Sympathectomy-Mediated Vasodilatation and Differential Sensory Block After Epidural Bupivacaine: a Randomized Concentration Ranging Study
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Index of sympathectomy: photoplethysmography derived amplitude-baseline ratio from foot and hand; data measured at time 0, 5, 10 and 20 min following epidural; data expressed as % change from baseline and as area under time effect curve.
研究概览
简要总结
This study aims to compare human subjects receiving epidural bupivacaine local anesthetic at different doses and concentrations and to assess the effect on vasodilatation (sympathectomy), sensory and motor block.
The hypothesis is that the drug concentration is more important than drug dose in the determination of the extent and intensity of differential sympathetic, sensory and motor block following epidural local anesthetic.
详细描述
There is controversy regarding the factors that determine the extent and intensity of epidural drug action. Most studies have focused on the inter-related triad of dose, concentration and volume.
We compare three groups: group A: 10ml of 0.5% bupivacaine; group B: 10ml of 0.25% bupivacaine and group C: 40ml of 0.0625% bupivacaine. When comparing these groups, groups A & B have the same volume of epidural drug, and groups B & C have the same total dose.
In particular this study compares different methods of assessing the sympathetic block (causing vasodilatation). These methods include skin temperature changes, hemodynamic changes and photoplethysmography.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients scheduled for extracorporeal shock wave lithotripsy (ESWL) under epidural anesthesia between March to September 1999
排除标准
- •graded as ASA 3 or higher, below 18 or above 70 years of age, if they had peripheral vascular disease, baseline neurological deficit, or had any other contraindication for regional anesthesia.
结局指标
主要结局
Index of sympathectomy: photoplethysmography derived amplitude-baseline ratio from foot and hand; data measured at time 0, 5, 10 and 20 min following epidural; data expressed as % change from baseline and as area under time effect curve.
次要结局
- 3. Motor block (Bromage scale)
- 1. Other indices of sympathectomy:
- a. Photoplethysmography derived baseline change (ln (Blepi/Blo));
- b. Photoplethysmography derived time lag between pulse reaching hand and foot;
- c. Blood pressure (mean, systolic, diastolic);
- 2. Sensory level (pinprick, touch, cold)
- d. Skin temperature changes (finger and toe temperature change from baseline, toe-thigh and finger-arm temperature gradients).
- All assessments made at 0, 5, 10 and 20 minutes after epidural drug administration.