此页面是自动翻译的,不保证翻译的准确性。请参阅 英文版 对于源文本。

Ultrasound Guided Retrolaminar Block Versus Transverse Abdominis Plane Block in Laparoscopic Upper Abdominal Surgeries

2026年9月11日 更新者:Mansoura University

Safety and Efficacy of Ultrasound Guided Retrolaminar Block Versus Transverse Abdominis Plane Block on Quality of Recovery in Laparoscopic Upper Abdominal Surgeries: A Randomized Comparative Clinical Trial

This study aims to compare and evaluate the safety and efficacy of ultrasound guided retrolaminar block versus transverse abdominis plane block in laparoscopic upper abdominal surgeries. Both RLB and TAP blockade are hypothesized to reduce analgesic consumption, manage pain effectively and minimize side effects but their comparative effectiveness has not yet to be thoroughly explored.

研究概览

详细说明

Laparoscopic surgery is now a widely accepted practice, offering several advantages, including better cosmetic outcomes, increased patient satisfaction, and shorter hospital stays . The complexity and range of procedures performed laparoscopically have grown significantly, now including complex operations like cholecystectomy, nephrectomy, hernia repair, and an increasing number of emergency surgeries .

Despite these benefits, postoperative pain following laparoscopic procedures, such as cholecystectomy, can be substantial and hinder recovery . This pain may negatively affect respiratory function, delay ambulation, and ultimately prolong their hospital stay. Historically, pain management has often relied on high doses of narcotics, which may lead to complications like dizziness, respiratory depression, and postoperative nausea and vomiting (PONV) . These drawbacks have spurred the search for alternative and improved pain relief strategies .

Ultrasound-guided nerve blocks have become an essential component of multimodal postoperative analgesia due to their effectiveness, precision, and safety profile . One of such techniques is the Transversus Abdominis Plane (TAP) block, which is used as part of a comprehensive strategy to optimize postoperative pain control. Local anesthetic is injected into the neurovascular plane of the abdominal wall . The TAP block works by providing sensory blockade to the spinal nerves that run between the internal oblique and transverse abdominis muscles. The anesthetic infiltration affects the thoracic intercostal nerves, the ilioinguinal and iliohypogastric nerves, and the lateral cutaneous branches of the lumbar nerves.

Another important technique is the Retrolaminar Block (RLB), introduced in 2006 as a simpler alternative to the thoracic paravertebral block (TPVB) . The RLB is less invasive because it targets the bony vertebral lamina, unlike the TPVB, which requires puncturing the superior costotransverse ligament . The procedure involves injecting a local anesthetic (LA) into the fascial plane located between the posterior thoracic lamina and the overlying transversus spinae muscles allowing spread of the local anesthetic to the thoracic paravertebral and epidural spaces, thus the blockade of the dorsal branch of the spinal nerves that cross the retrolaminar plane .Studies, including cadaveric models, have confirmed that the anesthetic injected during an RLB spreads through the intertransverse ligaments into the paravertebral and epidural spaces, effectively numbing 2-4 spinal segments . For instance, a 2022 clinical trial showed that ultrasound-guided RLBs significantly reduced opioid consumption in patients recovering from laparoscopic cholecystectomy compared to conventional pain management , highlighting its potential as a safe and effective option.

研究类型

介入性

注册 (估计的)

164

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

  • 姓名:mohamed elnagar Mohamed A. Elnagar MB BCh, MB BCh
  • 电话号码:+20 1009344804
  • 邮箱:melnaggar789@gmail.com

学习地点

    • Dakahlia Governorate
      • Al Mansurah、Dakahlia Governorate、埃及
        • 招聘中
        • Mansoura University
        • 接触:

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

  • 成人
  • 年长者

接受健康志愿者

不

描述

Inclusion Criteria:

  • Age between 21 and 65 years.
  • American Society of Anesthesiologists (ASA) physical status I or II.
  • Body mass index (BMI) less than 30 kg/m².
  • Scheduled for elective laparoscopic upper abdominal surgery under general anesthesia.

Exclusion Criteria:

  • Refusal to participate in the study.
  • Known allergy or hypersensitivity to any of the study drugs.
  • Infection at the planned block insertion site.
  • Severe uncontrolled cardiac, renal, hepatic, neurological, or respiratory disease.
  • Pre-existing chronic pain.
  • Immunodeficiency.
  • Coagulation abnormalities, anticoagulant therapy, or platelet count less than 80,000/µL.
  • Emergency surgery.

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:Retrolaminar Block Group
Patients will receive an ultrasound-guided retrolaminar block using 20 ml of 0.25% of bupivacaine administered at the T7 level at both sides
Ultrasound-guided bilateral retrolaminar block performed before surgery using the study local anesthetic.
有源比较器:Transverses Abdominis Plane (TAP) Block Group
Patients will receive an ultrasound-guided TAP block using 20 ml of 0.25% bupivacaine at both sids
Ultrasound-guided bilateral transversus abdominis plane (TAP) block performed before surgery using the study local anesthetic.

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
The postoperative Quality of Recovery-15 score
大体时间:24 hour postoperative
The Quality of Recovery-15 (QoR-15) questionnaire consists of 15 items. The total score ranges from 0 to 150, with higher scores indicating better postoperative recovery.
24 hour postoperative

次要结果测量

结果测量
措施说明
大体时间
Numeric Rating Scale (NRS) at rest and during coughing
大体时间:Immediately after arrival in the post-anesthesia care unit (0 hours), and at 2, 4, 6, 12, and 24 hours after surgery.
Postoperative pain intensity at rest and during coughing will be assessed using the Numeric Rating Scale (NRS). The NRS ranges from 0 to 10, where 0 indicates no pain and 10 indicates the worst pain . Higher scores indicate greater pain intensity (worse outcome).
Immediately after arrival in the post-anesthesia care unit (0 hours), and at 2, 4, 6, 12, and 24 hours after surgery.
Total dose of rescue analgesics administered (mg) within the first 24 hours after surgery
大体时间:From the end of surgery to 24 hours after surgery.
The cumulative dose of rescue postoperative analgesics administered to each participant during the first 24 hours after surgery will be recorded. Higher values indicate greater postoperative analgesic requirements.
From the end of surgery to 24 hours after surgery.
Time to first postoperative opioid analgesic request (hours)
大体时间:From the end of surgery until the first request for opioid analgesia, up to 24 hours postoperatively
Time from the end of surgery until the first postoperative request for opioid analgesia
From the end of surgery until the first request for opioid analgesia, up to 24 hours postoperatively
Duration of hospital stay
大体时间:From the date of surgery until hospital discharge, assessed for up to 30 days after surgery
Duration of hospital stay, measured as the number of days from the date of surgery until hospital discharge.
From the date of surgery until hospital discharge, assessed for up to 30 days after surgery
Mean intraoperative mean arterial pressure (mmHg)
大体时间:At baseline (before block), immediately after block (0 minutes), at 5, 10, 20, 30, 60, 90, and 120 minutes after block , or until the end of surgery, whichever occurs first.
Mean arterial pressure (MAP), measured in millimeters of mercury (mmHg), will be recorded during surgery
At baseline (before block), immediately after block (0 minutes), at 5, 10, 20, 30, 60, 90, and 120 minutes after block , or until the end of surgery, whichever occurs first.
Mean intraoperative heart rate (beats/min)
大体时间:At baseline (before block), immediately after block (0 minutes), at 5, 10, 20, 30, 60, 90, and 120 minutes after block , or until the end of surgery, whichever occurs first.
Heart rate (HR), measured in beats per minute (beats/min), will be recorded during surgery
At baseline (before block), immediately after block (0 minutes), at 5, 10, 20, 30, 60, 90, and 120 minutes after block , or until the end of surgery, whichever occurs first.
Mean intraoperative peripheral oxygen saturation (%)
大体时间:At baseline (before block), immediately after block (0 minutes), at 5, 10, 20, 30, 60, 90, and 120 minutes after block , or until the end of surgery, whichever occurs first.
Peripheral oxygen saturation (SpO₂), measured as percentage (%), will be recorded during surgery
At baseline (before block), immediately after block (0 minutes), at 5, 10, 20, 30, 60, 90, and 120 minutes after block , or until the end of surgery, whichever occurs first.
Number of participants with postoperative nausea
大体时间:From the end of surgery to 24 hours after surgery
Number of participants who experienced postoperative nausea
From the end of surgery to 24 hours after surgery
Number of participants with postoperative vomiting
大体时间:From the end of surgery to 24 hours after surgery
Number of participants who experienced postoperative vomiting
From the end of surgery to 24 hours after surgery
Number of participants with postoperative shivering
大体时间:From the end of surgery to 24 hours after surgery
Number of participants who experienced postoperative shivering
From the end of surgery to 24 hours after surgery
Number of participants with postoperative hypotension
大体时间:From the end of surgery to 24 hours after surgery
Number of participants who experienced postoperative hypotension
From the end of surgery to 24 hours after surgery
Number of participants with postoperative bradycardia
大体时间:From the end of surgery to 24 hours after surgery
Number of participants who experienced postoperative bradycardia
From the end of surgery to 24 hours after surgery
Number of participants with postoperative headache
大体时间:From the end of surgery to 24 hours after surgery
Number of participants who experienced postoperative headache
From the end of surgery to 24 hours after surgery
Total intraoperative ephedrine dose administered (mg)
大体时间:From induction of anesthesia until the end of surgery
The cumulative dose of ephedrine administered intraoperatively for the treatment of hypotension, measured in milligrams (mg).
From induction of anesthesia until the end of surgery
Number of participants requiring intraoperative ephedrine administration
大体时间:From induction of anesthesia until the end of surgery
Number of participants who required ephedrine administration for the treatment of intraoperative hypotension.
From induction of anesthesia until the end of 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。

调查人员

  • 学习椅:hatem saber mohamed ali, Professor、Faculty of Medicine, Mansoura University
  • 学习椅:Naglaa A Elnegeery, Associate Professor、Faculty of Medicine, Mansoura University
  • 研究主任:Ola Shawky Naguib El Nagar, Lecturer、Faculty of Medicine, Mansoura University

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)

2026年7月1日

初级完成 (估计的)

2027年1月1日

研究完成 (估计的)

2027年2月1日

研究注册日期

首次提交

2026年7月1日

首先提交符合 QC 标准的

2026年7月17日

首次发布 (实际的)

2026年7月22日

研究记录更新

最后更新发布 (实际的)

2026年9月16日

上次提交的符合 QC 标准的更新

2026年9月11日

最后验证

2026年7月1日

更多信息

与本研究相关的术语

其他研究编号

  • Retrolamianr and TAP blocks

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

未定

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.

订阅