跳至主要内容
临床试验/NCT02895022
NCT02895022Unknown不适用

Determination of ED95 of 2% Lidocaine With Epinephrine for Converting Analgesia Epidural Anesthesia in Surgical Epidural in the Labor Current Cesarean

University Hospital, Clermont-Ferrand1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2016年9月5日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
发起方
入组人数
40
试验地点
1
主要终点
Success or failure of lidocaine 2% with epinephrine dose administered

研究概览

简要总结

The need to resort to a midwifery course work in cesarean is a common practice. Epidural analgesia for labor analgesia is practiced in 90% of women in obstetric work, as when the cesarean decision is taken course work in practice and the recommendations are to use the epidural catheter in place to convert the epidural analgesia in epidural anesthesia by re-injecting a local anesthetic on the catheter. General anesthesia is reserved only cases of extreme urgency and cons-indications for regional anesthesia as a purveyor of high maternal morbidity and mortality.

The initial assumption is that the 2% lidocaine with epinephrine is the optimal and recommended local anesthetic solution.

详细描述

There is a real variability in the volume administered by practitioners repository fault.

The main objective is to determine the ED95 dose of 2% lidocaine with epinephrine injected into the epidural catheter for which it does not arise from failure to surgical anesthesia for cesarean during labor.

The secondary objectives are to determine the failure risk factors, the hemodynamic consequences related to the volume administered and evaluate maternal satisfaction.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

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 > 37SA
  • Between 150 and 190cm
  • IMC between 20 and 40
  • Single pregnancy
  • Elective cesarean indication during obstetric labor

排除标准

  • Presentation of siege
  • Extreme and semi emergency caesarean indication

研究组 & 干预措施

Lidocaine 2% adrénalinée

Experimental

The main objective is to determine the ED95 dose of 2% lidocaine with epinephrine injected into the epidural catheter for which it does not arise from failure to surgical anesthesia for cesarean during labor.

干预措施: Lidocaine 2% adrénalinée (Drug)

Lidocaine 2% adrénalinée

Experimental

The main objective is to determine the ED95 dose of 2% lidocaine with epinephrine injected into the epidural catheter for which it does not arise from failure to surgical anesthesia for cesarean during labor.

干预措施: Epidural catheter (Device)

Lidocaine 2% adrénalinée

Experimental

The main objective is to determine the ED95 dose of 2% lidocaine with epinephrine injected into the epidural catheter for which it does not arise from failure to surgical anesthesia for cesarean during labor.

干预措施: Caesarean section (Procedure)

结局指标

主要结局

Success or failure of lidocaine 2% with epinephrine dose administered

时间窗: at day 1

次要结局

  • blood pressure (PAM, PAS (mmHg))(at day 1)
  • fluid replacement (ml)(at day 1)
  • hypotension(at day 1)
  • necessary to use vasopressors(at day 1)
  • nausea and vomiting intraoperatively(at day 1)
  • Study tolerance of epidural anesthesia for caesarean section(at day 1)
  • maternal pain (Visual Analog Scale)(at day 1)
  • maternal satisfaction(at day 1)
  • fetal arterial and venous cord pH(at day 1)
  • Apgar score(at day 1)
  • Intravenous sedation for inadequate anesthesia(at day 1)

研究者

发起方
University Hospital, Clermont-Ferrand
申办方类型
Other
责任方
Sponsor

研究点 (1)

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