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Evaluation of the Effectiveness of Two Methods of Regional Anesthesia During S-ICD Implantation Procedure.
Sponsor: 4th Military Clinical Hospital with Polyclinic, Poland
Summary
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.
Official title: Evaluation of the Effectiveness of Two Methods of Regional Anesthesia During Subcutaneous Implantable Cardioverter-defibrillator (SICD) Implantation Procedure.
Key Details
Gender
All
Age Range
18 Years - 90 Years
Study Type
INTERVENTIONAL
Enrollment
32
Start Date
2024-06-16
Completion Date
2025-12-01
Last Updated
2024-07-25
Healthy Volunteers
No
Conditions
Interventions
Regional anaesthetic combined fascial plane block
Prior 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
administration under ultrasound guidance of a mixture of 2 local anaesthetics in a fixed total volume
Locations (1)
4th Military Clinical Hospital with Polyclinic
Wroclaw, Lower Silesian Voivodeship, Poland