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临床试验/NCT01449214
NCT01449214已完成不适用

Ultrasound-Guided Technique for Thoracic Epidural Insertion: A Randomized Controlled Trial

Samuel Lunenfeld Research Institute, Mount Sinai Hospital4 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2011年10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
60
试验地点
4
主要终点
Needle redirections

研究概览

简要总结

Thoracic epidural analgesia and anesthesia are effective in improving the quality of intraoperative and postoperative pain relief during thoracic and abdominal surgical procedures. Conventional epidural techniques have significant limitations. Due to the anatomic characteristics of the thoracic versus the lumbar intervertebral spaces, the insertion requires a more technically challenging paramedian approach. The safety and feasibility of bedside ultrasonography for the lumbar spine has already been established and it proves to be a valuable tool for neuraxial anesthesia in obstetric anesthesia

详细描述

• The feasibility and the reliability of US imaging for the thoracic spine has been proven by comparing the findings of ultrasound scans to MRI measurements, which is the standard imaging technique for the depiction of the spine. Pre-puncture US assessment may contribute to the safety and efficacy of the thoracic epidural technique. The purpose of this study is to compare the ultrasound-guided thoracic epidural insertion technique with the conventional anatomic landmarking technique of contacting bone and walking-off the lamina

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age > 18 years old.
  • Elective major abdominal or thoracic surgery requiring thoracic epidural anesthesia/analgesia.
  • Consent to participate and signed consent form.

排除标准

  • Contraindication to epidural anesthesia.
  • Marked spinal deformities or a history of spinal instrumentation
  • Emergency surgery.
  • Inability to communicate in English.
  • BMI>35 kgm-2

结局指标

主要结局

Needle redirections

时间窗: 30 minutes

Number of needle redirections defined as the need to withdraw the epidural needle for the purpose of continuing on a different angle (sagittal or axial plane)

次要结局

  • duration of ultrasound scanning(30 minutes)
  • Bony contacts(30 minutes)
  • New insertion point(30 minutes)
  • Number of insertions(30 minutes)
  • duration of epidural procedure(30 minutes)
  • complications during epidural insertion(30 minutes)

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 (4)

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