NCT06520150 Evaluation of the Effectiveness of Two Methods of Regional Anesthesia During S-ICD Implantation Procedure.
| NCT ID | NCT06520150 |
| Status | Recruiting |
| Phase | — |
| Sponsor | 4th Military Clinical Hospital with Polyclinic, Poland |
| Condition | Chest Pain |
| Study Type | INTERVENTIONAL |
| Enrollment | 32 participants |
| Start Date | 2024-06-16 |
| Primary Completion | 2025-12-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 32 participants in total. It began in 2024-06-16 with a primary completion date of 2025-12-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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.
Contact & Investigator
Marek Szamborski, MD
PRINCIPAL INVESTIGATOR
Senior Assistant
Frequently Asked Questions
Who can join the NCT06520150 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 90 Years, studying Chest Pain. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06520150 currently recruiting?
Yes, NCT06520150 is actively recruiting participants. Contact the research team at mszamborski@4wsk.pl for enrollment information.
Where is the NCT06520150 trial being conducted?
This trial is being conducted at Wroclaw, Poland.
Who is sponsoring the NCT06520150 clinical trial?
NCT06520150 is sponsored by 4th Military Clinical Hospital with Polyclinic, Poland. The principal investigator is Marek Szamborski, MD at Senior Assistant. The trial plans to enroll 32 participants.