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临床试验/NCT04255121
NCT04255121已完成3 期

Interest of the Alkalinization of the Adrenaline Lidocaine Solution for Conversion of Epidural Analgesia Into Epidural Anesthesia During an Emergency Caesarean

CHU de Reims1 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2020年6月22日最近更新:
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
400
试验地点
1
主要终点
delay in obtaining a T6 anesthetic level

研究概览

简要总结

During labor, pain is systematic. In France, epidural analgesia is the gold standard to fight pain.

Sometimes, emergency situations involve the maternal or fetal prognosis and require an emergency fetal extraction by caesarean. When an effective epidural analgesia is in place, an injection of adrenaline lidocaine converts this epidural analgesia into an epidural anesthesia allowing a surgical procedure. Sometimes, the time required to set up the anesthesia cannot be expected and a general anesthesia is performed.

Local anesthetics used during epidural analgesia have Pka between 7.8 and 8.1. In solution, local anesthetics exist in two forms: an un-ionized form and an ionized form. The non-ionized form is liposoluble and crosses the lipid membranes to reach the site of intracellular action. The non-ionized form conditions the time taken to install anesthesia.

When the pH of the solution is equal to Pka, un-ionized and ionized form are present in equal quantity. Commercial local anesthetic solutions have acidic pH and so contained a majority of ionized form. Alkalinization of local anesthetics solution should bring the pH closer to pKa and therefore to favor a greater proportion of non-ionized form.

详细描述

The aim of this study is to evaluate impact of an alkalinization of adrenaline lidocaine solution for conversion of epidural analgesia into epidural anesthesia during an emergency caesarean.

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
Double (Participant, Outcomes Assessor)

入排标准

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

入选标准

  • pregnant women followed up in the Reims University Hospital
  • women whose birth is expected by vaginal delivery in the Reims University Hospital
  • women wishing to benefit from epidural analgesia
  • women agreeing to participate in the research and having signed informed consent
  • women aged 18 years old and more
  • women affiliated to a social security system

排除标准

  • women who don't benefit from emergency caesarian (vaginal delivery or scheduled caesarian)
  • women for whom epidural analgesia cannot be used
  • women for whom epidural analgesia is not effective

研究组 & 干预措施

alkalinization of adrenaline lidocaine solution arm

Experimental

conversion of epidural analgesia into epidural anesthesia during an emergency caesarean using an alkalinization of adrenaline lidocaine solution

干预措施: 2% adrenaline lidocaine associated with 4.2% sodium bicarbonate (Drug)

adrenaline lidocaine solution arm

Active Comparator

conversion of epidural analgesia into epidural anesthesia during an emergency caesarean using a adrenaline lidocaine solution

干预措施: 2% adrenaline lidocaine (Drug)

结局指标

主要结局

delay in obtaining a T6 anesthetic level

时间窗: 15 minutes

delay to obtain a T6 anesthetic level evaluated in minute

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 (1)

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