Actively Recruiting
Evaluation of the Effectiveness of Two Methods of Regional Anesthesia During S-ICD Implantation Procedure.
Led by 4th Military Clinical Hospital with Polyclinic, Poland · Updated on 2024-07-25
32
Participants Needed
1
Research Sites
76 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Evaluation of the Effectiveness of Two Methods of Regional Anesthesia During S-ICD Implantation Procedure.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 18 to 90 years requiring S-ICD implantation for cardiac reasons
- Classified as high risk for anesthesia (ASA II or higher)
- Provided informed consent to participate in the study
You will not qualify if you...
- Generalized bleeding or coagulation disorders
- Inflammation at the anesthesia site
- Allergy to regional anesthesia drugs used in the study
- Refusal to consent to the procedure
- Inability to cooperate due to severe mental retardation, unregulated mental illness with agitation, or advanced neurodegenerative diseases such as Parkinson's or Alzheimer's
- Unable to provide informed consent
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
4th Military Clinical Hospital with Polyclinic
Wroclaw, Lower Silesian Voivodeship, Poland, 50-981
Actively Recruiting
Research Team
M
Marek Szamborski, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SCREENING
Number of Arms
2
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