Influence of the Intraoperative Tourniquet Application Method on the Perioperative Blood Loss, Frequency of Transfusion and Close Postoperative Outcomes in Primary Total Knee Arthroplasty Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Perioperative blood loss.
研究概览
简要总结
Different strategies of tourniquet application during elective primary total knee arthroplasty are thought to be associated with different outcomes. In that context, the study investigates different tactics in the search of optimal application of the tourniquet and the related fluid management during 24 perioperative hours.
详细描述
The optimal application of tourniquet should reduce perioperative blood loss, create bloodless operative field, improve cementing technique and shorten surgery time. Meanwhile, inadequate application may increase the risk of deep vein thrombosis and pulmonary thromboembolism. Previous attempts to compare the tourniquet strategies in respect to the perioperative blood loss did not show significant difference. The investigators use the volume loading test aiming to optimize the fluid status and obtain the hemoglobin concentration in the conditions of standardized plasma dilution. The test is deployed just before the surgery and after postoperative 24 hrs in ICU. Functional outcomes and possible length of hospital stay is also evaluated.
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
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with osteoarthritis of the knee undergoing total knee arthroplasty with spinal-epidural anesthesia
- •Age > 50 and < 80 years
- •ASA (American Society of Anesthesiology Classification) II physical status
- •Signed informed consent form
排除标准
- •History of a bleeding disorder
- •Current chronic anticoagulation therapy
- •History of DVT (Deep Vein Thrombosis), thromboembolic complications, acute cardiac insufficiency
- •Anemia before surgery required blood transfusion
- •ASA I, ASA>=III physical status
- •Age < 50 and > 80 years
- •BMI (Body Mass Index) < 20 and > 40kg/m2
- •Intravascular fluid infusion within 24 hours before study
- •Chronic non-steroidal anti-inflammatory drug use (more than 6month daily use)
- •Rheumatoid arthritis
- •Diabetes mellitus
- •Psychiatric illness (intake of other psychiatric medication than selective serotonin reuptake inhibitors)
- •Alcohol intake 5 U daily
- •Contraindication to epidural catheter insertion
- •Surgery not by project surgeon
- •Participation in the other study
- •Active malignancy
- •Previous open knee surgery
结局指标
主要结局
Perioperative blood loss.
时间窗: Before (baseline) the surgery and 24 hrs postoperatively
The volume loading test is deployed for the comparison of perioperative hemoglobin in the standardized plasma dilution.
次要结局
- Wound healing(Within 6 days postoperatively)
- Hemodilution(Within 6 days postoperatively)
- Cardiac stroke volume(Within 6 days postoperatively)
- Body temperature(Within 6 days postoperatively)
- Pain (Visual Analog Scale)(Within 6 days postoperatively)
- Number of opiate injections(Within 6 days postoperatively)
- Straight-leg raising test(Within 6 days postoperatively)
- Timed up and go test(Within 6 days postoperatively)
- Knee flexion, extension, extension lag(Within 6 days postoperatively)
- Knee swelling(Within 6 days postoperatively)
- Complications(Within 6 days postoperatively)
研究者
Narunas Porvaneckas
Pofessor, PhD
Vilnius University