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临床试验/NCT07336043
NCT07336043进行中(未招募)不适用

Optimizing Regional Analgesia in Pediatric Laparoscopic Splenectomy: External Oblique Intercostal Block Versus Transversus Abdominis Plane Block: Randomized Controlled Study

Tanta University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2026年1月13日最近更新:
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
60
试验地点
1
主要终点
Numerical rating scale score

研究概览

简要总结

The aim of study is to compare the efficacy of the External Oblique Intercostal plane block with the Transversus Abdominis Plane block in acute postoperative pain control in pediatric patients undergoing laparoscopic Splenectomy.

详细描述

Optimal postoperative pain control in children is particularly challenging despite advances in multimodal pharmaceutical strategies. Laparoscopic approaches have improved postoperative outcomes when compared to open surgery, particularly in terms of postoperative pain. Pain after laparoscopic surgeries has three components; including incisional, visceral, and referred shoulder pain secondary to peritoneal insufflation. Opioid analgesia can be an effective adjunct to an existing non-opioid pain regimen. However, opioids are known to decrease bowel motility, result in nausea, and cause respiratory depression, particularly in the pediatrics. Traditionally, neuraxial blocks have been used for abdominal surgeries but in patients with low platelet count as splenectomy, this might not be a feasible option.

Effective fascial plane blocks have recently become popular as candidates to be a part of multimodal analgesia, especially for patients who require limited use of drugs in multimodal analgesia (such as liver failure, renal failure, platelet dysfunction, and peptic ulcer) or those with hypersensitivity to any of these drugs. As there are potential advantages such as a longer distance between the needle and neurovascular structures, less motor blockade and less hemodynamic change, fascial plane blocks can provide effective solutions to many difficulties faced by anesthesiologists in the perioperative period. Transversus Abdominis Plane block has emerged as an effective method to minimize postoperative pain in adult patients undergoing abdominal surgery. Several randomized trials in children undergoing laparoscopic appendicectomy, minimally invasive cholecystectomy, and other laparoscopic abdominal procedures have demonstrated that ultrasound-guided Transversus Abdominis Plane block reduces pain scores, opioid consumption, and even pulmonary complications such as atelectasis when compared with port site infiltration or systemic analgesia alone.

External oblique intercostal block is a novel block, which has been described as an important modification of the fascial plane blocks that can consistently involve the upper lateral abdominal walls. External oblique intercostal block block targets the external oblique intercostal plane, allowing for effective analgesia across the upper abdominal wall, including both median and lateral regions. This contrasts with the Transversus Abdominis Plane block block, which may not adequately cover the lateral cutaneous intercostal branches, limiting its effectiveness in certain surgical procedures. Many previous studies that have concentrated on the use of different TAP block strategies, including subcostal Transversus Abdominis Plane block; have shown that it could not sufficiently block the lateral cutaneous intercostal branches.

The aim of study is to compare the efficacy of the External Oblique Intercostal plane block with the Transversus Abdominis Plane block in acute postoperative pain control in pediatric patients undergoing laparoscopic Splenectomy.

  • Primary outcome: Postoperative Numerical rating scale score.
  • Secondary outcomes

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Care Provider)

入排标准

年龄范围
8 Years 至 16 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Children of both gender,
  • aged 8 to 16 years with American Society of Anesthesiologists Physical Status I to III,
  • who were scheduled for laparoscopic Splenectomy surgery.

排除标准

  • Parents declined to participate in the trial.
  • Physical or developmental delay.
  • Pre-existing renal or cardiovascular disease, bone disease, or gastrointestinal disorders.
  • Infection at proposed injection sites.
  • Prior major abdominal surgery

研究组 & 干预措施

EOI group (Group E)

Experimental

30 patients will receive ultrasound-guided left EOI block

干预措施: EOI group (Procedure)

TAP group (Group T)

Experimental

30 patients will receive ultrasound-guided left TAP block

干预措施: TAP group (Procedure)

结局指标

主要结局

Numerical rating scale score

时间窗: Numerical rating scale score will be assessed postoperatively 10, 30 and 60 minutes then 2 , 4 , 6 , 12 , 24 hours postoperatively

Numerical rating scale score

次要结局

  • Intraoperative Heart rate values(every 15 minutes until end of surgery)

研究者

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

Esraa Rabie Amer

Lecturer

Tanta University

研究点 (1)

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