A prospective comparative study on efficacy of IV fentanyl versus femoral nerve block for positioning prior to subarachnoid block in patients undergoing fracture femur surgeries.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Preoperative pain relief and patient comfort before shifting into OT and while positioning for spinal anesthesia
研究概览
简要总结
This is a prospective randomised clinical study comparing the efficacy of 1mcg/kg IV fentanyl versus femoral nerve block with 0.2% ropivacaine 15ml for positioning prior to subarachnoid block in patients undergoing fracture femur surgeries. It will be conducted in a total of 70 patients, 35 in each group, in all the hospitals attached to Bangalore Medical College and Research Institute. The primary outcome is to compare preoperative pain relief and patient comfort before shifting into OT and while positioning for spinal anesthesia. Secondary outcome is to observe other effects of femoral nerve blockade when used in combination with regional anesthesia techniques in first 24 hours.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Adult patients(18 – 65yrs) of both genders will be included after receiving informed written consent 2.Patients belonging to American Society of Anesthesiologist class 1&2 3.Patients with painful femoral fractures planned for open reduction and internal fixation.
排除标准
- •1.Patient does not have pain 2.Patient refusing to participate in study 3.Patient with allergy to local anaesthetics 4.Patient with peripheral neuropathy, bleeding diathesis, previous femoral bypass surgery, inguinal hernia, inflammation or infection over injection site, morbid obesity, spine abnormality.
- •5.Patient with psychiatric disorders and poly trauma / communited fractures.
- •6.Use of analgesics for premedication.
结局指标
主要结局
Preoperative pain relief and patient comfort before shifting into OT and while positioning for spinal anesthesia
时间窗: Preoperative period
次要结局
- VAS score assessed at 0hr, 4hr, 8hr, 12hr, 24hr(Post operative period)
- Duration of sensory and motor block(Intra and post operative period)
- Time for requirement of first rescue analgesia(Post operative period)