Ultrasound-Guided PECS II Block for Permanent Pacemaker Implantation

Официальное название

The Contribution of Ultrasound-Guided PECS II Block to Standard Local Infiltration Anesthesia During Elective Permanent Pacemaker Implantation: A Prospective Randomized Controlled Trial

Обзор

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.

Подробное описание

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

Вмешательства

• Другое Ultrasound-Guided PECS II Block
  Ultrasound-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.
• Другое Standard Local Infiltration Anesthesia
  Standard 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.

Первичные конечные точки

• Pain intensity during pacemaker pocket creation measured by the Numerical Rating Scale (NRS, 0-10) [Срок оценки: During pacemaker pocket creation (intraoperative assessment)]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

• Kilin M, Kavakli AS, Karaveli A, Sugur T, Kus G, Cagirci G, Arslan S. PECS II block for cardiac implantable electronic device insertion: A pilot study. Pacing Clin Electrophysiol. 2023 Oct;46(10):1251-1257. doi: 10.1111/pace.14811. Epub 2023 Sep 4. PMID 37665000

Идентификаторы

NCT: NCT07739407 · 2026/194-28

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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