Local Infiltration Analgesia During Total Knee Arthroplasty - Reduced Opiate Consumption and Faster Mobilisation Postoperatively - Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- oxycodone consumption during the first 48 postoperative hours
研究概览
简要总结
The primary objective is to evaluate whether local infiltration analgesia (LIA) will reduce oxycodone consumption during the first 48 postoperative hours in patients undergoing total knee arthroplasty (TKA).
详细描述
The goal of LIA is to gain an effective and safe pain control during the first postoperative days. The study is a single-center, randomized controlled trial, which will be performed in Coxa Hospital for Joint Replacement in Tampere, Finland. The injectant mixture consists of 150 mg levobupivacaine mixed with 30 mg ketorolac and 0.5 mg adrenaline with occasional variations if the patient is unusually small, very elderly, infirm or has a history of significant intolerance to analgesics or anesthetic agents. The RKA mixture is diluted with normal saline. Total volume of the solution is 100 ml depending on the size of the wound. The normal saline injection are used in the control group in the same manner than in the RKA group.
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients requiring primary TKA for primary OA
- •Patients aged 75 years or less
- •Patients suitable for all applicable devices
排除标准
- •Rheumatoid arthritis or other inflammatory diseases
- •Patients requiring bone grafting during surgery
- •Unwilling to provide informed consent
- •BMI > 35
- •Renal dysfunction
- •Allergic to ASA
- •Previous high tibial osteotomy or previous osteosynthesis
- •> 15 degrees varus / valgus malalignment
- •Physical, emotional or neurological conditions which would comprise the patient´s compliance with postoperative rehabilitation and follow-up (e.g. drug or alcohol abuse, serious mental illness, general neurological conditions such as Parkinson, MS, etc.)
- •Known sensitivity to materials in the devices
研究组 & 干预措施
local infiltration analgesia
The injectant mixture consists of 150 mg levobupivacaine mixed with 30 mg ketorolac and 0.5 mg adrenaline
干预措施: The injectant mixture consists of 150 mg levobupivacaine mixed with 30 mg ketorolac and 0.5 mg adrenaline (Drug)
saline injection
The normal saline injection are used in the control group in the same manner than in the RKA group.
干预措施: saline injection (Other)
结局指标
主要结局
oxycodone consumption during the first 48 postoperative hours
时间窗: 48 hours
次要结局
- functional outcome after TKA(1 year)
研究者
Mika Niemeläinen
orthopaedic surgeon
Coxa, Hospital for Joint Replacement