Implementation of a Fast-track Knee Arthroplasty Concept: a Randomized, Controlled, Open Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- time to first mobilisation (standing)
研究概览
简要总结
Mobilisation following knee arthroplasty is an important aspect to achieve early and enhanced recovery after surgery and sufficient joint function. Analgesia is a crucial therapeutic element in this context. This RCT evaluates two analgetic regimens for patients undergoing primary total knee-replacement to assess impact on postoperative recovery.
详细描述
Mobilisation following knee arthroplasty is important for patients to achieve early and enhanced recovery after surgery and sufficient joint function. Analgesia is a crucial therapeutic element in this context. There is evidence that regional- anaesthesiological catheter techniques are very efficient to control pain postoperatively. On the other hand, motoric function may be reduced due to nerve blocks depending on location and concentration of drug used. Local infiltration of the knee during surgery is an alternative component in pain management that may reduce impaired motor function and allow early mobilisation of patients. However, currently it is not known which analgesia technique provides optimal pain control paralleled with sufficient motor function. Against this background, this RCT evaluates two analgesia regimens for patients undergoing primary total knee-replacement to assess impact on postoperative recovery.
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
- Double (Investigator, Outcomes Assessor)
盲法说明
Investigator and treating physicians are different in this trial, that means, the assessor of primary study endpoint will be blinded regarding group allocation. Patients receive either regional-anaesthesiological catheters preoperatively or are treatet with local infiltration technique perioperatively. For the purpose of this trial is would not be feasable to perform sham regional-anaesthesiological procedures and blinding of the treating physisican will not be possible.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients undergoing elective, primary knee joint replacement in combined general anaesthesia
排除标准
- •heart insufficiency NYHA >2
- •liver insufficiency > CHILD B
- •evidence of diabetic polyneuropathy
- •severe adipositas BMI >40
- •patients < 18 years
- •pregnancy
- •in case of police custody
- •participation in a paralleled interventional RCT in a time frame of 30 days
- •chronic opioid therapy >3 months before scheduled surgery
- •allergy against medication required for surgery or anaesthesia
研究组 & 干预措施
local infiltration analgesia
Patient receive an infiltration of local anaesthetics around the knee to achieve maximal distal block of nerve fibres. Infiltration is performed directly after knee replacement and during weaning of general anaesthesia.
干预措施: local infiltration analgesia (Procedure)
Regional anaesthesia
Patients receive a combined anaesthesia with a regional-anaesthesiological catheter placed close to the distal Nervus saphenus and a single shot anaesthesia of Nervus ischiadicus using local anaesthetics (regional-anaesthesiological catheter analgesia).
干预措施: regional-anaesthesiological catheter analgesia (Procedure)
结局指标
主要结局
time to first mobilisation (standing)
时间窗: up to 48h postoperatively
time from end of surgery until patients is able to stand
次要结局
- complications(up to 7 days postoperatively)
- time to achieve full joint mobility(up to 7 days postoperatively)
- rescue pain medication(up to 7 days postoperatively)
- patients satisfaction (11-point likert scale)(up to 7 days postoperatively)
- time to first mobilisation (walking)(up to 7 days postoperatively)
- pain intensity of patients (11-point likert visual analogue scale) measured 3 times daily (mean)(up to 7 days postoperatively)
- pain medication perioperatively(up to 7 days postoperatively)
- time to discharge(up to 14 days postoperatively)
研究者
Sascha Treskatsch
Head of department
Charite University, Berlin, Germany