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临床试验/NCT02868944
NCT02868944已完成3 期

Interest of the Injection of Morphine, in Addition to a Local Anesthetic When Performing a Combined Spinal-epidural for Labor Analgesia

CHU de Reims2 个研究点 分布在 1 个国家目标入组 144 人开始时间: 2014年8月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
已完成
发起方
CHU de Reims
入组人数
144
试验地点
2
主要终点
Visual analog pain scale

研究概览

简要总结

The addition of morphine to a local anesthetic when performing an epidural analgesia during labor analgesia has improved the efficiency and the action duration of analgesia. One limitation of this technique is the time of installation of the analgesic effect (about 30 minutes) when using the only epidural. Therefore, the technique of sequential combined spinal epidural was introduced. This is to shorten the installation time by direct injection into the cerebrospinal fluid. This allows a good efficiency in less than 10 minutes. It has been shown that low doses of sufentanil (strong opioid) in spinal anesthesia could potentiate the effect of the local anesthetic.

详细描述

Compare the results of obstetric analgesia by sequential combined spinal epidural with local anesthetic injection associated with morphine and a sequential obstetric analgesia by sequential combined spinal epidural with local anesthetic injection alone

研究设计

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

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • pregnant patients
  • patients who experienced a physiological course of pregnancy
  • patients for which it was estimated eutrophic fetus without pathology found during ultrasound
  • patient consenting to participate to the study
  • patient enrolled in the national healthcare insurance program
  • patient older than 18 years and younger than 40 years

排除标准

  • twin pregnancy
  • contraindication to sequential combined spinal epidural

研究组 & 干预措施

experimental group

Experimental

sequential combined spinal epidural with local anesthetic injection associated with morphine

干预措施: experimental group : sequential combined spinal epidural with local anesthetic injection (chirocaine) associated with morphine (sufentanil). (Drug)

control group

Active Comparator

sequential combined spinal epidural with local anesthetic injection alone

干预措施: control group : sequential combined spinal epidural with local anesthetic injection (chirocaine) alone. (Drug)

结局指标

主要结局

Visual analog pain scale

时间窗: after 5 minutes

Pain evaluated inferior at 3 on 10 using a visual analog pain scale

次要结局

未报告次要终点

研究者

发起方
CHU de Reims
申办方类型
Other
责任方
Sponsor

研究点 (2)

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