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临床试验/NCT02838056
NCT02838056Unknown不适用

Early Detection of the Effect of Epidural Local Anesthetic by Temperature Change on the Big Toe

Taipei Medical University WanFang Hospital1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2017年2月21日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
入组人数
40
试验地点
1
主要终点
measurement of skin temperature change over big toe after epidural local anesthetic injection

研究概览

简要总结

Traditionally, placement of the epidural catheter is based on hand feel of passing through the ligamentum flavum as well as "loss of resistance" while injecting the air through the needle. However, both are subjective and not necessarily encountered consistently. Moreover, the onset of sensory block is usually slow, thus making confirmation of catheter position a tough task and may delay the turnover of the operating room. The only way to confirm the catheter position objectively without delaying surgery is to find a reliable indicator within minutes of local anesthetic injection. In this study, we try to use the change of temperature in the big toe as a surrogate indicator of correct epidural catheterization.

详细描述

Epidural anesthesia loading dose: 17ml 2% xylocaine + 2.3ml sodium bicarbonate + 2ml Rapifen (1088 mcg) + 0.1 mg epinephrine

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

年龄范围
20 Years 至 79 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Body weight:50-90kg,
  • American Society of Anesthesiologists physical status classification I-II,
  • Under epidural anesthesia for surgery

排除标准

  • History of receiving lumbar surgery
  • Allergy to alfentanil ,xylocaine, bicarbonate

研究组 & 干预措施

epidural injection

Experimental

epidural injection of 2% lidocaine 17 ml + 2 ml alfentanil (544 mcg x 2 = 1088 mcg) + 7% sodium bicarbonate 2.3 ml (1.9 mEq) + 0.1mg epinephrine (1:200000)

干预措施: epidural injection (Drug)

结局指标

主要结局

measurement of skin temperature change over big toe after epidural local anesthetic injection

时间窗: within 10 mins after injection

SPECTRUM 9000MB to detect lower limb color changes

次要结局

  • measurement of skin sensation change between inguinal area to umbilicus(within 15 mins after injection)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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