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临床试验/NCT07540689
NCT07540689
招募中
不适用

The Analgesic Efficacy of Modified Thoracoabdominal Nerve Block Through Perichondrial Approach for Laparoscopic Abdominal Surgery in Children: Randomized Controlled Trial

Kasr El Aini Hospital1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2026年5月1日最近更新:

概览

阶段
不适用
状态
招募中
发起方
Kasr El Aini Hospital
入组人数
60
试验地点
1
主要终点
FLACC pain score

概览

简要总结

This investigation aims to assess the efficacy of M-TAPA in children undergoing laparoscopic abdominal surgery.

Sixty pediatric patients undergoing laparoscopic abdominal surgery under general anesthesia will be enrolled in this single-center study. Preoperatively, participants will be randomly assigned to receive either port-site local anesthetic infiltration or M-TAPA.

详细描述

This investigation aims to assess the efficacy of M-TAPA in children undergoing laparoscopic abdominal surgery.

Sixty pediatric patients undergoing laparoscopic abdominal surgery under general anesthesia will be enrolled in this single-center study. Preoperatively, participants will be randomly assigned to a port site local anesthetic infiltration. or M-TAPA.

  1. port-site local anesthetic infiltration Before the skin incision, the surgeon will inject 0.17 mL/kg of 0.25% bupivacaine (up to 2 mg/kg) via infiltration into the skin, subcutaneous tissue, and muscle fascia at the three laparoscopic ports.
  2. M-TAPA. Before skin incision, Ultrasound will be used to perform bilateral M-TAPA.0.25 mL/kg of 0.25% bupivacaine will be administered at each side.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Triple (Participant, Care Provider, Outcomes Assessor)

入排标准

年龄范围
1 Year 至 7 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Age (1-7) years.
  • Both genders.
  • American Society of Anaesthesiologists (ASA) - physical status I-II.
  • Children undergoing elective laparoscopic abdominal surgery.

排除标准

  • Parental refusal.
  • Bleeding disorders with INR \> 1.5 and/or platelets \< 50
  • History of allergic reactions to local anesthetics.
  • Rash or signs of infection at the injection site.

研究组 & 干预措施

port site infiltration

Active Comparator

Children will receive port site LA infiltration.

干预措施: port site infiltration (Procedure)

M-TAPA

Active Comparator

Children will receive bilaterall ultrasound guided M-TAPA block.

干预措施: M-TAPA (Procedure)

结局指标

主要结局

FLACC pain score

时间窗: 6 hours postoperatively.

The FLACC pain score at 6 hours postoperatively.

次要结局

未报告次要终点

研究者

发起方
Kasr El Aini Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ahmed Mohamed Mohamed Elhaddad

Assisstent Professor

Kasr El Aini Hospital

研究点 (1)

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