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临床试验/NCT06470542
NCT06470542已完成4 期

Two-level Erector Spinae vs iPack With ACB Plane Block in Total Knee Arthroplasty

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11月7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
Total Opioid Consumption

研究概览

简要总结

Effect of two-level ESPB in Total Knee Arthroplasty

详细描述

Knee 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

iPACK + ACB

Active Comparator

Ultrasound-guided iPACK +ACB

干预措施: 2 x 20 ml of Ropivacaine 0.2% Injectable Solution (Drug)

Two-Level ESPB

Active Comparator

Bi-level Ultrasound-guided ESPB et the L1 and S1

干预措施: 2 x 20ml of Ropivacaine 0.2% Injectable Solution (Drug)

结局指标

主要结局

Total Opioid Consumption

时间窗: 48 hours after surgery

Total opioid consumption after surgery - within 48 hours after surgery

次要结局

  • Numerical Rating Scale [range 0:10](48 hours after surgery)
  • NLR(48 hours after surgery)
  • PLR(48 hours after surgery)
  • Quadriceps muscle strength assessed using medical research council scale [range 0:5](48 hours after surgery)
  • Time to first rescue opioid analgesia(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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