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临床试验/NCT07273136
NCT07273136
招募中
不适用

Safety and Efficacy of Combined Subcostal and Lateral Transversus Abdominis Plane Block for Postoperative Analgesia Versus Thoracic Epidural Analgesia in Patients Undergoing Major Abdominal Cancer Surgery

Assiut University1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2025年12月10日最近更新:

概览

阶段
不适用
状态
招募中
入组人数
50
试验地点
1
主要终点
Total morphine consumption

概览

简要总结

This study aims to evaluate the safety and efficacy of combined subcostal and lateral transversus abdominis plane (TAP) for postoperative analgesia versus thoracic epidural anesthesia (TEA) in patients undergoing major abdominal cancer surgery.

详细描述

Postoperative pain is treated using a variety of techniques. It is possible to deliver opioids intravenously, neuraxially, or both.

Thoracic epidural anesthesia (TEA) has long been considered the benchmark for analgesia in major abdominal operations due to its consistent efficacy in pain control and additional benefits such as reduced ileus and improved pulmonary function.

Transversus abdominis plane (TAP) blocks can be a critical component of postoperative pain management, and they play a crucial role in Enhanced Recovery After Surgery (ERAS) protocols, as they significantly affect recovery and patient well-being.

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
Double (Participant, Outcomes Assessor)

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

  • Age ≥ 18 years.
  • Both sexes.
  • American Society of Anesthesiologists (ASA) physical status I-III.
  • Scheduled for major abdominal surgeries including: (e.g., gastrectomy, colectomy, hepatectomy, cystectomy, total abdominal hysterectomy, Nephrectomy, pancreatectomy).

排除标准

  • Intraoperative hemodynamic instability.
  • History or evidence of coagulopathy.
  • Infection or abdominal wall masses at injection site.
  • Morbid obesity.
  • Other Medical conditions including mental illness or substance abuse.
  • Known allergy to local anesthetics.
  • Chronic opioid use or chronic pain conditions.
  • Pregnancy.

结局指标

主要结局

Total morphine consumption

时间窗: 24 hours postoperatively

Rescue analgesia of morphine will be given as 3 mg bolus if the Visual Analogue Scale (VAS) \> 3 to be repeated after 30 min if pain persists until the VAS \< 4.

次要结局

  • Time to the 1st rescue analgesia(24 hours postoperatively)
  • Mean arterial pressure(Till the end of surgery (Up to 2 hours))
  • Heart rate(Till the end of surgery (Up to 2 hours))
  • Degree of pain(24 hours postoperatively)
  • Incidence of adverse events(24 hours postoperatively)

研究者

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

Bahaa Gamal Saad Mohamed

Anesthesia and Intensive Care, Faculty of Medicine, Assiut University, Assiut, Egypt.

Assiut University

研究点 (1)

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