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临床试验/CTRI/2016/09/007316
CTRI/2016/09/007316尚未招募不适用

Comparative evaluation of ultrasound guided femoral nerve block versus fascia iliaca block for positioning during central neuraxial anesthesia in patients with proximal femoral fractures

St Johns Medical College1 个研究点 分布在 1 个国家目标入组 46 人开始时间: 2016年3月10日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
46
试验地点
1
主要终点
PRIMARY OBJECTIVE: To compare the efficacy of analgesia provided by ultrasound guided femoral nerve block versus fascia iliaca block in facilitating positioning for central neuraxial procedure in patients with proximal femoral fractures.

研究概览

简要总结

Fracture femur is a common orthopedic problem following trauma in all age groups and central neuraxial blocks such as spinal / epidural is the preferred technique for providing anaesthesia. Correct positioning during central neuraxial anesthesia  is a prerequisite for successful procedure. However limb immobility and extreme pain are the deterrents for an ideal positioning. Various modalities like femoral nerve block, fascia iliaca block systemic opioids and non opioids, have been advocated to provide analgesia and improve positioning in these patients.

Femoral nerve block and fascia iliaca block are proposed to provide analgesia and improve positioning in patients with femoral fractures. Conflicting results are available in the literature, there is no study comparing efficacy of ultrasound guided femoral block and fascia iliaca block. We decided to conduct this study with the aim to compare the benefits of block prior to  positioning for central neuraxial procedure in patients undergoing surgery for fracture femur.

Methodology : Approval from institutional ethical committee will be obtained. All patients with proximal femoral fractures undergoing surgery under central neuraxial anesthesia will be enrolled for the study. A detailed pre-anaesthetic checkup will be carried out in each patient. The patient will be given Pantoprazole 40mg on the morning of surgery. Patient will be kept nil per orally from 10pm previous night of surgery. On arrival to Operation theatre, standard monitors including ECG, Pulse oximeter, and non invasive blood pressure will be attached and baseline vital parameters will be recorded. Intravenous access will be secured with 18 G IV cannula and  GROUP1: Patients will receive ultrasound guided femoral nerve block with 15ml of equal mixture of 0.5% bupivacaine and 2% xylocaine with adrenaline. GROUP 2: patients will receive fascia iliaca block with 15ml of equal mixture of 0.5% bupivacaine and 2% xylocaine with adrenaline. Central neuroaxial anesthesia will be performed in these patients after 15 minutes of giving block, patient comfort for positioning, and quality of positioning for performing central neuraxial procedure will be assessed by ease of insertion.

Patients will be monitored for 24 hours for the postoperative analgesia . Data will be collected in a study proforma for each patient. and will be later analyzed statistically.

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 80.00 Year(s)(—)
性别
All

入选标准

  • All patients with proximal femoral fractures undergoing surgery under central neuraxial anesthesia.
  • Age 18 to 80 years.

排除标准

  • Patients with coagulopathies 2)Patients allergic to local anesthetics 3) Mentally challenged patients.
  • Obese patients 5)Poly trauma patients.

结局指标

主要结局

PRIMARY OBJECTIVE: To compare the efficacy of analgesia provided by ultrasound guided femoral nerve block versus fascia iliaca block in facilitating positioning for central neuraxial procedure in patients with proximal femoral fractures.

时间窗: a) prior to spinal administartion | b) postoperative period for 4 hours

次要结局

  • SECONDARY OBJECTIVE: - To evaluate analgesics requirement in 24hrs postoperatively in both groups.

研究者

申办方类型
Private medical college

研究点 (1)

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