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临床试验/NCT03902860
NCT03902860已完成不适用

Recording Sympathetic Nerve Activity From the Skin During Stellate, Thoracic, and Lumbar Sympathetic Ganglia Block : a Pilot Study

Seoul National University Hospital1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2019年5月15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
32
试验地点
1
主要终点
The skin sympathetic nerve activity presented as uV obtained via skin leads.

研究概览

简要总结

Sympathetic nerve activity can be measured transcutaneously in awake patients by computer-based filtering of raw signal obtained via skin leads attached on the chest and the right arm. Electrocardiogram can be removed by applying a high-pass filter setting of 150 Hz. Electromyogram can be filtered by applying a high-pass filter setting of 500 Hz or a band-pass filter setting of 500-1000 Hz.

Currently, the therapeutic effect of stellate, thoracic, and lumbar sympathetic ganglia block (SGB, TSGB, and LSGB, respectively) in patients with chronic pain is generally evaluated by using thermogram/thermography (change in temperature of the upper or lower extremeties) or questionnaire-based scoring.

However, it is not known whether the skin sympathetic nerve activity (SKNA) can be measured in patients undergoing SGB/TSGB/LSGB and used as an alternative tool for assessing the therapeutic effect of SGB/TSGB/LSGB.

Therefore, we planned this pilot study to observe whether the SKNA can be obtained in patients undergoing SGB/TSGB/LSGB and whether it is well correlated to thermogram or questionnaire-based scoring. If the SKNA is observed and decreases after SGB/TSGB/LSGB, it will be presented in milivolt (uV) and compared to that of pre-block values.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Outpatient patients undergoing stellate, thoracic, and lumbar sympathetic block for chronic pain disease

排除标准

  • patients denial
  • peripheral vascular disease in the head and the upper extremities.
  • prior thoracic sympathectomy/sympathicotomy
  • prior resection or ablation (chemically or mechanically) of stellate, thoracic, and lumbar sympathetic
  • coagulapathy
  • infectious disease
  • allergy to local anesthetics

结局指标

主要结局

The skin sympathetic nerve activity presented as uV obtained via skin leads.

时间窗: From the beginning of stellate, thoracic, or lumbar sympathetic block procedure and the next outpatient visiting 4 weeks (an average) after the procedure.

A few studies reported that skin sympathetic nerve activity (SKNA) signal could be potentially observed by applying a high-pass filter of 500 Hz or a band-pass filter of 500\~1000 Hz to electric signal from skin leads attached on the skin of the chest in awake volunteers. However, it is not known if it would be also possible to observe the SKNA signal in patients undergoing stellate, thoracic, and lumbar sympathetic block. Also, there is no established, objective tool for quantitative or qualitative assessment of the effect of stellate, thoracic, and lumbar sympathetic 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

Yunseok Jeon

Professor of Anesthesiology and Pain Medicine

Seoul National University Hospital

研究点 (1)

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