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临床试验/NCT06386250
NCT06386250已完成不适用

Comparison of Regional Block, Caudal Block and Wound Infiltration for Post-operative Pain Management in Children Undergoing Inguinal Herniotomy

King Edward Medical University1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2019年1月5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
300
试验地点
1
主要终点
Postoperative pain intensity

研究概览

简要总结

Background: Although Inguinal herniotomy in children is taken as a day care procedure, post-operative pain management still remain controversial in these cases and superiority of wound infiltration, caudal block or regional block over each isn't known.

Objective: The objective of the study was compare regional block, caudal block and wound infiltration for post-operative pain management in children undergoing inguinal herniotomy

详细描述

Three hundred patients rom the department of pediatric surgery, KEMU/Mayo Hospital, were randomized in three study groups by a computer generated table. Regional block group (Group A), wound infiltration group (Group B), caudal block group (Group C). . Patients were assessed for postoperative pain intensity using FLACC pain scale at 0, 1, 2, 4, 8, 24 hours after surgery in children less than 8 years of age. Wong-Baker Faces pain Scale at 0, 1, 2, 4, 8, 24 hours after surgery in children more than 8 years of age. Patients were discharged after 24 hours. If pain score ≥ 4 was given intravenously, Ketoralac. Urinary retention was observed after 24 hours, wound infection was observed after 7 days.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
3 Years 至 12 Years(Child)
性别
All
接受健康志愿者
否

入选标准

  • •Both Male and female inguinal hernia patients
  • •Patients from 3-12 years age

排除标准

  • •History of allergy to any drugs used in study documented on history .Infection at the site of regional, caudal or local infiltration, documented on clinical examination.
  • •.Irreducible, obstructed or strangulated hernia, documented on clinical examination.

研究组 & 干预措施

Group B

Active Comparator

In group B 0.25% bupivacaine 0.5ml/Kg was infiltrated at the surgical site.

干预措施: Caudal block (Procedure)

Group B

Active Comparator

In group B 0.25% bupivacaine 0.5ml/Kg was infiltrated at the surgical site.

干预措施: Epidural (Procedure)

Group C

Experimental

In group C 0.25% Bupivacaine 1ml /kg was given into epidural space at L4-L5 or L5-S1.

干预措施: regional block (Procedure)

Group C

Experimental

In group C 0.25% Bupivacaine 1ml /kg was given into epidural space at L4-L5 or L5-S1.

干预措施: Caudal block (Procedure)

Group C

Experimental

In group C 0.25% Bupivacaine 1ml /kg was given into epidural space at L4-L5 or L5-S1.

干预措施: Epidural (Procedure)

Group A

Active Comparator

In group A, iliohypogastric and ilioinguinal nerves were blocked by using 0.25% bupivacaine 2ml/kg of combined with skin infiltration of adrenaline 1:200 000.

干预措施: regional block (Procedure)

Group A

Active Comparator

In group A, iliohypogastric and ilioinguinal nerves were blocked by using 0.25% bupivacaine 2ml/kg of combined with skin infiltration of adrenaline 1:200 000.

干预措施: Caudal block (Procedure)

Group A

Active Comparator

In group A, iliohypogastric and ilioinguinal nerves were blocked by using 0.25% bupivacaine 2ml/kg of combined with skin infiltration of adrenaline 1:200 000.

干预措施: Epidural (Procedure)

Group B

Active Comparator

In group B 0.25% bupivacaine 0.5ml/Kg was infiltrated at the surgical site.

干预措施: regional block (Procedure)

结局指标

主要结局

Postoperative pain intensity

时间窗: 24 hours

Patients were assessed for postoperative pain intensity using FLACC pain scale at 0, 1, 2, 4, 8, 24 hours after surgery in children less than 8 years of age. Wong-Baker Faces pain Scale at 0, 1, 2, 4, 8, 24 hours after surgery in children more than 8 years of age.

次要结局

未报告次要终点

研究者

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

Muhammad Sharif

PROFESSOR

King Edward Medical University

研究点 (1)

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