A Randomised Comparative Study Of Ultrasound Guided Femoral Nerve Block Vs Fascia Iliaca Compartment Block For Reducing Pain Associated With Positioning For Spinal Anesthesia In Patients With Proximal Femur Fracture At SMS Hospital, Jaipur.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 86
- 试验地点
- 1
- 主要终点
- To determine the change in VAS score from baseline to post induction at different time intervals.
研究概览
简要总结
Patient randomization will be performed using computerized random number table, in which patient will be randomly allocated in a ratio of 1：1 to receive one of the two assigned blocks.
Group A (n = 43) will receive Femoral nerve Block with 15 mL of 0.25% bupivacaine).
Group B (n = 43) will receive Fascia iliaca compartment block with 30 mL of 0.25% bupivacaine).
Depending on the allotted group, patients will receive the block under the guidance of ultrasound in the Operation Theatre under all aseptic precautions.
Effect will be checked by pin prick on anterior part of thigh at every 2 min interval. VAS (Visual Analogue Scale) Score will be recorded before the block and immediately after the block at every 1 min interval upto 15 min until VAS is <3. The time taken to achieve VAS <3 will be noted. When VAS Score is achieved<3 under all aseptic precautions SAB will be given in sitting position in L3-L4 space using 0.5% hyperbaric Bupivacaine 12.5mg +25mcg of fentanyl using 25 gauze quinke’s needle. When adequate sensory and motor blockade will be achieved, surgery will be started. Intraoperative parameters such as Heart Rate, SBP, DBP, MAP andSpo2 will be monitored according to proforma.
When surgery will complete patient will be shifted to PACU. Inj. Tramadol 100 mg will be given as rescue analgesia. Time for the need of first rescue analgesia will be noted. This time will be calculated from VAS<3 after the block to request of first rescue analgesia by patient at VAS >3.VAS Score will be assessed at hourly interval for first 6 hrs., 2 hrly interval for 12hrs, 4 hrly interval for 24 hrs.Total dose of Tramadol required in 24hrs will be noted. Anesthesiologist Satisfaction Score, and Patient’s satisfaction score will be assessed.Side effect if develop will be noted and managed accordingly.
研究设计
- 研究类型
- Interventional
- 分配方式
- Random Number Table
- 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
- •1.Patient undergoing elective surgery for proximal femur fracture unable to sit for SAB due to severe pain.(VAS >7) 2.Patients consenting to participate.
- •3.Adult patients aged 18-80 Years.
- •4.Patients belonging to American Society Of Anesthesiologists(ASA) grade I, II and III.
- •5.Weight 40-80 kgs.
排除标准
- •1.Patients with psychiatric illness, anxious, agitated.
- •2.Patients with peripheral sensorineural deficit.
- •3.Patients allergic to local anesthetics.
- •4.Patients on anticoagulant therapy.
- •5.Infection at block site.
- •6.Patients with multiple trauma.
- •7.Patients with suspected compartment syndrome in lower limbs.
- •8.Patients on analgesia within 8 hours before performing nerve block.
- •9.Block failure cases.
结局指标
主要结局
To determine the change in VAS score from baseline to post induction at different time intervals.
时间窗: To determine the change in VAS score from baseline to post induction at different time intervals maximum up to 15 minutes (until the VAS score is less than 3)Â in both groups.
次要结局
- 1.To estimate Anesthesiologist satisfaction score.(2.To determine the difference in mean time of first rescue analgesia in both groups by using VAS score.)