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.


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
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

33-43

Subventions

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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Auteurs

Julien Amour (J)

Department of Anesthesiology and Critical Care Medicine, Pitié-Salpêtrière Hospital, Institut de Cardiologie, Réanimation de Chirurgie Cardiaque, Sorbonne Université, UMR INSERM 1166, IHU ICAN, Assistance Publique-Hôpitaux de Paris (AP-HP), 47-83 Boulevard de l'Hôpital, 75013, Paris, France. profjulien.amour@gmail.com.

Bernard Cholley (B)

Department of Anesthesiology and Critical Care Medicine, Hôpital Européen Georges Pompidou, Université Paris-Descartes, Sorbonne Paris Cité, AP-HP, Paris, France.

Alexandre Ouattara (A)

Biology of Cardiovascular Diseases and Department of Anesthesiology and Critical Care, Magellan Medico-Surgical Center, University of Bordeaux, INSERM, UMR 1034, Bordeaux, France.

Dan Longrois (D)

Department of Anesthesiology and Critical Care Medicine, Hôpital Bichat-Claude Bernard, Unité INSERM U1148 (Laboratory for Vascular Translational Science), Université Paris-Diderot, Sorbonne Paris Cité, AP-HP, Paris, France.

Pascal Leprince (P)

Department of Cardiovascular and Thoracic Surgery, Pitié-Salpêtrière Hospital, Sorbonne Université, UMR INSERM 1166, IHU ICAN, Assistance Publique-Hôpitaux de Paris (AP-HP), Paris, France.

Jean-Luc Fellahi (JL)

Université Claude Bernard Lyon 1, Inserm U1060, Department of Anesthesiology and Critical Care Medicine, Hôpital Louis Pradel, Hospices Civils de Lyon, Lyon, France.

Bruno Riou (B)

Department of Emergency Medicine and Surgery, Pitié-Salpêtrière Hospital, Sorbonne Université, UMR INSERM 1166, IHU ICAN, Assistance Publique-Hôpitaux de Paris (AP-HP), Paris, France.

Sarah Hariri (S)

Department of Anesthesiology and Critical Care Medicine, Pitié-Salpêtrière Hospital, Institut de Cardiologie, Réanimation de Chirurgie Cardiaque, Sorbonne Université, UMR INSERM 1166, IHU ICAN, Assistance Publique-Hôpitaux de Paris (AP-HP), 47-83 Boulevard de l'Hôpital, 75013, Paris, France.

Christian Latrémouille (C)

Department of Cardiovascular and Thoracic Surgery, Hôpital Européen Georges Pompidou, Université Paris-Descartes, Sorbonne Paris Cité, AP-HP, Paris, France.

Alain Rémy (A)

Biology of Cardiovascular Diseases and Department of Anesthesiology and Critical Care, Magellan Medico-Surgical Center, University of Bordeaux, INSERM, UMR 1034, Bordeaux, France.

Sophie Provenchère (S)

Department of Anesthesiology and Critical Care Medicine, Hôpital Bichat-Claude Bernard, Unité INSERM U1148 (Laboratory for Vascular Translational Science), Université Paris-Diderot, Sorbonne Paris Cité, AP-HP, Paris, France.

Aude Carillion (A)

Department of Anesthesiology and Critical Care Medicine, Pitié-Salpêtrière Hospital, Institut de Cardiologie, Réanimation de Chirurgie Cardiaque, Sorbonne Université, UMR INSERM 1166, IHU ICAN, Assistance Publique-Hôpitaux de Paris (AP-HP), 47-83 Boulevard de l'Hôpital, 75013, Paris, France.

Paul Achouh (P)

Department of Cardiovascular and Thoracic Surgery, Hôpital Européen Georges Pompidou, Université Paris-Descartes, Sorbonne Paris Cité, AP-HP, Paris, France.

Louis Labrousse (L)

Department of Cardiovascular and Thoracic Surgery, Magellan Medico-Surgical Center, University of Bordeaux, INSERM, UMR 1034, Bordeaux, France.

Alexy Tran Dinh (A)

Department of Anesthesiology and Critical Care Medicine, Hôpital Bichat-Claude Bernard, Unité INSERM U1148 (Laboratory for Vascular Translational Science), Université Paris-Diderot, Sorbonne Paris Cité, AP-HP, Paris, France.

Nora Ait Hamou (N)

Department of Anesthesiology and Critical Care Medicine, Pitié-Salpêtrière Hospital, Institut de Cardiologie, Réanimation de Chirurgie Cardiaque, Sorbonne Université, UMR INSERM 1166, IHU ICAN, Assistance Publique-Hôpitaux de Paris (AP-HP), 47-83 Boulevard de l'Hôpital, 75013, Paris, France.

Ahmed Charfeddine (A)

Department of Anesthesiology and Critical Care Medicine, Pitié-Salpêtrière Hospital, Institut de Cardiologie, Réanimation de Chirurgie Cardiaque, Sorbonne Université, UMR INSERM 1166, IHU ICAN, Assistance Publique-Hôpitaux de Paris (AP-HP), 47-83 Boulevard de l'Hôpital, 75013, Paris, France.

Alexandre Lafourcade (A)

Department of Biostatistic, Public Health and Medical Information, Pitié-Salpêtrière Hospital, Sorbonne Université, Assistance Publique-Hôpitaux de Paris (AP-HP), Paris, France.

David Hajage (D)

Department of Biostatistic, Public Health and Medical Information, Pitié-Salpêtrière Hospital, Sorbonne Université, Assistance Publique-Hôpitaux de Paris (AP-HP), Paris, France.

Adrien Bouglé (A)

Department of Anesthesiology and Critical Care Medicine, Pitié-Salpêtrière Hospital, Institut de Cardiologie, Réanimation de Chirurgie Cardiaque, Sorbonne Université, UMR INSERM 1166, IHU ICAN, Assistance Publique-Hôpitaux de Paris (AP-HP), 47-83 Boulevard de l'Hôpital, 75013, Paris, France.

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