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临床试验/NCT00373893
NCT00373893已完成1 期

Effects of Lidocaine Patch on Intradermal Capsaicin Induced Pain and Hyperalgesia

University of California, San Diego1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2005年12月1日最近更新:
适应症
相关药物

试验速览

阶段
1 期
状态
已完成
入组人数
12
试验地点
1
主要终点
Neurosensory testing

研究概览

简要总结

To determine the effects of Lidocaine patch on the pain and hyperalgesia induced by intradermal capsaicin

详细描述

A randomized, double-blinded, placebo controlled methodology will be conducted. At the session subjects will be exposed to placebo patch and lidocaine patch. Prior to study drug administration, a baseline neurosensory test on the volar aspect of both forearms will be performed and baseline vital signs will be measured. A placebo patch and a lidocaine patch will then be applied to the volar aspect of each forearm. The arms will be randomized to which arm receives placebo and which one receives the lidocaine patch. After four hours of application the right forearm patch will be removed the neurosensory testing will be repeated on the right forearm. After completing the testing, capsaicin (10µl, 10 mg/ml) will be injected intradermally on the volar aspect of the right forearm. Elicited and spontaneous pain scores, blood pressure, heart rate, and respiratory rate will be measured at the time of injection and every 2.5 minutes for 10 minutes. A McGill Pain Questionnaire will be administered at the time of capsaicin injection only. Ten minutes after the capsaicin injection, the hyperalgesic area will be established to von Frey hair, stroking, and heat; the flare response will be outlined; and neurosensory testing will performed halfway between the edge of this defined area and the capsaicin injection site. At the completion of the testing on the right forearm, the left forearm patch will be removed and the procedures described for the right forearm will be repeated for the left forearm.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Treatment
盲法
Double

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Age 18 and above

排除标准

  • •Pregnancy.
  • •Allergy to lidocaine
  • •Current painful condition
  • •Current use of analgesics for the treatment of pain
  • •Lack of ability to understand the experimental protocol and to adequately communicate in English. The neurosensory testing we plan to perform requires the complete cooperation and understanding of the subject. It would be impossible to perform these studies on patients who do not adequately communicate in English.

结局指标

主要结局

Neurosensory testing

Four neurosensory tests: warm and cold sensation,warm/cold pain/touch/mechanical pain.

Warm and cold sensation measured w/a Thermal Sensory

Touch will be measured using von Frey hairs. Calibrated von Frey hairs are filaments of varying size. The filament are selected at random and 3 successive stimuli are applied for 1.5 second at 5 second intervals per filament

Mechanical pain will be measured using von Frey hairs. Endpoint will be pain.

次要结局

  • Allodynia and Hyperalgesia
  • At the completion of the stimulation, areas of cutaneous allodynia and hyperalgesia will be mapped. The region of hyperalgesia will be established with a 5.18 von Frey hair, and the area of allodynia with a foam brush gently stroked on the skin.

研究者

申办方类型
Other

研究点 (1)

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