The Effect of Different Applications of Tourniquet on Total Knee Arthroplasty
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Postoperative pain
研究概览
简要总结
This is a randomized controlled trial designed to research the effects of different tourniquet applications on postoperative pain in patients undergoing total knee arthroplasty, and to guide early postoperative recovery.
详细描述
Sixty participants undergoing unilateral TKA would be recruited in this study. On one side, the tourniquet would be inflated immediately before incision and deflated after the use of the cement , and 10 minutes later(after the hardening of the cement) , reinflate the tourniquet and deflate at the end of the operation. On the other side the tourniquet would be inflated immediately before incision and deflated at the end of the operation.The total time of tourniquet inflation is controlled within 90 minutes. The postoperative pain, limb swelling , the score of surgical field, blood pressure during the operation, blood loss, operating time, transfusion rate, deep vein thrombosis (DVT) incidence and clinical outcomes would be monitored for comparison.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, 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
- 否
入选标准
- •American Society of anesthesiologists Grade 1-3 Patients
- •Undergoing unilateral total knee arthroplasty under general anesthesia
- •Should be treated with tourniquet
排除标准
- •Tourniquet inflation time is less than 1h, greater than 1.5h
- •Abnormal coagulation function
- •BMI < 20kg/m2 or > 35kg/m2
- •History of cerebral infarction
- •History of Peripheral vascular disease
- •Anemia (hemoglobin<90g/L)
- •Systolic blood pressure (SBP) ≥ 170mmHg
- •Pregnant blood glucose > 10mmol/L or HbA1c > 8.5% of diabetic patients
- •History of chronic narcotic use
- •Participate in other clinical trials at the same time
- •Asked to withdraw from the trial
研究组 & 干预措施
Reinflation after early deflation
The tourniquet would be inflated immediately before incision and deflated after the use of the cement, and 10 minutes later (after the hardening of the cement) , reinflate the tourniquet and deflate at the end of the operation.The total time of tourniquet inflation is controlled within 90 minutes.
干预措施: Reinflation after early deflation (Procedure)
Control
The tourniquet would be inflated immediately before incision and deflated at the end of the operation. The inflation of tourniquet should not last more than 90 minutes.
干预措施: Control (Procedure)
结局指标
主要结局
Postoperative pain
时间窗: 48 hours post surgery
tested by Visual Analogue Scale
次要结局
- Hemoglobin(one minute before tourniquet inflation, tourniquet inflation for an hour, one minute before tourniquet deflation, fifteen minutes after tourniquet deflation)
- The rate of postoperative limb swelling(24 hours post surgery, 48 hours post surgery)
- Lac(one minute before tourniquet inflation, tourniquet inflation for an hour, one minute before tourniquet deflation, fifteen minutes after tourniquet deflation)
- Endothelin-1(one minute before tourniquet inflation, tourniquet inflation for an hour, one minute before tourniquet deflation, fifteen minutes after tourniquet deflation)
- Nitric Oxide(one minute before tourniquet inflation, tourniquet inflation for an hour, one minute before tourniquet deflation, fifteen minutes after tourniquet deflation)
- partial pressure of oxygen in artery(one minute before tourniquet inflation, tourniquet inflation for an hour, one minute before tourniquet deflation, fifteen minutes after tourniquet deflation)