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临床试验/NCT04221568
NCT04221568Unknown1 期

The Comparison of Intrathecal Bupivacaine With Fentanyl and Levobupivacaine With Fentanyl for Labour Analgesia

Assiut University0 个研究点目标入组 70 人开始时间: 2020年3月1日最近更新:
适应症
相关药物

试验速览

阶段
1 期
入组人数
70
主要终点
Compare the duration of analgesia of bupivacaine and fentanyl versus levobupivacaine and fentanyl.

研究概览

简要总结

Primary outcome: Compare the duration of analgesia. Secondary outcome: analgesic potency of bupivacaine and fentanyl versus levobupivacaine and fentanyl.

详细描述

The pain of childbirth is the most severe pain any women can endure in their life time. Painful uterine contractions lead to maternal hyperventilation and increased catecholamine concentrations resulting im maternal and fetal hypoxemia.

Labour pain when unrelieved can have adverse effect on the course of labour as well as on the fetal wellbeing. An effective labour analgesia lead to better fetal and maternal outcome.

Although the gold standard in labour analgesia is utilization of epidural services which are widely used to provide pain-free labour in many parts of the world and and have the advantage of providing flexibility to meet the needs of each patient . Epidurals have long been associated with increased oxytocin use, increased fetal malposition, increased rates of instrumental and cesarian delivery, and longer labour .

The use of single-shot intrathecal low dose found to be effective . The advantages of this form of technique include the rapidity of onset and reliability, with minimal hemodynamic changes and motor block. Spinal block is cheaper as well as less technically challenging when compared to epidural and combined spinal epidural block. Intrathecal analgesia alone is useful when duration of labour can be reasonably estimated. Opioid combined with a small dose of local anesthetic provides rapid analgesia and dissipates when no longer needed.

Bupivacaine because of its least placental transfer, due to high protein binding and minimal motor block compared to sensory block in lower doses, has become the popular choice for labor analgesia. Addition of neuraxial lipid soluble opioids permitted reduction in the dose while maintaining effective analgesia and minimizing potential adverse effects on the progress of labor and lower extremity motor block .

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Investigator)

入排标准

年龄范围
25 Years 至 35 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • singleton pregnancies
  • vertex presentation who will be in the active phase of labour with a cervical dilatation >4cm
  • normal fetal heart rate.

排除标准

  • 1-Parturients with systemic diseases 2-Suspected cesarian section which include, in order of frequency, labor dystocia, abnormal or indeterminate (formerly, nonreassuring) fetal heart rate tracing, fetal malpresentation, multiple gestation, and suspected fetal macrosomia.
  • 3 Fetus with known or suspected congenital abnormalities, and 4-Administration of parentral or oral analgesics before initiation of neuraxial analgesia will be excluded from the study.

结局指标

主要结局

Compare the duration of analgesia of bupivacaine and fentanyl versus levobupivacaine and fentanyl.

时间窗: From2 to 8 hours. It is the time between the end of the spinal injection and the moment additional analgesia requested by parturients owing to the reappearance of labor pain was assessed by Visual Analog Scale for Pain (VAS Pain)

Defined as the time between the end of the spinal injection and the moment additional analgesia requested by parturients owing to the reappearance of labor pain was assessed.

次要结局

  • Analgesic potency of bupivacaine and fentanyl versus levobupivacaine and fentanyl.(From2-8 hours. It is the time between the end of the spinal injection and the moment additional analgesia requested by parturients owing to the reappearance of labor pain was assessed by Visual Analog Scale for Pain (VAS Pain))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Peter Elesha Roshdy

Principal Investigator

Assiut University

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