The Success of Lumbar Sympathetic Ganglion Block Using Lower Extremity Perfusion Index

Not Applicable

Completed

• Conditions: Peripheral Neuropathy; Complex Regional Pain Syndromes; Chronic Pain; Post Herpetic Neuralgia
• Interventions: Procedure: Lumbar Sympathetic Ganglion Block

• Registration Number: NCT06241820
• Lead Sponsor: Jeongsoo Kim

Brief Summary

The patient, who is experiencing chronic pain in the lower extremities persisting for more than three months, is scheduled to undergo lumbar sympathetic ganglion block. To evaluate the technical success of the sympathetic blockade, temperature and perfusion index (PI) will be measured at one-minute intervals over a 20-minute period before and after the procedure on the treated side and the opposite side foot. Additionally, other variables related to the procedure will be assessed before the procedure, after the procedure, before discharge, and during follow-up outpatient visits or phone surveys at 1 week and 1 month after the procedure.

Detailed Description

Patients aged 19 to 85 experiencing lower limb pain and scheduled to undergo lumbar sympathetic ganglion block at the Seoul National University Hospital Pain Center will be directly informed about the study, and their participation will be sought and registered. Continuous monitoring of electrocardiography, blood pressure, and pulse oximetry will be conducted before and after the procedure.

Upon admission to the pain center's operating room, the patient will assume a prone position. Thermometers will be attached to the soles of both feet, and perfusion index probes will be attached to the second toe on both sides. Using fluoroscopy guidance, a needle will be inserted at the painful side, either right or left, at the L3. After confirming the needle's position in front of the desired vertebral body using contrast medium in lateral and anteroposterior (AP) views, 7 mL of 0.5% ropivacaine will be injected. Baseline temperature and PI values will be recorded before drug administration, followed by recording every minute for 20 minutes after injection.

Other variables related to the procedure will be assessed before and after the procedure, before discharge, and through outpatient visits or phone surveys at one week after the procedure.

Study Timeline

• Study First Submitted: 2024-01-28
• Study First Submitted QC: 2024-01-28
• Study First Posted: 2024-02-05
• Study Start: 2024-02-13
• Primary Completion: 2024-04-30
• Study Completion: 2024-05-30
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-09
• Last Update Posted: 2024-07-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Lower extremity pain
• Pain for more than 3 months
• 19 - 85 years

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Exclusion Criteria

• If the patient refuses to undergo the procedure
• In the presence of vascular disorders in the lower extremities
• If the patient has previously undergone lumbar sympathetic ganglion removal or neurolysis
• When there are abnormalities in blood coagulation tests
• If there is a systemic infection or infection at the injection site
• In the presence of anatomical deformities at the injection site
• If the patient has allergies to the injected medication
• In other cases where the researcher deems the patient unsuitable for participation

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Lumbar Sympathetic Ganglion Block (LSGB)	Lumbar Sympathetic Ganglion Block	FS-guided LSGB at L3 level.

Primary Outcome Measures

Name	Time	Method
Difference of perfusion index (%)	before and 1 - 20 minutes after FS-guided lumbar sympathetic ganglion block	Difference of perfusion index (%) between ipsilateral foot and contralateral foot

Secondary Outcome Measures

Name	Time	Method
Proportion of patients reaching ≥ 1.5°C rise	20 minutes after FS-guided lumbar sympathetic ganglion block	Proportion of patients reaching ≥ 1.5°C rise of temperature in the ipsilateral foot compared to the contralateral foot
Proportion of patients reaching ≥ 2.0°C rise	20 minutes after FS-guided lumbar sympathetic ganglion block	Proportion of patients reaching ≥ 2.0°C rise of temperature in the ipsilateral foot compared to initial temperature in the ipsilateral foot
Difference of temperature change (°C)	before and 1 - 20 minutes after FS-guided lumbar sympathetic ganglion block	Difference of temperature change (°C) between ipsilateral foot and contralateral foot
Severity of pain	Time before block and 20 minutes, 1 week, 4 weeks after FS-guided lumbar sympathetic ganglion block ( The higher the score, the more severe the pain)	11-point Numerical Rating Scale (NRS, 0-10)
Proportion of patients reaching ≥ 100% rise of perfusion index (%)	1 - 20 minutes after FS-guided lumbar sympathetic ganglion block	Proportion of patients reaching ≥ 100% rise of perfusion index (%) in the ipsilateral foot compared to the initial perfusion index (%) in the ipsilateral foot
Patient satisfaction	Time 20 minutes, 1 week, 4 weeks after FS-guided lumbar sympathetic ganglion block (The higher the score, the higher the satisfaction)	Patient Global Impression of Change (1-5)

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of