About this trial
This single-center, prospective, randomized, controlled clinical trial aims to evaluate whether ultrasound-guided PECS II block, when added to standard local infiltration anesthesia, improves perioperative analgesia in patients undergoing elective permanent pacemaker implantation.
Seventy-two adult patients scheduled for elective permanent pacemaker implantation will be randomly assigned in a 1:1 ratio to receive either ultrasound-guided PECS II block plus standard local infiltration anesthesia or standard local infiltration anesthesia alone. The primary outcome is pain intensity during pacemaker pocket creation measured using the Numerical Rating Scale (NRS). Secondary outcomes include intraoperative pain scores, additional local anesthetic, opioid and sedative requirements, postoperative pain scores, analgesic consumption during the first 24 hours, patient and operator satisfaction, procedure duration, and procedure-related complications. The study is designed to determine whether PECS II block provides additional analgesic benefit during permanent pacemaker implantation.
Eligibility criteria
Qualifiers
Age 18 years or older.
Scheduled for elective permanent pacemaker implantation.
American Society of Anesthesiologists (ASA) physical status I-III.
Ability to understand the study procedures and provide written informed consent.
Disqualifiers
Infection at the planned block site.
Known allergy or hypersensitivity to local anesthetics.
Uncorrected coagulopathy or active bleeding disorder.
Contraindication to PECS II block because of anticoagulant or antiplatelet therapy.
Trial design
Treatments tested in this trial
- Ultrasound-Guided PECS II Block
- Standard Local Infiltration Anesthesia
Treatment groups
Locations
Sponsors and collaborators
ferdi gülaştı
Lead sponsor
Aydin Adnan Menderes University
Sponsor institution