The systemic toxicity of local anaesthetics may be treated using lipid emulsions ("lipid
rescue"). However, there is no evidence-based proof of the efficacy of the treatment. The aim
of the intended protocol is to study the effect of the emulsion Intralipid® on the toxicity
prodromes in volunteers receiving either levobupivacaine or ropivacaine. After a
sensitization session with lidocaine, subjects will receive in a double blind, crossover
manner an i.v. infusion of levobupivacaine or ropivacaine followed by a rapid infusion of
Intralipid®. The primary outcome will be the time of appearance of early neurologic signs of
toxicity. In addition, the EEG and ECG will be monitored and blood sampling will be performed
in order to evaluate the changes in pharmacokinetics induced by the emulsion.
Phase:
Phase 2
Details
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Collaborator:
Institut National de la Santé Et de la Recherche Médicale, France