Comparison Study of Three Different Methods of Postoperative Pain Management After Total Knee Arthroplasty
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 72
- 试验地点
- 2
- 主要终点
- Postoperative analgesia
研究概览
简要总结
The study compares three different analgesic techniques in order to determine which one serves as the optimal method for postoperative pain management after Total Knee Arthroplasty in patients suffering from Osteoarthritis
详细描述
Prospective, randomized, controlled study. Approval of the study from the University Hospital of Patras Ethics Committee. The Total Knee Arthroplasty procedure is performed always from the same team of Orthopedic surgeons who follow the same technique in each patient for the arthroplasty and the placement of the intraarticular catheter as well. The same team of Anesthesiologists (two Anesthesiologists) performs always the same technique for each analgesic method and is responsible for the patients' perioperative condition concerning anesthesia and analgesia.
Preoperatively, one hour prior to the surgery, all patients receive preemptive multimodal analgesia in the following way; 40mg Parecoxib (iv), 1gr Paracetamol (iv), 150mg Pregabalin (po), 8mg Dexamethasone (iv) και 50mg Ranitidine (iv).
All patients receive subarachnoid anesthesia with Ropivacaine 0.75% (7,5mg/ml) in a dosage of 2-3ml titrated according to patient's age and height.
Three groups
- Continuous epidural infusion (control group) with Ropivacaine 0.2% + clonidine 150μg.
- Continuous femoral nerve blockade infusion with Ropivacaine 0.2% + clonidine 150μg.
- Continuous intraarticular infusion with Ropivacaine 0.2% + clonidine 150μg.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients scheduled for unilateral total knee arthroplasty (TKA) to treat knee osteoarthritis (OA)
- •Fully conversant in the Greek language
- •Written informed consent to participate in the trial
排除标准
- •Age less than 50 years and greater than 85 years.
- •ASA score >III
- •Subarachnoid anesthesia failure
- •Hypersensitivity/ allergy to certain agent used
- •Participation in other research/ study
- •Severe mental disease (schizophrenia, major depression, severe bipolar disorder, substance abuse)
结局指标
主要结局
Postoperative analgesia
时间窗: Up to 3 days
Pain scores, during rest and movement (active and passive) according to NRS (Numeric Rating Scale) right after the end of the surgery and 2, 4, 6, 12, 24, 36, 48, 60 and 72 hours later (postoperatively)
次要结局
- Mobilization(Up to 3 days)
- LOS(Up to 3 months)
研究者
Georgios Karpetas
Anesthesiologist MD
University Hospital of Patras