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    Summary
    EudraCT Number:2017-000180-32
    Sponsor's Protocol Code Number:761
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2017-01-25
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedNetherlands - Competent Authority
    A.2EudraCT number2017-000180-32
    A.3Full title of the trial
    Pharmacokinetic Profile of Ropivacaine after Periarticular Local Infiltration Analgesia for Primary Total Knee Arthroplasty Without the use of a Tourniquet.
    Farmacokinetiek van ropivacaïne, gebruikt voor lokale verdoving van de knie bij totale knievervangende operaties zonder gebruik van een bloedleegteband.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to describe the processing of ropivacaine in the body when injected in the knee for pain treatment in total knee arthroplasty
    Studie om te beschrijven hoe ropivacaine opgenomen en verwerkt wordt door het lichaam, wanneer het in de knie wordt ingespoten ter pijnstilling na een totale knie prothese.
    A.3.2Name or abbreviated title of the trial where available
    LIAkin II
    A.4.1Sponsor's protocol code number761
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorSint Maartenskliniek Nijmegen
    B.1.3.4CountryNetherlands
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportSint Maartenskliniek Nijmegen
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSint Maartenskliniek Nijmegen
    B.5.2Functional name of contact pointafdeling research
    B.5.3 Address:
    B.5.3.1Street AddressHengstdal 3
    B.5.3.2Town/ cityUbbergen
    B.5.3.3Post code6574 NA
    B.5.3.4CountryNetherlands
    B.5.6E-mailsecretariaat.rde@maartenskliniek.nl
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Naropin
    D.2.1.1.2Name of the Marketing Authorisation holderFresenius Kabi
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameRopivacaine
    D.3.4Pharmaceutical form Solution for injection/infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPPeriarticular use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product Yes
    D.3.11.13.1Other medicinal product typeamide type local anesthetic
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    patients receiving primary total knee replacement
    Patiënten die een primaire totale knieprothese ondergaan
    E.1.1.1Medical condition in easily understood language
    Patients receiving total knee arthroplasty
    Patiënten bij wie in verband met slijtage van het gewricht het kniegewricht wordt vervangen.
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of this study is to describe a pharmacokinetic profile of total and unbound plasma concentrations of ropivacaine, when used for LIA in TKA surgery without tourniquet.
    Het doel van dit onderzoek is het bepalen van de maximale totale en vrije concentratie ropivacaïne (Cmax en Cumax) en het tijdstip van het bereiken van de maximale en vrije (Tmax en Tumax) concentratie na het zetten van een LIA bij een TKP-operatie wanneer er per-operatief geen bloedleegteband wordt gebruikt.

    Samengevat geeft dit de onderzoeksvraag ‘Wat is de farmacokinetiek van 400 mg ropivacaïne bij LIA voor een TKP-operatie, wanneer peroperatief geen bloedleegteband wordt gebruikt?’
    E.2.2Secondary objectives of the trial
    Not applicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - age 50-80 years
    - ASA physical health classification I – II
    - Body Mass Index (BMI) < 40
    - patient planned for a primary unilateral posterior-stabilized tri-compartmental cemented total knee replacement (Genesis II - PS) under unilateral spinal anesthesia with 2 mL hyperbaric bupivacaine 0.5%
    - scheduled for fast-track protocol TKA
    - haemoglobin (Hb) concentration ≥ 7.5 mMol/L
    - written informed consent
    - 50-80 jaar
    - ASA classificatie I-II
    - BMI<40
    -Staat op wachtlijst voor unilaterale genesis II TKP-procedure
    -Afgesproken anesthesietechniek is spinaalanesthesie (2ml hyperbare bupivacaine 0.5%) met LIA
    -revalidatie volgens Fast-track protocol
    - hb≥7.5mMol/L
    - getekende informed consent formulier
    E.4Principal exclusion criteria
    - Placement of a surgical drain
    - Contra-indications for spinal anesthesia
    - Known hypersensitivity to amide-type local anesthetics
    - Hepatic or renal insufficiency
    - Use of fluvoxamine, ciprofloxacin, ketoconazole, erythromycin, clarithromycin, itraconazole, or rifampicin because of their effect on ropivacaine clearance.
    - Any reason to perform surgery with the use of a tourniquet
    - Any other reason which in the opinion of the investigator makes the patient unsuitable for participation in the study
    - (verwacht) Gebruik van drain(s) postoperatief
    - contra-indicatie voor spinaal anesthesie
    - bekende overgevoeligheid voor amidetype lokaal anestheticum
    - Nier- en/of leverfalen
    - Gebruik van fluvoxamine, ciprofloxacine, ketoconazol, erythromycine, claritromycine, itraconazol, of rifampicine vanwege een effect op de klaring van ropivacaïne
    - (verwacht) Gebruik van een bloedleegteband
    - Enig andere reden die de patiënt ongeschikt maakt voor de studie in de ogen van de onderzoeker (m.n. emotionele of psychologische redenen)
    E.5 End points
    E.5.1Primary end point(s)
    - Mean total and unbound maximum serum concentration of ropivacaine (Cmax and Cumax)
    - Mean time to total and unbound maximum serum concentration of ropivacaine (Tmax an Tumax)
    - gemiddelde totale en ongebonden maximum serum concentratie van ropivacaine (Cmax en Cumax)
    - gemiddelde tijd tot maximum serum concentratie van totaal en ongebonden ropivacaine (Tmax en Tumax)
    E.5.1.1Timepoint(s) of evaluation of this end point
    baseline and 20, 40, 60, 90 , 120, 240, 360, 480, 600, 720 and 1440 minutes after ropivacain infiltration
    baseline en 20, 40, 60, 90, 120, 240, 360, 480, 600, 720 en 1440 minutes na ropivacaine infiltratie
    E.5.2Secondary end point(s)
    Age, weight, height, gender, co-medication, complications and signs of systemic toxicity will be recorded.
    Leeftijd, gewicht, geslacht, leeftijd, comedicatie en tekenen van systemische toxiciteit
    E.5.2.1Timepoint(s) of evaluation of this end point
    baseline and/or post study
    baseline en of/ tot en met het einde van de studie
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety No
    E.6.5Efficacy No
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    cohort study
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    The end point is defined as the last patient's last sampling
    Eindpunt van de trial is gedefinieerd als de laatste bloedafname bij de twintigste patiënt
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months3
    E.8.9.1In the Member State concerned days
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 20
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state20
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2017-01-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-02-10
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-02-12
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