- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03902860
Measurement of the Skin Sympathetic Nerve Activity During Stellate, Thoracic, and Lumbar Sympathetic Ganglia Block
Recording Sympathetic Nerve Activity From the Skin During Stellate, Thoracic, and Lumbar Sympathetic Ganglia Block : a Pilot Study
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.
Study Overview
Status
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Seoul, Korea, Republic of, 03080
- Department of Anesthesiology and Pain Medicine, Seoul National University Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Outpatient patients undergoing stellate, thoracic, and lumbar sympathetic block for chronic pain disease
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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The skin sympathetic nerve activity presented as uV obtained via skin leads.
Time Frame: From the beginning of stellate, thoracic, or lumbar sympathetic block procedure and the next outpatient visiting 4 weeks (an average) after the procedure.
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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.
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From the beginning of stellate, thoracic, or lumbar sympathetic block procedure and the next outpatient visiting 4 weeks (an average) after the procedure.
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SGB SKNA pilot
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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