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临床试验/NCT02715999
NCT02715999已完成不适用

Transversus Abdominis Plane Versus Quadratus Lumborum Block for Pediatrics

Kahramanmaras Sutcu Imam University1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2016年2月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
50
试验地点
1
主要终点
time to first use of analgesic

研究概览

简要总结

The purpose of this research study is to find the best way to decrease pain in children whom have had low abdominal surgery. Investigators will perform two technique of trunk block; Transversus abdominis plane or Quadratus lumborum block .The method used is often chosen by which one the doctor has more experience using. The Investigator plans to find out if one of the methods is more effective and/or safer than the other method.

The results of this study will help learn how to best control pain in children having surgery low abdominal surgery.

详细描述

Children aged 1-7 years undergoing lower abdominal surgeries would be recruited in this randomized study.

Children would be monitored by electrocardiogram, pulse oximeter and non-invasive blood pressure.

After preoxygenation for three minutes, anesthesia would be induced with 8% sevoflurane inhalation in 50% oxygen and % 50 air ; 1ug/kg fentanyl and 3 mg/kg propofol is administered intravenously. Then laryngeal mask is inserted when conditions are satisfactory (jaw relaxed, lash reflex disappeared, no coughing, gagging, swallowing).After ethical committee approval, informed written consent will be obtained from all patients.

Consenting patients scheduled to have unilaterally low abdominal surgery(inguinal hernia,hydrocele,undescended testicles surgery will be randomised to unilateral Quadratus lumborum block or Transversus abdominis plane block at the begin of surgery.

All patients will be in the lateral position . Under ultrasound guidance a 22 Gauge, Pajunk Sonoplex(medical Germany) needle will be used for both techniques. The spread of injectate will be seed on ultrasound.The dose of local anaesthetic in both groups will be 0.5 ml/kg 0.2 % Bupivacaine. Anesthesia would be maintained with 2% sevoflurane An increase in blood pressure or heart rate by more than 15% from preoperative value was defined as insufficient analgesia and was treated with fentanyl 0.5 µ/kg. Saline dextrose 5% (1:1) solution was infused in a dose of 12 ml/ kg /h.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Triple (Participant, Investigator, 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
否

入选标准

  • •ASA physical status I-II
  • •undergoing unilateral low abdominal surgery

排除标准

  • •history of allergic reactions to local anesthetics
  • •rash or infection at the injection site
  • •anatomical abnormality
  • •bleeding diatheses, coagulopathy, liver diseases

研究组 & 干预措施

Quadratus Lumborum Block

Active Comparator

Quadratus Lumborum block group (QL) patients will receive unilaterally Quadratus Lumborum block using Bupivacaine 0.2 %

干预措施: Quadratus Lumborum Block (Procedure)

Transversus abdominis plane block

Active Comparator

Transversus abdominis plane block (TAP) patients will receive unilaterally TAP block using Bupivacaine 0.2 %

干预措施: Transversus Abdominis Plane Block (Procedure)

结局指标

主要结局

time to first use of analgesic

时间窗: 24 hour

By investigators until hospital discharge, then through telephone interview with parents after that

次要结局

  • Parent satisfaction scores(24 hour)
  • Total paracetamol consumption(24 hour)
  • FLACC (face, legs, activity, cry, consolability)(1,2,4,6,12,24 hour)

研究者

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

Gözen Öksüz

Associate Professor

Kahramanmaras Sutcu Imam University

研究点 (1)

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