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临床试验/NCT05281991
NCT05281991已完成不适用

Agreement Between Laterality of Tsui Test and Laterality of Color Flow Doppler Signals During Labor Epidural Analgesia: a Prospective Observational Study

Samuel Lunenfeld Research Institute, Mount Sinai Hospital1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2022年6月8日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
25
试验地点
1
主要终点
Tsui test motor response: questionnaire

研究概览

简要总结

Epidural analgesia for relief of labor pain is a very common, safe and reliable technique that requires placement of a catheter in the epidural space. About 5% of labor epidural catheters may need to be re-sited due to failure of analgesia. This is often caused by malposition of the epidural catheter. Many factors may influence the position of the tip of the epidural catheter and the resulting spread of local anesthetic solution within the epidural space and consequently the quality of labor pain management. The electrical stimulation of the epidural catheter, commonly known as Tsui test, can reliably confirm its positioning within the epidural space if this stimulus produces a muscular twitch under a certain current amplitude threshold. This muscular response is unilateral in 90% of the cases, not having any relationship between unilaterality and unsatisfactory catheter performance. It is unknown if this unilateral response has any correlation with the actual position of the catheter tip in terms of right or left side of the epidural space. Furthermore, the Tsui test does not give any information on the spread of anesthetic solution into the epidural space. Recent investigation shows that color flow doppler ultrasound during fluid injection through the epidural catheter may be helpful in determining the laterality of the tip of the epidural catheter; furthermore it may be able to inform about the spread the anesthetic solution, which is a limitation of the Tsui test. The investigators will perform an observational study to investigate the response patterns of Tsui test and Color flow Doppler ultrasound in the obstetric population. Women who have delivered under epidural analgesia will be approached for the study before the epidural catheter is removed. The investigators aim to characterize the laterality and current thresholds of Tsui test response and the laterality of the lumbar epidural catheter tip by color doppler ultrasound. The investigators hope to describe the findings and to correlate them with other clinical outcomes.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 55 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Patients who have delivered vaginally under epidural anesthesia

排除标准

  • Patients who refuse, are unable to give or have withdrawn consent
  • Patients unable to communicate fluently in English.
  • Patients who experience fetal or maternal complications during delivery.

结局指标

主要结局

Tsui test motor response: questionnaire

时间窗: 5 minutes

Tsui test motor response will be recorded as either: left, right or bilateral

Colour flow Doppler ultrasound assessment: questionnaire

时间窗: 5 minutes

Colour flow Doppler ultrasound assessment will be recorded as either: left, right or bilateral

次要结局

  • Tsui test current threshold amplitude(5 minutes)
  • Tsui test motor response dermatome: abdomen, thigh, leg, feet(5 minutes)
  • Location of epidural catheter tip flow as detected by Doppler(5 minutes)
  • Need for catheter mobilization: questionnaire(12 hours)
  • Presence of asymmetric block: questionnaire(12 hours)

研究者

发起方
Samuel Lunenfeld Research Institute, Mount Sinai Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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