A Comparative Study of Efficacy and Safety of Lornoxicam Versus Etoricoxib After Total Knee Arthroplasty
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 主要终点
- Total morphine consumption
研究概览
简要总结
The purpose of this study is to assess efficacy and safety of lornoxicam compared with that of etoricoxib after total knee replacement.
详细描述
Total primary knee arthroplasty (TKA) remains a model of severe pain for major orthopedic surgery. The concept of multimodal analgesia for the postoperative pain therapy is a routine in many hospitals but the question is still under debate about the ideal combination between techniques and drugs regarding early mobilization and low risk of complications.
After obtaining Ethical Committee approval and informed consent, 110 patients American Society of Anesthesiologists score (ASA ) I-II undergoing knee replacement under spinal anesthesia were randomized to receive postoperative either lornoxicam (8 mg per os (PO) /12 hours (h) for 48 h) or etoricoxib (120mg PO/24 h for 48 h) both administered in the postoperative care unit, at the end of surgery.
The groups received postoperative analgesia when Numeric Rating Scale (NRS) over 3 with IV Perfalgan in fixed dose 1g every 8 h and morphine (loading dose 0,1mg/kg and titration until NRS under 3, followed by subcutaneous (SC) administration of ½ of the total loading dose on demand for the following 48 h).The lornoxicam group received gastric protection with IV pantoprazole.
The effectiveness was evaluated by the time from the initiation of spinal anesthesia until the first analgesic dose at NRS over 3, the total amount of morphine in the first 24 and 48 h 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
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 75 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
排除标准
- •history of asthma
- •peptic ulcer
- •severe hepatic or renal dysfunction
- •neuropathies
- •bleeding disorders
- •uncooperative
- •drugs abuse
- •sensibility to the drugs used
- •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 LORNOXICAM
Immediately in postoperative care unit patients received lornoxicam 8 mg PO/12 hours for 48 hours
干预措施: Lornoxicam (Drug)
GROUP ETORICOXIB
Immediately in postoperative care unit patients received etoricoxib 120 mg PO and another pill at 24 hours.
干预措施: Etoricoxib (Drug)
结局指标
主要结局
Total morphine consumption
时间窗: At 48 hours 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(At 48 hours postoperative)
- Duration of analgesia(At 48 hours postoperative)
研究者
Munteanu Ana Maria, MD, PhD
MD, PhD
Foisor Orthopedics Clinical Hospital
