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临床试验/CTRI/2017/08/009523
CTRI/2017/08/009523已完成不适用

To compare the analgesic efficacy and hemodynamic stability in femoral block and fascia iliaca block in pre-operative pain management of patients with hip fractures.

Ganga Medical Centre and Hospital1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2014年3月26日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
90
试验地点
1
主要终点
VAS score less than 3

研究概览

简要总结

The study comprised of hundred patients (50 in each group) of theage group 18-90 years, of either sex, suffering from hip fracture categorizedunder American Society of Anaesthesiologists (ASA) physical status I, II&III, after the conditions of the inclusion and exclusion criteria weresatisfied. They were divided into 2 groups using the computerized randomizationtechnique as follows: **Group A (N=50)**Femoral Nerve Block wasperformed using 0.25% bupivacaine (According to the weight) with 8mgdexamethasone under combined ultrasonography and peripheral nerve stimulationguidance and **Group B (N=50)**Fascia iliaca Nerve Block wasperformed using 0.25% bupivacaine (according to the weight) with 8mgdexamethasone under combined ultrasonography and peripheral nerve stimulation guidance.The study aims to compare the onset, duration of sensory and motor block,duration of analgesia, hemodynamic stability and need of rescue analgesia.

 Theaim of the study is to compare analgesic efficacy and hemodynamic stability infemoral nerve block versus fascia iliaca block as pain management in hipfractures during the pre-operative period, with objectives  todetermine Time of onset and duration of sensory block, time of onset andduration of motor block, Range and duration of analgesia, Efficacy of analgesiausing VAS assessment scale at rest and at movement and the number of rescueanalgesics required in these patients, Hemodynamic stability in terms of heartrate, blood pressure, saturation for a period of 24 hours.

Resultof our study showed that in the pre- operative period, prolonged duration ofanalgesia with better hemodynamic stability is better achieved in femoral nerveblock group than the fascia iliaca block group. Femoral nerve blockadministration resulted in lower VAS both at rest and during passive hipflexion of 15 degree, longer duration of sensory and motor block, Longerduration of analgesia and decreased amount of rescue analgesics as compared tofascia iliaca block. Though fascia iliaca block gives a better pain reliefduring the first two hours longer and better pain control in given by femoralblock. Both the blocks provided good hemodynamic stability. Thus we concludethat femoral nerve block is better than fascia iliaca block in pain managementpre-operatively for hip fractures, whereas fascia iliaca can be preferred justbefore surgery for positioning and for pain relief during the surgicalincision.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant, Investigator and Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 90.00 Year(s)(—)
性别
All

入选标准

  • All patients with isolated hip fracture 2) Patients of ASA physical Status I, II and III 3) Patients who have not been subjected to other analgesics after the fracture 4) Patients who are oriented to give consent.

排除标准

  • Pathological and periprosthetic hip fractures 2) Patients allergic to local anesthetics 3) Recent vascular injury involving the lower limb 4) Bleeding diathesis, patients on anti-platelets 5) Patients who shall be taken up for surgery within 18 hours 6) Patients less than 18 years of age 7) Patients more than 90 years of age 8) Hemodynamically compromised patients 9) Non consenting patients / relative refusal for procedure 10) Patients in ASA physical status class IV.

结局指标

主要结局

VAS score less than 3

时间窗: 24 hours

次要结局

  • Motor Blockade, Sensory Blockade, Duration, Rescue analgesia, Side effect(24 Hours)

研究者

申办方类型
Research institution and hospital

研究点 (1)

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