Regional anesthesia techniques for subcutaneous implantable cardioverter-defibrillator (S-ICD) placement

The study aim is to assess the effectiveness and safety of regional anesthesia techniques for subcutaneous implantable cardioverter-defibrillator (S-ICD) implant procedure using the combined block methods including pectoral nerve block type II (PECS I) and type II (PECS II) as well as serratus plane block (SPB). All participants will receive all three regional anesthesia techniques (PACS I, PECS II, and SPB). All participants will receive a single injection of local anesthetics. All participants will receive scheduled blocks before the implantation procedure due to the various factors (the length of procedure, the availability of ultrasound, the availability of anesthetic and cardiologic team, the time between administration of the local anesthesia and start of S-ICD procedure will range from a minimum of 20 minutes to a maximum of 100 minutes, with an average waiting time of 55 minutes). The procedure will last from a minimum of 70 minutes to a maximum of 185 minutes, with an average waiting time of 95 minutes. The project will be performed in the Department of Anesthesiology and Intensive Care of the 4th Military Hospital of Wroclaw in Poland. Adult patients of both sexes qualified for planned S-ICD implantation procedures will be included in the study. Included patients will be subjected to a combined block method using PECS I, PECS II, and SPB. PECS I and II are compartmental thoracic wall blocks, commonly used as one of the components of multimodal analgesia for anterior and lateral thoracic procedures. PECS I is a compartmental block, in which a local anesthetic is deposited between the major and minor pectoral muscles blocking the lateral and medial pectoral nerves. Stages of PECS I anesthesia: 1. Skin cleaning according to aseptic principles. 2. The linear ultrasound head, initially located in the midclavicular line at the level of the 3rd rib, moves laterally and identifies the following structures: the pectoralis major (PMA) and minor (PMI) muscles, the serratus anterior (SA) muscle (located below the PMI muscle), the intercostal muscles. 3. The block is usually performed using the in-plane technique, inserting the needle from the medial side and directing it to the rib. 4. Local anesthetic is deposited at the level of 3 ribs, between the fascia of the PMA and PMI muscles, in order to obtain a characteristic separation of both muscles. 5. Identification of the correct needle end position by applying 5-10ml 0,125% Ropimol +0,25% Lignocaine solution. PECS II is a modification of the PECS I blockade, in which, after deposition of the anesthetic between the PMA and PMI muscles, the additional dose of local anesthetics is spilled between the PMA and PMI muscles and the SA muscle or below SA muscle, blocking the lateral branches of the Th2-4 intercostal nerves, the intercostobrachial nerve, and the long thoracic nerve. Stages of PECS II: 1. After the PECS I block, the needle is guided deeper, depositing another dose of the anesthetic between the PMA and PMI muscles and below located the SA muscle. 2. Identification of the correct needle end position by applying 10-15ml 0,125% Ropimol +0,25% Lignocaine solution. SBP is a compartmental thoracic block, which involves the deposition of local anesthesia at the Th5 vertebrae between the middle and posterior axillary lines, in the interfacial interval between the latissimus dorsi (LD) muscle and SA muscle. The range of the block includes the Th3-Th9 intercostal nerve and the thoracodorsal nerve. The whole procedure will be ultrasound-guided using the EchoPlex 22G (50mm, 75mm) (VYGON). Stages of SBP: 1. Skin cleaning according to aseptic principles. 2. The linear ultrasound head is located in the frontal plane at the level of Th5 vertebrae between the central and posterior axillary lines. 3. The block is usually performed using the in-plane technique, inserting the needle from the caudal side and directing it to the rib. 4. Identification of the correct needle end position by applying 20-30ml 0,125% Ropimol +0,25% Lignocaine solution. The detailed procedure of the anesthesia: Local anesthesia with a soaked 5-10ml Lignocaine 1% with adrenaline administered subcutaneously (1-2 cm) between II-V ribs. Additionally, during anesthesia a superficial intravenous analgosedation is used with the possibility of contact with the operated person, the operator performs local anesthesia of the parasternal region with a small volume of short-acting local analgesic. The person performing both procedures will be the same anesthesiologist with at least 3 years of professional expertise, including a minimum of 50 PECS I, PECS II, and SPB. The course of the procedure: A patient classified for S-ICD implantation is qualified for scheduled anesthesia. The patient signs the anesthesiological agreement and consent to participate in the study. The patient remains fasting for 6 hours before the procedure. For 40 minutes before arrival in the preparation room/surgery room, the patient receives the recommended premedication. This will normally be 150 mg Pregabalin orally and 1g Paracetamol orally. After the patient is monitored, the scheduled blockade is performed. At the end of the procedure, intravenous anesthesia is performed to test the device - ventricular fibrillation (VF) release and electrotherapy. After the procedure, the patient requires 2 hours of observation due to the analgosedation performed. During this time the analgesic effect of the block will be assessed. Adverse events that occurred during the patient's stay will be noted, such as postoperative delirium, excessive sleepiness, significant pain, early complications such as bleeding or arrhythmias. The total time of hospitalization will be recorded. Importantly, during the postoperative period, coanalgesics will be used according to the standard: Paracetamol (Acetaminophen) 0-1.0 g intravenously every 6-8 hours, Metamizole 0-2.5 g intravenously every 12 hours, Ketoprofen 0-100 mg intravenously every 12 hours. In case of allergy or any contraindications to the above-mentioned medications will be excluded.