Skip to main content
OpenTrials
Completed

NCT Number: NCT02750917

Lornoxicam Versus Etoricoxib in Postoperative Pain After Total Knee Arthroplasty

The purpose of this study is to assess efficacy and safety of lornoxicam compared with that of etoricoxib after total knee replacement.

Completed

Looking for future studies?

Notify Me

Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ASA I-III
  • weight (kilos) over 40 kg
  • height (centimeters) over 155 cm
  • non-anemic
  • indication for primary TKA

Exclusion criteria

  • 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

Treatment and study plan

Lornoxicam

Drug

At the end of surgery patients in group LORNOXICAM received one pill of 8 mg lornoxicam every 12 hours in the surgery day and first postoperative day.

Other names: XEFO RAPID, XEFO

Etoricoxib

Drug

At the end of surgery patients in the ETORICOXIB group received one pill of 120 mg etoricoxib at the end of surgery and a second one after 24 hours. This group also received placebo pills at 12 h, between the active pills.

Other names: Arcoxia, Tauxib

Primary outcomes

  1. Total morphine consumption

    Time frame: At 48 hours postoperative

    Amount of IV and subcutaneous (SC) morphine (mg) required to reach NRS under 3

Secondary outcomes

  1. Number of patients with side effects of drugs used

    Time frame: At 48 hours postoperative

    Number of patients with postoperative nausea and vomiting (PONV) or respiratory depression or gastric complaint or allergic reactions

  2. Duration of analgesia

    Time frame: At 48 hours postoperative

    Time from spinal anesthesia until the first rescue morphine analgesia

Sponsors and collaborators

Lead sponsor

Foisor Orthopedics Clinical Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Apr 26, 2016
Registry last updated
Apr 26, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.