跳至主要内容
临床试验/NCT04354571
NCT04354571Unknown不适用

Evaluation of Post Operative Analgesia of the Erector Spinae Plane Block in Pediatric Patients Undergoing Hip Surgery: a Randomized Control Trial

Alexandria University1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2019年8月11日最近更新:
适应症

试验速览

阶段
不适用
入组人数
80
试验地点
1
主要终点
Pain assessment

研究概览

简要总结

Hip Surgery in pediatric patients is considered an extremely painful procedure. Managing pain in this surgery is challenging even with several available options, each with limitations. Erector spinae plane (ESP) block is a novel technique that has been used in different types of surgery, with promising results. Many case reports for use of ESPB are available in the literature but to our knowledge, no cohort studies or randomized controlled trials have been performed on ESPB for hip surgery in pediatrics age group against a traditional method as caudal block.1,2 AIM OF WORK

. The Primary outcome of this study is to compare the efficacy of analgesia resulting from the Erector spinae plane block versus the caudal block in pediatric patients undergoing hip surgery using the FLACC score and the duration of the analgesia of both methods till the first rescue analgesic.

The Secondary outcome is to compare the analgesic rescue frequency and total dose given in both groups as well as comparing the complications that might occur from each analgesic technique.

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, Investigator, Outcomes Assessor)

盲法说明

closed envelope technique

入排标准

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

入选标准

  • ASA I II scheduled for hip surgery.

排除标准

  • • Parent refusal
  • Coagulopathy
  • Patient with congenital heart disease
  • Infection at the site of puncture
  • Significant spinal anatomical anomaly
  • Patient with neuromuscular disorder
  • Any known allergy to the drug used

结局指标

主要结局

Pain assessment

时间窗: 1 day .

Pain was assessed using face, legs, activity, and cry consolability scale \[FLACC\] 1-10 1 is no pain and 10 is the worst pain.

次要结局

  • complications(through study completion, an average of 1 day)

研究者

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

Yasser Mohamed Mohamed Osman

assistant professor of anesthesia Alexandria university

Alexandria University

研究点 (1)

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