Efficacy Testing of Different Tourniquet Pressure Used for Postoperative Pain Reduction in Total Knee Arthroplasty: A Prospective, Randomized Controlled Trials
试验速览
- 阶段
- 不适用
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Postoperative visual analogue scale for pain
研究概览
简要总结
Tourniquet use during total knee replacement (TKR) improves visibility, significantly decreases intra-operative blood loss and reduce operative time. However, tourniquet use also has a negative effect on postoperative pain, postoperative range of motion(ROM), wound complication, deep vein thrombosis (DVT), pulmonary embolism (PE), thigh muscle strength, and functional recovery after TKR. Therefore, the investigators conducted a three-arm prospective, randomized, controlled trial study to compare the efficacy of different tourniquet pressure used between systolic blood pressure + 75 mmHg, systolic blood pressure + 100 mmHg, and systolic blood pressure + 150 mmHg.
详细描述
Patients scheduled for unilateral primary TKA; 150 patients were randomly assigned to receive tourniquet pressure used of systolic blood pressure + 75 mmHg, systolic blood pressure + 100 mmHg, and systolic blood pressure + 150 mmHg.
All patients had spinal anesthesia, the same operative procedure, and postoperative pain protocol. A visual analogue scale (VAS) for pain were recorded 24, 48 hours, and 2 weeks postoperatively. Quality of bloodless visual field and calculated blood loss were evaluated perioperatively. Postoperative ROM, wound complication, deep vein thrombosis (DVT), pulmonary embolism (PE) were recorded at 2, 6, and 12 weeks. Furthermore, Knee Society Score (KSS) also recorded at 6 weeks, 3 and 6 months. The reviewers were blinded to the treatment group.
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 (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult patients with osteoarthritis in need of a TKR
排除标准
- •Inflammatory arthritis
- •Post-traumatic arthritis
- •Body mass index > 30 Kg/m2
- •A history of or current venous thromboembolic disease
- •Any underlying disease of hemostasis, cirrhosis, chronic renal failure, patients on anticoagulants or strong antiplatelet drugs (e.g. warfarin, clopidogrel)
- •Preoperative hemoglobin <10 g/dL or a platelet count < 140,000 /uL3
- •Allergy to transamine
结局指标
主要结局
Postoperative visual analogue scale for pain
时间窗: 48 hours after operation
(VAS, 0 = no pain, 10 = the worst imaginable pain)
次要结局
- Quality of bloodless visual field(Intraoperative evaluation)
- Postoperative range of motion(2 weeks, 6 weeks and 12 weeks)
- Number of patient with venous thromboembolism(14 days after the operation)
- Changes from baseline hemoglobin concentrations(48 hours after operation)
- Number of patient with local soft tissue complications(14 days after the operation)
- Knee society score(6 weeks, 12 weeks and 6 months)
研究者
piya pinsornsak
Principal Investigator
Thammasat University