RecruitingNot Applicable

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

Poland32 participantsStarted 2024-06-16

Plain-language 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.

Who can participate

Age range

18 Years – 90 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

NRS

Timeframe: Checked at regular 15-minute intervals during the procedure and every 6 hours for the first 24 hours after the procedure

VAS

Timeframe: Checked at regular 15-minute intervals during the procedure and every 6 hours for the first 24 hours after the procedure

QoR - 15

Timeframe: Administered to the patient before surgery and 24 hours after surgery

RASS

Timeframe: Checked at regular 15 minute intervals during the procedure

GCS

Timeframe: Checked at regular 15 minute intervals during the procedure

EOA

Timeframe: Checked immediately after the procedure (last suture)

Trial details

NCT IDNCT06520150

Sponsor4th Military Clinical Hospital with Polyclinic, Poland

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-12-01

Contact for this trial

Marek Szamborski, MD

698448639 mszamborski@4wsk.pl

View on ClinicalTrials.gov More Chest Pain trials

Plain-language summary

Who can participate

Age range

18 Years – 90 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

NRS

Timeframe: Checked at regular 15-minute intervals during the procedure and every 6 hours for the first 24 hours after the procedure

VAS

Timeframe: Checked at regular 15-minute intervals during the procedure and every 6 hours for the first 24 hours after the procedure

QoR - 15

Timeframe: Administered to the patient before surgery and 24 hours after surgery

RASS

Timeframe: Checked at regular 15 minute intervals during the procedure

GCS

Timeframe: Checked at regular 15 minute intervals during the procedure

EOA

Timeframe: Checked immediately after the procedure (last suture)