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External Oblique Intercostal Plane Block Versus Erector Spinae Plane Block in Paediatric Upper Abdominal Surgeries

2026年5月24日 更新者:Belal Mohamed Bakr、Alexandria University

Ultrasound Guided External Oblique Intercostal Plane Block Versus Erector Spinae Plane Block in Paediatric Upper Abdominal Surgeries

This study aims to compare between ultrasound guided external oblique intercostal plane block and ultrasound guided erector spinae plane block in paediatric upper abdominal surgeries.

研究概览

详细说明

Paediatric nerve blocks are increasingly recognized as new standard for managing pain in children. The advantages of regional anesthesia in this population include enhanced operating conditions, expedited recovery of bowel function, and reduced postoperative pain.

The caudal epidural block remains the most used method; however, the external oblique intercostal block, a novel technique involves administering local anesthesia deep to the external oblique muscle at the sixth intercostal space, thereby blocking thoracoabdominal nerves from T6 to T10. This technique offers several advantages, including straightforward anatomy, a single muscle strip that is easily identifiable even in obese patients, a bony backstop, and an easily expandable fascial plane that can accommodate a catheter.

The erector spinae plane block involves injecting local anesthetic into the fascial plane beneath the erector spinae muscle at the tip of the vertebral transverse process. This allows the local anesthetic to spread in the craniocaudal fascial plane.

研究类型

介入性

注册 (估计的)

40

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

学习地点

      • Alexandria、埃及、21526
        • 招聘中
        • Alexandria University
        • 接触:
        • 副研究员:
          • Wafaa M Shafshak, MD
        • 副研究员:
          • Ola M Zanaty, MD
        • 副研究员:
          • Mohamed W Nassar, MD

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 孩子

接受健康志愿者

不

描述

Inclusion Criteria:

  • Children aged between 6 and 12 years of both sex.
  • Patients with the American Society of Anesthesiologists (ASA) physical status I/II.
  • Patients undergoing upper abdominal surgeries involving upper abdominal incisions.

Exclusion Criteria:

  • Guardian refusal.
  • Allergy to local anesthetics.
  • Surgical procedures exceeding 3 hours.
  • Infection at the area planned for the block injection.
  • Prolonged opioid medication.
  • Patients preoperatively medicated by Beta blockers

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:双倍的

武器和干预

参与者组/臂
干预/治疗
实验性的:Group I
Patients will receive ultrasound-guided external oblique intercostal plane block.
Patients will receive ultrasound-guided external oblique intercostal plane block.
实验性的:Group II
Patients will receive ultrasound-guided erector spinae plane block.
Patients will receive ultrasound-guided erector spinae plane block.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Degree of pain
大体时间:12 hours after surgery

Postoperative pain will be assessed using Faces pain score revised. The Faces Pain Scale revised (FPS-R) is a validated self-report instrument designed to measure pain intensity in pediatric populations.

The scale comprises a series of facial expressions, ranging from a smiling face at 0, indicating "no pain," to a crying face at 10, indicating "very much pain".

Children are instructed to select the face that most accurately reflects their current pain level.

The faces are scored (0, 2, 4, 6, 8, 10), providing a quantifiable measure of pain intensity.

12 hours after surgery

次要结果测量

结果测量
措施说明
大体时间
Heart rate
大体时间:Every 15 minutes intraoperative
Heart rate will be recorded preoperative basal readings, after induction of anesthesia, during skin incision, and every 15 minutes intraoperative.
Every 15 minutes intraoperative
Mean arterial blood pressure
大体时间:Every 15 minutes intraoperative
Mean arterial blood pressure will be recorded preoperative basal readings, after induction of anesthesia, during skin incision, and every 15 minutes intraoperative.
Every 15 minutes intraoperative
Peripheral oxygen saturation
大体时间:Every 15 minutes intraoperative
Peripheral oxygen saturation will be recorded preoperative basal readings, after induction of anesthesia, during skin incision, and every 15 minutes intraoperative.
Every 15 minutes intraoperative
Duration of analgesia
大体时间:12 hours after surgery
Duration of analgesia will be recorded from block completion till first postoperative rescue analgesia requirement.
12 hours after surgery
Total rescue analgesia requirement
大体时间:12 hours after surgery
In Faces Pain Scale score-revised, cut of points for analgesic requirement is ≧ 4, rescue analgesia will be administered in the form of nalbuphine 0.1 mg/kg, with a maximum dose of 0.2 mg/kg.
12 hours after surgery
Incidence of complications
大体时间:12 hours after surgery
Incidence of complications including hematomas block failure, intravascular injection, pneumothorax or injection into the peritoneal cavity, with associated risks of damage to bowel and other abdominal viscera at the block site will be recorded.
12 hours after surgery

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2025年5月1日

初级完成 (估计的)

2026年10月1日

研究完成 (估计的)

2026年10月1日

研究注册日期

首次提交

2026年5月24日

首先提交符合 QC 标准的

2026年5月24日

首次发布 (实际的)

2026年6月1日

研究记录更新

最后更新发布 (实际的)

2026年6月1日

上次提交的符合 QC 标准的更新

2026年5月24日

最后验证

2026年5月1日

更多信息

与本研究相关的术语

其他研究编号

  • 00012098 (0109306)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

是的

IPD 计划说明

The data will be available upon a reasonable request from the corresponding author after the end of study for one year.

IPD 共享时间框架

After the end of study for one year.

IPD 共享访问标准

The data will be available upon a reasonable request from the corresponding author.

IPD 共享支持信息类型

  • 研究方案

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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