跳至主要内容
临床试验/NCT03890640
NCT03890640已完成不适用

Evaluation of the Accuracy of Real-time Ultrasound-assisted Thoracic Epidural Catheter Insertion: a Pilot Study

Asan Medical Center2 个研究点 分布在 1 个国家目标入组 38 人开始时间: 2019年7月4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
38
试验地点
2
主要终点
Success rate of ultrasound-guided thoracic epidural catheter insertion

研究概览

简要总结

The aim of the present study is to access the success rate of ultrasound-guided thoracic epidural catheter insertion, using fluoroscopy.

详细描述

Thoracic epidural anesthesia has been associated with reduced acute postoperative pain for a wide variety of surgical procedures. It has also been associated with reductions in perioperative cardiac stress, chronic post-thoracotomy pain, and improvements in postoperative pulmonary function. Although a variety of methods can be used to confirm the position of the epidural needle in the epidural space, a blind technique and fluoroscopic guided approach are a widely used method. A thoracic epidural block is a relatively more difficult procedure than procedures used in other regions, because the spinous process of the thoracic vertebra is longer than that of the lumbar vertebra, and the area through which the needle can approach the epidural space is relatively smaller due to an acute angle and larger distance between the skin and the epidural space. Therefore, the success rate of thoracic epidural intervention is only about 68% under a blind technique due to inadequate position of the needle tip, misplacement, occlusion, and migration of the catheter.

Although fluoroscopic guided thoracic epidural intervention is the safest and most accurate method to identify the correct anatomical structures and confirm the epidural space with contrast medium, its use is limited because of the difficulty of using fluoroscope and the burden of radiation exposure. As the use of ultrasound has become popularized and universal, it has been widely used in regional anesthesia and analgesia, has continuously replaced the modality such as a blind technique and fluoroscopic guidance. Ultrasound-guided thoracic epidural catheter insertion was also recently investigated, and then it was conducted successfully in 15 cases of thoracic and upper abdominal surgery. Moreover, it showed several advantages including lowering the number of needle passes and increasing the success rate. However, it has not yet been studied how accurately the catheter is located in the thoracic epidural space during thoracic epidural catheter insertion using real-time ultrasound. Although it is possible to speculate the success of the thoracic epidural catheterization clinically, the identification of the location of the catheter is only possible under fluoroscopic guidance. Therefore, in the present study, we aimed to confirm the success rate of ultrasound-guided thoracic epidural catheter insertion, using fluoroscopy with contrast medium.

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
20 Years 至 79 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients who will undergo upper abdomen or thoracic surgery
  • Scheduled for thoracic epidural catheter insertion
  • 20 ≤ age <80
  • When obtaining informed consent voluntarily

排除标准

  • Allergy to local anesthetics and contrast dye, and steroid
  • Use of anticoagulants or antiplatelet medication, coagulopathy
  • Infection at the insertion site
  • Neurological or psychiatric disorders
  • Prior spine instrumentation
  • Pregnancy

结局指标

主要结局

Success rate of ultrasound-guided thoracic epidural catheter insertion

时间窗: on the day of the procedure

Confirmation success of ultrasound-guided thoracic epidural catheter insertion using fluoroscopic images; success means that the catheter tip is located in the epidural space.

次要结局

  • First attempt success rate(on the day of the procedure)
  • Number of skin punctures(on the day of the procedure)
  • Number of needle passes(on the day of the procedure)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jong Hyuk Lee

Clinical professor

Asan Medical Center

研究点 (2)

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