Ultrasound-Guided PECS II Block for Permanent Pacemaker Implantation

Permanent pacemaker implantation is commonly performed under local infiltration anesthesia; however, patients may still experience significant pain during skin incision, pocket creation, and generator placement, frequently requiring supplemental local anesthetics, opioids, or sedatives. Ultrasound-guided PECS II block has recently emerged as a promising regional anesthesia technique for cardiac implantable electronic device procedures by providing sensory blockade of the anterior chest wall.

This investigator-initiated, single-center, prospective, parallel-group, randomized controlled trial will compare ultrasound-guided PECS II block combined with standard local infiltration anesthesia with standard local infiltration anesthesia alone in patients undergoing elective permanent pacemaker implantation.

A total of 72 adult patients will be randomized in a 1:1 ratio into two treatment groups. Patients assigned to the intervention group will receive an ultrasound-guided PECS II block with 20 mL of 0.25% bupivacaine before the procedure, followed by standard local infiltration anesthesia. Patients in the control group will receive standard local infiltration anesthesia alone. Rescue analgesia and light sedation will be administered only when clinically required according to a predefined protocol.

The primary endpoint is the Numerical Rating Scale (NRS, 0-10) pain score during pacemaker pocket creation. Secondary endpoints include the highest intraoperative pain score, pain scores at different procedural stages and during the first 24 postoperative hours, total intraoperative local anesthetic consumption, additional opioid and sedative requirements, postoperative analgesic consumption, patient and operator satisfaction, procedure duration, block performance time, and procedure-related complications.

The study is expected to provide evidence regarding the effectiveness of ultrasound-guided PECS II block as an adjunct to standard local infiltration anesthesia for improving perioperative pain control and reducing additional analgesic requirements during elective permanent pacemaker implantation

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.