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临床试验/NCT05504590
NCT05504590已完成不适用

Comparison of Tuohy Needle and Quincke Needle on the Incidence of Intravascular Injection During Caudal Epidural Injection Under Ultrasound Guidance: Prospective Randomized Controlled Study

Gangnam Severance Hospital2 个研究点 分布在 2 个国家目标入组 230 人开始时间: 2022年8月31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
230
试验地点
2
主要终点
incidence of intravascular injection

研究概览

简要总结

Park et al. reported the results of a randomized study of the use of ultrasound and the use of C-arm in caudal epidural block. However, it is difficult to determine the overall epidural space contrast agent spread with ultrasound alone, and intravascular injection can be avoided with ultrasound. It was said that the evidence for the efficacy of exclusion of intravascular infusion was not as good as that of the C-arm. Therefore, it was suggested that ultrasound in caudal epidural block should be considered only when it is difficult to use the C-arm as an auxiliary means to guide the needle when the sacral hiatus is less than 2 mm and has a complex anatomical structure. The purpose of this study is to determine the difference between intravascular injection and epidural spread according to the type of needle during caudal block under ultrasound guidance.

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
Double (Participant, Outcomes Assessor)

盲法说明

Double

入排标准

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

入选标准

  • A patient who visited the pain clinic complaining of lower back pain due to lumbar disc/stenosis
  • When NRS of back and/or radiating pain is 4 or more
  • Patients over 19 years of age

排除标准

  • Systemic infection
  • Bleeding tendency
  • Contrast Allergy
  • Pregnant women
  • If you cannot read or agree to the consent form
  • If you cannot sign the consent form yourself

结局指标

主要结局

incidence of intravascular injection

时间窗: 1 minute after finishing caudal epidural block

incidence of intravascular injection during caudal epidural block

次要结局

  • time required to complete caudal epidural block(Baseline, 1 second after the completion of caudal epidural block)

研究者

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

Do-Hyeong Kim

Associate Professor

Gangnam Severance Hospital

研究点 (2)

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