The Contribution of Ultrasound-Guided PECS II Block to Standard Local Infiltration Anesthesia During Elective Permanent Pacemaker Implantation: A Prospective Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 72
- 主要终点
- Pain intensity during pacemaker pocket creation measured by the Numerical Rating Scale (NRS, 0-10)
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
The anesthesiologist performing the PECS II block will not be blinded because of the nature of the intervention. Participants and the implanting physician will be aware of the assigned treatment. However, investigators responsible for postoperative pain assessment, patient satisfaction evaluation, data collection, and statistical analysis will remain blinded to group allocation.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Pain intensity during pacemaker pocket creation measured by the Numerical Rating Scale (NRS, 0-10)
时间窗: During pacemaker pocket creation (intraoperative assessment)
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.
次要结局
未报告次要终点
研究者
ferdi gülaştı
Aydin Adnan Menderes University Faculty of Medicine
Aydin Adnan Menderes University