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

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.