Seoul National University Hospital
Seoul, South Korea
NCT Number: NCT06241820
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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Notify Me19 year–85 year
All sexes
Interventional
Not applicable
Seoul, South Korea
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: before and 1 - 20 minutes after FS-guided lumbar sympathetic ganglion block
Difference of perfusion index (%) between ipsilateral foot and contralateral foot
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
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)
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
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
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
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)
Jeongsoo Kim
Other
The Success of Lumbar Sympathetic Ganglion Block Using Lower Extremity Perfusion Index: A Prospective Observational Study
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