Is There Any Analgesic Benefit From Preoperative vs. Postoperative Etoricoxib Administration in Total Knee Arthroplasty?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 165
- 试验地点
- 1
- 主要终点
- Total morphine consumption
研究概览
简要总结
Evaluation of the efficacy of preemptive versus postoperative administration of etoricoxib in total knee arthroplasty (TKA).
详细描述
The investigators conducted a prospective randomized controlled study in 165 patients American Society of Anesthesiologists (ASA) score I-III scheduled for primary TKA, divided in 3 groups: group A (Etoricoxib 120 mg orally one hour before surgery), group B (Etoricoxib 120 mg orally at the end of surgery) and group C placebo. Surgery has been performed under spinal anesthesia.
All groups received postoperative analgesia when Numeric Rating Scale (NRS) over 3 with intravenous (IV) Perfalgan and morphine on demand for the following 48 h.
The effectiveness was evaluated by the time from the initiation of spinal anesthesia until the first analgesic dose at NRS > 3, the total amount of morphine in the first 24 and 48 hours postoperative, the side effects and necessary amount of adjuvant medication.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
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
- •weight (kilos) over 40 kg
- •height (centimeters) over 155 cm
- •non-anemic
- •indication for primary TKA (total knee arthroplasty)
排除标准
- •history of asthma
- •peptic ulcer
- •severe hepatic or renal dysfunction
- •neuropathies
- •bleeding disorders
- •uncooperative
- •drug abuse
- •sensibility to etoricoxib
- •paracetamol or morphine
- •long acting nonsteroidal antiinflammatory drugs (NSAID) in the last 4 days preoperative
- •cerebrovascular and peripheric vascular disease
- •arterial hypertension (HTA) not adequately controlled
- •congestive heart failure.
研究组 & 干预措施
Group ETORICOXIB PREOP
Preoperative (1 h) per os (PO) 120 mg Etoricoxib (Arcoxia) and 1 placebo pill PO at the end of surgery.
干预措施: Etoricoxib (Drug)
Group ETORICOXIB PREOP
Preoperative (1 h) per os (PO) 120 mg Etoricoxib (Arcoxia) and 1 placebo pill PO at the end of surgery.
干预措施: Placebo (Drug)
Group ETORICOXIB POSTOP
Preoperative (1 h) 1 placebo pill PO and 120 mg Etoricoxib PO at the end of surgery (Arcoxia).
干预措施: Etoricoxib (Drug)
Group ETORICOXIB POSTOP
Preoperative (1 h) 1 placebo pill PO and 120 mg Etoricoxib PO at the end of surgery (Arcoxia).
干预措施: Placebo (Drug)
Group PLACEBO
1 placebo pill PO 1 h preoperative and 1 placebo pill PO postoperative at the end of surgery.
干预措施: Placebo (Drug)
结局指标
主要结局
Total morphine consumption
时间窗: At 48 hour postoperative
Amount of IV and subcutaneous (SC) morphine (mg) required to reach NRS under 3
次要结局
- Number of patients with side effects of drugs used(48 hour postoperative)
- Duration of analgesia(At 48 hours postoperative)
研究者
Munteanu Ana Maria, MD, PhD
Medical Director
Foisor Orthopedics Clinical Hospital