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临床试验/NCT06731920
NCT06731920招募中不适用

The Incidence of Inadvertent Intravascular Injection During Ultrasound-guided Cervical Medial Branch Blocks: a Fluoroscopically Controlled Study

Montreal General Hospital1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2025年1月10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
300
试验地点
1
主要终点
Incidence of vascular uptake

研究概览

简要总结

Injections that freeze neck joints can be done using x-rays or ultrasound imaging, which as a newer way of guiding the needle to the right spot. This study will look at how often freezing liquid goes into a blood vessel during neck injections that freeze neck joints when ultrasound guidance is used to place the needle. When this happens, it can go undetected because it does not make the patient feel any different, however it could cause a test block to be falsely negative, leading to the wrong diagnosis. Based on previous studies, we think that this happens rarely, and the purpose of this study is to prove that conclusively

详细描述

Cervical medial branch blocks (CMBB) are commonly employed for the diagnosis and management of facet-related pain. The latter constitutes the most important cause of axial neck pain and has been implicated in 40% of all cases. In addition, the upper cervical joints can also cause cervicogenic headaches, an often-debilitating condition representing up to 20% of chronic headaches3. Well-defined pain referral patterns for each joint can help operators select the appropriate injection level. While fluoroscopy has long been the imaging standard for spinal procedures, ultrasound guidance (USG) is being increasingly adopted as an alternative and presents several advantages such as the ability to identify and avoid soft tissue structures such as blood vessels during needle insertion. From a clinical perspective, avoiding blood vessels and reducing the incidence of vascular breach can lessen the occurrence of intravascular injections that are associated with false negative diagnostic blocks. Indeed, a recent study examining the safety of USG CMBB reported a lower incidence of vascular breach than previous studies that had used fluoroscopic guidance. While these findings suggested a potential benefit associated with USG, further confirmatory studies employing digital subtraction angiography (DSA), the current imaging standard to detect intravascular spread, are required. We hypothesize that USG will be associated will a lower incidence of intravascular spread during primary needle placement than has been reported with fluoroscopic guidance.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

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

  • Consenting patients over 19 years of age undergoing an ultrasound-guided cervical medial branch blocks as part of their usual care.

排除标准

  • Subjects with one or more of the following characteristics will be excluded from the study:
  • Known bleeding disorder or coagulopathy Patients on antiplatelet medication other than aspirin and those on anticoagulants (coumadin, AT III agents) Inability to visualize targeted structures on ultrasound Known allergy to contrast agents

结局指标

主要结局

Incidence of vascular uptake

时间窗: During the course of needle placement

Incidence of intravascular spread of contrast as determined after a review of the DSA sequences by a physician not involved in the patient's care.

次要结局

  • Observed blood vessels(During needle placement)
  • Incidence of vascular breach(During needle placement)
  • Number of needle repositionings(During needle placement)
  • Complications(From beginning to completion of block procedure)

研究者

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

Roderick Finlayson

RODERICK FINLAYSON MD

University of British Columbia

研究点 (1)

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