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Intensive Care Medicine

, Volume 45, Issue 1, pp 33–43 | Cite as

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

  • Julien AmourEmail author
  • Bernard Cholley
  • Alexandre Ouattara
  • Dan Longrois
  • Pascal Leprince
  • Jean-Luc Fellahi
  • Bruno Riou
  • Sarah Hariri
  • Christian Latrémouille
  • Alain Rémy
  • Sophie Provenchère
  • Aude Carillion
  • Paul Achouh
  • Louis Labrousse
  • Alexy Tran Dinh
  • Nora Ait Hamou
  • Ahmed Charfeddine
  • Alexandre Lafourcade
  • David Hajage
  • Adrien Bouglé
  • for the STERNOCAT investigators
Original

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.

Keywords

Pneumonia Cardiac surgery Critical care medicine Postoperative pain Local anesthetics 

Notes

Acknowledgements

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.

Author contributions

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.

Funding

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.

Supplementary material

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References

  1. 1.
    Eljezi V, Imhoff E, Bourdeaux D et al (2017) Bilateral sternal infusion of ropivacaine and length of stay in ICU after cardiac surgery with increased respiratory risk: a randomised controlled trial. Eur J Anaesthesiol 34:56–65CrossRefGoogle Scholar
  2. 2.
    Hulzebos EH, Helders PJ, Favié NJ, De Bie RA, Brutel de la Riviere A, Van Meeteren NL (2006) Preoperative intensive inspiratory muscle training to prevent postoperative pulmonary complications in high-risk patients undergoing CABG surgery: a randomized clinical trial. JAMA 296:1851–1857CrossRefGoogle Scholar
  3. 3.
    Scott NBL, Turfrey DJ, Ray DA, Nzewi O, Sutcliffe NP, Lal AB, Norrie J, Nagels WJ, Ramayya GP (2001) A prospective randomized study of the potential benefits of thoracic epidural anesthesia and analgesia in patients undergoing coronary artery bypass grafting. Anesth Analg 93:528–535CrossRefGoogle Scholar
  4. 4.
    Ailawadi G, Chang HL, O’Gara PT et al (2017) Pneumonia after cardiac surgery: experience of the National Institutes of Health/Canadian Institutes of Health Research Cardiothoracic Surgical Trials Network. J Thorac Cardiovasc Surg 153:1384–1391CrossRefGoogle Scholar
  5. 5.
    Ng CS, Wan S, Yim AP, Arifi AA (2002) Pulmonary dysfunction after cardiac surgery. Chest 121:1269–1277CrossRefGoogle Scholar
  6. 6.
    Gao F, Yang LH, He HR et al (2016) The effect of reintubation on ventilator-associated pneumonia and mortality among mechanically ventilated patients with intubation: a systematic review and meta-analysis. Heart Lung 45:363–371CrossRefGoogle Scholar
  7. 7.
    Sasseron AB, Figueiredo LC, Trova K et al (2009) Does the pain disturb the respiratory function after open heart surgery? Rev Bras Cir Cardiovasc 24:490–496CrossRefGoogle Scholar
  8. 8.
    Baumgarten MC, Garcia GK, Frantzeski MH et al (2009) Pain and pulmonary function in patients submitted to heart surgery via sternotomy. Rev Bras Cir Cardiovasc 24:497–505CrossRefGoogle Scholar
  9. 9.
    Wynne R, Botti M (2004) Postoperative pulmonary dysfunction in adults after cardiac surgery with cardiopulmonary bypass: clinical significance and implications for practice. Am J Crit Care 13:384–393Google Scholar
  10. 10.
    Puntillo K, Max A, Timsit JF et al (2018) Pain distress: the negative emotion associated with procedures in ICU patients. Intensive Care Med 44:1493–1501CrossRefGoogle Scholar
  11. 11.
    Devlin JW, Skrobik Y, Gélinas C et al (2018) Clinical practice guidelines for the prevention and management of pain, agitation/sedation, delirium, immobility, and sleep disruption in adult patients in the ICU. Crit Care Med 46:e825–e873CrossRefGoogle Scholar
  12. 12.
    Bigeleisen PEL, Goehner N (2015) Novel approaches in pain management in cardiac surgery. Curr Opin Anaesthesiol 28:89–94CrossRefGoogle Scholar
  13. 13.
    Bouza E, Hortal J, Munoz P, Pascau J, Perez MJ, Hiesmayr M (2006) Postoperative infections after major heart surgery and prevention of ventilator-associated pneumonia: a one-day European prevalence study (ESGNI-008). J Hosp Infect 64:224–230CrossRefGoogle Scholar
  14. 14.
    Dowling R, Thielmeier K, Ghaly A, Barber D, Boice T, Dine A (2003) Improved pain control after cardiac surgery: results of a randomized, double-blind, clinical trial. J Thorac Cardiovasc Surg 126:1271–1278CrossRefGoogle Scholar
  15. 15.
    White PF, Rawal S, Latham P et al (2003) Use of a continuous local anesthetic infusion for pain management after median sternotomy. Anesthesiology 99:918–923CrossRefGoogle Scholar
  16. 16.
    Chiu KM, Wu CC, Wang MJ et al (2008) Local infusion of bupivacaine combined with intravenous patient-controlled analgesia provides better pain relief than intravenous patient-controlled analgesia alone in patients undergoing minimally invasive cardiac surgery. J Thorac Cardiovasc Surg 135:1348–1352CrossRefGoogle Scholar
  17. 17.
    Tirotta CF, Munro HM, Salvaggio J et al (2009) Continuous incisional infusion of local anesthetic in pediatric patients following open heart surgery. Paediatr Anaesth 19:571–576CrossRefGoogle Scholar
  18. 18.
    Schulz KF, Altman DG, Moher D, CONSORT Group (2010) CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials. BMC Med 8:18CrossRefGoogle Scholar
  19. 19.
    Manganas H, Lacasse Y, Bourgeois S, Perron J, Dagenais F, Maltais F (2007) Postoperative outcome after coronary artery bypass grafting in chronic obstructive pulmonary disease. Can Respir J 14:19–24CrossRefGoogle Scholar
  20. 20.
    Rock P, Rich PB (2003) Postoperative pulmonary complications. Curr Opin Anaesthesiol 16:123–131CrossRefGoogle Scholar
  21. 21.
    Gol MK, Karahan M, Ulus AT et al (1998) Bloodstream, respiratory, and deep surgical wound infections after open heart surgery. J Card Surg 13:252–259CrossRefGoogle Scholar
  22. 22.
    Calandra T, Cohen J (2005) The international sepsis forum consensus conference on definitions of infection in the intensive care unit. Crit Care Med 33:1538–1548CrossRefGoogle Scholar
  23. 23.
    Leone M, Bouadma L, Bouhemad B et al (2018) Hospital-acquired pneumonia in ICU. Anaesth Crit Care Pain Med 37:83–98CrossRefGoogle Scholar
  24. 24.
    Van Wingerden JJ, Ubbink DT, Van Der Horst CM, De Mol BA (2014) Poststernotomy mediastinitis: a classification to initiate and evaluate reconstructive management based on evidence from a structured review. J Cardiothorac Surg 9:179CrossRefGoogle Scholar
  25. 25.
    Amour J, Birenbaum A, Langeron O et al (2008) Influence of renal dysfunction on the accuracy of procalcitonin for the diagnosis of postoperative infection after vascular surgery. Crit Care Med 36:1147–1154CrossRefGoogle Scholar
  26. 26.
    Casagrande JT, Pike MC (1978) An Improved approximation formula for calculating sample sizes for comparing two binomial distributions. Biometrics 34:483–486CrossRefGoogle Scholar
  27. 27.
    Jakobsen JC, Gluud C, Wetterslev J, Winkel P (2017) When and how should multiple imputation be used for handling missing data in randomised clinical trials—a practical guide with flowcharts. BMC Med Res Methodol 17:162CrossRefGoogle Scholar
  28. 28.
    Rubin DB (1987) Multiple imputation for nonresponse in surveys. Wiley, New YorkCrossRefGoogle Scholar
  29. 29.
    Bang J, Kim JU, Lee YM et al (2011) Spinal epidural hematoma related to an epidural catheter in a cardiac surgery patient—a case report. Korean J Anesthesiol 6:524–527CrossRefGoogle Scholar
  30. 30.
    Rosen DA, Hawkinberry DW, Rosen KR, Gustafson RA, Hogg JP, Broadman LM (2004) An epidural hematoma in an adolescent patient after cardiac surgery. Anesth Analg 98:966–969CrossRefGoogle Scholar
  31. 31.
    Liu SS, Richman JM, Thirlby RC, Wu CL (2006) Efficacy of continuous wound catheters delivering local anesthetic for postoperative analgesia: a quantitative and qualitative systematic review of randomized controlled trials. J Am Coll Surg 203:914–932CrossRefGoogle Scholar
  32. 32.
    Ruka E, Dagenais F, Mohammadi S, Chauvette V, Poirier P, Voisine P (2016) Bilateral mammary artery grafting increases postoperative mediastinitis without survival benefit in obese patients. Eur J Cardiothorac Surg 50:1188–1195CrossRefGoogle Scholar
  33. 33.
    Toumpoulis IKL, Theakos N, Dunning J (2007) Does bilateral internal thoracic artery harvest increase the risk of mediastinitis? Interact Cardiovasc Thorac Surg 6:787–791CrossRefGoogle Scholar

Copyright information

© Springer-Verlag GmbH Germany, part of Springer Nature 2018

Authors and Affiliations

  • Julien Amour
    • 1
    Email author
  • Bernard Cholley
    • 2
  • Alexandre Ouattara
    • 3
  • Dan Longrois
    • 4
  • Pascal Leprince
    • 5
  • Jean-Luc Fellahi
    • 6
  • Bruno Riou
    • 7
  • Sarah Hariri
    • 1
  • Christian Latrémouille
    • 8
  • Alain Rémy
    • 3
  • Sophie Provenchère
    • 4
  • Aude Carillion
    • 1
  • Paul Achouh
    • 8
  • Louis Labrousse
    • 9
  • Alexy Tran Dinh
    • 4
  • Nora Ait Hamou
    • 1
  • Ahmed Charfeddine
    • 1
  • Alexandre Lafourcade
    • 10
  • David Hajage
    • 10
  • Adrien Bouglé
    • 1
  • for the STERNOCAT investigators
  1. 1.Department of Anesthesiology and Critical Care MedicinePitié-Salpêtrière Hospital, Institut de Cardiologie, Réanimation de Chirurgie Cardiaque, Sorbonne Université, UMR INSERM 1166, IHU ICAN, Assistance Publique-Hôpitaux de Paris (AP-HP)ParisFrance
  2. 2.Department of Anesthesiology and Critical Care Medicine, Hôpital Européen Georges PompidouUniversité Paris-Descartes, Sorbonne Paris Cité, AP-HPParisFrance
  3. 3.Biology of Cardiovascular Diseases and Department of Anesthesiology and Critical Care, Magellan Medico-Surgical CenterUniversity of Bordeaux, INSERM, UMR 1034BordeauxFrance
  4. 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-HPParisFrance
  5. 5.Department of Cardiovascular and Thoracic Surgery, Pitié-Salpêtrière HospitalSorbonne Université, UMR INSERM 1166, IHU ICAN, Assistance Publique-Hôpitaux de Paris (AP-HP)ParisFrance
  6. 6.Université Claude Bernard Lyon 1, Inserm U1060, Department of Anesthesiology and Critical Care MedicineHôpital Louis Pradel, Hospices Civils de LyonLyonFrance
  7. 7.Department of Emergency Medicine and Surgery, Pitié-Salpêtrière HospitalSorbonne Université, UMR INSERM 1166, IHU ICAN, Assistance Publique-Hôpitaux de Paris (AP-HP)ParisFrance
  8. 8.Department of Cardiovascular and Thoracic Surgery, Hôpital Européen Georges PompidouUniversité Paris-Descartes, Sorbonne Paris Cité, AP-HPParisFrance
  9. 9.Department of Cardiovascular and Thoracic Surgery, Magellan Medico-Surgical CenterUniversity of Bordeaux, INSERM, UMR 1034BordeauxFrance
  10. 10.Department of Biostatistic, Public Health and Medical Information, Pitié-Salpêtrière HospitalSorbonne Université, Assistance Publique-Hôpitaux de Paris (AP-HP)ParisFrance

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