Comparison of Outcomes Between Multimodal Intraosseous Femoral Injection and Multimodal Intraosseous Tibial Injection, a Randomized Controlled Trial in Simultaneous Bilateral Total Knee Arthroplasty Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Pain score (Visual analog scale)
研究概览
简要总结
In patients with osteoarthritis of the knee whose pain cannot be relieved by conservative treatment, total knee arthroplasty (TKA) is the operation that increases the quality of life for the patient. Pain management after total knee arthroplasty TKA is an important consideration to improve patient outcomes and reduce length of stay. Periarticular injections of the knee are one of the techniques used to reduce pain after surgery. Studies have shown that compared to other methods of pain relief, they are effective and safe. At present, no studies to compare between multimodal intraosseous femoral injection & multimodal intraosseous tibial injection in Simultaneous Bilateral TKA patients.
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
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who will undergo bilateral Total knee Replacement due to osteoarthritis of both knees
- •Used of a cemented, PS design TKA surgery.
- •Able to give informed consent
排除标准
- •Revision TKA
- •History of previous knee or hip surgery
- •History of allergic reaction or side effects to the drug that will be used in the experiment
- •Underlying diseases of chronic kidney disease or chronic liver disease (Child Pugh B or C)
- •Pregnancy
- •History of coagulopathy or abnormal blood coagulation profile(INR >1.4 or aPTT ratio > 1.4)
- •History of platelet dysfunction or platelet count < 140,0000/mm3
- •History of Thromboembolism
- •Use of Anticoagulants.
研究组 & 干预措施
Multimodal Intraosseous Femoral Injection
Intraosseous injection of Ketorolac 15mg and Tranexamic acid 500mg in femoral canal
干预措施: Multimodal Intraosseous Femoral Injection (Drug)
Multimodal Intraosseous Tibial Injection
Intraosseous injection of Ketorolac 15mg and Tranexamic acid 500mg in tibial canal
干预措施: Multimodal Intraosseous Tibial Injection (Drug)
结局指标
主要结局
Pain score (Visual analog scale)
时间窗: at 12 hours, 24 hours, 48 hours and 2 weeks after surgery
Visual analog scale (VAS) score from 0-10(0 was no pain, 10 was worst pain ) between multimodal intraosseous femoral injection \& multimodal intraosseous tibial injection
次要结局
- Amount of painkillers used(up to 24 hours after surgery)
- Post operative blood loss(intraoperative and up to 48 hours postoperatively (include intraoperative and drain))
- Knee and Osteoarthritis Outcome Score (KOOS)(post operative 2 weeks)
- Length of hospital stay(Admit to discharge date (up to 7 days))
- knee range of motion(post operative 2 weeks)
- Side effects and complications(intraoperative to post operative 2weeks)