EUCTR2013-001008-13-NL进行中（未招募）不适用
Fast-track rehabilitation protocol for Total Knee Arthroplasty: A Randomized Controlled Trial comparing Local Infiltration Analgesia with Femoral Nerve Block - Fast track TKA: LIA vs FNB
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •age 50-80 years
- •ASA physical health classification I – II
- •patient presents with non-inflammatory primary knee osteoarthritis (radiological confirmation)
- •patient planned for a primary unilateral posterior-stabilized tri-compartmental cemented total knee replacement (Genesis II - PS)
- •scheduled for fast-track protocol TKA
- •patient plans to be available for follow-up through one year postoperative
- •written informed consent
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 30
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 50
排除标准
- •any contra-indication for regional anesthesia
- •any contra-indication for spinal anesthesia
- •traumatic osteoarthritis requiring TKA
- •an active, local infection or systemic infection
- •known hypersensitivity to amide-type local anesthetics
- •known hypersensitivity to opioids
- •a Body Mass Index (BMI) > 40 kg/m2
- •inability to walk independently (inability to walk at least 10 consecutive meters without a walking aid)
- •scheduled for contralateral TKA within 1 year post-operative
- •scheduled for another operation within 3 months post-operative
- •physical, emotional or neurological conditions that would compromise compliance with postoperative rehabilitation and follow-up
- •chronic opioid analgesic therapy
- •rheumatoid arthritis
研究者
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