Status:
RECRUITING
Evaluation of the Effectiveness of Two Methods of Regional Anesthesia During S-ICD Implantation Procedure.
Lead Sponsor:
4th Military Clinical Hospital with Polyclinic, Poland
Conditions:
Chest Pain
Pain, Procedural
Eligibility:
All Genders
18-90 years
Phase:
NA
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 ...
Detailed Description
The current study is a continuation of the 2021-2023 project, during which 16 patients were anesthetized using a combination of previously known regional (PSP +SSAP) blocks in the thoracic area for S-...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 16 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT06520150
Start Date
June 16 2024
End Date
December 1 2025
Last Update
July 25 2024
Active Locations (1)
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1
4th Military Clinical Hospital with Polyclinic
Wroclaw, Lower Silesian Voivodeship, Poland, 50-981