The Success of Lumbar Sympathetic Ganglion Block Using Lower Extremity Perfusion Index: A Prospective Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Difference of perfusion index (%)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Lower extremity pain
- •Pain for more than 3 months
- •19 - 85 years
排除标准
- •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
结局指标
主要结局
Difference of perfusion index (%)
时间窗: before and 1 - 20 minutes after FS-guided lumbar sympathetic ganglion block
Difference of perfusion index (%) between ipsilateral foot and contralateral foot
次要结局
- Proportion of patients reaching ≥ 1.5°C rise(20 minutes after FS-guided lumbar sympathetic ganglion block)
- Proportion of patients reaching ≥ 2.0°C rise(20 minutes after FS-guided lumbar sympathetic ganglion block)
- Difference of temperature change (°C)(before and 1 - 20 minutes after FS-guided lumbar sympathetic ganglion block)
- 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))
- Proportion of patients reaching ≥ 100% rise of perfusion index (%)(1 - 20 minutes after FS-guided lumbar sympathetic ganglion block)
- Patient satisfaction(Time 20 minutes, 1 week, 4 weeks after FS-guided lumbar sympathetic ganglion block (The higher the score, the higher the satisfaction))
研究者
Jeongsoo Kim
Professor
Seoul National University Hospital