跳至主要内容
临床试验/NCT03995576
NCT03995576已完成不适用

Incidence of Inadvertent Intercostal or Epidural Spread During Thoracic Sympathetic Ganglion Block

Keimyung University Dongsan Medical Center2 个研究点 分布在 1 个国家目标入组 53 人开始时间: 2019年6月23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
53
试验地点
2
主要终点
incidence of intercostal spread

研究概览

简要总结

This study wants to identify the incidence of inadvertend intercostal or epidural spread of thoracic sympathetic block

详细描述

Clinically, sympathetic blocks (SB) have been used widely to relieve the symptoms of SMP or to differentiate between SMP and sympathetically independent pain. In order to an SB has a diagnostic value, it requires the successful disturbance of the sympathetic activity for a proper duration of time.

For the diagnosis of SMP using an SB, it is essential achieving complete interruption of the sympathetic activity while preserving the sensory and motor function. The sympathetic trunk at lumbar region runs on the anterolateral surface of the vertebral column from L1 to L4 levels, and deep to the medial aspect of the psoas major muscle. Therefore, the investigators can hardly find epidural contrast spread during lumbar SB due to an anterior location of lumbar sympathetic ganglion to the lateral vertebral body. However, frequent psoas muscle injection can be encountered due to a close proximity of lumbar sympathetic ganglion.

In contrast to lumbar sympathetic ganglion, the thoracic sympathetic ganglion is not separated from somatic nerves by muscles and connective tissue. Moreover, the upper thoracic ganglion runs on the posterior surface of vertebral column with close proximity to adjacent epidural region.

This difference of thoracic sympathetic ganglion leads to a frequent epidural and intercostal spread if the investigators perform thoracic SB. Such spread to epidural and intercostal space lowers the diagnostic value of thoracic SB. In addition, serious adverse outcome can be encountered if neurolytic agent is injected into epidural or intercostal space for the purpose of thoracic sympathectomy. Considering the diagnostic value and safety of thoracic SB, evaluation of actual incidence of occurrence of intercostal and epidural spread is important.

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

入选标准

  • complex regional pain syndrome
  • lymphedema after breast cancer surgery

排除标准

  • coagulopathy
  • infection
  • previous spine fusion at thoracic level

结局指标

主要结局

incidence of intercostal spread

时间窗: 60 seconds after the completion of thoracic sympathetic ganglion block. 60 seconds means the time when the outcome was measured after thoracic sympathetic ganglion block

intercostal spread which appears at fluorosopic view after contrast medium injection

incidence of epidural spread

时间窗: 60 seconds after the completion of thoracic sympathetic ganglion block. 60 seconds means the time when the outcome was measured after thoracic sympathetic ganglion block

epidural spread which appears at fluorosopic view after contrast medium injection

次要结局

  • degree of finger tip skin temperature increase(5, 10, 15, 20 minutes after the completion of the intervention 5, 10, 15, 20 minutes mean the time that the outcome was measured after performing the intervention)

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)

Loading locations...

相似试验