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临床试验/NCT05849324
NCT05849324招募中不适用

The Difference of Intravascular Injection Rate During Lumbar Transforaminal Epidural Block Using Bent Needle Compared to Straight Needle: a Prospective Study

Kyungpook National University Hospital2 个研究点 分布在 1 个国家目标入组 260 人开始时间: 2023年4月27日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
260
试验地点
2
主要终点
Intravascular injection

研究概览

简要总结

The primary aim of this study was to compare intravascular injection rates during LTFESI between commonly used straight and bent chiba needles.

详细描述

Lumbar transforaminal epidural steroid injection (LTFESI) is widely used in clinical practice to effectively deliver injectate into the ventral epidural space. Complications associated with intravascular injection such as spinal cord infarction and paraplegia can occur during LTFESI. The incidence of intravascular injection during LTFESI was known as 9.9% ~ 17.7%. To improve the safety of the procedure, avoidance of intravascular injection is crucial, for which appropriate needle selection is important. Currently, the most commonly used block needles in LTFESI are straight or bent chiba needles.

The primary aim of this study was to compare intravascular injection rates during LTFESI between commonly used straight and bent chiba needles.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Screening
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with radiating pain from lumbar spinal stenosis and herniated nucleus pulposus.

排除标准

  • Pregnancy, allergic to contrast media, patient refusal, and patients with persistent contraindication to nerve block such as coagulopathy and infection of the injection site.

结局指标

主要结局

Intravascular injection

时间窗: During procedure

Intravascular injection is defined as contrast media spreading out through the vascular channel during injection of contrast media under real time fluoroscopy

次要结局

  • Ventral epidural spreading(up to 24 weeks)
  • Procedure time(During procedure)
  • Medial epidural spreading(up to 24 weeks)

研究者

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

Saeyoung Kim, MD, PhD

Professor

Kyungpook National University Hospital

研究点 (2)

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