasound guided Femoral 3 in 1 nerve block versus Single shot blind Fascia Iliaca Compartment Block prior positioning for spinal anaesthesia in femur fracture surgery.
- There is no difference in term of analgesic effect between ultrasound guided Femoral 3 in 1 nerve block versus Single shot blind Fascia Iliaca Compartment Block prior positioning for spinal anaesthesia in femur fracture surgery.
- There is no different in term of onset of analgesia between Femoral 3 in 1 nerve block versus Fascia Iliaca Compartment Block prior positioning for spinal anaesthesia in femur fracture surgery.
Recruitment and Randomization Eligible patients will be approach and offered to participate in this study prior operation. Agreed patients will have to sign informed consent Subject will be randomized into 2 groups using computer assisted randomization
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 (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ASA I - III with stable hemodynamic parameters
- •Planned for open reduction internal fixation of fracture femur under spinal anaesthesia
排除标准
- •Coagulopathy/ Bleeding diathesis
- •Known allergy to amide local anaesthetic used in the study
结局指标
主要结局
The percentage of success rate between ultrasound guided femoral 3 in 1 block versus single shot blind fascia iliaca compartment block as analgesic method for positioning prior spinal anaesthesia in femur fracture surgery
时间窗: From the time of local anaesthetic injection to successful block at least 2 out of 3 dermatomes of either lateral femoral cutaneous nerve, femoral nerve or obturator nerve up to 30 minutes.
Using pin prick to test the sensory level at different dermatomes after given local anaesthetic following each block
次要结局
- The onset of analgesia in term of minutes between ultrasound guided Femoral 3 in 1 nerve block versus single shot blind Fascia Iliaca Compartment Block prior positioning for spinal anaesthesia in femur fracture surgery.(From the time of local anaesthetic given to a reduction in visual analogue pain score to less than 2 up to 30 minutes.)
- The quality of blocks(From the sitting up the patients till successful spinal anesthesia was achieved up to 10 minutes.)
研究者
Rhendra Hardy Mohamad Zaini
Doctor
Universiti Sains Malaysia