Evaluation Of Efficacy And Safety Of Labour Analgesia By Intrathecal Morphine With Fentanyl Compared To Morphine With Bupivacaine In Mulago Hospital: A Double-blinded Randomized Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 138
- 主要终点
- Duration of analgesia
研究概览
简要总结
This study is aimed at evaluating single short spinal technique as a form of labour analgesia in a setting where more expensive and labor intensive techniques are not feasible.The study will examine the safety and efficacy of two drug combinations (intrathecal morphine+fentanyl vs intrathecal morphine+bupivacaine) through a randomized control trial.
The investigators hypothesize that a single shot of either intrathecal morphine plus fentanyl or intrathecal morphine plus bupivacaine achieve analgesia and are safe in parturients experiencing normal labour.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 14 Years 至 60 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Parturients with singleton pregnancy
- •Emancipated minors
排除标准
- •Those who declined.
- •Parturients with any identified complication of labour like preeclampsia, severe cardiac disease or previous operative delivery.
- •Sepsis or wound at site of spinal injection.
- •Allergy to any of the study drugs elicited from history.
研究组 & 干预措施
Intrathecal morphine with fentanyl
Single shot of intrathecal morphine 100mcg mixed with 25mcg of fentanyl and filled up to make a 2ml solution. This would then be injected into the subarachnoid space through L2-3 or L3-4 following standard procedures.
干预措施: Intrathecal morphine with fentanyl (Drug)
Intrathecal morphine with bupivacaine
Single shot of intrathecal morphine 100mcg mixed with 2.5mg of spinal bupivacaine and filled up to make a 2ml solution.This would then be injected into the subarachnoid space through L2-3 or L3-4 following standard procedures.
干预措施: Intrathecal morphine with bupivacaine (Drug)
结局指标
主要结局
Duration of analgesia
时间窗: 10 hours
Monitoring the level of pain by the visual analogue scale to determine the total duration of analgesia in hours starting 5 min after drug administration
次要结局
- APGAR score(6 minutes)
- Maternal side effects (composite)(34 hours)