跳至主要内容
临床试验/NCT07238348
NCT07238348尚未招募不适用

Prospective Evaluation of Analgesic Outcomes of Serratus Posterior Superior Intercostal Plane Block Versus Thoracic Epidural Analgesia and Systemic Opioid Analgesia After Video-Assisted Thoracoscopic Surgery

Karadeniz Technical University0 个研究点目标入组 120 人开始时间: 2025年12月15日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
120
主要终点
Opioid Consumption

研究概览

简要总结

This prospective observational study aims to compare the postoperative analgesic effectiveness of three commonly used pain management strategies in video-assisted thoracoscopic surgery (VATS): Serratus Posterior Superior Intercostal Plane Block (SPSIPB), Thoracic Epidural Analgesia (TEA), and systemic opioid analgesia. The study evaluates postoperative pain scores, opioid consumption, and the need for rescue analgesics within the first 24 hours after surgery. By analyzing analgesic performance and safety profiles of these techniques, the study seeks to provide evidence to guide optimal postoperative pain management for patients undergoing minimally invasive thoracic procedures.

详细描述

This prospective observational clinical study investigates the comparative analgesic performance of three postoperative pain management strategies in patients undergoing video-assisted thoracoscopic surgery (VATS): Serratus Posterior Superior Intercostal Plane Block (SPSIPB), Thoracic Epidural Analgesia (TEA), and systemic opioid analgesia. SPSIPB is a recently defined interfascial plane block that may provide multi-dermatomal analgesia of the upper thoracic region with a less invasive profile compared with traditional neuraxial techniques. TEA, although considered effective for thoracic surgery, is associated with technical difficulty and potential adverse effects such as hypotension, urinary retention, and motor block. Systemic opioid analgesia remains widely used but may be limited by nausea, sedation, and opioid-related complications.

In this study, adult patients scheduled for elective VATS under general anesthesia will be managed with one of the three analgesic strategies as part of routine clinical practice. No randomization or allocation will be performed by the investigators; analgesic technique selection will follow standard clinical decision-making by the treating anesthesiologist. Postoperative pain will be evaluated using the Numerical Rating Scale (NRS) at predefined time points, including 0, 1, 2, 6, 12, and 24 hours after surgery. Total opioid consumption within the first 24 hours will be quantified as the primary outcome, expressed in tramadol-equivalent dosing. Secondary outcomes include the requirement for rescue analgesics, postoperative nausea and vomiting, hemodynamic parameters, and the Quality of Recovery-15 (QoR-15) score.

The study aims to provide comparative clinical evidence on the analgesic efficacy and tolerability of SPSIPB relative to TEA and systemic opioid analgesia in minimally invasive thoracic surgery. By identifying potential advantages or limitations of each technique, the findings may support optimization of multimodal analgesia protocols, improve postoperative comfort, and contribute to enhanced recovery strategies in VATS patients.

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)
  • ASA physical status I-III
  • Ability to understand study procedures and provide written informed consent
  • Hemodynamically stable preoperatively

排除标准

  • Known allergy or contraindication to local anesthetics or study medications
  • Coagulopathy or use of anticoagulants not suitable for regional anesthesia
  • Local infection or skin lesions at the injection site
  • Severe pulmonary disease (e.g., severe COPD, uncontrolled asthma)
  • Chronic opioid use or chronic pain disorders
  • Neurological or psychiatric disorders impairing cooperation
  • Pregnancy or breastfeeding
  • BMI > 35 kg/m²
  • Conversion from VATS to thoracotomy
  • Inability to comply with postoperative assessments

结局指标

主要结局

Opioid Consumption

时间窗: 24 hours postoperatively

Total Opioid Consumption at 24 Hours

次要结局

  • Pain Scores(0, 1, 2, 6, 12, and 24 hours after surgery)
  • Need for Rescue Analgesia(First 24 hours postoperatively)
  • Incidence of Postoperative Nausea and Vomiting (PONV)(First 24 hours postoperatively)
  • Heart Rate (beats per minute)(Intraoperative and first 24 hours postoperative)
  • Quality of Recovery Score (QoR-15)(Preoperative baseline and 24 hours postoperative)
  • Time to First Opioid Request(First 24 hours postoperatively)
  • Mean Arterial Pressure (mmHg)(Intraoperative and first 24 hours postoperative)
  • Peripheral Oxygen Saturation (SpO₂,%)(Intraoperative and first 24 hours postoperative)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ali AKDOĞAN

Prof Dr

Karadeniz Technical University

相似试验