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
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−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.
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.
KeywordsPneumonia Cardiac surgery Critical care medicine Postoperative pain Local anesthetics
We thank Dr David Baker, DM, FRCA (Emeritus Consultant Anesthesiologist, Department of Anesthesiology and Critical Care, Hôpital Necker-Enfants Malades, APHP, Paris, France) for editing the article. STERNOCAT Investigators: Hôpital Pitié-Salpêtrière, AP-HP, and Sorbonne Université, Paris, France: Louis Puybasset, MD, PhD, Dimitri Margetis, MD, PhD, Guillaume Lebreton, MD, Mojgane Laalie, MD, PhD; Théodoro Barreda, MD, Cossimo D’Alessandro, MD; Hôpital Européen Georges Pompidou, Paris: Marie-Fazia Boughenou, MD, Alain Bel, MD, Jérôme Jouan, MD, Leonara Du Puy Montbrun, MD, Philippe Menasché, MD, PhD; Magellan Medico-Surgical Center, Bordeaux: Astrid Quessard, MD.
Drs JA and DH had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis. Concept and design: AB, BC, AO, DL, J-LF, DH, BR, JA. Acquisition of data: all authors. Analysis, or interpretation of data: AB, BR, AL, DH, JA. Drafting of the manuscript: AB, BR, JA. Critical revision of the manuscript for important intellectual content: All authors. Statistical analysis: AL, DH. Obtained funding: JA. Administrative, technical, or material support: DH. Supervision: JA, DH.
The STERNOCAT study was funded by the French Ministry of Health (Programme Hospitalier de Recherche Clinique National, P100107) and sponsored by Assistance Publique-Hôpitaux de Paris (AP-HP). Baxter provided multiperforated wound catheters, Abbott France provided l-bupivacaine, and Wym France provided elastomeric pumps, all free of charge.
Compliance with ethical standards
Conflicts of interest
All authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. No disclosure was reported.
Role of the funder/sponsor
Baxter, Abbott France, and Wym France Orion Pharma had no role in the design and conduct of the study, collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.
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