A Randomized Comparison Between Parecoxib and Placebo Added to a Standard Perioperative Analgesic Protocol for Total Knee Arthroplasty
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Morphine consumption
研究概览
简要总结
Early mobilization and rehabilitation can be difficult after total knee arthroplasty (TKA) due to a high incidence of moderate to severe postoperative pain. Non-steroidal anti-inflammatory drugs (NSAIDs) are important to multimodal analgesic protocols. Parecoxib is an NSAID that selectively inhibits the enzyme cyclooxygenase-2 (COX-2). Clinical trials have shown that it does not alter platelet function or gastric mucosa. A recent study, after comparing ketorolac and parecoxib used at the same time in infiltration and systemically, found no differences in perioperative analgesia with a tendency to less bleeding in the parecoxib group. This randomized study will compare the effectiveness of adding a COX-2 inhibitor in the pain management of patients undergoing TKA as part of a multimodal analgesia regimen. The morphine consumption was selected as the primary outcome. The study hypothesis is that patients receiving parecoxib would have a lower opioid consumption.
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
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ASA I - III BMI 20 - 35 (kg/m2)
排除标准
- •Adults who are not capable of giving their own consent
- •Pre-existing neuropathy (assessed in the history and physical examination)
- •Coagulation disturbance (assessed on history and physical examination, if clinically necessary, by blood test, i.e. platelets ≤ 100,000, international normalized ratio ≥ 1.4 or prothrombin time ≥ 50)
- •Renal failure (assessed by history and physical examination, if considered clinically necessary, by blood test, i.e. creatinine ≥ 1.04 mg/dl)
- •Hepatic impairment (assessed by history and physical examination, if considered clinically necessary, by blood tests, i.e. transaminases (GGT ≥ 50 u/lt)
- •Allergy to local anesthetics, morphine, paracetamol, ketorolac or parecoxib
- •Pregnancy
- •Chronic pain syndromes that require the use of opioids at home
- •Known history of sulfa allergy
- •History of ischemic heart disease
- •History of chronic gastritis or peptic ulcer
研究组 & 干预措施
Parecoxib
This arm will receive intravenous parecoxib in the intraoperative period.
干预措施: Intravenous study drug (Drug)
Placebo
This arm will receive a placebo intravenous injection containing saline solution in the same volume as the intervention group
干预措施: Intravenous saline solution (Other)
结局指标
主要结局
Morphine consumption
时间窗: 24 hours
Morphine consumed postoperatively during the first 24 hrs utilizing a patient-controlled analgesia device programmed 1mg/ml morphine solution, no infusion, 1ml dose, 8 minutes lockout.
次要结局
- Basal quadriceps strength in the operative side(1 hour before surgery)
- Nerve block performance time(5 minutes after anesthesia induction (before surgical incision))
- Incidence of Block complications(5 minutes after anesthesia induction and before surgical incision)
- Basal level of pain during leg extension in the operative side(1 hour before surgery)
- Basal plasmatic creatinine(1 hour before surgery)
- Time to first morphine dose request(24 hours)
- Postoperative dynamic pain level at 12 hours(12 hours)
- Postoperative dynamic pain level at 48 hours(48 hours)
- Morphine consumption during first 48 hours(48 hours)
- Incidence of opioid related side effects(48 hours)
- Incidence of NSAIDs related clinical side effects(48 hours)
- Postoperative static pain level at 3 hours(3 hours)
- Postoperative dynamic pain level at 3 hours(3 hours)
- Postoperative static pain level at 6 hours(6 hours)
- Postoperative dynamic pain level at 6 hours(6 hours)
- Postoperative dynamic pain level at 24 hours(24 hours)
- Postoperative static pain level at 48 hours(48 hours)
- Medial malleolus sensory block level(24 hours)
- Postoperative quadriceps strength(24 hours)
- Postoperative static pain level at 12 hours(12 hours)
- Postoperative static pain level at 24 hours(24 hours)
- Incidence of restriction to perform physiotherapy(48 hours)
- Postoperative plasmatic creatinine level(48 hours)
- Lateral malleolus sensory block level(24 hours)
研究者
Julian Aliste
Associate Professor
University of Chile