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临床试验/NCT04204720
NCT04204720已完成不适用

A Comparison of Intravascular Injection With Chiba Needle and Whitacre Needle During Caudal Epidural Block : a Prospective Study

Kyungpook National University Hospital2 个研究点 分布在 1 个国家目标入组 164 人开始时间: 2018年4月1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
164
试验地点
2
主要终点
incidence of intravascular injection

研究概览

简要总结

Caudal epidural injection (CEI) is effective for spinal pain. However, intravascular injection may occur during CEI, which can lead to hematoma, neurologic deficit and local anesthetics systemic toxicity. Whitacre type needle has been reported to be effective for reducing intravascular injection during transforaminal epidural injection. In this study, we compared the Chiba needle and Whitacre needle on incidence of intravascular injection during CEI.

详细描述

A total of 164 caudal epidural injections were performed in patients with disc herniation or spinal stenosis on lumbosacral region. Patients were randomly allocated to Group Whitacre (n=82) and Group Chiba (n=82). Patients in Group Whitacre received caudal epidural injection using Whitacre type needle and those in Group Chiba received the procedure using Chiba type needle. Intravascular injection was assessed with blood aspiration and angiography during real-time fluoroscopy.

研究设计

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

入排标准

性别
All
接受健康志愿者

入选标准

  • patients with low back pain and/or leg radicular pain under diagnoses as disc herniation or spinal stenosis

排除标准

  • allergy to local anesthetics or contrast medium, coagulopathy, local infection at the injection site, and systemic infection

结局指标

主要结局

incidence of intravascular injection

时间窗: 5 minute

incidence of intravascular injection during caudal block

次要结局

未报告次要终点

研究者

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

Younghoon Jeon

Professor

Kyungpook National University Hospital

研究点 (2)

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