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临床试验/CTRI/2024/02/062327
CTRI/2024/02/062327尚未招募4 期

Comparison Of Bupivacaine Versus Bupivacaine With Dexmedetomidine in Fascia Iliaca Compartment Block To Provide Analgesia For Positioning Femur Fracture Patients Before Spinal Anaesthesia

Government medical college, Vadodara1 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2024年2月14日最近更新:

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
64
试验地点
1
主要终点
Visual analogue scale at 5 ,10,15,20 minutes after fascia iliaca compartment block

研究概览

简要总结

This study is randomised  prospective comparative clinical  study evaluate the addition of dexmedetomidine to bupivacaine in FICB to provide analgesia for positioning femur fracture patients before spinal anaesthesia   will lead to rapid achievement of  ease of positioning as well as prolonged duration of postoperative analgesia.

After pre aneasthestic evaluation and 6 -8 hours of fasting , informed written consent will be taken

from the patient .Then patient will be taken inside operation theatre , multipara monitors will be

attached and all baseline vital parameters and baseline VAS score will be recorded .Premedication and Adequate pre

loading will be done.

Ultrasound-guided FICB is usually performed with the patient lying in the supine position. The Femoral artery is visualized by placing the transducer transversely on the inguinal crease, followed by slightly moving the probe either medially or laterally. The fascia iliacaplane which is hyper echoic is identified superficial to the hypo-echoic iliopsoas muscle. Medially in the fascia iliaca compartment , the femoral nerve is identified deep to the fascia and lateral to the Femoral artery.

Grouping of the patient : - The study population will be randomly allocated into two groups by computer generated random numbers.

Group B:- 28 ml of 0.25% bupivacaine+2 ml of normal saline in USG guided FICB

Group BD-: 28 ml of 0.25% bupivacaine+ 50  mcg of dexmedetomidine in 2 ml of normal saline in USG guided FICB

Subarachnoid block will be given with 3 ml of 0.5% hyperbaric bupivacaine when the VAS score will be <4.

Following parameter will be recorded in both the group:

  1. Visual analogue scale score at 5,10,15,20 minutes after FICB.

  2. Ease of spinal positioning score

3)patient acceptance score

4)Duration of analgesia

5)Number of rescue analgesic doses required in 24 hours

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • ASA Grade I, II, III femur fracture patient operated under spinal anaesthesia.

排除标准

  • 1.Patients with contraindications for subarachnoid block like refusal for spinal anaesthesia, local infection ,patients with raised intracranial tension and coagulopathy
  • Morbid obesity
  • Patients with uncontrolled Diabetes Mellitus, Hypertension, cerebrovascular disease, liver and renal disease
  • Patients with multiple bone fractures
  • Pregnant and lactating mothers
  • Patients with psychiatric illness
  • Patients with peripheral sensorineural deficit
  • Patients with drug addiction or alcohol abuse.

结局指标

主要结局

Visual analogue scale at 5 ,10,15,20 minutes after fascia iliaca compartment block

时间窗: at baseline, 5min,10min,15min,20min

次要结局

  • patient acceptance score(at the end of surgery)
  • Duration of analgesia(immediately post,1 hour,2hour,4 hour,6hour,8hour,12hour,16hour,20hour,24hour)
  • Number of rescue analgesic doses required in 24 hours(in 24 hour)

研究者

发起方
Government medical college, Vadodara
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Utsavi Yakeshkumar Shah

Government medical college, Vadodara

研究点 (1)

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