Safety and Efficacy of Cocktail Periarticular Injection for Pain Management in Simultaneous Bilateral Total Knee Arthroplasty- A Prospective, Randomized Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- To evaluate the Morphine consumption and PCIA duration
研究概览
简要总结
We investigated the safety and efficacy of the bilateral periarticular cocktail injection at a reduced dosage in patients undergoing simultaneous bilateral total knee arthroplasty.
详细描述
It is hypothesized that intraoperative periarticular injection with cocktail analgesics can reduce postoperative parenteral narcotics use and improve patient satisfaction following total knee arthroplasty.
A prospective, randomized trial is conducted to testify the hypothesis above by recruiting patients who go through simultaneous bilateral TKA and observing their postoperative analgesic consumption, visual analog scores and functional recovery. Potential side-effects of the multimodal drugs is also under observation.
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 (Participant, Investigator)
入排标准
- 年龄范围
- — 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with tricompartmental knee disease undergoing simultaneous bilateral TKA
排除标准
- •diabetes mellitus
- •neuromuscular deficit
- •a known allergy to one of the drugs being injected
- •a history of cardiac disease or arrhythmia requiring special monitoring
研究组 & 干预措施
cocktail analgesia
The local infiltration mixture of ropivacaine, fentanyl, adrenaline is used intra-articularly during operation. The patients in the cocktail analgesia group received an injection of 200mg ropivacaine, 100ug fentanyl, and 0.25mg adrenaline into knee collateral ligaments, posterior aspect of the capsule, quadriceps tendon, patellar tendon, fat pad, periosteum, and synovium, along with PCIA morphine postoperatively.
干预措施: ropivacaine, fentanyl, adrenaline (Drug)
结局指标
主要结局
To evaluate the Morphine consumption and PCIA duration
时间窗: 12 hours to 3 days after the surgery
次要结局
- To evaluate the visual analog scale (VAS) in each group patients underwent total knee arthroplasty(4 hours to 5 days after the surgery)
- Function recovery evaluation for patients received surgery(1, 3 and 5 days after the surgery)
研究者
Zhihong Wu
Prof.
Peking Union Medical College Hospital