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Neurological and histological outcomes after subarachnoid injection of a liposomal bupivacaine suspension in pigs: a pilot study.
Zel, J; Hadzic, A; Cvetko, E; Seliskar, A; Damjanovska, M; Kuroda, M M; Sega Jazbec, S; Stopar Pintaric, T.
Afiliação
  • Zel J; Small Animal Clinic, Veterinary Faculty, Slovenia. Electronic address: jurij.zel@vf.uni-lj.si.
  • Hadzic A; NYSORA (The New York School of Regional Anaesthesia), New York, NY, USA; Department of Anaesthesiology, Ziekenhuis Oost-Limburg, Genk, Belgium.
  • Cvetko E; Institute of Anatomy, Faculty of Medicine, University of Ljubljana, Ljubljana, Slovenia.
  • Seliskar A; Small Animal Clinic, Veterinary Faculty, Slovenia.
  • Damjanovska M; Clinical Department of Anaesthesiology and Intensive Therapy, Slovenia.
  • Kuroda MM; NYSORA (The New York School of Regional Anaesthesia), New York, NY, USA; SciMedBE, Leuven, Belgium.
  • Sega Jazbec S; Department of Neurology, University Medical Centre Ljubljana, Ljubljana, Slovenia.
  • Stopar Pintaric T; Institute of Anatomy, Faculty of Medicine, University of Ljubljana, Ljubljana, Slovenia; Clinical Department of Anaesthesiology and Intensive Therapy, Slovenia.
Br J Anaesth ; 122(3): 379-387, 2019 Mar.
Article em En | MEDLINE | ID: mdl-30770056
ABSTRACT

BACKGROUND:

An injectable liposomal bupivacaine suspension (EXPAREL™) is approved by the US Food and Drug Administration for analgesia by tissue infiltration and interscalene brachial plexus, but not for use in the neuraxial space. This pilot study describes neurological and histological outcomes of escalating doses of this extended-release formulation of bupivacaine after subarachnoid administration.

METHODS:

Twenty-five pigs (Sus scrofa domesticus) weighing 36.2 (4.4) kg were randomly assigned to one of five groups to receive a subarachnoid injection of sodium chloride 0.9%, 3 ml (negative control), preservative-free bupivacaine hydrochloride 0.5%, 3 ml (positive control), or one of three doses of liposomal bupivacaine suspension 1.33% 1.5, 3, or 5 ml. After recovering from general anaesthesia, neurological outcomes were assessed by blinded observers. Three weeks later, the animals were sacrificed for histological evaluations of neurotoxicity.

RESULTS:

Animals that received sodium chloride 0.9%, bupivacaine hydrochloride, or liposomal bupivacaine 1.5 ml recovered within 2, 5, or 4 h, respectively. Animals that received liposomal bupivacaine 3 or 5 ml exhibited signs of neuraxial block (decreased nociception and proprioception) up to 32 h after injection. No histological evidence of neurotoxicity was found in any of the groups.

CONCLUSIONS:

Subarachnoid administration of liposomal bupivacaine in pigs exhibited a dose-response effect, and resulted in longer duration of neuraxial block than bupivacaine hydrochloride without histological evidence of neurotoxicity. Our study contributes preliminary data to inform further toxicological assessments and regulatory approval before subarachnoid administration in humans.
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Texto completo: 1 Base de dados: MEDLINE Assunto principal: Bupivacaína / Síndromes Neurotóxicas / Anestésicos Locais Limite: Animals Idioma: En Ano de publicação: 2019 Tipo de documento: Article

Texto completo: 1 Base de dados: MEDLINE Assunto principal: Bupivacaína / Síndromes Neurotóxicas / Anestésicos Locais Limite: Animals Idioma: En Ano de publicação: 2019 Tipo de documento: Article