About this trial
Our study consists of a combination of regional blockade ('local' anesthesia) of the anterior and lateral chest wall in the form of a thin needle prick and the supply of local anesthetic drugs to the area of the relevant chest wall structures to exclude all stimuli, including pain from the operative site. A short-acting analgesic and sedative drug will be administered intravenously throughout the procedure - in a dose that allows the required contact between the patient and the anesthetist. If necessary, the dose of the drug may be increased to maintain pain comfort throughout the procedure.
The anesthetic team will be with the patient throughout the procedure to ensure comfort and safety.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
patients aged 18-90 years requiring S-ICD implantation for cardiac indications,
high risk of anesthesia (ASA II or higher), patients giving informed consent to participate in the study.
Disqualifiers
absolute contraindications to regional anesthesia such as generalized coagulation disorders, inflammation at the site of anesthesia, allergy to the drugs used for regional anesthesia
lack of consent of the patient for the conducted procedure,
inability to cooperate with the patient - such as severe mental retardation, unregulated mental illness with motor agitation, advanced neurodegenerative diseases such as Parkinson's disease/Alzheimer's,
inability to give informed consent to participate in the study.
Trial design
Parallel
Treatments tested in this trial
Regional anaesthetic combined fascial plane block
Procedure/SurgeryPrior to the procedure, the anaesthetists will receive an envelope from a person not related to the project (a hospital administrative staff member). This envelope will contain a randomly indicated method of anaesthesia based on simple randomisation. This will determine the type of regional block used during the procedure. It is important to note that the patient will not know which study group they have been classified in. Furthermore, the operator performing the procedure will not be informed of the type of anaesthesia performed. This is to ensure double-blinding. In order to ensure the highest standards of objectivity, the operator performing the procedure will not be informed about the type of block performed. This will allow us to assess the extent and quality of anaesthesia after the procedure, We will use a proprietary scale of subjective operator comfort scale.
Ropivacaine 0.125% Injectable Solution +Lignocaine 0,25% Injectable Solution
Drugadministration under ultrasound guidance of a mixture of 2 local anaesthetics in a fixed total volume
Treatment groups
Trial outcomes
Primary outcomes
NRS
numerical pain scale 0-10 points
VAS
visual analogue scale 0-10 points
QoR - 15
post-operative quality of life and improvement scale 0-150 points
RASS
Richmond arousal/sedation scale) (-5 \<-\>+5) points
Secondary outcomes
SpO2
hemoglobin oxygen saturation 50-99%
NIBP
non-invasive blood pressure measurement of 0-200 millimeters of the mercury column (mmHg)
HR
heart rate
Other outcomes
BMI
Body mass index 15-45
bioimpedance
volume od lipids 30-80%
Sponsors and contacts
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