Comparison of Analgesic Effect of Intrathecal Morphine and Buprenorphine as adjuvants to Bupivacaine for major gynaecological surgery : a Prospective, Randomized Double Blinded Study.

chettinad health city1 个研究点分布在 1 个国家目标入组 70 人开始时间: 2021年1月10日最近更新: 2021年6月9日

试验速览

阶段: 4 期
状态: 尚未招募
发起方
入组人数: 70
试验地点: 1
主要终点: To compare the duration of analgesia using Morphine and Buprenorphine as adjuvants to Bupivacaine

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The primary aim of this study is to compare the analgesic effect of morphine and buprenorphine as adjuvants to bupivacaine.Morphine 100mcg is added with 3.4ml of 0.5 % H bupivacaine in one sample and buprenorphine 60mcg is addded with 0.5% H bupivacine in another sample and the ana;lgesic effect of both the samples are compared. IN ADDITION TO THIS THE ONSET OF SENSORY AND MOTOR BLOCKADE ,THE SEDATION EFFECT AND ADVERSE EFFECTS ARE ALSO compared

研究设计

研究类型: Interventional
分配方式: Computer generated randomization
盲法: Participant and Investigator Blinded

入排标准

年龄范围: 18.00 Year(s) 至 60.00 Year(s)（—）
性别: Female

入选标准

•Major gynaecological surgeries BMI<35Kg/m2 Height more than 150cm Duration of surgery more than60min.

排除标准

•Spine deformity Patients not willing for spinal anaesthesia Coagulopathy local infection at site of injection Increased intracranial pressure Patient allergic or sensitive to local anaesthetic agents.

结局指标

主要结局

To compare the duration of analgesia using Morphine and Buprenorphine as adjuvants to Bupivacaine

时间窗: The duration of analgesia is noted for 24hrs from the time of injection of drug to the time when the patient complaints of pain

次要结局

To compare the onset and duration of sensory blockade(Onset of sensory blockade is assessed from immediately after giving spinal anaesthesia till it reaches the highest level)
To compare the onset and duration of motor blockade(The time for the onset of motor blockade is assessed immediately after giving spinal)
To compare the haemodynamics between two groups(All haemodynamic parameters are measured 5min once for first half an hour after injecting drug then at an interval of 15 min for 4hrs.Then at an interval of 1hour for 12hrs .Then at an interval of 3hrs for 24 hours)
To compare the sedation between two groups(sedation is assessed hourly after injecting the drug for 12hrs)
To compare the associated side effects(Side effects are assessed hourly for 24hrs)

研究者

发起方

chettinad health city

申办方类型

Private medical college

研究点 (1)

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