Evaluation of the Effectiveness of Two Methods of Regional Anesthesia During S-ICD Implantation Procedure.
Launched by 4TH MILITARY CLINICAL HOSPITAL WITH POLYCLINIC, POLAND · Jul 23, 2024
Trial Information
Current as of June 26, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is looking at how effective two different methods of regional anesthesia are during a procedure called S-ICD implantation, which is done for heart-related issues. The goal is to provide patients with pain relief and comfort during the procedure by using a local anesthetic that numbs the chest area. Patients will also receive a short-acting medication through an IV to help them relax and remain comfortable throughout the procedure. An anesthetic team will be present to ensure that participants feel safe and cared for at all times.
To participate in this trial, individuals should be between 18 and 90 years old and need the S-ICD implantation for heart reasons. They should also be at an increased risk for anesthesia-related issues, as determined by a doctor. However, people with certain health conditions, allergies to anesthesia drugs, or those who cannot provide informed consent or cooperate during the procedure will not be eligible. This trial aims to improve pain management during heart procedures, ensuring patients have a better experience overall.
Gender
ALL
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.
About 4th Military Clinical Hospital With Polyclinic, Poland
The 4th Military Clinical Hospital with Polyclinic in Poland is a leading healthcare institution dedicated to providing advanced medical care and conducting innovative clinical research. As a prominent sponsor of clinical trials, the hospital integrates military and civilian health services, ensuring the highest standards of patient safety and care. With a multidisciplinary team of experienced medical professionals, the facility focuses on various therapeutic areas, contributing to the advancement of medical knowledge and the development of new treatment options. The hospital's commitment to excellence and collaboration with various stakeholders positions it as a key player in the clinical research landscape in Poland.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Wrocław, Dolnośląskie, Poland
Wrocław, , Poland
Patients applied
Trial Officials
Marek Szamborski, MD
Principal Investigator
Senior Assistant
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported