Local Infiltration Analgesia With Ropivacaine, Ketorolac and Epinephrine Intra- and Postoperatively in Total Knee Arthroplasty
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Morphine consumption
研究概览
简要总结
The primary aim of this study is to evaluate if intra- and postoperative administration of ropivacaine, ketorolac and epinephrine into the operating field would affect morphine consumption. Secondary end-points are hospital stay, pain intensity and side effects. In an attempt to assess the safety of this technique, knee function and patient satisfaction scores are assessed up to 3 months after surgery.
详细描述
Postoperative pain is often severe following knee arthroplasty. Recently, a local infiltration analgesia (LIA) technique was developed by Drs Kerr and Kohan in Sydney, Australia. With this LIA-technique, a long-acting local anesthetic (ropivacaine), a nonsteroidal anti-inflammatory drug (ketorolac), and epinephrine are infiltrated intraoperatively and via an intraarticular catheter postoperatively. We ahve completed a study on unicompartmental knee arthroplasty and the present study is investigating total knee arthroplasties.
The primary aim of this study is to evaluate if intra- and postoperative administration of ropivacaine, ketorolac and epinephrine into the operating field would affect morphine consumption. Secondary end-points are hospital stay, pain intensity and side effects. In an attempt to assess the safety of this technique, knee function and patient satisfaction scores are assessed up to 3 months after surgery.
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
- 20 Years 至 85 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients scheduled for total knee arthroplasty
- •Aged 20-85 yrs
- •ASA physical status I-III and mobility indicating normal postoperative mobilization
排除标准
- •Known allergy or intolerance to one of the study drugs
- •Serious liver-, heart- or renal decease
- •Rheumatoid arthritis
- •Chronic pain or bleeding disorder
研究组 & 干预措施
1 Group A(Active)
Group A (Active) receives a multimodal injection intra- and postoperatively
干预措施: ropivacaine, ketorolac and epinephrine (Drug)
2 Group P (Placebo)
Group P (Placebo) receives no injection intraoperatively and a saline injection postoperatively
干预措施: saline (Drug)
结局指标
主要结局
Morphine consumption
时间窗: 0-48 hours
次要结局
- hospital stay, pain intensity, side effects, knee function and patient satisfaction scores(0-3 months)