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临床试验/NCT06470139
NCT06470139已完成4 期

Pericapsular Nerve Group (PENG) Block with Ropivacaine Vs Ropivacaine and Dexamethasone in Total Hip Arthroplasty: a Randomized Controlled Trial

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8月13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
Time to first rescue opioid analgesia

研究概览

简要总结

Effect of adding Dexamethasone to Periarticular Nerve Group Block in Patients undergoing Total Hip Arthroplasty

详细描述

Hip arthroplasty is one of the most common orthopaedic procedures, especially in elderly patients, due to the deformation of joints. Patients may complain of severe pain due to surgical trauma and prostheses. Regional anaesthesia methods may be performed to reduce the inflammatory response, opioid consumption, and opioid-related side effects.

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
65 Years 至 100 Years(Older Adult)
性别
All
接受健康志愿者

入选标准

  • patients scheduled for total hip arthroplasty
  • patients aged >65 and <100 years
  • patients able to provide informed consent
  • patients able to reliably report symptoms to the research team

排除标准

  • inability to provide first-party consent due to cognitive impairment or a language barrier

研究组 & 干预措施

Ropivacaine

Active Comparator

Ultrasound-guided PENG block - 20ml 0,2% ropivacaine + 2ml 0.9% NaCl

干预措施: Ropivacaine 0.2% Injectable Solution (Drug)

Ropivacaine+Dexamethasone

Active Comparator

Ultrasound-guided PENG block - 20ml 0,2% ropivacaine + 4mg Dexamethasone

干预措施: Ropivacaine 0.2% Injectable Solution + 4mg Dexamethasone (Drug)

结局指标

主要结局

Time to first rescue 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

  • Quadriceps muscle strength assessed using medical research council scale [range 0:5](48 hours after surgery)
  • Nerve damage(48 hours after surgery)
  • glucose(48 hours after surgery)
  • Numerical Rating Scale [range 0:10](48 hours after surgery)
  • Total Opioid Consumption(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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