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The purpose of this study is to evaluate the local anesthetic properties of neosaxitoxin in humans
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neosaxitoxin | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alberto Rodriguez-Navarro, MD | University of Chile | Principal Investigator |
| Nestor Lagos, PhD | Faculty of Medicine, University of Chile | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Henry Mayer Center, Hospital ClĂnico Universidad de Chile | Santiago | Santiago Metropolitan | 0 | Chile |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17264729 | Result | Rodriguez-Navarro AJ, Lagos N, Lagos M, Braghetto I, Csendes A, Hamilton J, Figueroa C, Truan D, Garcia C, Rojas A, Iglesias V, Brunet L, Alvarez F. Neosaxitoxin as a local anesthetic: preliminary observations from a first human trial. Anesthesiology. 2007 Feb;106(2):339-45. doi: 10.1097/00000542-200702000-00023. |
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| ID | Term |
|---|---|
| C034902 | neosaxitoxin |
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