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临床试验/NCT07012603
NCT07012603已完成不适用

External Oblique and Rectus Abdominis Plane (EXORA) Block for Postoperative Analgesia in Patients Undergoing Umbilical Hernia Repair: A Randomized Controlled Trial

Tanta University1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2025年6月10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
50
试验地点
1
主要终点
Total morphine consumption

研究概览

简要总结

This study aims to evaluate the effect of the external oblique and rectus abdominis plane (EXORA) block for postoperative analgesia in patients undergoing umbilical hernia repair.

详细描述

Umbilical hernias account for approximately 6-14% of adult abdominal wall hernias. These hernias are typically acquired and are mainly caused by increased abdominal pressure. Umbilical hernias do not heal on their own and usually require surgical intervention.

The external oblique and rectus abdominis plane (EXORA) block is an emerging technique providing a sensory block to the anterolateral abdominal wall. The EXORA block involves local anaesthetic injection into the fascial plane between the external oblique and rectus abdominis muscles. This method provides better dermatomal coverage, making the EXORA block particularly effective in the treatment of somatic pain in the anterolateral area of the upper and middle abdomen.

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 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age from 18 to 65 years.
  • Both sexes.
  • American Society of Anesthesiology (ASA) physical status I-II.
  • Undergoing umbilical hernia repair.

排除标准

  • History of allergies to local anesthetics.
  • Bleeding or coagulation disorders.
  • Anatomical abnormalities.
  • Psychiatric and neurological disorders.
  • Local infection at the site of injection.
  • Complicated hernial defects [strangulated, incarcerated, or obstructed cases].

研究组 & 干预措施

EXORA block group

Experimental

Patients will receive an external oblique and rectus abdominis plane (EXORA) block using 20 mL of bupivacaine 0.25%.

干预措施: External oblique and rectus abdominis plane (EXORA) block (Other)

Control group

Sham Comparator

Patients will receive a sham block using 20 mL of normal saline as a control group.

干预措施: Sham block (Other)

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 5 mg bolus if the numeric rating scale (NRS) \> 3 to be repeated after 30 min if pain persists until the NRS \< 4.

次要结局

  • Degree of pain(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))
  • Incidence of adverse events(24 hours postoperatively)
  • Time to the 1st rescue analgesia(24 hours postoperatively)
  • Intraoperative fentanyl consumption(Intraoperatively)

研究者

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

Mohammed Said ElSharkawy

Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Tanta University, Tanta, Egypt.

Tanta University

研究点 (1)

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