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临床试验/NCT04754282
NCT04754282
已完成
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Impact of a Cross-legged Versus Traditional Sitting Position for the Success of an Epidural Analgesia Catheter Placement During Labor

Assistance Publique - Hôpitaux de Paris1 个研究点 分布在 1 个国家目标入组 457 人2021年2月24日

概览

阶段
不适用
干预措施
Position of labouring women for epidural analgesia catheter placement : Traditional Sitting Position (TSP)
疾病 / 适应症
Epidural Analgesia for Labour and Delivery
发起方
Assistance Publique - Hôpitaux de Paris
入组人数
457
试验地点
1
主要终点
Epidural analgesia success rate
状态
已完成
最后更新
上个月

概览

简要总结

The success of an epidural analgesia catheter placement depends on the parturient position. A poor posture can increase the number of punctures, patient discomfort, and risk of complications. An adequate position reverses lumbar lordosis, facilitating the access to the intervertebral space. In most cases, insertion of the epidural analgesia catheter is performed in sitting position or in lateral decubitus, the choice being generally guided by the preference of the anesthetist.

According to anesthetists' experience in the obstetrical anesthesia unit at Necker-Enfants Malades hospital, a cross-legged sitting position is comfortable for parturients, restricts interfering movements during the procedure, and provides adequate widening of interspinous spaces. This position results in knees and hips flexion, tilting the pelvis backward and opening the interspinous spaces, while limiting muscular strain to maintain the position. However, literature on this matter is scarce.

The aim of this study is to prove the superiority of the cross-legged position for successful placement of the epidural analgesia catheter at the first puncture without needle reorientation compared to a traditional sitting position on the edge of the bed.

详细描述

Labour pain is one of the most intense pain known. To relieve this pain, epidural analgesia is both the most effective and the safest technique. An epidural analgesia catheter also allows for anesthesia in the event of the need for instrumental extraction or emergency caesarean section; it is thus recommended by learned societies. The 2016 national perinatal survey conducted by the National Institute of Health and Medical Research (INSERM) and the Directorate of Research, Studies, Evaluation and Statistics (DREES) in France revealed that more than 80% of women had chosen to benefit from an epidural analgesia during labour. The first puncture failure rate ranges from 3% to almost 40% depending on the study. Identified factors for difficult epidural analgesia catheter placement were: non-palpable spinous processes, obesity, spine deformity, inability for the patient to maintain an adequate position and poor experience of the operator. The success of an epidural analgesia catheter placement depends on the parturient position. A poor posture can increase the number of punctures, patient discomfort, and risk of complications. An adequate position reverses lumbar lordosis, facilitating the access to the intervertebral space. Different positions have been described: the lateral decubitus, the traditional sitting position, and its variants such as the squatting position, the "hamstring stretch" position, the "pendant position" (with a bilateral axillary support) and more recently the cross-legged position. In most cases, insertion of the epidural analgesia catheter is performed in sitting position or in lateral decubitus, the choice being generally guided by the preference of the anesthetist. According to anesthetists' experience in the obstetrical anesthesia unit at Necker-Enfants Malades hospital, a cross-legged sitting position is comfortable for parturients, restricts interfering movements during the procedure, and provides adequate widening of interspinous spaces. This position results in knees and hips flexion, tilting the pelvis backward and opening the interspinous spaces, while limiting muscular strain to maintain the position. However, literature on this matter is scarce. The aim of this study is to prove the superiority of the cross-legged position for successful placement of the epidural analgesia catheter at the first puncture without needle reorientation compared to a traditional sitting position on the edge of the bed.

注册库
clinicaltrials.gov
开始日期
2021年2月24日
结束日期
2022年3月26日
最后更新
上个月
研究类型
Interventional
研究设计
Parallel
性别
Female

研究者

入排标准

入选标准

  • Adult women admitted to the delivery room and requesting an epidural analgesia during labour
  • Written informed consent
  • French speaking patient

排除标准

  • Patient with a contraindication to neuraxial analgesia
  • Impossibility for the patient to seat in a cross-legged position
  • No health insurance

研究组 & 干预措施

Traditional sitting position

Expecting women are positioned in a traditional sitting position for epidural analgesia catheter placement during labour.

干预措施: Position of labouring women for epidural analgesia catheter placement : Traditional Sitting Position (TSP)

Cross-legged sitting position

Expecting women are positioned in a crosse-legged sitting position for epidural analgesia catheter placement during labour.

干预措施: Position of labouring women for epidural analgesia catheter placement : Cross-legged Sitting Position (CSP)

结局指标

主要结局

Epidural analgesia success rate

时间窗: 20 minutes

Percentage of epidural analgesia catheter placement success at first puncture without needle reorientation

次要结局

  • Epidural analgesia success rate in obese patients(20 minutes)
  • Patient's comfort(20 minutes)
  • Operator satisfaction(20 minutes)
  • Patient's pain(20 minutes)
  • Adverse event occurrence rate(20 minutes)
  • Successful rate of epidural analgesia catheter placement by residents(20 minutes)

研究点 (1)

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