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临床试验/NCT06616220
NCT06616220已完成4 期

Dexamethasone for ESPB in Pain Management After Pediatric Idiopathic

Poznan University of Medical Sciences1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年10月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
60
试验地点
1
主要终点
First need of opioid analgesia

研究概览

简要总结

Effect of perineurial dexamethasone on erector spinal plane block duration for pediatric, idiopathic scoliosis surgery.

详细描述

This study proposes to explore the effect of perineurial Dexamethasone on erector spinal plane block duration for pediatric idiopathic scoliosis surgery.

Children need good analgesia after scoliosis surgery. Peripheral nerve blocks have provided a safe, effective method to control early postoperative pain when symptoms are most severe.

The safety of local anesthesia is essential in children due to the much lower toxicity threshold of local anesthetics. An effective adjuvant, such as Dexamethasone, could allow for a higher dilution of local anesthetics while maintaining and enhancing their analgesic effect.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
10 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • children scheduled for idiopathic scoliosis surgery
  • age >10 and <18 years

排除标准

  • age < 10 years
  • age < 18 years
  • infection at the site of the regional blockade
  • coagulation disorders
  • immunodeficiency
  • ASA= or >4
  • steroid medication in regular use

研究组 & 干预措施

DEXAMETHASONE

Active Comparator

0.2% ropivacaine + 0.1mg/kg Dexamethasone for erector spinae plane block

干预措施: Dexamethasone (Drug)

CONTROL

Placebo Comparator

0.2% ropivacaine for erector spinae plane block

干预措施: 0.9%NaCl (Drug)

结局指标

主要结局

First need of opioid analgesia

时间窗: 48 hours after surgery

Time after surgery when the patient needs opiate for the first time

次要结局

  • Opioid consumption(48 hours after procedure)
  • Numerical Rating Scale [range 0:10](48 hours after surgery)
  • MEP(durring surgery)
  • Nerve damage [range 0-4](48 hours after surgery)
  • glucose(48 hours after surgery)

研究者

发起方
Poznan University of Medical Sciences
申办方类型
Other
责任方
Sponsor

研究点 (1)

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