Ultrasound-Guided PECS II Block for Permanent Pacemaker Implantation (NCT07739407) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Ultrasound-Guided PECS II Block for Permanent Pacemaker Implantation
72 participantsStarted 2026-08-05
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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.
* Severe cognitive impairment or inability to use the Numerical Rating Scale (NRS).
* Emergency pacemaker implantation.
* Planned generator replacement, lead revision, or device revision procedure.
* Anatomical abnormalities preventing safe block performance.
* Refusal to participate in the study.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Pain intensity during pacemaker pocket creation measured by the Numerical Rating Scale (NRS, 0-10)
Timeframe: During pacemaker pocket creation (intraoperative assessment)