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临床试验/CTRI/2021/07/034773
CTRI/2021/07/034773尚未招募不适用

A study of Efficacy of Dural Puncture Epidural v/s Conventional Epidural Analgesia for Onset of Analgesia during Labour Analgesia among Parturients: A Randomized Controlled Trial

Dept of Anaesthesiology1 个研究点 分布在 1 个国家目标入组 76 人开始时间: 2021年7月18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
76
试验地点
1
主要终点
To compare the time of onset of analgesia following dural puncture epidural analgesia with that of conventional epidural analgesia given for labour analgesia to parturients in the labour room of tertiary care hospital using the VAS score

研究概览

简要总结

Labour pains are considered to be the most painful events in the life of a woman. Neuraxial techniques have become the effective form of labour analgesia.labour epidural is considered the traditional technique for providing labour analgesia. Dural puncture epidural is a novel technique which enhances the onset and adequacy of analgesia. This study will be comparison of dural puncture epidural and conventional epidural  analgesia for labour analgesia.Parturients will be Randomized into two groups A and B. Pt will be kept unaware of the technique used. The same drug of same concentration will be administered to both the groups. After administration of first bolus ,the adequacy of analgesia will be assessed every 2 minutes till adequate analgesia is achieved. Analgesia is considered to be adequate if the VAS score is less than 3. First time to top up will be recorded as duration of analgesia. The incidence of hypotension and post dural puncture headache will also be noted.

研究设计

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

入排标准

年龄范围
18.00 Year(s) 至 35.00 Year(s)(—)
性别
Female

入选标准

  • Parturients presenting for normal vaginal delivery in active labour Uncomplicated pregnancy Vertex presentation Cervical dilatation < 5 cm.

排除标准

  • Hypersensitivity to drugs used for labour analgesia Patients contraindicated for neuraxial analgesia Bleeding disorders Local or systemic sepsis Blood/CSF in epidural catheter Accidental dural puncture with epidural needle.

结局指标

主要结局

To compare the time of onset of analgesia following dural puncture epidural analgesia with that of conventional epidural analgesia given for labour analgesia to parturients in the labour room of tertiary care hospital using the VAS score

时间窗: After 5 minutes of the first bolus, the adequacy of analgesia will be assessed every 2 minutes till adequate analgesia is achieved ie. VAS less than 3

次要结局

  • To compare the duration of analgesia after the first dose(At the time when the patient asks for first epidural top up)
  • Incidence of side effects like hypotension(Anytime after drug instillation)
  • Incidence of post dural puncture headache(After 24 to 48 hrs after the neuraxial analgesia)

研究者

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

研究点 (1)

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