Julien Amour1, Bernard Cholley2, Alexandre Ouattara3, Dan Longrois4, Pascal Leprince5, Jean-Luc Fellahi6, Bruno Riou7, Sarah Hariri8, Christian Latrémouille9, Alain Rémy3, Sophie Provenchère4, Aude Carillion8, Paul Achouh9, Louis Labrousse10, Alexy Tran Dinh4, Nora Ait Hamou8, Ahmed Charfeddine8, Alexandre Lafourcade11, David Hajage11, Adrien Bouglé8. 1. 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. 2. Department of Anesthesiology and Critical Care Medicine, Hôpital Européen Georges Pompidou, Université Paris-Descartes, Sorbonne Paris Cité, AP-HP, Paris, France. 3. Biology of Cardiovascular Diseases and Department of Anesthesiology and Critical Care, Magellan Medico-Surgical Center, University of Bordeaux, INSERM, UMR 1034, Bordeaux, France. 4. 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. 5. 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. 6. Université Claude Bernard Lyon 1, Inserm U1060, Department of Anesthesiology and Critical Care Medicine, Hôpital Louis Pradel, Hospices Civils de Lyon, Lyon, France. 7. 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. 8. 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. 9. Department of Cardiovascular and Thoracic Surgery, Hôpital Européen Georges Pompidou, Université Paris-Descartes, Sorbonne Paris Cité, AP-HP, Paris, France. 10. Department of Cardiovascular and Thoracic Surgery, Magellan Medico-Surgical Center, University of Bordeaux, INSERM, UMR 1034, Bordeaux, France. 11. Department of Biostatistic, Public Health and Medical Information, Pitié-Salpêtrière Hospital, Sorbonne Université, Assistance Publique-Hôpitaux de Paris (AP-HP), Paris, France.
Abstract
PURPOSE: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. METHODS: 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-1) of L-bupivacaine (12.5 mg h-1) or placebo (saline) via a pre-sternal multiperforated catheter. Anesthesia and analgesia protocols were standardized. The primary end point was the incidence of pneumonia during the study period, i.e., until hospital discharge or 30 days. We hypothesized a 30% reduction in the incidence of pneumonia. RESULTS: 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). CONCLUSIONS: 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. TRIAL REGISTRATION: EudraCT Number: 2011-003292-10; Clinicaltrials.gov Identifier: NCT01648777.
RCT Entities:
PURPOSE: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. METHODS: 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-1) of L-bupivacaine (12.5 mg h-1) or placebo (saline) via a pre-sternal multiperforated catheter. Anesthesia and analgesia protocols were standardized. The primary end point was the incidence of pneumonia during the study period, i.e., until hospital discharge or 30 days. We hypothesized a 30% reduction in the incidence of pneumonia. RESULTS: 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). CONCLUSIONS: 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. TRIAL REGISTRATION: EudraCT Number: 2011-003292-10; Clinicaltrials.gov Identifier: NCT01648777.
Entities:
Keywords:
Cardiac surgery; Critical care medicine; Local anesthetics; Pneumonia; Postoperative pain
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