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临床试验/NCT02750917
NCT02750917已完成3 期

A Comparative Study of Efficacy and Safety of Lornoxicam Versus Etoricoxib After Total Knee Arthroplasty

Foisor Orthopedics Clinical Hospital0 个研究点目标入组 120 人开始时间: 2014年9月最近更新:
适应症
干预措施
相关药物

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

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

Experimental

Immediately in postoperative care unit patients received lornoxicam 8 mg PO/12 hours for 48 hours

干预措施: Lornoxicam (Drug)

GROUP ETORICOXIB

Active Comparator

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

发起方
Foisor Orthopedics Clinical Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Munteanu Ana Maria, MD, PhD

MD, PhD

Foisor Orthopedics Clinical Hospital

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