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临床试验/CTRI/2024/03/064555
CTRI/2024/03/064555尚未招募Phase 3 4

A comparative study of effect of intrathecal hyperbaric Ropivacaine 0.75% vs hyperbaric Bupivacaine 0.5% for postoperative analgesia in Infraumblical surgeries

Jawahar lal nehru medical college1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年3月7日最近更新:

试验速览

阶段
Phase 3 4
状态
尚未招募
发起方
入组人数
100
试验地点
1
主要终点
duration of analgesia

研究概览

简要总结

With due approval of institutional ethical committee a double blinded randomized study will be conducted. 100 participatnts who will be undergoing infraumbilical surgeries under spinal anaesthesia. 50 participants will be grouped into Group R and will be recieving Hyperbaric Ropivacaine 0.75% 3ml intrathecally under all aseptic precautions. 50 participants will be grouped into Group B Will be recieving hyperbaric Bupivacaine 0.5% 3ml intrathecally . A  written informed consent will be taken prior to procedure.Participants will be monitored for duration of analgesia as primary outcome and onset and duration of sensory block, motor block and hemodynamic adverse effects as secondary outcome in intraopertive and  post operative period till patients complains of pain or demands for rescue analgesia for fisrt time. Data will be collected and analyzed using standard test  and p value of less than 0.05 will be considered significant.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Investigator Blinded

入排标准

年龄范围
20.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • 1.Body weight 40 to 80 kg
  • ASA class I and II
  • patients undergoing infraumblical surgeries.

排除标准

  • 1.Patients refusal and uncooperative patients 2.Hypersensitivity to study drugs
  • local site infection.

结局指标

主要结局

duration of analgesia

时间窗: pain will be assessed using Visual Analogue Score in immediate postoperative period follwoed by hourly interval till 24 hrs post opertively

次要结局

  • 1. onset and duration of sensory block(2.onset and duration of motor block)

研究者

发起方
Jawahar lal nehru medical college
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr VEENA PATODI

jawahar lal nehru medical college

研究点 (1)

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