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临床试验/NCT07165041
NCT07165041已完成不适用

Efficacy of Serratus Posterior Superior Intercostal Plane Block in Cardiac Implantable Electronic Device Implantation: A Prospective, Double-Blind, Randomized Controlled Clinical Trial

Gozde Altun2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年6月30日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
试验地点
2
主要终点
Postoperative pain intensity assessed by Visual Analog Scale (VAS)

研究概览

简要总结

This randomized controlled clinical trial investigates the efficacy of the serratus posterior superior intercostal plane block (SPSIPB) in patients undergoing cardiac implantable electronic device (CIED) implantation. Participants will be randomized to receive either SPSIP block with local anesthetic or a sham procedure with saline injection. Pain intensity will be evaluated intraoperatively and at 3, 6, 12, and 24 hours postoperatively using the Visual Analog Scale (VAS). Secondary outcomes include sleep quality at 24 hours assessed with the Sleep Quality Numeric Rating Scale (SQ-NRS), and patient and clinician satisfaction assessed with a 5-point Likert scale. The study is designed as prospective, double-blind, and parallel-group, aiming to improve perioperative pain management in CIED procedures.

详细描述

Cardiac implantable electronic device (CIED) implantation is a common procedure for the management of arrhythmias and prevention of sudden cardiac death. Although routinely performed under local anesthesia, patients may experience intraoperative and postoperative pain, which can affect hemodynamic stability, recovery, and satisfaction. Effective perioperative analgesia is therefore critical in this patient group, who often present with multiple comorbidities and advanced age. Conventional systemic analgesics may be insufficient or associated with side effects, highlighting the need for alternative approaches.

The serratus posterior superior intercostal plane block (SPSIPB) is a recently described regional anesthesia technique targeting the interfascial plane between the rhomboid major and serratus posterior superior muscles. Previous studies have shown its efficacy in thoracic, breast, clavicular, and minimally invasive cardiac surgeries. However, its role in the context of CIED implantation has not been systematically studied.

This study is designed as a prospective, double-blind, randomized controlled trial. A total of 60 patients scheduled for first-time CIED implantation will be randomized into two groups: the intervention group (SPSIPB with 30 mL 0.25% bupivacaine) and the control group (sham injection with 1 mL saline). All procedures will be performed under standard local anesthesia. The primary outcome is perioperative pain assessed by VAS intraoperatively and at 3, 6, 12, and 24 hours postoperatively. Secondary outcomes include postoperative sleep quality (SQ-NRS) and both patient and clinician satisfaction (5-point Likert scale). The trial will provide evidence regarding the potential of SPSIP block to improve perioperative analgesia and patient-centered outcomes in CIED 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
Triple (Participant, Care Provider, Outcomes Assessor)

盲法说明

Participants, care providers, and outcome assessors will be blinded to group allocation. The block (bupivacaine or sham saline) will be prepared and administered by an anesthesiologist not involved in outcome assessment.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adults ≥18 years of age
  • Scheduled for first-time cardiac implantable electronic device (CIED) implantation (pacemaker or ICD)
  • Able to provide written informed consent
  • Normal coagulation profile
  • No local infection at the planned block site

排除标准

  • Severe heart failure (NYHA class IV)
  • Morbid obesity (BMI >35 kg/m²)
  • Known allergy to local anesthetics (e.g., bupivacaine)
  • Coagulopathy or ongoing anticoagulant therapy contraindicating regional block
  • An established history of chronic pain, or diagnosed sleep disorders requiring active treatment (e.g., obstructive sleep apnea syndrome, insomnia)
  • Local infection at injection site
  • Psychiatric or neurologic disorders interfering with pain/sleep assessment
  • Revision or replacement CIED implantation (not first-time)

研究组 & 干预措施

Sham Control

Sham Comparator

Sham procedure with 1 mL saline injection at the same anatomical site, without administration of local anesthetic, prior to CIED implantation.

干预措施: Sham procedure (Procedure)

SPSIP Block

Experimental

Ultrasound-guided serratus posterior superior intercostal plane (SPSIP) block performed with 30 mL of 0.25% bupivacaine administered prior to CIED implantation

干预措施: SPSIP Block (Procedure)

结局指标

主要结局

Postoperative pain intensity assessed by Visual Analog Scale (VAS)

时间窗: Intraoperative and postoperative at 3, 6, 12, and 24 hours

Pain levels will be assessed using a 0-10 Visual Analog Scale (VAS), where 0 = no pain and 10 = worst imaginable pain. Scores will be recorded intraoperatively and at 3h, 6h, 12h, and 24h postoperatively.

Postoperative pain intensity assessed by Visual Analog Scale (VAS)

时间窗: Intraoperative and postoperative at 3, 6, 12, and 24 hours

Pain levels will be assessed using a 0-10 Visual Analog Scale (VAS), where 0 = no pain and 10 = worst imaginable pain. Scores will be recorded intraoperatively and at 3h, 6h, 12h, and 24h postoperatively.

次要结局

  • Sleep quality assessed by Sleep Quality Numeric Rating Scale (SQ-NRS)(24 hours after surgery)
  • Patient satisfaction with procedure(24 hours after surgery)
  • Clinician satisfaction with procedure(24 hours after surgery)
  • Sleep quality assessed by Sleep Quality Numeric Rating Scale (SQ-NRS)(24 hours after surgery)
  • Patient satisfaction with procedure(24 hours after surgery)
  • Clinician satisfaction with procedure(24 hours after surgery)

研究者

发起方
Gozde Altun
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Gozde Altun

Lecturer, Department of Anesthesiology and Reanimation, Istanbul University-Cerrahpasa, Cardiology Institute

Istanbul University - Cerrahpasa

研究点 (2)

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