A Randomised Controlled Study Comparing Ultrasound Guided Fascia Iliaca Compartment Block and Femoral Nerve Block for Positioning Patients with Proximal Femur Fracture for Subarachnoid Block
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Time taken for sensory blockade after administration of the block
研究概览
简要总结
Patients with proximal femur fractures undergoing surgical treatment for the same are usually operated under subarachnoid block. Positioning for the subarachnoid block can be painful. The purpose of this study is to compare ultrasound-guided fascia iliaca compartment block and ultrasound-guided femoral nerve block, which will be given prior to positioning of patients with a proximal femur fracture, for subarachnoid block, which will alleviate the pain during positioning.
Null hypothesis: There is no difference in outcomes between ultrasound-guided fascia iliaca compartment block and ultrasound-guided femoral nerve block.
Alternative hypothesis: There is a difference in outcomes between ultrasound-guided fascia iliaca compartment block and ultrasound-guided femoral neve block.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients belonging to Americal Society of Anesthesiologists Physical Status I, II and III.
- •All patients undergoing surgery for proximal femur fracture under spinal anaesthesia.
排除标准
- •Patient refusal.
- •Subjects with allergy to the drugs involved in the study.
- •Contraindications to central neuraxial anaesthesia.
- •Infection at the site of block.
- •Use of analgesics 8 hours prior to the administration of the block.
- •Subjects with peripheral sensorineural deficits.
- •Patients with poor cognitive function which might lead to difficulties in assessing pain scores.
结局指标
主要结局
Time taken for sensory blockade after administration of the block
时间窗: At baseline, 1 minute, 3 minutes, 5 minutes, 10 minutes and 15 minutes.
次要结局
- Pain score is assessed using the Numerical Pain Rating Scale(Pain score will be measured upon arrival of the patient to the premedication area, followed by 1, 3, 5 and 10 minutes after the block administration. Pain score will be assessed again while positioning the patient for subarachnoid block.)
- Ease for subarachnoid block measures according to the time taken as well as number of attempts of needle insertion.(Time measured starting from positioning of the patient for subarachnoid block till drug injection is completed.)
- Hemodynamic parameters(Recorded upon arrival to the premedication area, followed by 1, 3, 5 and 10 minutes after nerve block administration.)
- Patient satisfaction score measured as per 5-point Likert scale(Measured after the subarachnoid block has been given.)