Chronic Pain, Complex Regional Pain Syndromes, Peripheral Neuropathy, Post Herpetic Neuralgia
Conditions
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.
Interventions
PROCEDURELumbar Sympathetic Ganglion Block
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.
Sponsors
Jeongsoo Kim
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 ≥ 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 |
| 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 |
| 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) |
| 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 |
Countries
South Korea
Outcome results
None listed