跳至主要内容
临床试验/NCT05897814
NCT05897814已完成不适用

Evaluation of M-mode Ultrasonography for Epidural Catheter Identification, and Correct Placement, in Obstetric Anesthesia

Assistance Publique - Hôpitaux de Paris2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2023年9月9日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
100
试验地点
2
主要终点
Success rate of epidural catheter localisation in M-mode (M-m) ultrasonography

研究概览

简要总结

In France, 80% of women choose epidural analgesia for delivery and birth. The localization of the epidural space is classically achieved by loss of resistance to saline. This blind technique means the passage of the needle through the ligamentum flavum. However, epidural analgesia failure has been reported in 27-32% of cases.

Currently, lumbar neuraxial ultrasound has become a valuable tool facilitating the placement of an epidural catheter. Although lumbar neuraxial ultrasound has been the source of many studies, few have focused on its use to confirm the exact location of the epidural catheter in the epidural space.

In the Pediatric and Obstetric Anesthesia-Resuscitation Department of the Necker-Enfants Malades Hospital, pre procedural lumbar neuraxial ultrasound for epidural anesthesia is a regular practice.

The objective of this study is to evaluate the ability of M-mode (M-m) and color Doppler (cD) ultrasonography to identify the epidural catheter position for parturients in the delivery room.

详细描述

In France, 80% of women choose epidural analgesia for delivery and birth. The localization of the epidural space is classically achieved by loss of resistance to saline. This blind technique means the passage of the needle through the ligamentum flavum. However, epidural analgesia failure has been reported in 27-32% of cases.

Currently, lumbar neuraxial ultrasound has become a valuable tool facilitating the placement of an epidural catheter. Although lumbar neuraxial ultrasound has been the source of many studies, few have focused on its use to confirm the exact location of the epidural catheter in the epidural space.

Indeed, only 2 retrospective studies have described this strategy on cohorts with small numbers of adult patients. One demonstrated in a mixed population the possible localization of the epidural analgesia catheter using color Doppler (cD) mode (67.5% of cases) and M-mode (M-m) ultrasonography (M-m) (75%). Only one study identified the position of the epidural catheter in the obstetric context due to the cD mode ; with a low rate of visualization (37.1% of cases).

In the Pediatric and Obstetric Anesthesia-Resuscitation Department of the Necker-Enfants Malades Hospital, pre procedural lumbar neuraxial ultrasound for epidural anesthesia is a regular practice.

The objective of this study is to evaluate the ability of the M-m and cD mode to identify proper catheter placement in parturients in the delivery room.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
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

  • Adult women admitted to the delivery room for a vaginal delivery with an epidural analgesia.
  • Written informed consent.
  • French speaking patient.

排除标准

  • Patient with a contraindication to neuraxial analgesia.
  • Visual Analogue Scale score >7 at epidural analgesia pose.
  • No health insurance.

结局指标

主要结局

Success rate of epidural catheter localisation in M-mode (M-m) ultrasonography

时间窗: Day 0

The location of the epidural catheter is based on the visualization of the "beach and sea" sign with injection of the analgesic solution through the epidural catheter into the epidural space.

次要结局

  • Success rate of epidural catheter localisation in color Doppler (cD) ultrasonography(Day 0)
  • Risk factors associated with location failure in M-m et cD mode(14 months)
  • Evaluate the effectiveness of epidural analgesia when the catheter is considered in the epidural space by lumbar neuraxial ultrasound(Day 0)
  • Assess operator satisfaction with M-mode (M-m) and color Doppler (cD) to locate the epidural catheter(Day 0)
  • Best neuraxial ultrasound view to locate the epidural analgesia catheter with M-mode (M-m) and color Doppler (cD) mode(14 months)
  • Evaluate the satisfaction of parturients in terms of comfort during the lumbar neuraxial ultrasound to identify the epidural catheter(Day 0)
  • Duration of neuraxial ultrasound's research to determine the localization of epidural analgesia catheter(Day 0)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验