Trial Outcomes & Findings for Changes in Skin Conductance Measurement as an Endpoint Monitor for Sympathetic Blocks (NCT NCT02390323)

NCT ID: NCT02390323

Last Updated: 2022-08-09

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 13 participants
• Primary outcome timeframe: 10 minutes
• Results posted on: 2022-08-09

Participant Flow

Participant milestones

Measure	Lumbar Sympathetic Block Patients receiving a Lumbar Sympathetic Block as treatment for lower extremity pain. Skin conductance algesimeter will be used to measure sympathetic activity. Lumbar Sympathetic Block: 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 algesimeter: 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 algesimete
Overall Study STARTED	13
Overall Study COMPLETED	13
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Lumbar Sympathetic Block n=13 Participants Patients receiving a Lumbar Sympathetic Block as treatment for lower extremity pain. Skin conductance algesimeter will be used to measure sympathetic activity. Lumbar Sympathetic Block: 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 algesimeter: 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 algesimete
Age, Continuous	54 years STANDARD_DEVIATION 13 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants

PRIMARY outcome

Timeframe: 10 minutes

Population: Lower back or leg pain

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

Outcome measures

Measure

Lumbar Sympathetic Block n=13 Participants Patients receiving a Lumbar Sympathetic Block as treatment for lower extremity pain. Skin conductance algesimeter will be used to measure sympathetic activity. Lumbar Sympathetic Block: 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 algesimeter: 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 algesimete

Time to Indication of Successful Blockade Between the Skin Conductance Numeric Value and Bilateral Thermometry.

0.08 Seconds Interval 0.04 to 0.17

PRIMARY outcome

Timeframe: 10 minutes

Population: Subjects who received a sympathetic nerve block to treat lower back or leg pain

Outcome measures

Measure

Lumbar Sympathetic Block n=13 Participants Patients receiving a Lumbar Sympathetic Block as treatment for lower extremity pain. Skin conductance algesimeter will be used to measure sympathetic activity. Lumbar Sympathetic Block: 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 algesimeter: 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 algesimete

Difference in Time to Indication of Successful Blockade Between the Skin Conductance Numeric Value and Unilateral Thermometry.

0.04 seconds Interval 0.01 to 0.11

PRIMARY outcome

Timeframe: 10 minutes

Population: Lower back or leg pain

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.

Outcome measures

Measure

Lumbar Sympathetic Block n=13 Participants Patients receiving a Lumbar Sympathetic Block as treatment for lower extremity pain. Skin conductance algesimeter will be used to measure sympathetic activity. Lumbar Sympathetic Block: 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 algesimeter: 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 algesimete

Hazard Ratio for Time to Successful Blockade Between the Skin Conductance Numeric Value and Plethysmography.

0.29 Hazard Ratio Interval 0.14 to 0.63

PRIMARY outcome

Timeframe: 10 minutes

Population: Subjects who needed a sympathetic nerve block as treatment for lower back or leg pain

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.

Outcome measures

Measure

Lumbar Sympathetic Block n=13 Participants Patients receiving a Lumbar Sympathetic Block as treatment for lower extremity pain. Skin conductance algesimeter will be used to measure sympathetic activity. Lumbar Sympathetic Block: 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 algesimeter: 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 algesimete

Hazard Ratio for Difference in Time to Indication of Successful Blockade Between the Skin Conductance Numeric Value and Subjective Temperature Difference.

0.06 Hazard Ratio Interval 0.02 to 0.17

PRIMARY outcome

Timeframe: 10 minutes

Population: Subjects who needed a sympathetic nerve block as treatment for lower back or leg pain.

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.

Outcome measures

Measure

Lumbar Sympathetic Block n=13 Participants Patients receiving a Lumbar Sympathetic Block as treatment for lower extremity pain. Skin conductance algesimeter will be used to measure sympathetic activity. Lumbar Sympathetic Block: 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 algesimeter: 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 algesimete

Hazard Ratio for Time to Indication of Successful Blockade Between the Skin Conductance Numeric Value and Clinically Visible Hyperemia.

0.04 Hazard Ratio Interval 0.01 to 0.13

PRIMARY outcome

Timeframe: 10 minutes

Population: Subjects with lower back or leg pain who needed a sympathetic nerve block for its treatment

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.

Outcome measures

Measure

Lumbar Sympathetic Block n=13 Participants Patients receiving a Lumbar Sympathetic Block as treatment for lower extremity pain. Skin conductance algesimeter will be used to measure sympathetic activity. Lumbar Sympathetic Block: 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 algesimeter: 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 algesimete

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 Hazard Ratio Interval 0.01 to 0.13

Adverse Events

Lumbar Sympathetic Block

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Semih Gungor

Hospital for Special Surgery

Phone: 212-606-1206

Email: gungors@hss.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place