Evaluation of the Effectiveness of Two Methods of Regional Anesthesia During S-ICD Implantation Procedure.

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-90
Sponsor4th Military Clinical Hospital with Polyclinic, Poland

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

Qualifiers

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

Treatments tested in this trial

  • Regional anaesthetic combined fascial plane block
  • Ropivacaine 0.125% Injectable Solution +Lignocaine 0,25% Injectable Solution

Treatment groups

32 Participants
are divided into 2 treatment groups