Fast-track Rehabilitation Protocol for Total Knee Arthroplasty: A Randomized Controlled Trial Comparing Local Infiltration Analgesia With Femoral Nerve Block
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Stair Climbing Task (SCT)
研究概览
简要总结
The objective of this study is to determine whether either a femoral nerve block (FNB) or local infiltration analgesia (LIA) is a better anesthetic technique to achieve optimal functional outcome after one year in patients receiving a total knee arthroplasty and following a fast track rehabilitation protocol.
详细描述
For an optimal and fast recovery after total knee arthroplasty (TKA), a fast track rehabilitation protocol has been developed. The literature is not yet conclusive about the optimal anesthestic technique. The optimal technique should support fast mobilization by giving good pain relieve with minimal side effects such as nausea, drowsiness and muscle weakness. If pain relieve is optimal, the patient mobilizes fast and length of stay is shortened. But does fast recovery lead to better functional outcome? The objective of this study is to determine whether either a femoral nerve block (FNB) or local infiltration analgesia (LIA) is a better anesthetic technique to achieve optimal functional outcome after one year in patients receiving a total knee arthroplasty and following a fast track rehabilitation protocol.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •American Society of Anesthesiologists (ASA) physical health status I-II
- •patient presents with non-inflammatory primary knee osteoarthritis (radiological confirmation)
- •patient is planned for a primary unilateral posterior-stabilized tri-compartmental cemented total knee replacement (Genesis II - PS)
- •patient is scheduled for fast track protocol
- •patient plans to be available fot follow-up through one year post-operative
- •written informed consent
排除标准
- •any contra-indication for locoregional 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 intolerance or contraindication for opioids, nonsteroidal antiinflammatory drugs (NSAIDs) or paracetamol
- •a Body Mass Index > 40 kg/m2
- •inability to walk independently (inability to walk at least 10 consecutive meters without a walking aid)
- •scheduled for contralateral TKA within one year postoperative
- •scheduled for another operation within 3 months postoperative
- •physical, emotional or neurological conditions that would compromize compliance with postoperative rehabilitation and follow-up
- •chronic opioid analgesic therapy
- •chronic gabapentin or pregabalin analgesic therapy
- •rheumatoid arthritis
结局指标
主要结局
Stair Climbing Task (SCT)
时间窗: one year
The SCT assesses the ability to ascend and descend a flight of stairs, as well as lower extremity strength, power, and balance.
次要结局
- Six Minute Walking Test (6MWT)(1 year)
- Timed Up and Go Test (TUG)(1 year)
研究者
Maaike Fenten
Anesthesiologist, Head of anesthesiology department
Sint Maartenskliniek