Actively Recruiting
Evaluation of the Effectiveness of Two Regional Anesthesia Methods During Subcutaneous Implantable Cardioverter-defibrillator (S-ICD) Implantation Procedure
Led by 4th Military Clinical Hospital with Polyclinic, Poland · Updated on 2024-07-25
32
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating two different regional anesthesia methods during the implantation of a subcutaneous implantable cardioverter-defibrillator (S-ICD) in patients aged 18 to 90 who require this cardiac procedure. This study aims to determine if the combination of superficial parastenal intercostal plane (SPIP) block plus superficial serratus anterior plane (SSAP) block is the optimal anesthesia form compared to the pectoserratus plane (PSP) block plus SSAP. The study includes patients at high anesthesia risk and uses a double-blind randomized design to objectively assess anesthesia quality and patient comfort. Participants are randomly assigned to one of two groups: Group I receives PSP+SSAP anesthesia, and Group II receives SPIP+SSAP anesthesia. Both groups receive a mixture of 0.125% ropivacaine and 0.25% lidocaine in a total volume of 60 mL administered under ultrasound guidance. During the procedure, short-acting intravenous analgesics and sedatives are given to maintain patient comfort and safety. Additional local anesthesia or intravenous pain medications may be administered if needed, with specific criteria for disqualification if dosages exceed limits. Throughout the procedure, patients’ pain levels and sedation status are monitored every 15 minutes using numerical and visual pain scales (NRS and VAS), Richmond agitation/sedation scale (RASS), and Glasgow coma scale (GCS). Vital signs including oxygen saturation, blood pressure, and heart rate are checked every 5 minutes. Postoperative pain is assessed every 6 hours for 24 hours, and patients complete a quality of recovery questionnaire 24 hours after surgery. The primary outcomes include pain, sedation, and operator comfort scores collected throughout and after the procedure.
CONDITIONS
Brief 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 indications
- High risk of anesthesia (ASA II or higher)
- Patients giving informed consent to participate in the study
You will not qualify if you...
- Generalized coagulation disorders
- Inflammation at the site of anesthesia
- Allergy to drugs used for regional anesthesia
- Lack of patient consent for the procedure
- Inability to cooperate, such as severe mental retardation or unregulated mental illness with agitation
- Advanced neurodegenerative diseases like Parkinson's or Alzheimer's
- Inability to give informed consent to participate in the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit (in-person)
Duration - Day of the S-ICD implantation procedure
Participants receive one of two types of regional anesthesia blocks prior to S-ICD implantation. The procedure includes administration of local anesthetic under ultrasound guidance and the use of short-acting intravenous analgesics as needed to control pain during the surgery.
1 procedure visit (in-person)
Duration - 24 hours after the procedure
Participants are monitored for pain levels and sedation after the procedure. Pain scales are checked every 6 hours on the first day, and quality of recovery is assessed 24 hours after surgery.
1 post-operative visit (in-person)
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
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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