Ultrasound-Guided PECS II Block for Permanent Pacemaker Implantation
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
Sponsorferdi gülaştı
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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Ultrasound-Guided PECS II Block
Other interventionUltrasound-guided PECS II block will be performed before permanent pacemaker implantation using 20 mL of 0.25% bupivacaine. The local anesthetic will be injected between the pectoralis major and pectoralis minor muscles and between the pectoralis minor and serratus anterior muscles under ultrasound guidance.
Standard Local Infiltration Anesthesia
Other interventionStandard local infiltration anesthesia will be administered by the implanting physician using 1% lidocaine at the incision site and pacemaker pocket according to routine clinical practice.
Treatment groups
72 Participants
are divided into 2 treatment groupsGroup A: PECS II Block + Standard Local InfiltrationExperimental treatment 2 interventions
Group B: Standard Local InfiltrationActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Pain intensity during pacemaker pocket creation measured by the Numerical Rating Scale (NRS, 0-10)
Pain intensity will be assessed using an 11-point Numerical Rating Scale (NRS), where 0 indicates no pain and 10 indicates the worst imaginable pain. The primary endpoint is the NRS pain score recorded during pacemaker pocket creation.
Time frame
During pacemaker pocket creation (intraoperative assessment)Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
ferdi gülaştı
Lead sponsor
Aydin Adnan Menderes University
Sponsor institution
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: