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临床试验/NCT07330479
NCT07330479已完成不适用

Evaluation of the Efficacy of Ultrasound-Guided Serratus Posterior Superior Intercostal Plane Block For Postoperative Analgesia in Thoracic Surgery

University of Gaziantep1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年2月2日最近更新:
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
1
主要终点
Postoperative Pain Intensity

研究概览

简要总结

Background: Adequate pain control after video-assisted thoracoscopic surgery (VATS) remains a major clinical challenge. Traditional techniques such as thoracic epidural analgesia are effective but limited by potential complications. Interfascial plane blocks have recently gained interest as safer alternatives. The serratus posterior superior intercostal plane block (SPSIPB) is a novel regional anesthesia technique with potential benefits in thoracic surgery.

Objective: The purpose of this study was to evaluate the analgesic efficacy of ultrasound-guided SPSIPB compared with subcutaneous morphine administration in patients undergoing VATS.

Methods: In this prospective, randomized controlled trial, 60 patients scheduled for elective VATS were randomized into two groups: SPSIPB group (n=30) and control group receiving subcutaneous morphine (n=30). The primary outcome was postoperative pain intensity measured by the visual analog scale (VAS) at rest and during coughing. Secondary outcomes included opioid consumption, number of patient-controlled analgesia (PCA) demands, rescue analgesia requirements, and incidence of adverse effects.

详细描述

Background and Rationale:

Effective postoperative analgesia after thoracic surgery is essential to prevent pulmonary complications, enhance recovery, and improve patient satisfaction. Although thoracic epidural analgesia has traditionally been considered the gold standard, its use is limited due to potential complications such as hypotension, urinary retention, and technical difficulties. With the increased use of minimally invasive thoracic procedures, including video-assisted thoracoscopic surgery (VATS), safer and less invasive analgesic techniques are being explored.

The serratus posterior superior intercostal plane block (SPSIPB) is a newly described regional anesthesia technique that targets the posterior thoracic intercostal nerves. Preliminary evidence suggests that SPSIPB may provide effective postoperative analgesia while minimizing procedure-related risks.

Objective:

The aim of this study was to evaluate the analgesic efficacy and safety of ultrasound-guided SPSIPB compared with subcutaneous morphine injection for postoperative pain management in patients undergoing VATS.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age between 18 and 70 years
  • American Society of Anesthesiologists (ASA) physical status I-III
  • Scheduled for elective video-assisted thoracoscopic surgery (VATS) under general anesthesia
  • Provision of written informed consent

排除标准

  • Conversion to thoracotomy during surgery
  • Coagulopathy or ongoing anticoagulant therapy
  • Local infection at the injection site
  • Known allergy to local anesthetics or morphine
  • Severe cardiopulmonary disease contraindicating regional anesthesia
  • Refusal to participate in the study

研究组 & 干预措施

SPSIPB Group

Experimental

Patients received an ultrasound-guided SPSIPB with 20 mL local anesthetic at the end of surgery.

干预措施: Ultrasound-guided Serratus Posterior Superior Intercostal Plane Block (Procedure)

Active Comparator

Active Comparator

Patients received a subcutaneous morphine injection according to institutional standard practice after surgery.

干预措施: Subcutaneous Morphine (Drug)

结局指标

主要结局

Postoperative Pain Intensity

时间窗: 24 hours after surgery (measured at 0, 2, 4, 8, 16, and 24 hours)

Pain intensity was assessed using the Visual Analog Scale (VAS; 0 = no pain, 10 = worst pain imaginable) at rest and during coughing.

次要结局

  • Total opioid consumption within 24 hours(24 hours after surgery (cumulative from 0 to 24 hours))

研究者

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

Elzem SEN

Assoc. Prof.

University of Gaziantep

研究点 (1)

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