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临床试验/NCT07073495
NCT07073495已完成不适用

A Prospective Observational Study Comparing Edge Laminar Block (ELB) and Serratus Posterior Superior Intercostal Plane Block (SPSIPB) for Postoperative Pain Management After Video-Assisted Thoracoscopic Surgery (VATS)

Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年7月15日最近更新:

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
1
主要终点
Postoperative pain intensity measured by Visual Analog Scale (VAS) at rest at 2, 6, 12, and 24 hours after surgery.

研究概览

简要总结

This prospective observational study aims to compare the effectiveness of Edge Laminar Block (ELB) and Serratus Posterior Superior Intercostal Plane Block (SPSIPB) in managing postoperative pain after Video-Assisted Thoracoscopic Surgery (VATS). The study will evaluate postoperative pain scores (VAS/NRS), opioid consumption, incidence of postoperative nausea and vomiting (PONV), additional analgesic requirements, and patient satisfaction between the two regional analgesic techniques. This research seeks to provide guidance for optimal postoperative pain management in VATS patients.

详细描述

Video-Assisted Thoracoscopic Surgery (VATS) is a widely used minimally invasive surgical method in thoracic surgery. However, it is known to cause moderate to severe postoperative pain, which can lead to significant respiratory complications such as atelectasis and pneumonia by inhibiting deep breathing and coughing. Inadequate pain control also increases sympathetic nervous system activity, potentially leading to tachycardia, hypertension, and increased myocardial oxygen consumption, especially in patients with cardiac conditions. Furthermore, delayed mobilization due to pain can increase the risk of deep vein thrombosis (DVT) and pulmonary embolism, while insufficient acute pain management may contribute to chronic postoperative pain syndrome. These issues highlight the critical need for effective postoperative pain management. While traditional methods like thoracic epidural analgesia (TEA) and thoracic paravertebral block (TPVB) exist, they are often invasive. In this context, interfascial block techniques such as Edge Laminar Block (ELB) and Serratus Posterior Superior Intercostal Plane Block (SPSIPB) emerge as safer and effective alternatives.

ELB effectively blocks both anterior and posterior branches of thoracic nerves, providing extensive dermatomal sensory loss. It is considered a safer alternative to TPVB due to a lower risk of damage to sensitive structures like the pleura or major vessels during needle placement. ELB has been shown to be effective in postoperative pain management and reducing opioid consumption in surgeries like VATS. SPSIPB, applied by injecting local anesthetic between the serratus posterior superior muscle and intercostal muscles, provides both anteroposterior and lateral thoracic analgesia, creating a broad sensory block area. Studies have reported that SPSIPB provides an effective sensory block between C3-T10 levels and significantly reduces postoperative pain scores.

Study Objectives:

The primary objective of this study is to compare the effectiveness of ELB and SPSIPB in postoperative pain management in patients undergoing VATS. The study will focus on the following specific aims:

To evaluate the effects of ELB and SPSIPB on postoperative pain scores (Visual Analog Scale/Numeric Rating Scale - VAS/NRS).

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adults aged 18-75 years Scheduled for elective video-assisted thoracoscopic surgery (VATS) American Society of Anesthesiologists (ASA) physical status I-III Ability to provide informed consen

排除标准

  • Known allergy or contraindication to local anesthetics Chronic opioid use or chronic pain conditions Coagulopathy or use of anticoagulant therapy Infection at the injection site Severe hepatic or renal dysfunction Pregnancy or breastfeeding Inability to understand or complete pain assessment scales

研究组 & 干预措施

ELB Group

Patients undergoing VATS who received Edge Laminar Block (ELB) for postoperative pain management. ELB involves the injection of local anesthetic at the edge of the thoracic lamina as a regional anesthesia technique. The efficacy and safety of ELB will be evaluated in this group.

SPSIPB Group

Patients undergoing VATS who received Serratus Posterior Superior Intercostal Plane Block (SPSIPB) for postoperative pain management. SPSIPB involves the injection of local anesthetic into the intercostal plane beneath the serratus posterior superior muscle. The efficacy and safety of SPSIPB will be evaluated in this group.

结局指标

主要结局

Postoperative pain intensity measured by Visual Analog Scale (VAS) at rest at 2, 6, 12, and 24 hours after surgery.

时间窗: 2, 6, 12, and 24 hours postoperatively

Pain intensity will be assessed using the Visual Analog Scale (VAS), where 0 indicates no pain and 10 indicates the worst imaginable pain. The primary outcome is the comparison of VAS scores between the two groups at specified time points.

次要结局

  • Incidence of postoperative complications (e.g., nausea, vomiting, respiratory depression) within 24 hours after surgery.(First 24 hours postoperatively)
  • Total opioid consumption (in mg morphine equivalents) within the first 24 hours after surgery(First 24 hours postoperatively)
  • Patient satisfaction with pain management, assessed by a numerical rating scale (1-5) at 24 hours after surgery.(24 hours postoperatively)

研究者

发起方
Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Eda Cennet Caferoğlu

Dr. Eda Cennet Caferoğlu

Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital

研究点 (1)

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