Comparison of the Analgesic Effect of Ultrasound-Guided Suprainguinal Fascia Iliaca Block (SIFI) Versus Femoral Nerve Block (FNB) for Positioning During Central Neuraxial Block in Patients Undergoing Proximal Femur Fracture Surgery: A Double-Blinded Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- To compare the analgesic effect of ultrasound guided suprainguinal fascia iliaca block versus femoral nerve block using Numerical Rating Scale (NRS) at rest for performing central neuraxial block in patients undergoing proximal femur fracture surgery.
研究概览
简要总结
This study is a double-blinded, randomized controlled trial on proximal femur fracture patients after ethical clearance and informed consent. Patients are randomized into two groups (SIFI block vs. femoral nerve block) using computer-generated numbers and sealed envelopes. A thorough preoperative evaluation, investigations, and counseling regarding the procedure are performed. Standard fasting guidelines and prophylactic medications are followed.
Intraoperatively, patients are monitored with ASA standard monitors, and baseline parameters are recorded. Group A receives an ultrasound-guided suprainguinal fascia iliaca block with 30 ml 0.2% ropivacaine + dexamethasone, while Group B receives an ultrasound-guided femoral nerve block with 20 ml 0.2–0.25% ropivacaine + dexamethasone. Pain (NRS) and hemodynamic parameters are assessed up to 20 minutes post-block. Rescue fentanyl is administered if NRS >4.
Central neuraxial blockade follows: an epidural catheter is placed at L2/L3 and tested with lignocaine-adrenaline, followed by spinal anesthesia at L3/L4 using 0.5% heavy bupivacaine. Adequate analgesia (paracetamol) and hemodynamic stability are ensured. Post-surgery, patients are shifted to HDU for monitoring and pain management.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)(—)
- 性别
- All
入选标准
- •Elective procedures of proximal femur fracture surgeries under central blockage
- •Patients belonging American Society of Anaesthesiologist (ASA) physical status of l- lll.
排除标准
- •Inability to comprehend Numerical Rating Score
- •Patients with Coagulopathies
- •Patients on treatment for chronic pain.
结局指标
主要结局
To compare the analgesic effect of ultrasound guided suprainguinal fascia iliaca block versus femoral nerve block using Numerical Rating Scale (NRS) at rest for performing central neuraxial block in patients undergoing proximal femur fracture surgery.
时间窗: Numerical rating scale (NRS)pain measured at Rest ,15 degree passive leg raise at 5,10,15,20 minutes before spinal anaesthesia .
次要结局
- 1)The pain using Numerical Rating Scale at the time of positioning between the 2 groups.(2)The hemodynamic parameters (Heart Rate, Systolic Blood Pressure, Diastolic Blood Pressure, Mean Arterial Pressure, Oxygen saturation) pre-intervention, from the time of nerve block till central neuraxial block between the 2 groups.)
研究者
Swathi M
pondicherry institute of medical science
