Comparison of the Effect of Single Adductor-canal-block and Peri-articular Infiltration on the Outcome After Unilateral Total Knee Arthroplasty
试验速览
- 阶段
- 不适用
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- the time required for functional recovery
研究概览
简要总结
The purpose of this study is to compare the effect of single adductor-canal-block versus single femoral nerve block on the recovery after total knee arthroplasty.
详细描述
The aim of this study is to assess the effect of different analgesic effects on the outcome of patients undergoing total knee arthroplasty. Patients who will have primary unilateral total knee replacement between September 2016 to June 2018 at Peking Union Medical College Hospital and meet the inclusion criteria will be included. They are randomized into two groups. The total knee arthroplasty is performed by one surgeon and adductor-canal block is performed by one anesthesiologist who is not responsible for follow-up. Patients on both groups will have intravenous patient control analgesia with 1 mg morphine/bolus. One residency is responsible for the follow-up.
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 (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •osteoarthritis
- •unilateral total knee arthroplasty
- •ASA grade I - II
- •normal cognitive function.
排除标准
- •patients refuse
- •BMI > 35
- •diagnosis other than osteoarthritis
- •allergy to the drugs used or contraindication to the intervention
研究组 & 干预措施
single adductor-canal-block
Patients in this group will receive ultrasound guided single adductor-canal- block with 0.35% ropivacaine 25ml.
干预措施: single adductor-canal-block (Drug)
periarticular infiltration
patients in this group will receive periarticular infiltration of local anesthetic.
干预措施: periarticular infiltration (Drug)
结局指标
主要结局
the time required for functional recovery
时间窗: from the date of the surgery to the time when the patients meet the criteria of functional recovery. The earliest day on which the patient achieves the criteria of functional recovery will be recorded and the average time is 7 days after surgery.
Patients are evaluated postoperatively to determine whether the patients have meet the criteria of functional recovery.The criteria of functional recovery are as followings: walking distance more than 70m with crutch, getting up or standing up independently and visual analog score less than 5 both in rest and after movement. Before discharge, patients are assessed every morning. After discharge, patients are followed up by phone every two days.
次要结局
- postoperative morphine consumption(6h, 24h, 48h after the surgery)
- postoperative WOMAC scales(pre-operative, three months,six months and one year afer the surgery)
- Postoperative complications(daily after the surgery until discharge from hospital, expected average up to 5 days after the surgery)
- postoperative VAS scale(pre-operative, 6h postoperative, 24h postoperative, 48h postoperative, one month postoperative, three-month postoperative, one year postoperative)
- postoperative SF-36 score(pre-operative, three months,six months and one year afer the surgery)