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临床试验/NCT02867046
NCT02867046已完成不适用

The Incidence of the Intravascular Injection During S1 Transforaminal Epidural Steroid Injection in Two Approaches: Medial vs Lateral in Anteroposterior View

Yonsei University1 个研究点 分布在 1 个国家目标入组 165 人开始时间: 2016年7月29日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
165
试验地点
1
主要终点
the incidence of intravascular injection in the medial approach group in S1 foramen

研究概览

简要总结

Lumbosacral transforaminal epidural steroid injection (TFESI) is helpful for the treatment of lumbosacral radicular pain, but in case of intravascular injection, infrequently serious complication can be developed. Against this backdrop, if there is any difference of frequency of intravascular injection incidence during S1 (sacrum 1) TFESI between method using medial approach and method using lateral approach in anteroposterior view, the result can be crucial factor in selecting the approach. In addition, appropriate volume of injection will be checked in each approach.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Participant)

入排标准

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

入选标准

  • Adult patients (20-80 years of age) who were scheduled to receive S1 transforaminal epidural steroid injection for lumbosacral radicular pain at pain management clinic

排除标准

  • coagulopathy
  • systemic infection
  • any active infection at the injection site
  • history of allergy to contrast media, local anesthetics, corticosteroid
  • patients unable to communicate or patients with cognitive dysfunction

研究组 & 干预措施

medial approach group

Experimental

干预措施: S1 transforaminal epidural steroid(dexamethasone) injection (Drug)

lateral approach group

Active Comparator

干预措施: S1 transforaminal epidural steroid(dexamethasone) injection (Drug)

结局指标

主要结局

the incidence of intravascular injection in the medial approach group in S1 foramen

时间窗: 5 seconds after injection of contrast media via block needle.

the incidence of intravascular injection in the lateral approach group in S1 foramen

时间窗: 5 seconds after injection of contrast media via block needle.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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