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Local Anesthetic Properties of Neosaxitoxin

This study has been completed.
Information provided by:
University of Chile Identifier:
First received: January 4, 2006
Last updated: February 16, 2007
Last verified: February 2007
The purpose of this study is to evaluate the local anesthetic properties of neosaxitoxin in humans

Condition Intervention Phase
Healthy Volunteers Drug: Neosaxitoxin Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Phase 1 Study of Local Infiltration of Neosaxitoxin as a Local Anesthetic

Resource links provided by NLM:

Further study details as provided by University of Chile:

Primary Outcome Measures:
  • 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:
  • 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

Estimated Enrollment: 10
Study Start Date: May 2005
Estimated Study Completion Date: September 2005
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.


Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Healthy males with the abilities to understand and respond the tests to perform

Exclusion Criteria:

  • 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
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Please refer to this study by its identifier: NCT00273065

Henry Mayer Center, Hospital Clínico Universidad de Chile
Santiago, Chile, 0
Sponsors and Collaborators
University of Chile
Principal Investigator: Alberto Rodriguez-Navarro, MD University of Chile
Principal Investigator: Nestor Lagos, PhD Faculty of Medicine, University of Chile
  More Information

Publications: Identifier: NCT00273065     History of Changes
Other Study ID Numbers: HCUCH-AR-NEOSAX-0001
Study First Received: January 4, 2006
Last Updated: February 16, 2007

Keywords provided by University of Chile:
Local Anesthetic

Additional relevant MeSH terms:
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Neuromuscular Blocking Agents
Neuromuscular Agents processed this record on September 21, 2017