The goal of this clinical trial is to evaluate the analgesic effect of locoregional anaesthesia, specifically the interpectoral pectoserratus plane (IPP-PSP) block, in comparison to a placebo (sham block) after Aortic Valve Replacement via Right Anterior Minithoracotomy (AVR-RAT). The main question the trial aims to answer is: Can the IPP-PSP block effectively reduce opioid consumption within the first 48 hours after AVR-RAT surgery? The purpose is to understand the impact of the IPP-PSP block on postoperative pain. Therefore, the aim is to investigate the influence of the IPP-PSP block on the amount of pain medication administered during the patients' first 48 hours after surgery.
Participants, who are scheduled for AVR-RAT surgery, will be randomly assigned to receive either the IPP-PSP block or the sham block. Researchers will compare opioid consumption among other outcomes, including differences in pain scores, incidence of nausea and vomiting, quality of recovery, quality of life, and the length of hospital stay between the two groups.
Patients will be monitored during their hospitalization, and a follow-up phone call will be conducted 30 days after surgery.
Adult patients (18 years of age or older);
Patients scheduled for minimally invasive aortic valve replacement via right anterior minithoracotomy;
Patients with American Society of Anesthesiologists (ASA) physical status classification II, III or IV;
Patients with European System for Cardiac Operative Risk Evaluation (EuroSCORE) 2 ≤ 4%;
BMI > 35;
Patients under legal protection (curatorship, guardianship);
Patients subject to a legal protection measure;
An adult who is incapable or unable to give consent;
Parallel
Levobupivacaine Hydrochloride 0.25 % Injectable Solution
DrugAfter wound closure, the IPP-PSP block is performed at the level of the 4th rib. At the pre-axillary line, the pectoralis major, the pectoralis minor and the serratus anterior muscle are identified. At first, the needle is positioned in the fascial plane between the pectoralis minor and the serratus anterior muscle. The needle position is confirmed by hydro-dissection of this plane with 2 mL of normal saline 0.9%.The 20 ml syringe with trial drug solution is injected in this pectoserratus plane (PSP). The needle tip is repositioned in the interpectoral plane between both the pectoralis major and minor muscle. The 10 ml syringe with trial drug solution is administered in this interpectoral plane (IPP).
Sodium chloride 0.9%
DrugUnilateral (right) IPP-PSP block with 30 mL normal saline 0.9%, administered after the closure of the wounds. The IPP-PSP block procedure will be carried out as described in the intervention description of the IPP-PSP block.
Cumulative opioid consumption
Cumulative opioid consumption (in oral morphine milligram equivalents (OMEs)) in the first 48 postoperative hours after the completion of the surgical procedure
Number of episodes of postoperative pain
Number of episodes of postoperative pain (NRS score ≥ 4) at rest and at deep inspiration in the first 48 postoperative hours after the completion of the surgical procedure
Time to need for rescue medication
Time to need for rescue medication for breakthrough pain (e.g. tramadol, oxycodone) in the first 48 postoperative hours after the completion of the surgical procedure (minutes)
Number of patients with respiratory complications
Number of patients with respiratory complications, leading to non-invasive ventilation (NIV) or high-flow nasal cannula (HFNC) oxygen therapy, orotracheal intubation for more than 24 hours or orotracheal re-intubation
PaCO2 levels
Levels of arterial partial pressure of carbon dioxide (PaCO2) measured every 4 hours during the 48 postoperative hours after the completion of the surgical procedure or until Intensive Care Unit (ICU) discharge, whichever occurs first
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