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
- 1
- 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
研究组 & 干预措施
Local Infiltration Analgesia (LIA)
local infiltration analgesia is an anesthetic technique that consists of the infiltration of operated tissue with a long acting local anesthetic during surgery to achieve postoperative pain relieve. In this study LIA of the knee will exist of: 1. local infiltration analgesia (LIA) of the posterior capsule of the knee, 2. LIA of the anterior capsule of the knee and 3. LIA of the subcutaneous tissue of the knee
干预措施: LIA of the posterior capsule of the knee (Procedure)
Local Infiltration Analgesia (LIA)
local infiltration analgesia is an anesthetic technique that consists of the infiltration of operated tissue with a long acting local anesthetic during surgery to achieve postoperative pain relieve. In this study LIA of the knee will exist of: 1. local infiltration analgesia (LIA) of the posterior capsule of the knee, 2. LIA of the anterior capsule of the knee and 3. LIA of the subcutaneous tissue of the knee
干预措施: LIA of the anterior capsule of the knee (Procedure)
Local Infiltration Analgesia (LIA)
local infiltration analgesia is an anesthetic technique that consists of the infiltration of operated tissue with a long acting local anesthetic during surgery to achieve postoperative pain relieve. In this study LIA of the knee will exist of: 1. local infiltration analgesia (LIA) of the posterior capsule of the knee, 2. LIA of the anterior capsule of the knee and 3. LIA of the subcutaneous tissue of the knee
干预措施: LIA of the subcutaneous tissue of the knee (Procedure)
Femoral Nerve Block (FNB)
a femoral nerve block is an anaesthetic technique that consists of anesthetizing the femoral nerve proximal of the operating area to achieve numbness distal of the block puncture site. A catheter can be placed, so the nerve can be anesthetized continuously or repeatedly for post-operative pain relieve.
In this study the FNB with catheter will be combined with local infiltration analgesia (LIA) of the posterior capsule of the knee
干预措施: LIA of the posterior capsule of the knee (Procedure)
Femoral Nerve Block (FNB)
a femoral nerve block is an anaesthetic technique that consists of anesthetizing the femoral nerve proximal of the operating area to achieve numbness distal of the block puncture site. A catheter can be placed, so the nerve can be anesthetized continuously or repeatedly for post-operative pain relieve.
In this study the FNB with catheter will be combined with local infiltration analgesia (LIA) of the posterior capsule of the knee
干预措施: FNB with catheter (Procedure)
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