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临床试验/NCT05717374
NCT05717374招募中不适用

Efficacy and Safety of Methylprednisolone Versus Dexamethasone in Caudal Block for Children Undergoing Hypospadias Surgical Repair: A Bi-center Randomized Controlled Study

Mansoura University1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2023年2月13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
招募中
入组人数
80
试验地点
1
主要终点
duration of analgesia

研究概览

简要总结

This randomized, double-blind, controlled bi-center study was designed to compare the postoperative analgesic efficacy of dexamethasone and methylprednisolone in caudal block for children undergoing hypospadias surgical repair using the duration of analgesia as the primary outcome. We hypothesize that methylprednisolone will provide superior postoperative analgesia than dexamethasone when added to bupivacaine for caudal block. This study will be conducted on 80 male patients of American Society of Anesthesiologists physical status I-II of with their age ranging from 1 to 6 years scheduled for surgical repair of hypospadias. The patients will be randomly assigned into 2 groups:- Group D: will receive 0.5 ml/kg volume (bupivacaine 0.25 % + dexamethasone 0.1mg/kg) Group M: will receive 0.5 ml/kg volume (bupivacaine 0.25% + methylprednisolone 0.5mg/kg) The main collected data will be the duration of analgesia (first need for rescue analgesia ), the severity of postoperative pain according to FLACC and the side effects like nausea and vomiting, respiratory depression.

详细描述

Hypospadias repair surgery is an invasive surgery that results in significant postoperative pain. pain alters the quality of life and satisfaction of the patients and results in manipulation of wounds, infection, bleeding, and wound dehiscence leading to unfavorable surgical outcome .

As a plan for postoperative pain prophylaxis in children, different analgesic techniques have been used as preemptive analgesia such as local infiltration of anesthesia, penile block, epidural block and caudal block in addition to general anesthesia. Caudal block is found to be one of most succeeded technique in hypospadias repair and decreases the postoperative analgesia consumption.

Bupivacaine is a local anesthetic commonly used via caudal epidural route but gives limited duration of analgesia. Therefore, the addition of other drugs in an attempt to improve the quality and duration of analgesia given by bupivacaine has been studied.

Examples of additives drugs used in the caudal epidural are opioids, alpha 2 agonist as dexmedtomidine and clonidine which produce prolongation of the duration of the analgesia, but their undesirable effect may limit its use as nausea, vomiting, pruritus, urinary retention and respiratory depression.

Epidural corticosteroids have a long history of safe and effective use in the treatment of low back and radicular pain due to their strong anti-inflammatory effect encouraging use in management of acute postoperative pain.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

盲法说明

The study subjects and the resident assessing the outcomes will be blinded to the study group. A single investigator will assess the patients for eligibility, obtain written informed consent, open the sealed opaque envelopes containing group allocation

入排标准

年龄范围
1 Year 至 6 Years(Child)
性别
Male
接受健康志愿者

入选标准

  • Male patients
  • American Society of Anesthesiologists physical status I-II of
  • age ranging from 1 to 6 years
  • scheduled for surgical repair of hypospadias

排除标准

  • a history of neurodevelopmental delay
  • type I diabetes
  • coagulopathy
  • known allergy to any local anesthetic or steroid,
  • known congenital anomaly of the spine and local infection.

研究组 & 干预措施

Group Dexamethasone

Active Comparator

will receive 0.5 ml/kg volume (bupivacaine 0.25 % + dexamethasone 0.1mg/kg) for caudal block

干预措施: caudal block using dexamethasone (Drug)

Group Methylprednisolone

Experimental

will receive 0.5 ml/kg volume (bupivacaine 0.25% + methylprednisolone 0.5mg/kg) for caudal block

干预措施: caudal block using methylprednisolone (Drug)

结局指标

主要结局

duration of analgesia

时间窗: Up to 24 hours after the procedure]

first need for rescue analgesia will be recorded

次要结局

  • the severity of postoperative pain according to FLACC score(Up to 24 hours after the procedure])
  • side effects(Up to 24 hours after the procedure])

研究者

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

Mahmoud Mohammed Alseoudy

Lecturer of anesthesia, ICU & pain management; Faculty of Medicine

Mansoura University

研究点 (1)

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