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临床试验/NCT05082220
NCT05082220已完成不适用

Comparison of the Spread Level During Thoracic Erector Spinae Plane Block Using Two Volumes of Local Anesthetics

Keimyung University Dongsan Medical Center2 个研究点 分布在 1 个国家目标入组 157 人开始时间: 2022年2月21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
157
试验地点
2
主要终点
spread level in the cranio-caudal direction

研究概览

简要总结

The primary purpose of this study was to identify the ESPB spread level in the craniocaudal direction when performed at the T2 level. The secondary purpose was to determine the incidence of spread into epidural, paravertebral, intercostal, and intravascular injections with ESPB

详细描述

The ESPB requires ultrasound guidance which enables visible local anesthetic spread underneath the erector spinae muscles. The spinalis, longissimus thoracis, and iliocostalis muscles comprise the ES muscles, which run vertically along both sides of the vertebral column from the sacrum up to the skull base. The ESPB can be performed in the cervical, thoracic, and lumbar regions. Among them, upper or mid thoracic ESPB has been used more widely compared to cervical and lumbar regions. Previous cadaveric studies on the ESPB at the T5 level using computed tomography (CT) reconstruction or direct dissection demonstrated the extensive craniocaudal distribution of methylene blue ranging from T1 to T8 vertebral segments deep to the ES muscles and variable involvement of epidural, paravertebral, and intercostal spaces. The ESPB performed at the T2 level of the cadaver demonstrated an injected dye distribution ranging from C4 to T10. Also, 36% of cadavers showed the spread of an injected dye to the ventral, dorsal ramus, paravertebral space, and even the contralateral side. The exact mechanism of action of ESPB remains unclear. A recent study suggested that the analgesic effect of ESPB could be obtained by blocking the ventral and dorsal ramus of the spinal nerves by passing through the costotransverse foramen. However, in clinical practice, we can encounter highly variable clinical outcomes or sensory block after the ESPB. The study of the physical spread of the injected agent can be used to predict the clinical result and elucidate the possible mechanism of action of ESPB.

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)

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

  • cervical facet joint arthrosis
  • cervical foraminal stenosis
  • cervical herniated intervertebral disc
  • myofascial pain syndrome of upper back muscle

排除标准

  • allergy to local anesthetics or contrast medium
  • pregnancy
  • prior history of cervical spine surgery
  • coagulation abnormality

结局指标

主要结局

spread level in the cranio-caudal direction

时间窗: Baseline, 5 minutes after erector spinae plane block

fluoroscopic contrast medium spread level in the cranio-caudal direction

次要结局

  • Number of participant showing intravascular spread(baseline, 5 minute after erector spinae plane block)
  • Number of participant showing paravertebral spread(baseline, 5 minute after erector spinae plane block)
  • Number of participant showing intercostal spread(baseline, 5 minute after erector spinae plane block)
  • Number of participant showing epidural spread(baseline, 5 minute after erector spinae plane block)

研究者

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

Ji Hee Hong

Professor

Keimyung University Dongsan Medical Center

研究点 (2)

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