NCT01134289Unknown3 期
An Analysis of Photoplethysmographic Signal in Diagnostic Lumbar Sympathetic Block for Complex Regional Pain Syndrome
适应症
试验速览
- 阶段
- 3 期
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Index of sympathetic block
研究概览
简要总结
This study aims to compare the alternative current and the direct current signal changes of photoplethysmography between both feet during one side lumbar sympathetic block.
The hypothesis is that signal changes occur earlier than other indices to decide whether it is successful following lumbar sympathetic block on only one-side.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Physically examined for complex regional pain syndrome on lower extremity,
- •Scheduled for diagnostic lumbar sympathetic blockade.
排除标准
- •Graded as ASA 3 or higher,
- •Below 18 or above 70 years of age, or
- •Had any other contraindication for regional anesthesia.
结局指标
主要结局
Index of sympathetic block
时间窗: 1 minute at intervals from baseline through end of procedure
change of slope of signals of the alternative current and the direct current from foot The baseline is defined as the point of surgical drap. The end of procedure is decided when the temperature of foot is increased more than 2 degrees from baseline within 20 minutes after local anesthetics injection
次要结局
- skin temperature changes(1 minute at intervals during procedure)
- electrocardiogram(1 minute at intervals from baseline through end of procedure)
研究者
研究点 (2)
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