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临床试验/NCT07127601
NCT07127601已完成不适用

Comparative Study Between US Guided Erector Spinae and US Guided Cudal Epidural Block in Paediatric Unilateral Inguinal Hernia Repair Adjuvant to General Anaesthesia

Ain Shams University1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2023年1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
入组人数
50
试验地点
1
主要终点
heart rate response to skin incision

研究概览

简要总结

Inguinal hernia is a common condition requiring surgical repair in the pediatric age group. The incidence of inguinal hernias is approximately 3% to 5% in term infants and 13% in infants born at less than 33 weeks of gestational age. Inguinal hernias in both term and preterm infants are commonly repaired shortly after diagnosis to avoid incarceration of the hernia. Given the lack of definitive data, optimal timing for repair of inguinal hernias in infants remains debatable[1].

: An erector spinae plane block is a relatively new regional anesthetic technique. Apart from case reports and small series, the literature regarding pediatric use is limited.

The first author to describe caudal anaesthesia as applied to children (here in connection with urologic surgical procedures) was Meredith Campbell in 1933.(2) Over time, this idea has developed into a technique of great interest, especially for use in premature infants and in newborns, considering that these paediatric subgroups are, as a result of an immature state of the CNS, at high risk of perioperative respiratory depression.

This study will be conducted to compare caudal versus ESPB as regard intraoperative and postoperative analgesia in unilateral inguinal hernia and the feasibility of ESPB in paediatric patient.

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
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
3 Months 至 6 Years(Child)
性别
All
接受健康志愿者
是

入选标准

  • •age 3 moonths 6 years old
  • •American Society of Anesthesiologists physical status I, II for non complicated inguinal hernia.

排除标准

  • •Patients with a sepsis
  • •malignancy anywhere
  • •patient with bleeding tendencies or on anticoagulation therapy,
  • •allergy to study drugs
  • •congenital anomalies
  • •delayed motor or developmental milestones

研究组 & 干预措施

Ultrasound guided erector spinae plain block (ESPB).

Experimental

干预措施: Ultrasound guided erector spinae plain block (ESPB). (Procedure)

caudal analgesia (anatomically)with lumber level of anagesia

Active Comparator

干预措施: Ultrasound guided erector spinae plain block (ESPB). (Procedure)

结局指标

主要结局

heart rate response to skin incision

时间窗: basal before surgery, after 5 minutes intra-operative, 10 minutes intra-operative, 15 minutes intra-operative

count of heart beats per minute

次要结局

  • pain scores(at recovery, 30 minutes postoperative, 1 hour postoperative, 3 hours postoperative, 6 hours postoperative)

研究者

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

Mohamed Noser

Lecturer

Ain Shams University

研究点 (1)

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