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Lornoxicam Versus Etoricoxib in Postoperative Pain After Total Knee Arthroplasty

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ClinicalTrials.gov Identifier: NCT02750917
Recruitment Status : Completed
First Posted : April 26, 2016
Last Update Posted : April 26, 2016
Sponsor:
Information provided by (Responsible Party):
Munteanu Ana Maria, MD, PhD, Foisor Orthopedics Clinical Hospital

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

Condition or disease Intervention/treatment Phase
Postoperative Pain Drug: Lornoxicam Drug: Etoricoxib Phase 3

Detailed Description:

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Comparative Study of Efficacy and Safety of Lornoxicam Versus Etoricoxib After Total Knee Arthroplasty
Study Start Date : September 2014
Actual Primary Completion Date : January 2015
Actual Study Completion Date : March 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Knee Replacement

Arm Intervention/treatment
Experimental: GROUP LORNOXICAM
Immediately in postoperative care unit patients received lornoxicam 8 mg PO/12 hours for 48 hours
Drug: Lornoxicam
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

Active Comparator: GROUP ETORICOXIB
Immediately in postoperative care unit patients received etoricoxib 120 mg PO and another pill at 24 hours.
Drug: Etoricoxib
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 Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02750917


Sponsors and Collaborators
Foisor Orthopedics Clinical Hospital
Investigators
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Study Director: Ioan Cristian Stoica, Prof Foisor Orthopedics Clinical Hospital

Publications of Results:
Other Publications:
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Responsible Party: Munteanu Ana Maria, MD, PhD, MD, PhD, Foisor Orthopedics Clinical Hospital
ClinicalTrials.gov Identifier: NCT02750917     History of Changes
Other Study ID Numbers: ID ANALG-002-13
First Posted: April 26, 2016    Key Record Dates
Last Update Posted: April 26, 2016
Last Verified: February 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Munteanu Ana Maria, MD, PhD, Foisor Orthopedics Clinical Hospital:
postoperative pain
lornoxicam
etoricoxib
total knee arthroplasty

Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Etoricoxib
Lornoxicam
Piroxicam
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action