A Phase 1, Dose-escalation, Double-blind, Block-randomized, Controlled Trial of Safety and Efficacy of Neosaxitoxin Alone and in Combination With 0.2% Bupivacaine, With and Without Epinephrine, for Cutaneous Anesthesia

Abstract

(Anesthesiology. 2015;123(4):873–885) Prolonged local anesthesia has been successfully achieved in both animals and humans using a site-1 sodium channel blocker called Neosaxitoxin (NeoSTX). The purpose of this study was to assess the safety of NeoSTX when administered through injection by itself, combined with bupivacaine, and combined with bupivacaine and epinephrine. The authors hypothesized that the drug would prove safe from a cardiovascular, neuromuscular, and respiratory standpoint. A secondary aim for this study was to evaluate the association between plasma concentrations of NeoSTX and any possible negative symptoms or bodily changes.