Evaluating two regional anesthesia methods for S-ICD implantation
Evaluation of the Effectiveness of Two Methods of Regional Anesthesia During Subcutaneous Implantable Cardioverter-defibrillator (SICD) Implantation Procedure.
This study is testing two different ways to numb the area during the implantation of a subcutaneous defibrillator to see which one helps patients feel less pain and discomfort.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 32 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | 4th Military Clinical Hospital with Polyclinic, Poland Academic / other |
| Locations | 1 site (Wroclaw, Lower Silesian Voivodeship) |
| Trial ID | NCT06520150 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of two regional anesthesia techniques, the Superficial Serratus Anterior Plane Block (SSAP) and the Superficial Parasternal Intercostal Plane Block (SPIP), during the implantation of a subcutaneous implantable defibrillator (S-ICD). The approach involves administering a combination of local anesthetics to minimize pain and discomfort during the procedure. An anesthetic team will monitor patients throughout the process to ensure their comfort and safety. The study builds on previous research that explored optimal anesthetic volumes and concentrations for effective pain management.
Who should consider this trial
Good fit: Ideal candidates include patients aged 18-90 years who require S-ICD implantation and are at high risk for general anesthesia.
Not a fit: Patients with absolute contraindications to regional anesthesia or those unable to provide informed consent may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance pain management during S-ICD implantation, leading to improved patient comfort and safety.
How similar studies have performed: Previous studies have shown promising results with similar regional anesthesia techniques, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Wroclaw, Lower Silesian Voivodeship
- 4th Military Clinical Hospital with Polyclinic — Wroclaw, Lower Silesian Voivodeship, Poland (Recruiting)
Study contacts
- Principal investigator: Marek Szamborski, MD — Senior Assistant
- Study coordinator: Marek Szamborski, MD
- Email: mszamborski@4wsk.pl
- Phone: 698448639
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.