CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 13 enrolled
Drug / intervention
Lumbar Sympathetic Block +1 moreprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02390323
NCT02390323N/ACompleted

Changes in Skin Conductance Measurement as an Endpoint Monitor for Sympathetic Blocks

Hospital for Special Surgery, New York·interventional·Posted Mar 17, 2015·Updated Aug 9, 2022

In Brief

A clinical study evaluating Lumbar Sympathetic Block and Skin conductance algesimeter for Nerve; Disorder, Sympathetic. Completed, enrolled 13 participants.

Detailed Summary

This study is intended to evaluate a monitor that will facilitate ascertainment of an effective sympathetic blockade following Lumbar Sympathetic blocks. Utilization of a monitor with a rapid response and easy clinical applicability which can demonstrate effective sympathetic block would increase efficiency within the procedure suite and also serve to function as an objective endpoint for the evaluation of sympathetic blockade in future research.In current clinical practice, the most commonly used monitoring methods are clinical observations of sympathetic blockade, skin temperature monitoring, pulse pressure monitoring and any combination of these monitoring methods. The skin temperature and pulse pressure may increase after sympathetic block. However, changes in the skin temperature and pulse pressure often demonstrate an unpredictable or delayed response. Confounding variables, such as ambient temperature, coexisting vascular disease, use of other vasoactive medications may contribute to inconsistencies in the temperature or pulse pressure responses. Normal sympathetic activity stimulates muscarinic receptors in the periphery that subsequently stimulate the sweat glands to secrete and fill with sweat containing sodium and other electrolytes. The electrolytes present in the sweat increase the electrical conductance while decreasing the electrical resistance at the skin level. The real-time changes in skin conductance indices can be monitored at the skin level, by use of non-invasive electrodes attached to the skin (similar to EKG electrodes). A computer program analyzes the data and produces a real-time graphic and numeric data demonstrating the skin conductance response. The initiation of successful sympathetic blockade can cause rapid cessation of the skin sympathetic activity that leads to a decrease in skin conductance within seconds.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
Countries--

Timeline

N/ACompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedMar 17, 2015
Enrollment StartJan 1, 2014
Primary CompletionSep 1, 2014
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 11.3 years ago

Interventions

Lumbar Sympathetic Blockprocedure

A lumbar sympathetic block is an injection in the middle of the lower back, toward the left or right side. The "lumbar sympathetic nerves" are a small bundle of nerves that carries "sympathetic" nerve signals from the lower extremities. In some instances, certain injuries to the lower extremities can cause a burning, unusual pain called complex regional pain syndrome or reflex sympathetic dystrophy. Injecting a small amount of local anesthetic on the lumbar sympathetic nerves can identify whether or not this pain is carried by the sympathetic nervous system.

Skin conductance algesimeterdevice

The real-time changes in skin conductance indices can be monitored at the skin level, by use of non-invasive electrodes attached to the skin (similar to EKG electrodes) connected to the skin conductance algesimeter. A computer program analyzes the data and produces a real-time graphic and numeric data demonstrating the skin conductance response. The initiation of successful sympathetic blockade can cause rapid cessation of the skin sympathetic activity that leads to a decrease in skin conductance within seconds.