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

NARecruitingINTERVENTIONAL
Enrollment

32

Participants

Timeline

Start Date

June 16, 2024

Primary Completion Date

December 1, 2025

Study Completion Date

December 1, 2025

Conditions
Chest PainPain, ProceduralPain, PostoperativeAnalgesiaRegional Anesthesia MorbidityAnesthesia, LocalICD
Interventions
PROCEDURE

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.

DRUG

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

Trial Locations (1)

50-981

RECRUITING

4th Military Clinical Hospital with Polyclinic, Wroclaw

All Listed Sponsors
lead

4th Military Clinical Hospital with Polyclinic, Poland

OTHER