Local Anesthetic Properties of Neosaxitoxin
- Conditions
- Healthy Volunteers
- Registration Number
- NCT00273065
- Lead Sponsor
- University of Chile
- Brief Summary
The purpose of this study is to evaluate the local anesthetic properties of neosaxitoxin in humans
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 10
- Healthy males with the abilities to understand and respond the tests to perform
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Henry Mayer Center, Hospital Clínico Universidad de Chile
🇨🇱Santiago, Chile