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Completed

NCT Number: NCT06241820

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

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

Treatment and study plan

Lumbar Sympathetic Ganglion Block

Procedure

A needle will be inserted at the L3 on the side experiencing pain, either right or left, under fluoroscopy guidance. Once the needle is positioned in front of the desired vertebral body, its location is confirmed using a contrast medium. If the position is well visualized in lateral and anteroposterior (AP) views, 7 mL of 0.5% ropivacaine will be injected.

Primary outcomes

  1. Difference of perfusion index (%)

    Time frame: before and 1 - 20 minutes after FS-guided lumbar sympathetic ganglion block

    Difference of perfusion index (%) between ipsilateral foot and contralateral foot

Secondary outcomes

  1. Difference of temperature change (°C)

    Time frame: before and 1 - 20 minutes after FS-guided lumbar sympathetic ganglion block

    Difference of temperature change (°C) between ipsilateral foot and contralateral foot

  2. Severity of pain

    Time frame: 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)

  3. Proportion of patients reaching ≥ 1.5°C rise

    Time frame: 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

  4. Proportion of patients reaching ≥ 2.0°C rise

    Time frame: 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

  5. Proportion of patients reaching ≥ 100% rise of perfusion index (%)

    Time frame: 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

  6. Patient satisfaction

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Jeongsoo Kim

Other

Registry information

Official study title

The Success of Lumbar Sympathetic Ganglion Block Using Lower Extremity Perfusion Index: A Prospective Observational Study

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Feb 5, 2024
Registry last updated
Jul 11, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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