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Lornoxicam Versus Etoricoxib in Postoperative Pain After Total Knee Arthroplasty

Primary Purpose

Postoperative Pain

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Lornoxicam
Etoricoxib
Sponsored by
Foisor Orthopedics Clinical Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain focused on measuring postoperative pain, lornoxicam, etoricoxib, total knee arthroplasty

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    GROUP LORNOXICAM

    GROUP ETORICOXIB

    Arm Description

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

    Immediately in postoperative care unit patients received etoricoxib 120 mg PO and another pill at 24 hours.

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    Number of patients with side effects of drugs used
    Number of patients with postoperative nausea and vomiting (PONV) or respiratory depression or gastric complaint or allergic reactions
    Duration of analgesia
    Time from spinal anesthesia until the first rescue morphine analgesia

    Full Information

    First Posted
    February 18, 2016
    Last Updated
    April 25, 2016
    Sponsor
    Foisor Orthopedics Clinical Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02750917
    Brief Title
    Lornoxicam Versus Etoricoxib in Postoperative Pain After Total Knee Arthroplasty
    Official Title
    A Comparative Study of Efficacy and Safety of Lornoxicam Versus Etoricoxib After Total Knee Arthroplasty
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2014 (undefined)
    Primary Completion Date
    January 2015 (Actual)
    Study Completion Date
    March 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Foisor Orthopedics Clinical Hospital

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Postoperative Pain
    Keywords
    postoperative pain, lornoxicam, etoricoxib, total knee arthroplasty

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    120 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    GROUP LORNOXICAM
    Arm Type
    Experimental
    Arm Description
    Immediately in postoperative care unit patients received lornoxicam 8 mg PO/12 hours for 48 hours
    Arm Title
    GROUP ETORICOXIB
    Arm Type
    Active Comparator
    Arm Description
    Immediately in postoperative care unit patients received etoricoxib 120 mg PO and another pill at 24 hours.
    Intervention Type
    Drug
    Intervention Name(s)
    Lornoxicam
    Other Intervention Name(s)
    XEFO RAPID, XEFO
    Intervention Description
    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.
    Intervention Type
    Drug
    Intervention Name(s)
    Etoricoxib
    Other Intervention Name(s)
    Arcoxia, Tauxib
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Total morphine consumption
    Description
    Amount of IV and subcutaneous (SC) morphine (mg) required to reach NRS under 3
    Time Frame
    At 48 hours postoperative
    Secondary Outcome Measure Information:
    Title
    Number of patients with side effects of drugs used
    Description
    Number of patients with postoperative nausea and vomiting (PONV) or respiratory depression or gastric complaint or allergic reactions
    Time Frame
    At 48 hours postoperative
    Title
    Duration of analgesia
    Description
    Time from spinal anesthesia until the first rescue morphine analgesia
    Time Frame
    At 48 hours postoperative

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Ioan Cristian Stoica, Prof
    Organizational Affiliation
    Foisor Orthopedics Clinical Hospital
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    23428763
    Citation
    Ersan O, Akkaya T, Arik E, Ates Y. Intra-articular levobupivacaine, lornoxicam and morphine analgesia after knee arthroscopy: a randomized, controlled trial. Acta Orthop Traumatol Turc. 2012;46(6):411-5.
    Results Reference
    background
    PubMed Identifier
    10434236
    Citation
    Staunstrup H, Ovesen J, Larsen UT, Elbaek K, Larsen U, Kroner K. Efficacy and tolerability of lornoxicam versus tramadol in postoperative pain. J Clin Pharmacol. 1999 Aug;39(8):834-41. doi: 10.1177/00912709922008362.
    Results Reference
    background
    PubMed Identifier
    17953792
    Citation
    Sener M, Yilmazer C, Yilmaz I, Caliskan E, Donmez A, Arslan G. Patient-controlled analgesia with lornoxicam vs. dipyrone for acute postoperative pain relief after septorhinoplasty: a prospective, randomized, double-blind, placebo-controlled study. Eur J Anaesthesiol. 2008 Mar;25(3):177-82. doi: 10.1017/S0265021507002827. Epub 2007 Oct 22.
    Results Reference
    background
    PubMed Identifier
    24481580
    Citation
    Sivrikoz N, Koltka K, Guresti E, Buget M, Senturk M, Ozyalcin S. Perioperative dexketoprofen or lornoxicam administration for pain management after major orthopedic surgery: a randomized, controlled study. Agri. 2014;26(1):23-8. doi: 10.5505/agri.2014.09821.
    Results Reference
    result
    PubMed Identifier
    8951927
    Citation
    Norholt SE, Sindet-Pedersen S, Larsen U, Bang U, Ingerslev J, Nielsen O, Hansen HJ, Ersboll AK. Pain control after dental surgery: a double-blind, randomised trial of lornoxicam versus morphine. Pain. 1996 Oct;67(2-3):335-43. doi: 10.1016/0304-3959(96)03126-0.
    Results Reference
    result
    PubMed Identifier
    19606021
    Citation
    Buvanendran A, Kroin JS. Multimodal analgesia for controlling acute postoperative pain. Curr Opin Anaesthesiol. 2009 Oct;22(5):588-93. doi: 10.1097/ACO.0b013e328330373a.
    Results Reference
    result

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    Lornoxicam Versus Etoricoxib in Postoperative Pain After Total Knee Arthroplasty

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