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临床试验/NCT03463382
NCT03463382已完成不适用

Erector Spinae Plane Block Versus Quadratus Lumborum Block for Postoperative Analgesia in Children Undergoing Low Abdominal Surgery: A Randomized Controlled Trial

Kocaeli University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2018年3月12日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
1
主要终点
Pain scores

研究概览

简要总结

Postoperative pain management in children is still standing as a problem to solve. Effect of quadratus lumborum block has been shown to be a promising technique to overcome postoperative pain in children undergoing low abdominal surgeries. Erector spinae plane block is a new defined relatively safer and easier regional anesthesia technique which could be used for this purpose. Primary aim of this double blinded randomized controlled trial is to compare the analgesic efficacy of this two block techniques in this group of pediatric patients.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Prevention
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

  • 1-7 years of age
  • Undergoing elective low abdominal surgery

排除标准

  • infection of the skin at the site of needle puncture area
  • patients with known allergies to any of the study drugs
  • coagulopathy
  • ASA III-IV
  • Patients with neurological disorders

研究组 & 干预措施

ESP Group

Active Comparator

Erector Spinae Plane Block Group

Block Drug: 0,25% bupivacaine 0,5ml/kg (max.20ml) were used for blocks

干预措施: Erector Spinae Plane Block (Procedure)

ESP Group

Active Comparator

Erector Spinae Plane Block Group

Block Drug: 0,25% bupivacaine 0,5ml/kg (max.20ml) were used for blocks

干预措施: Bupivacaine (Block Drug) (Drug)

QLB Group

Active Comparator

Quadratus Lumborum Block Group

Block Drug: 0,25% bupivacaine 0,5ml/kg (max.20ml) were used for blocks

干预措施: Quadratus Lumborum Block (Procedure)

QLB Group

Active Comparator

Quadratus Lumborum Block Group

Block Drug: 0,25% bupivacaine 0,5ml/kg (max.20ml) were used for blocks

干预措施: Bupivacaine (Block Drug) (Drug)

结局指标

主要结局

Pain scores

时间窗: Postoperative first 6hours

FLACC scale will be used. The Face, Legs, Activity, Cry, Consolability scale or FLACC scale is a measurement used to assess pain for children between the ages of 2 months and 7 years or individuals that are unable to communicate their pain. The scale is scored in a range of 0-10 with 0 representing no pain. The scale has five criteria, which are each assigned a score of 0, 1 or 2.

次要结局

  • Time to first analgesic drug(first 48 hour)
  • Need for analgesic(24 hour)

研究者

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

Can AKSU

Assistant Professor

Kocaeli University

研究点 (1)

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