Efficacy of Multimodal Peri- and Intraarticular Drug Injections in Total Knee Arthroplasty
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 102
- 试验地点
- 1
- 主要终点
- Pain at Rest (VAS)
研究概览
简要总结
Total knee arthroplasty (TKA) is associated with moderate to severe postoperative pain, causing patient discomfort, mobilisation and hospital discharge.
The aim of this study is to:
- Compare analgetic efficacy of to types of local infiltration analgesia in total knee arthroplasty.
- Compare analgetic efficacy of local infiltration analgesia with continuous epidural analgesia.
详细描述
Total knee arthroplasty (TKA) is increasingly common in the treatment of knee osteoarthritis. TKA is associated with moderate to severe postoperative pain, causing patient discomfort, mobilisation and hospital discharge.
Continuous epidural analgesia is often used for controlling pain after TKA. Recent studies describe a new method for pain control after total knee arthroplasty which consists of local infiltration with local anesthetics and adrenaline. This infiltrations can be combined with ketorolac and/or morphine. The aim of this study is to:
- Compare analgetic efficacy of to types of local infiltration analgesia in total knee arthroplasty.
- Compare analgetic efficacy of local infiltration analgesia with continuous epidural analgesia.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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 at least 18 years of age
- •scheduled for elective total knee arthroplasty
- •ASA I-III
- •signed written informed consent
排除标准
- •age < 18
- •ASA > III
- •moderate or severe cardiac disease, bronchial asthma
- •allergy against ropivacaine, ketorolac or morphine
- •analgetic abuse
- •pregnancy or nursing women
- •severe psychiatric disease
- •moderate to severe dementia
研究组 & 干预措施
LIA IV
Local infiltration analgesia with ropivacaine and adrenaline and intravenous ketorolac and morphine
干预措施: ropivacaine (Drug)
LIA IV
Local infiltration analgesia with ropivacaine and adrenaline and intravenous ketorolac and morphine
干预措施: adrenaline (Drug)
LIA IV
Local infiltration analgesia with ropivacaine and adrenaline and intravenous ketorolac and morphine
干预措施: ketorolac (Drug)
LIA IV
Local infiltration analgesia with ropivacaine and adrenaline and intravenous ketorolac and morphine
干预措施: morphine (Drug)
LIA IA
Local infiltration analgesia with ropivacaine, adrenaline and ketorolac and morphine
干预措施: ropivacaine (Drug)
LIA IA
Local infiltration analgesia with ropivacaine, adrenaline and ketorolac and morphine
干预措施: adrenaline (Drug)
LIA IA
Local infiltration analgesia with ropivacaine, adrenaline and ketorolac and morphine
干预措施: ketorolac (Drug)
LIA IA
Local infiltration analgesia with ropivacaine, adrenaline and ketorolac and morphine
干预措施: morphine (Drug)
EDA
standard continuous epidural analgesia
干预措施: adrenaline (Drug)
EDA
standard continuous epidural analgesia
干预措施: fentanyl (Drug)
EDA
standard continuous epidural analgesia
干预措施: bupivacaine (Drug)
结局指标
主要结局
Pain at Rest (VAS)
时间窗: 48 hours postoperative
VAS (pain at rest) 0-100 mm. VAS 0 mm means no pain and VAS 100 mm means maximal pain.
次要结局
- Opioid Use(48 hours postoperative)
- Time to Readiness for Discharge(up to 10 days postoperative)