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临床试验/NCT04552548
NCT04552548已完成不适用

Ultrasound-Guided Quadratus Lumborum Block Versus Transversus Abdominis Plane Block for Postoperative Analgesia in Children Undergoing Laparoscopic Surgery.

Minia University2 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2019年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
90
试验地点
2
主要终点
quality of postoperative analgesia

研究概览

简要总结

The aim of the present study is to evaluate and compare the analgesic effect of ultrasound-guided Quadratus Lumborum Block with ultrasound-guided Transversus Abdominis plane block in pediatric Laparoscopic lower abdominal surgeries

详细描述

90 male and female patients aged from 1 to 7 years old from ASA class I to II undergoing elective laparoscopic lower abdominal surgery will be randomly divided into three equal groups of thirty patients each by using computer generated random table.

Technique of the study After insertion of venous access, all children received premedication in the form of atropine at a dose of 0.01-0.02 mg/kg. Perioperative monitoring included continuous ECG, pulse oximetry and non-invasive arterial blood pressure. Baseline reading of heart rate, mean arterial blood pressure was recorded after monitor attachment. General anesthesia will be induced using propofol 1.5-2.5 mg/kg over 20-30 sec. as tolerated, atracurium 0.5 mg/kg to facilitate endotracheal intubation and fentanyl 1 µg/kg. Anesthesia will be maintained using isoflurane (1 MAC) and atracurium 0.1 mg/kg supplements will be given to maintain muscle relaxation.

TAP block or quadratus lumborum block will be performed in all patients immediately after induction and before starting of surgery. patients will be allocated randomly into three equal groups , 30 patients in each as the following :-

Group C "Control group" will receive regular analgesics (1 µg /kg fentanyl with induction and 15mg/kg paracetamol before extubation).

Group TAP "TAP group" will receive bilateral TAP block using (0.5 ml/ kg bupivacaine 0.25%) in each side + regular analgesics.

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

入选标准

  • ASA I-II physical status patients
  • Children scheduled for laparoscopic surgery
  • Duration of Laparoscopic procedure not exceeding 90 minutes

排除标准

  • Sensitivities to local anesthetics
  • Significant renal, liver, or cardiac disease
  • Surgery requiring an open procedure
  • Participants refusing regional block
  • Those having bleeding disorders, skin lesions or wounds at the site of proposed needle insertion, evidence of peritonitis, septicemia
  • Children required emergency procedures.

结局指标

主要结局

quality of postoperative analgesia

时间窗: 24 hours after surgery

Postoperative Pain scores as FLACC score (face, legs, activity, cry and consolability)

次要结局

  • analgesic consumption(24 hours)
  • duration of analgesia(24 hours after block)

研究者

发起方
Minia University
申办方类型
Other
责任方
Principal Investigator
主要研究者

haidy salah mansour

Professor

Minia University

研究点 (2)

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