跳至主要内容
临床试验/NCT00792311
NCT00792311已完成不适用

Tsui Test as a Predictor of Bupivacaine Consumption in Labour Epidurals

Samuel Lunenfeld Research Institute, Mount Sinai Hospital2 个研究点 分布在 1 个国家目标入组 102 人开始时间: 2008年11月1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
102
试验地点
2
主要终点
Consumption of bupivacaine in mg/hour in the first 2 hours of epidural anesthesia

研究概览

简要总结

Low current electrical stimulation test, also called the Tsui test, has been used successfully to confirm the catheter location in the epidural space in various patient populations. The results of this study will show whether or not doing a Tsui test can predict inadequate epidural analgesia early in the course of placing the epidural, so that the appropriate measures could be applied immediately upon gathering unfavorable results.

详细描述

Despite its very high success rate, the epidural technique remains a rather blind technique, and failures continue to occur. The incidence and reasons for failure are not well understood. The Tsui test is not routinely performed with each epidural catheter insertion, but rather it is used when there is suspicion about the catheter location.

In this study, the Tsui test will be performed twice during the epidural procedure, and bupivacaine consumption will be recorded for the first 2 hours.

Information gained from this study could have great impact in clinical practice, since the incidence of inadequate labor analgesia is still relatively high (10-20%), leading to maternal distress and disappointing labor experience.

研究设计

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

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Women over 18 years of age requesting an epidural for labor and delivery
  • Cervix dilated 0-5 cm and pain VAS>6
  • Able to communicate in English
  • Informed consent

排除标准

  • Refusal to provide written informed consent
  • Patients unable to communicate in English
  • Contraindication to regional anesthesia
  • Allergy or hypersensitivity to lidocaine, bupivacaine or fentanyl
  • Sedatives or opioids received prior to insertion of epidural catheter
  • Abnormal vertebral anatomy, such as previous spine surgery and scoliosis
  • Coexisting neurological disorders
  • Patients with implanted electronic devices

结局指标

主要结局

Consumption of bupivacaine in mg/hour in the first 2 hours of epidural anesthesia

时间窗: 2 hours

次要结局

  • Incidence of inadequate epidural block.(2 hours)
  • Current (mA) needed to elicit motor response; 1. before test dose and 2. 5 minutes after test dose.(5 minutes)
  • Contraction pattern elicited by the Tsui test at baseline and after test dose.(5 minutes)

研究者

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

研究点 (2)

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