Nerve; Disorder, SympatheticNCT02390323
Changes in Skin Conductance Measurement as an Endpoint Monitor for Sympathetic Blocks
A study testing Lumbar Sympathetic Block and Skin conductance algesimeter in people with Nerve; Disorder, Sympathetic, run by Hospital for Special Surgery, New York.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nerve; Disorder, Sympathetic
- What is being tested?
- Lumbar Sympathetic Block and Skin conductance algesimeter
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- No sites listed yet
- Study dates
- Jan 2014to Sep 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients presenting for sympathetic block of the lower extremity (lumbar sympathetic block)
- Ages 18-99
Who cannot join
- 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
About this study
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.
Read the detailed description
Lumbar sympathetic blocks are clinically used for both diagnosis and treatment of sympathetically mediated pain. in variety of neuropathic pain conditions including complex regional pain syndrome. Sympathetic nerve block has been found successful in about 40% of the patients with neuropathic pain to improve their pain conditions. A sympathetic blockade refers to an injection of a local anesthetic around the sympathetic nerves to alter their functions. The local anesthetic block, often repeated with intervals, may reduce the activity of spontaneous discharges in hyperactive neurons. Reducing the sympathetic nerve activity in the painful region by blocking sympathetic nerve ganglia with a series of local anesthetic nerve blocks may therefore break the cycle of sympathetically mediated pain and provide pain relief. Despite the frequent use of these blocks, there is still a lack of objective methods for determining the successful achievement of sympathetic block in the clinical setting. In current clinical practice, the most commonly used monitoring methods to assess the success of a sympathetic block are observation of clinical signs of sympathetic blockade, skin temperature monitoring, pulse amplitude monitoring in pulse oximetry plethysmography, and any combination of these monitoring methods.
The skin temperature and pulse amplitude in pulse oximetry plethysmography may increase after sympathetic block. However, observation of clinical signs of sympathetic blockade, monitorization of skin temperature, and pulse amplitude often demonstrate an unpredictable or delayed response. Furthermore, confounding variables, such as ambient temperature, coexisting vascular disease, and use of other vasoactive medications, may contribute to inconsistencies in the temperature measurements, or pulse amplitude responses. Therefore, it is a clinical necessity to develop an objective monitoring method that is reliable, rapid response, and also not affected by the other confounders. One potential method is the examination of sympathetic nerve activity via a skin conductance monitor (SCM). Normal skin sympathetic nerve activity stimulates muscarinic receptors 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 SCM indices can be monitored at the skin level by use of noninvasive electrodes attached to the skin. This is best monitored in the areas with relatively dense sweat glands, such as palm and plantar skin. A computer program analyzes the data and produces 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 nerve activity that leads to a decrease in skin conductance responses within seconds. Currently, there is no rapid response monitor with easy clinical applicability to assess the achievement of a successful sympathetic blockade. Such a monitor could increase procedural accuracy and efficiency, thereby improving patient care. This is especially important in evaluating the response to the sympathetic blocks as they are important for diagnostic purposes to differentiate neuropathic pain types as the sympathetically mediated/maintained pain (SMP), or sympathetically independent pain (SIP). The patients with neuropathic pain presenting with similar symptoms can be classified into two groups depending on their negative or positive response to selective sympathetic blockade. If the pain is relieved by the selective sympathetic block, it is considered SMP. Sympathetically mediated pain is defined as a symptom in a subset of patients with neuropathic pain. The significance of differentiating between SMP or SIP is that SMP has a greater chance of responding favorably to sympatholytic blockade. Therefore, a prospective therapy plan of performing repeated sympatholytic blocks may be considered as these blocks are more efficacious in SMP. On the contrary, as the chance of responding favorably to sympathetic blocks is less likely in SIP, alternative therapies must be considered in this group of patients. In order to plan the prospective treatment options, objective confirmation of sympathectomy created by the attempted sympathetic block is important to differentiate SMP vs SIP. In this context, the utilization of a monitor with a rapid response and easy clinical applicability that can demonstrate effective sympathetic block would serve to function as an objective end point for the evaluation of sympathetic blockade both clinically and for future research. We hypothesize that the SCM is, on average, a more reliable rapid response indicator of a successful sympathetic blockade than traditional monitors such as clinical assessment, monitoring changes in the skin temperature, and pulse amplitude.
- Conditions
- Nerve; Disorder, Sympathetic
- Being tested
- Lumbar Sympathetic Block, Skin conductance algesimeter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lumbar Sympathetic BlockProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Lumbar Sympathetic Block | Experimental | Patients receiving a Lumbar Sympathetic Block as treatment for lower extremity pain. Skin conductance algesimeter will be used to measure sympathetic activity. Receives: Procedure: Lumbar Sympathetic Block; Device: Skin conductance algesimeter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Indication of Successful Blockade Between the Skin Conductance Numeric Value and Bilateral Thermometry.
The skin conductance monitor will be applied immediately prior to the beginning of the procedure. Measurements will be recorded at 0 minutes and every 1 minute until 10 minutes after completion of procedure. Additional measurements will be recorded at the following time points:
- Prior to start of procedure (Baseline measurement)
- Infiltration of Local Anesthetic
- Insertion of the needle
- Start of block (First local anesthetic injection after the test dose)
- End of block
- End of Procedure/Removal of monitor
Measured: 10 minutes
Difference in Time to Indication of Successful Blockade Between the Skin Conductance Numeric Value and Unilateral Thermometry.
Measured: 10 minutes
Hazard Ratio for Time to Successful Blockade Between the Skin Conductance Numeric Value and Plethysmography.
Hazard Ratios are calculated using a Cox proportional Hazards model to compare each traditional method to SCM using a marginal approach with a working independence assumption to account for the correlation between measurements on the same patients. A lower score is a better outcome.
Measured: 10 minutes
Hazard Ratio for Difference in Time to Indication of Successful Blockade Between the Skin Conductance Numeric Value and Subjective Temperature Difference.
Hazard Ratio for Time to Indication of Successful Blockade Between the Skin Conductance Numeric Value and Subjective Temperature Difference.
Hazard Ratios are calculated using a Cox proportional Hazards model to compare each traditional method to SCM using a marginal approach with a working independence assumption to account for the correlation between measurements on the same patients. A lower score is a better outcome.
Measured: 10 minutes
Hazard Ratio for Time to Indication of Successful Blockade Between the Skin Conductance Numeric Value and Clinically Visible Hyperemia.
Hazard Ratios are calculated using a Cox proportional Hazards model to compare each traditional method to SCM using a marginal approach with a working independence assumption to account for the correlation between measurements on the same patients.
The skin conductance monitor will be applied immediately prior to the beginning of the procedure. Measurements will be recorded at 0 minutes and every 1 minute until 10 minutes after completion of procedure. Additional measurements will be recorded at the following time points:
- Prior to start of procedure (Baseline measurement)
- Infiltration of Local Anesthetic
- Insertion of the needle
- Start of block (First local anesthetic injection after the test dose)
- End of block
- End of Procedure/Removal of monitor
A lower score is a better outcome.
Measured: 10 minutes
Hazard Ratio for Difference in Time to Indication of Successful Blockade Between the Skin Conductance Numeric Value and Clinically Visible Engorgement of Veins.
Hazard Ratios are calculated using a Cox proportional Hazards model to compare each traditional method to SCM using a marginal approach with a working independence assumption to account for the correlation between measurements on the same patients.
The skin conductance monitor will be applied immediately prior to the beginning of the procedure. Measurements will be recorded at 0 minutes and every 1 minute until 10 minutes after completion of procedure. Additional measurements will be recorded at the following time points:
- Prior to start of procedure (Baseline measurement)
- Infiltration of Local Anesthetic
- Insertion of the needle
- Start of block (First local anesthetic injection after the test dose)
- End of block
- End of Procedure/Removal of monitor
A lower score is a better outcome.
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2015 (estimated)
- Study startJan 2014
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Nerve; Disorder, SympatheticStudies of the same condition, open and under way.
- More trials run by Hospital for Special Surgery, New YorkThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital for Special Surgery, New York
- Sponsor type
- University, hospital or other
- Collaborators
- Oslo University Hospital
- Responsible party
- Sponsor
- Investigators
- Semih Gungor, MD, Principal investigator, Hospital for Special Surgery, New York
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02390323
- Sponsor's protocol ID
- 2012-012
- Status last verified
- Jul 2022
- First submitted
- 17 Feb 2015
- Last updated
- 9 Aug 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Storm H. Changes in skin conductance as a tool to monitor nociceptive stimulation and pain. Curr Opin Anaesthesiol. 2008 Dec;21(6):796-804. doi: 10.1097/ACO.0b013e3283183fe4.
PubMed 18997532
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in Skin Conductance Measurement as an Endpoint Monitor for Sympathetic Blocks
- ClinicalTrials.gov ID
- NCT02390323
- Acronym / sponsor ID
- 2012-012
- Conditions
- Nerve; Disorder, Sympathetic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Hospital for Special Surgery, New YorkUniversity, hospital or other
- Collaborators
- Oslo University Hospital
- Study start
- Jan 2014 (actual)
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 17 Mar 2015 (estimated)
- Results
- Posted 9 Aug 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Lumbar sympathetic blocks are clinically used for both diagnosis and treatment of sympathetically mediated pain. in variety of neuropathic pain conditions including complex regional pain syndrome. Sympathetic nerve block has been found successful in about 40% of the patients with neuropathic pain to improve their pain conditions. A sympathetic blockade refers to an injection of a local anesthetic around the sympathetic nerves to alter their functions. The local anesthetic block, often repeated with intervals, may reduce the activity of spontaneous discharges in hyperactive neurons. Reducing the sympathetic nerve activity in the painful region by blocking sympathetic nerve ganglia with a series of local anesthetic nerve blocks may therefore break the cycle of sympathetically mediated pain and provide pain relief. Despite the frequent use of these blocks, there is still a lack of objective methods for determining the successful achievement of sympathetic block in the clinical setting. In current clinical practice, the most commonly used monitoring methods to assess the success of a sympathetic block are observation of clinical signs of sympathetic blockade, skin temperature monitoring, pulse amplitude monitoring in pulse oximetry plethysmography, and any combination of these monitoring methods.
The skin temperature and pulse amplitude in pulse oximetry plethysmography may increase after sympathetic block. However, observation of clinical signs of sympathetic blockade, monitorization of skin temperature, and pulse amplitude often demonstrate an unpredictable or delayed response. Furthermore, confounding variables, such as ambient temperature, coexisting vascular disease, and use of other vasoactive medications, may contribute to inconsistencies in the temperature measurements, or pulse amplitude responses. Therefore, it is a clinical necessity to develop an objective monitoring method that is reliable, rapid response, and also not affected by the other confounders. One potential method is the examination of sympathetic nerve activity via a skin conductance monitor (SCM). Normal skin sympathetic nerve activity stimulates muscarinic receptors 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 SCM indices can be monitored at the skin level by use of noninvasive electrodes attached to the skin. This is best monitored in the areas with relatively dense sweat glands, such as palm and plantar skin. A computer program analyzes the data and produces 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 nerve activity that leads to a decrease in skin conductance responses within seconds. Currently, there is no rapid response monitor with easy clinical applicability to assess the achievement of a successful sympathetic blockade. Such a monitor could increase procedural accuracy and efficiency, thereby improving patient care. This is especially important in evaluating the response to the sympathetic blocks as they are important for diagnostic purposes to differentiate neuropathic pain types as the sympathetically mediated/maintained pain (SMP), or sympathetically independent pain (SIP). The patients with neuropathic pain presenting with similar symptoms can be classified into two groups depending on their negative or positive response to selective sympathetic blockade. If the pain is relieved by the selective sympathetic block, it is considered SMP. Sympathetically mediated pain is defined as a symptom in a subset of patients with neuropathic pain. The significance of differentiating between SMP or SIP is that SMP has a greater chance of responding favorably to sympatholytic blockade. Therefore, a prospective therapy plan of performing repeated sympatholytic blocks may be considered as these blocks are more efficacious in SMP. On the contrary, as the chance of responding favorably to sympathetic blocks is less likely in SIP, alternative therapies must be considered in this group of patients. In order to plan the prospective treatment options, objective confirmation of sympathectomy created by the attempted sympathetic block is important to differentiate SMP vs SIP. In this context, the utilization of a monitor with a rapid response and easy clinical applicability that can demonstrate effective sympathetic block would serve to function as an objective end point for the evaluation of sympathetic blockade both clinically and for future research. We hypothesize that the SCM is, on average, a more reliable rapid response indicator of a successful sympathetic blockade than traditional monitors such as clinical assessment, monitoring changes in the skin temperature, and pulse amplitude.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lumbar Sympathetic Block | Experimental | Procedure: Lumbar Sympathetic Block, Device: Skin conductance algesimeterPatients receiving a Lumbar Sympathetic Block as treatment for lower extremity pain. Skin conductance algesimeter will be used to measure sympathetic activity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients presenting for sympathetic block of the lower extremity (lumbar sympathetic block)
- Ages 18-99
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lumbar Sympathetic BlockA 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. | Procedure or surgery | Lumbar Sympathetic Block |
| Skin conductance algesimeterThe 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. | Device | Lumbar Sympathetic Block |
Primary outcome
Time to Indication of Successful Blockade Between the Skin Conductance Numeric Value and Bilateral Thermometry.
Time frame: 10 minutes
The skin conductance monitor will be applied immediately prior to the beginning of the procedure. Measurements will be recorded at 0 minutes and every 1 minute until 10 minutes after completion of procedure. Additional measurements will be recorded at the following time points: 1. Prior to start of procedure (Baseline measurement) 2. Infiltration of Local Anesthetic 3. Insertion of the needle 4. Start of block (First local anesthetic injection after the test dose) 5. End of block 6. End of Procedure/Removal of monitor
Difference in Time to Indication of Successful Blockade Between the Skin Conductance Numeric Value and Unilateral Thermometry.
Time frame: 10 minutes
Hazard Ratio for Time to Successful Blockade Between the Skin Conductance Numeric Value and Plethysmography.
Time frame: 10 minutes
Hazard Ratios are calculated using a Cox proportional Hazards model to compare each traditional method to SCM using a marginal approach with a working independence assumption to account for the correlation between measurements on the same patients. A lower score is a better outcome.
Hazard Ratio for Difference in Time to Indication of Successful Blockade Between the Skin Conductance Numeric Value and Subjective Temperature Difference.
Time frame: 10 minutes
Hazard Ratio for Time to Indication of Successful Blockade Between the Skin Conductance Numeric Value and Subjective Temperature Difference. Hazard Ratios are calculated using a Cox proportional Hazards model to compare each traditional method to SCM using a marginal approach with a working independence assumption to account for the correlation between measurements on the same patients. A lower score is a better outcome.
Hazard Ratio for Time to Indication of Successful Blockade Between the Skin Conductance Numeric Value and Clinically Visible Hyperemia.
Time frame: 10 minutes
Hazard Ratios are calculated using a Cox proportional Hazards model to compare each traditional method to SCM using a marginal approach with a working independence assumption to account for the correlation between measurements on the same patients. The skin conductance monitor will be applied immediately prior to the beginning of the procedure. Measurements will be recorded at 0 minutes and every 1 minute until 10 minutes after completion of procedure. Additional measurements will be recorded at the following time points: 1. Prior to start of procedure (Baseline measurement) 2. Infiltration of Local Anesthetic 3. Insertion of the needle 4. Start of block (First local anesthetic injection after the test dose) 5. End of block 6. End of Procedure/Removal of monitor A lower score is a better outcome.
Hazard Ratio for Difference in Time to Indication of Successful Blockade Between the Skin Conductance Numeric Value and Clinically Visible Engorgement of Veins.
Time frame: 10 minutes
Hazard Ratios are calculated using a Cox proportional Hazards model to compare each traditional method to SCM using a marginal approach with a working independence assumption to account for the correlation between measurements on the same patients. The skin conductance monitor will be applied immediately prior to the beginning of the procedure. Measurements will be recorded at 0 minutes and every 1 minute until 10 minutes after completion of procedure. Additional measurements will be recorded at the following time points: 1. Prior to start of procedure (Baseline measurement) 2. Infiltration of Local Anesthetic 3. Insertion of the needle 4. Start of block (First local anesthetic injection after the test dose) 5. End of block 6. End of Procedure/Removal of monitor A lower score is a better outcome.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 18997532Storm H. Changes in skin conductance as a tool to monitor nociceptive stimulation and pain. Curr Opin Anaesthesiol. 2008 Dec;21(6):796-804. doi: 10.1097/ACO.0b013e3283183fe4.
Related trials for Nerve; Disorder, Sympathetic
Not yet recruiting
Noninvasive CA Monitoring Validation and Autonomic Modulation in Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Hemorrhage, Aneurysmal, Delayed Cerebral Ischemia
RecruitingObservational study
Hydroxyephedrine PET/CT in Sympathetic Nervous System Disease
Sympathetic Nervous System Diseases, Sympathetic Nervous Structure Injury
Enrolling by invitationObservational study
Skin Sympathetic Nerve Activity and Sympathetic Tone
Nerve; Disorder, Sympathetic, Healthy
RecruitingObservational study
Hematological Indices and Sympathetic Block Response in Neuropathic Pain
Neuropathic Pain, Neuropathic Pain Diagnostic Questionnaire (DN4) ≥ 4
Active, not recruitingPhase 4
L-arginine to Reduce Sympathetic Nerve Activity in CKD Patients
Chronic Kidney Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Semih Gungor, MD principal investigator
Hospital for Special Surgery, New York
Questions about this trial
What is this clinical trial studying?
A study testing Lumbar Sympathetic Block and Skin conductance algesimeter in people with Nerve; Disorder, Sympathetic, run by Hospital for Special Surgery, New York.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Aug 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to Indication of Successful Blockade Between the Skin Conductance Numeric Value and Bilateral Thermometry. (time frame: 10 minutes). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02390323, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2022.