Single-centre, double-blind, randomised, parallel-group, superiority study to evaluate the effectiveness of general anaesthesia and ultrasound-guided transversus thoracis muscle plane block combination in adult cardiac surgery for reducing the surgical stress response: clinical trial protocol

A A Gde Putra Semara Jaya, Aida Rosita Tantri, Aldy Heriwardito, Arif Mansjoer, A A Gde Putra Semara Jaya, Aida Rosita Tantri, Aldy Heriwardito, Arif Mansjoer

Abstract

Introduction: Adult open-heart surgery is a major surgery that causes surgical stress response and activation of the immune system, contributing further to postoperative complications. Transversus thoracis muscle plane block (TTPB) may potentially benefit in reducing the surgical stress response. This study aims to know the effectiveness of preoperative TTPB in adult open-heart surgery for reducing the surgical stress response.

Methods and analysis: This study is a prospective, double-blind, randomised control trial comparing the combination of general anaesthesia and TTPB versus general anaesthesia only in adult open-heart surgery. Forty-two eligible subjects will be randomly assigned to the TTPB group or control group. The primary outcomes are the difference between the two groups in the means of postoperative cortisol and interleukin-6 plasma levels at 24 hours and 48 hours after cardiac intensive care unit admission. The secondary outcomes are the difference between the two groups in the means of total 24-hour postoperative morphine consumption and time of first postoperative patient-controlled analgesia (PCA) dose.

Ethics and dissemination: The study protocol and informed consent forms have been reviewed and approved by the Ethics Committee of Faculty of Medicine Universitas Indonesia/Dr. Cipto Mangunkusumo Hospital. The result will be released to the medical community through presentation and publication in peer-reviewed journals.

Trial registration number: NCT04544254.

Keywords: adult anaesthesia; anaesthesia in cardiology; cardiothoracic surgery; pain management.

Conflict of interest statement

Competing interests: None declared.

© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

References

    1. Asimakopoulos G. Systemic inflammation and cardiac surgery: an update. Perfusion 2001;16:353–60. 10.1177/026765910101600505
    1. Laffey JG, Boylan JF, Cheng DCH. The systemic inflammatory response to cardiac surgery: implications for the anesthesiologist. Anesthesiology 2002;97:215–52. 10.1097/00000542-200207000-00030
    1. Sugita J, Fujiu K. Systemic inflammatory stress response during cardiac surgery. Int Heart J 2018;59:457–9. 10.1536/ihj.18-210
    1. Shankar Hari M, Summers C. Major surgery and the immune system: from pathophysiology to treatment. Curr Opin Crit Care 2018;24:588–93. 10.1097/MCC.0000000000000561
    1. Hollmann MW, Durieux ME. Local anesthetics and the inflammatory response: a new therapeutic indication? Anesthesiology 2000;93:858–75. 10.1097/00000542-200009000-00038
    1. Loick HM, Schmidt C, Van Aken H, et al. . High thoracic epidural anesthesia, but not clonidine, attenuates the perioperative stress response via sympatholysis and reduces the release of troponin T in patients undergoing coronary artery bypass grafting. Anesth Analg 1999;88:701–9. 10.1097/00000539-199904000-00001
    1. Desborough JP. The stress response to trauma and surgery. Br J Anaesth 2000;85:109–17. 10.1093/bja/85.1.109
    1. Gutierrez T, Hornigold R, Pearce A. The systemic response to surgery. Surgery 2011;29:93–6. 10.1016/j.mpsur.2010.11.010
    1. Ivanovs I, Mihelsons M, Boka V. Stress response to surgery and possible ways of its correction. Proc Latv Acad Sci B: Nat Exact Appl Sci 2012;66:225–33. 10.2478/v10046-012-0014-z
    1. Saracevic A, Medved I, Hrabric Vlah S, et al. . The association of systemic inflammatory markers with indicators of stress and cardiac necrosis in patients undergoing aortic valve replacement and revascularization surgeries. Physiol Res 2020;69:261–74. 10.33549/physiolres.934243
    1. Moor D, Aggarwal G, Quiney N. Systemic response to surgery. Surgery 2017;35:220–3. 10.1016/j.mpsur.2017.01.013
    1. Marik PE, Flemmer M. The immune response to surgery and trauma: implications for treatment. J Trauma Acute Care Surg 2012;73:801–8. 10.1097/TA.0b013e318265cf87
    1. Burton D, Nicholson G, Hall G. Endocrine and metabolic response to surgery. BJA Education 2004;4:144–7. 10.1093/BJACEACCP/MKH040
    1. Golubovska I, Vanags I. Anaesthesia and stress response to surgery. Proc Latv Acad Sci B: Nat Exact Appl Sci 2008;62:141–7. 10.2478/v10046-008-0017-y
    1. Giannoudis PV, Dinopoulos H, Chalidis B, et al. . Surgical stress response. Injury 2006;37 Suppl 5:S3–9. 10.1016/S0020-1383(07)70005-0
    1. Gulielmos V, Menschikowski M, Dill H, et al. . Interleukin-1, interleukin-6 and myocardial enzyme response after coronary artery bypass grafting - a prospective randomized comparison of the conventional and three minimally invasive surgical techniques. Eur J Cardiothorac Surg 2000;18:594–601. 10.1016/S1010-7940(00)00553-4
    1. Meng F, Ma J, Wang W, et al. . Meta-analysis of interleukin 6, 8, and 10 between off-pump and on-pump coronary artery bypass groups. Bosn J Basic Med Sci 2017;17:85–94. 10.17305/bjbms.2017.1505
    1. Hahnenkamp K, Herroeder S, Hollmann MW. Regional anaesthesia, local anaesthetics and the surgical stress response. Best Pract Res Clin Anaesthesiol 2004;18:509–27. 10.1016/j.bpa.2004.01.004
    1. Djaiani G, Fedorko L, Beattie WS. Regional anesthesia in cardiac surgery: a friend or a foe? Semin Cardiothorac Vasc Anesth 2005;9:87–104. 10.1177/108925320500900109
    1. Roca J, Valero R, Gomar C. Pain locations in the postoperative period after cardiac surgery: chronology of pain and response to treatment. Rev Esp Anestesiol Reanim 2017;64:391–400. 10.1016/j.redar.2017.01.002
    1. Mello LCde, Rosatti SFC, Hortense P. Assessment of pain during rest and during activities in the postoperative period of cardiac surgery. Rev Lat Am Enfermagem 2014;22:136–43. 10.1590/0104-1169.3115.2391
    1. Li X, Feng Y, Yang B-X. Postoperative pain after cardiac surgery. J Cardiothorac Vasc Anesth 2010;24:1025–6. 10.1053/j.jvca.2010.01.009
    1. Zubrzycki M, Liebold A, Skrabal C, et al. . Assessment and pathophysiology of pain in cardiac surgery. J Pain Res 2018;11:1599–611. 10.2147/JPR.S162067
    1. Ueshima H, Kitamura A. Blocking of multiple anterior branches of intercostal nerves (Th2-6) using a transversus thoracic muscle plane block. Reg Anesth Pain Med 2015;40:388. 10.1097/AAP.0000000000000245
    1. Jellish WS, Oftadeh M. Enhanced recovery after surgery for cardiac surgery: will we have the techniques needed to reduce opioid use and still provide appropriate analgesia? J Cardiothorac Vasc Anesth 2019;33:547–8. 10.1053/j.jvca.2018.10.022
    1. Fujii S, Roche M, Jones PM, et al. . Transversus thoracis muscle plane block in cardiac surgery: a pilot feasibility study. Reg Anesth Pain Med 2019;44:556–60. 10.1136/rapm-2018-100178
    1. Aydin ME, Ahiskalioglu A, Ates I, et al. . Efficacy of ultrasound-guided transversus thoracic muscle plane block on postoperative opioid consumption after cardiac surgery: a prospective, randomized, double-blind study. J Cardiothorac Vasc Anesth 2020;34:2996–3003. 10.1053/j.jvca.2020.06.044
    1. Bloc S, Perot BP, Gibert H, et al. . Efficacy of parasternal block to decrease intraoperative opioid use in coronary artery bypass surgery via sternotomy: a randomized controlled trial. Reg Anesth Pain Med 2021;46:671–8. 10.1136/rapm-2020-102207
    1. Chan A-W, Tetzlaff JM, Gøtzsche PC, et al. . SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials. BMJ 2013;346:e7586. 10.1136/bmj.e7586
    1. Xu YJ, Chen WK, Zhu Y, et al. . Effect of thoracic epidural anaesthesia on serum vascular endothelial growth factor C and cytokines in patients undergoing anaesthesia and surgery for colon cancer. Br J Anaesth 2014;113 Suppl 1:i49–55. 10.1093/bja/aeu148

Source: PubMed

Sponsors en medewerkers

Medische omstandigheden

Geneesmiddelinterventies

3
Abonneren