search
Back to results

Dexketoprofen and Etoricoxib in Patients Undergoing Hip Arthroplasty (etoketo)

Primary Purpose

Pain, Postoperative

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Dexketoprofen
Etoricoxib
Sponsored by
Kuopio University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Postoperative focused on measuring Dexketoprofen, Etoricoxib, hip arthroplasty, pain

Eligibility Criteria

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

Inclusion Criteria:

  • agreed to participate the study
  • American Society of Anesthesiologist s physical status classification 1-3
  • elective hip arthroplasty planned
  • no contraindications to the study drugs
  • no contraindication to lumbar puncture

Exclusion Criteria:

  • refused to participate the study
  • age less than 40 or over 75 years
  • Planned anesthesia method other than spinal anesthesia
  • contraindications to the study drugs
  • Contraindications to lumbar puncture

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Etoricoxib

    Dexketoprofen

    Arm Description

    Etoricoxib 60mg if body weight≤ 60kg, 90mg if body weight 61-90kg and 120mg if body weight> 90kg by mouth

    Dexketoprofen 0,5 mg/kg up to 50 mg intravenously

    Outcomes

    Primary Outcome Measures

    Cerebrospinal fluid concentration dexketoprofen and etoricoxib
    Cerebrospinal fluid concentration of dexketoprofen and etoricoxib
    Plasma concentration dexketoprofen and etoricoxib
    Plasma concentration dexketoprofen and etoricoxib

    Secondary Outcome Measures

    Pain
    Pain assessed with numeral rating scale

    Full Information

    First Posted
    October 5, 2015
    Last Updated
    April 30, 2016
    Sponsor
    Kuopio University Hospital
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT02568735
    Brief Title
    Dexketoprofen and Etoricoxib in Patients Undergoing Hip Arthroplasty
    Acronym
    etoketo
    Official Title
    The Central Nervous Penetration of Dexketoprofen and Etoricoxib and Their Effect on Pain and Inflammatory Reaction in Patients Undergoing Hip Arthroplasty
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2013 (undefined)
    Primary Completion Date
    December 2014 (Actual)
    Study Completion Date
    December 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Kuopio University Hospital

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The main purpose of this study was to determine the plasma and central nervious system pharmacokinetics of dexketoprofen and etoricoxib. The secondary aim was to asses their effect on the concentrations of interleukin 6, prostaglandin E2 and other proinflammatory markers both in plasma and cerebrospinal fluid. Thirdly, the investigators aimed to evaluate their efficacy in postoperative pain treatment.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pain, Postoperative
    Keywords
    Dexketoprofen, Etoricoxib, hip arthroplasty, pain

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    24 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Etoricoxib
    Arm Type
    Experimental
    Arm Description
    Etoricoxib 60mg if body weight≤ 60kg, 90mg if body weight 61-90kg and 120mg if body weight> 90kg by mouth
    Arm Title
    Dexketoprofen
    Arm Type
    Active Comparator
    Arm Description
    Dexketoprofen 0,5 mg/kg up to 50 mg intravenously
    Intervention Type
    Drug
    Intervention Name(s)
    Dexketoprofen
    Intervention Description
    After total hip replacement surgery patient were given either etoricoxib or dexketoprofen
    Intervention Type
    Drug
    Intervention Name(s)
    Etoricoxib
    Intervention Description
    After total hip replacement surgery patient were given either etoricoxib or dexketoprofen
    Primary Outcome Measure Information:
    Title
    Cerebrospinal fluid concentration dexketoprofen and etoricoxib
    Description
    Cerebrospinal fluid concentration of dexketoprofen and etoricoxib
    Time Frame
    0-24 hours
    Title
    Plasma concentration dexketoprofen and etoricoxib
    Description
    Plasma concentration dexketoprofen and etoricoxib
    Time Frame
    0-24 hours
    Secondary Outcome Measure Information:
    Title
    Pain
    Description
    Pain assessed with numeral rating scale
    Time Frame
    0-24 h

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    40 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: agreed to participate the study American Society of Anesthesiologist s physical status classification 1-3 elective hip arthroplasty planned no contraindications to the study drugs no contraindication to lumbar puncture Exclusion Criteria: refused to participate the study age less than 40 or over 75 years Planned anesthesia method other than spinal anesthesia contraindications to the study drugs Contraindications to lumbar puncture

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Dexketoprofen and Etoricoxib in Patients Undergoing Hip Arthroplasty

    We'll reach out to this number within 24 hrs