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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Regional anaesthetic combined fascial plane block

    Procedure/Surgery

    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

    Drug

    administration under ultrasound guidance of a mixture of 2 local anaesthetics in a fixed total volume

Treatment groups

32 Participants
are divided into 2 treatment groups
Group A: Group I (PSP+SSAP)Active comparator 2 interventions
Group B: Group I (SPIP+SSAP)Active comparator 2 interventions

Trial outcomes

Primary outcomes

1

NRS

numerical pain scale 0-10 points

Time frame
Checked at regular 15-minute intervals during the procedure and every 6 hours for the first 24 hours after the procedure
2

VAS

visual analogue scale 0-10 points

Time frame
Checked at regular 15-minute intervals during the procedure and every 6 hours for the first 24 hours after the procedure
3

QoR - 15

post-operative quality of life and improvement scale 0-150 points

Time frame
Administered to the patient before surgery and 24 hours after surgery
4

RASS

Richmond arousal/sedation scale) (-5 \<-\>+5) points

Time frame
Checked at regular 15 minute intervals during the procedure

Secondary outcomes

1

SpO2

hemoglobin oxygen saturation 50-99%

Time frame
Monitored every 5 minutes during the procedure
2

NIBP

non-invasive blood pressure measurement of 0-200 millimeters of the mercury column (mmHg)

Time frame
Monitored every 5 minutes during the procedure
3

HR

heart rate

Time frame
Monitored every 5 minutes during the procedure

Other outcomes

1

BMI

Body mass index 15-45

Time frame
Before performing procedure
2

bioimpedance

volume od lipids 30-80%

Time frame
beforeperforming procedure

Sponsors and contacts

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