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临床试验/NCT02001259
NCT02001259已完成4 期

Efficacy of Epidural Steroid in Controlling Postoperative Pain After Primary Total Knee Arthroplasty: A Randomized Double-blinded Controlled Trial

Thammasat University1 个研究点 分布在 1 个国家目标入组 108 人开始时间: 2014年1月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
108
试验地点
1
主要终点
post-operative pain

研究概览

简要总结

The purpose of this study is to determine efficacy of epidural steroid for postoperative pain control after TKA

详细描述

Epidural triamsinolone can reduce postoperative pain and longer duration of pain control after TKA

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
Triple (Participant, Care Provider, Outcomes Assessor)

入排标准

年龄范围
50 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • osteoarthritis of the knee who undergoing unilateral primary total knee arthroplasty
  • 50-85 years old
  • ASA class 1-3

排除标准

  • unable to perform epidural anaesthesia
  • history of drug allergies: lidocaine, steroid
  • renal impairment (CrCl <30 mL/min)
  • liver impairment
  • cognitive function disorders
  • displacement of epidural catheter

研究组 & 干预措施

Epidural lidocaine

Active Comparator

epidural lidocaine: 3 mL of 1% lidocaine with adrenaline and 3 mL of 1% lidocaine without adrenaline into epidural catheter at 48 hr after surgery

干预措施: epidural lidocaine (Drug)

epidural triamsinolone

Experimental

epidural triamsinolone: 40 mg of triamsinolone (1 mL), 2.5 mL of 1% lidocaine with adrenaline and 2.5 mL of 1% lidocaine without adrenaline into epidural catheter at 48 hr after surgery

干预措施: epidural triamsinolone (Drug)

结局指标

主要结局

post-operative pain

时间窗: 3 months

measured with VAS for pain (VAS at rest and on motion)

次要结局

  • functional knee score(3 months)

研究者

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

Supakit Kanitnate

orthopaedic department

Thammasat University

研究点 (1)

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