The effect of local anesthetic continuous wound infusion for the prevention of postoperative pneumonia after on-pump cardiac surgery with sternotomy: the STERNOCAT randomized clinical trial.
Academic Medical Centers
/ organization & administration
Aged
Aged, 80 and over
Anesthetics, Local
/ administration & dosage
Bupivacaine
/ administration & dosage
Cardiac Surgical Procedures
/ adverse effects
Double-Blind Method
Female
France
/ epidemiology
Humans
Infusion Pumps
/ standards
Male
Middle Aged
Placebos
Pneumonia
/ drug therapy
Postoperative Complications
/ drug therapy
Sternotomy
/ adverse effects
Cardiac surgery
Critical care medicine
Local anesthetics
Pneumonia
Postoperative pain
Journal
Intensive care medicine
ISSN: 1432-1238
Titre abrégé: Intensive Care Med
Pays: United States
ID NLM: 7704851
Informations de publication
Date de publication:
01 2019
01 2019
Historique:
received:
26
08
2018
accepted:
04
12
2018
pubmed:
9
1
2019
medline:
18
12
2019
entrez:
9
1
2019
Statut:
ppublish
Résumé
Postoperative pain after cardiac surgery, exacerbated by cough and sternal mobilization, limits clearance of bronchopulmonary secretions and may predispose to postoperative pneumonia. In this study, we tested the ability of local anesthetic continuous wound infusion to prevent pneumonia after cardiac surgery with sternotomy and cardiopulmonary bypass (CPB) owing to better analgesia and bronchopulmonary drainage. In this randomized, double-blind, placebo-controlled trial conducted in five academic centers, patients undergoing cardiac surgery with sternotomy and CPB were enrolled from February 2012 until November 2014, and were followed over 30 days. Patients were assigned to a 48-h infusion (10 ml h Among 1493 randomized patients, 1439 completed the trial. Pneumonia occurred in 36/746 patients (4.9%) in the L-bupivacaine group and in 42/739 patients (5.7%) in the placebo group (absolute risk difference taking into account center and baseline risk of postoperative pneumonia, - 1.3% [95% CI - 3.4; 0.8] P = 0.22). In the predefined subgroup of patients at high risk, L-bupivacaine decreased the incidence of pneumonia (absolute risk difference, - 5.6% [95% CI - 10.0; - 1.1], P = 0.01). After cardiac surgery with sternotomy, continuous wound infusion of L-bupivacaine failed to decrease the incidence of pneumonia. These findings do not support the use of local anesthetic continuous wound infusion in this indication. Further study should investigate its effect in high-risk patients. EudraCT Number: 2011-003292-10; Clinicaltrials.gov Identifier: NCT01648777.
Identifiants
pubmed: 30617461
doi: 10.1007/s00134-018-5497-x
pii: 10.1007/s00134-018-5497-x
doi:
Substances chimiques
Anesthetics, Local
0
Placebos
0
Bupivacaine
Y8335394RO
Banques de données
ClinicalTrials.gov
['NCT01648777']
EudraCT
['2011-003292-10']
Types de publication
Journal Article
Randomized Controlled Trial
Langues
eng
Sous-ensembles de citation
IM
Pagination
33-43Subventions
Organisme : PHRC
ID : P100107
Pays : International
Investigateurs
Louis Puybasset
(L)
Dimitri Margetis
(D)
Guillaume Lebreton
(G)
Mojgane Laalie
(M)
Théodoro Barreda
(T)
Cossimo D'Alessandro
(C)
Marie-Fazia Boughenou
(MF)
Alain Bel
(A)
Jérôme Jouan
(J)
Leonara Du Puy Montbrun
(L)
Philippe Menasché
(P)
Astrid Quessard
(A)
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