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临床试验/CTRI/2023/05/052154
CTRI/2023/05/052154尚未招募不适用

Comparative evaluation of intrathecal hyperbaric levobupivacaine and ropivacaine with fentanyl as adjuvant in elective infraumbilical surgery

Department of Anaesthesiology1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2023年1月5日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
100
试验地点
1
主要终点
onset and duration of sensory block

研究概览

简要总结

The present study will be conducted in department of Anaesthesiology, GGS medical college and hospital Faridkot on 100 patients scheduled for infraumbilical surgeries under spinal anaesthesia. The patients will be divided into two groups as under:-

Group L- patiens will receive 3.5 ml of drug containing o.5% levobupivacaine and 25 mcg of fentanyl.

Group R- patiens will receive 3.5 ml of drug containing o.75% Ropivacaine and 25 mcg of fentanyl.

After administration of study drug onset of sensory and motor blockade will be assessed. Segmental sensory level of anaesthesia will be assessed by patient s response to pin prick every 2 min till 20 min and then every 10 min till highest level is achieved. time of onset of sensory block will be noted. Time of sensory block regression will be assessed from maximum block height attained to regression till L1 dermatome. Duration of sensory block is defined as time from intrathecal injection to regression of pin prick sensation to L1 dermatome. Motor block will be assessed every 5 min for 30 min and then every 15 min till recovery of motor blockade to modified bromage score of zero. Time of regression of motor block will be assessed from modified bromage score of 3 to zero. Duration of motor block is defined as time from intrathecal injection to regression of motor block to bromage score of zero.Intraoperative pulse rate, mean arterial blood pressure and oxygen saturation will be recorded every 2 min till 20 min and then every 5 min till end of surgery. Any side effects like nausea, vomiting, pruritis, bradycardia or hypotension will be recorded. In the post operative period the time to first analghesic demand will be noted and patient will be given rescue analgesia in the form of injection diclofenac sodium 1.5 mg/kg IV (intravenous) if VAS >3 and requirement of same will be noted for 24 hours. After completion of study, observations obtained will be tabulated and analysed using appropriate statistical methods.

研究设计

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

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • •American society of anaesthesiology grade I and II patients scheduled for elective infraumbilical surgeries under spinal anaesthesia.

排除标准

  • •patients with known allergy to any of the study drugs
  • •patients with coagulation disorders and on anticoagulants
  • •patients with local skin infection or disease
  • •patients with previous spine surgery or spine abnormality.

结局指标

主要结局

onset and duration of sensory block

时间窗: from time of injection of drug till loss of sensation at T6 dermatome which will be checked every 2 minutes till 20 min and then every 10 min till highest level attained

次要结局

  • onset and duration of motor block(every 5 minutes for 30 minutes and then every 15 minutes till recovery of motor blockade to modified bromage score of zero)

研究者

发起方
Department of Anaesthesiology
申办方类型
Government medical college

研究点 (1)

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