N/A
N=13
Changes in Skin Conductance Measurement as an Endpoint Monitor for Sympathetic Blocks
Nerve; Disorder, Sympathetic
Bottom Line
View on ClinicalTrials.gov: NCT02390323 ↗Enrolled (actual)
13
Serious AEs
0.0%
Results posted
Aug 2022
Primary outcome: Primary: Time to Indication of Successful Blockade Between the Skin Conductance Numeric Value and Bilateral Thermometry. — 0.08 Seconds
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Lumbar Sympathetic Block (Procedure); Skin conductance algesimeter (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Hospital for Special Surgery, New York
- Primary completion
- Sep 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to Indication of Successful Blockade Between the Skin Conductance Numeric Value and Bilateral Thermometry. |
0.08 | — |
| PRIMARY Difference in Time to Indication of Successful Blockade Between the Skin Conductance Numeric Value and Unilateral Thermometry. |
0.04 | — |
| PRIMARY Hazard Ratio for Time to Successful Blockade Between the Skin Conductance Numeric Value and Plethysmography. |
0.29 | — |
| PRIMARY Hazard Ratio for Difference in Time to Indication of Successful Blockade Between the Skin Conductance Numeric Value and Subjective Temperature Difference. |
0.06 | — |
| PRIMARY Hazard Ratio for Time to Indication of Successful Blockade Between the Skin Conductance Numeric Value and Clinically Visible Hyperemia. |
0.04 | — |
| PRIMARY Hazard Ratio for Difference in Time to Indication of Successful Blockade Between the Skin Conductance Numeric Value and Clinically Visible Engorgement of Veins. |
0.04 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Patients presenting for sympathetic block of the lower extremity (lumbar sympathetic block)
- Ages 18-99
Exclusion Criteria
- Patients with pacemakers or cardiac defibrillators
- Age <18
- IV sedation for anxiolysis or analgesia
- Burn patients or patients with severe dermatologic conditions (as defined by skin conditions causing further pain to patients that actively has to be treated)
- Allergy to adhesive tape
- Patient with diagnosis of: Dysautonomia, Sympathetic dysfunction (e.g.,Raynaud disease, Buerger disease) or Disorders of sweating (e.g.,Acquired idiopathic generalized anhidrosis)
- Patients on vasoactive drugs
Data sourced from ClinicalTrials.gov (NCT02390323). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.