Phase 1 Study of Local Infiltration of Neosaxitoxin as a Local Anesthetic
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Neural blockade of five parameters:
研究概览
简要总结
The purpose of this study is to evaluate the local anesthetic properties of neosaxitoxin in humans
详细描述
Neosaxitoxin is a phycotoxins that reversible block the voltage-gated sodium channels at neuronal level. Its activity is express as blocking the axonal conduction, stopping the propagation of the nerve impulse. The objective of the present work is to evaluate the neosaxitoxin efficacy and safety as local anesthetic in a human trial
Methods: Randomized, double-blind, placebo-controlled trial, with 10 healthy volunteers. The anesthetic effect will be evaluated using a standardized human sensory and pain model. TSA Neurosensory analyser and Von Frey Technique will be used to evaluate five parameters: sensory threshold for warm and cold, pain thresholds for heat and cold and mechanical touch perception threshold.
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 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy males with the abilities to understand and respond the tests to perform
排除标准
- •Use of any oral analgesics at least ten days before the study
- •Drugs abuse history
- •Showing at the clinical examination any signal of psychiatric disorder
结局指标
主要结局
Neural blockade of five parameters:
sensory threshold for warm
sensory threshold for cold
pain thresholds for heat
pain thresholds for cold
mechanical touch perception threshold
Measurements at 1,3,6,9,12,16,24 and 48 hrs after the injections
次要结局
- Pain on injection (VAS Score 0-10)
- Blood sample at 1 hour
- Orine sample at 4 hours after the injection, in order to determine amounts of neosaxitoxin