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临床试验/NCT04774458
NCT04774458已完成不适用

The Safety and Clinical Utilities of the Fluoroscopy-guided Cervical Epidural Approach Using the Contralateral Oblique View: a Prospective Observational Study

Asan Medical Center2 个研究点 分布在 1 个国家目标入组 439 人开始时间: 2021年3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
439
试验地点
2
主要终点
Dural puncture event - major complication

研究概览

简要总结

The aim of the present study is to investigate the safety and clinical utility of contralateral oblique view for fluoroscopic guided cervical epidural access.

详细描述

A cervical epidural block is a widely used intervention to reduce pain in patients with cervicalgia or cervical radicular pain. To achieve a successful procedure, accurate access to the cervical epidural space is needed. However, careful attention is required for this cervical epidural procedure due to a possibility of serious complications such as spinal cord infarction and quadriplegia due to blood vessel damage, convulsion due to an intravascular drug administration, cerebral infarction due to vascular embolism, subdural or subarachnoid injection, hematoma, and spinal cord injury. Although the use of fluoroscopy improves the safety and accuracy of cervical epidural access, this technique still has significant drawbacks, such as false loss of resistance and difficulty in assessing the depth of the needle tip in lateral views in relation to the epidural space. To overcome this issue, cervical epidural access using the contralateral oblique (CLO) view has been introduced and the ideal angle of CLO view for the cervical spine is reported as 50 degrees.

However, it has not been reported on the safety and clinical utility of using the CLO view during cervical epidural access. Therefore, the investigators planned this study to observe the safety and clinical utility of the CLO view at 50 degrees for the cervical epidural block.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
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 need an epidural space access at C6-7 or C7-T1 level
  • Patients who are expected to undergo cervical epidural block
  • Patients who are expected to undergo cervical epidural neuroplasty
  • 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
  • Not visible epidural space due to severe cervical spinal canal stenosis

结局指标

主要结局

Dural puncture event - major complication

时间窗: Immediately after contrast medium administration during the procedure

whether a dural puncture event occurs or not during the cervical epidural access

次要结局

  • Rate of success or failure(Immediately after procedure)
  • Needle tips location(One day after the procedure)
  • Needling time(Immediately after procedure)
  • First attempt success(Immediately after procedure)
  • False positive/negative loss of resistance(Immediately after procedure)
  • Radiation dose (cGy)(Immediately after procedure)
  • Total number of needle passes(Immediately after procedure)
  • Needle tip visualization(One day after the procedure)
  • Post-procedural complication(Up to one month after the procedure)
  • Global perceived effect (GPE)(One month after the procedure)
  • Other complications(Immediately after procedure)
  • Numerical rating scales (NRS)(One month after the procedure)

研究者

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

Doo-Hwan Kim

Assistant professor

Asan Medical Center

研究点 (2)

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