The Effect of Ischemic Preconditioning on Postoperative Pain After Total Knee Arthroplasty, a Randomized, Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Postoperative Pain at Rest and Exercise as Assessed by Visual Analogue Scale (VAS) Scores at 48h After Surgery
研究概览
简要总结
The application of a tourniquet for 5 minutes and subsequent reperfusion before actual inflation of the tourniquet for total knee arthroplasty (ischemic preconditioning) decreases the level of local inflammation and therefore postoperative pain in response to reperfusion of the ischemic extremity.
详细描述
During knee surgery your surgeon routinely uses a device called a tourniquet that allows us to temporarily cut of blood supply to the site of surgery. This helps to reduce blood loss and improves operating conditions. When allowing blood back into your leg at the end of the procedure, debris (bone, fat, tissue breakdown products and cement from the surgery) gets washed out and gains access to the rest of your body. In the vast majority of cases this event bares no major clinical consequences, but can rarely result in signs of inflammation of various body systems. Patients with evidence of impaired organ system function such as pre-existing lung and heart disease may be more vulnerable. Previous studies suggest that cutting off the blood supply for a short period of time just before a prolonged episode, could lead to a decrease in the extent of tissue breakdown products in this extremity and may thus be associated with a decrease in the inflammation of other organ systems. We propose to study this theory in knee surgery patients by looking at levels of markers of inflammation present in the blood before and after surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients undergoing primary total knee arthroplasty
排除标准
- •Patients who chronically use narcotics (<1 month).
- •Patients with contraindications (severe peripheral vascular disease, presence of femoral-popliteal bypass grafts, etc.) or no plan for tourniquet use as determined by the clinical care team.
- •Patients who are on corticosteroids prior to their surgery
研究组 & 干预措施
Ishcemic Preconditioning
In the study group, the patients' operative limb will be preconditioned by inflating the tourniquet for 5 minutes, followed by deflation and a 5-minute reperfusion period. Subsequently, the tourniquet will be inflated for the entire length of the operation (before skin incision to after insertion of the final components).
干预措施: Ischemic Preconditioning (Procedure)
Control
In the control group, the tourniquet will be used for the entire length of the operation without a preconditioning phase.
结局指标
主要结局
Postoperative Pain at Rest and Exercise as Assessed by Visual Analogue Scale (VAS) Scores at 48h After Surgery
时间窗: 48hrs after surgery
Visual Analogue Scale (VAS) are used to measure the intensity of pain. The total scale ranged from 0 (no pain) to 10 (excruciating pain). The average value at POD 48hours was reported for each arm/group.
次要结局
- Overall Epidural Volume(At 48hrs after surgery)
- Muscle Oxygenation Over Calf at 48h After Surgery(At 48 hrs after surgery)
- Levels of Interleukin 6 (IL6) in Drainage Fluid at 24hr Postoperatively(At 24 hours postoperatively)
- Periarticular Circumference of the Knee at 6h, 24h, and 48h(measured at 6 hours, 24 hours, and 48 hours)
- Hospital Length of Stay(Up to discharge date)
- Physical Therapy Milestone(Up to discharge date)
- Levels of Leukocytes in Drainage Fluid at 24hr Postoperatively(24 hours postoperatively)
- Levels of TNF-alpha in Drainage Fluid at 24hr Postoperatively(24 hours postoperatively)