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    Summary
    EudraCT Number:2014-005596-90
    Sponsor's Protocol Code Number:NL51548.100.14
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2015-04-21
    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 number2014-005596-90
    A.3Full title of the trial
    Comparison of femoral nerve block with posterior capsule infiltration versus anterior and posterior capsule infiltration after total knee replacement.
    Vergelijking van nervus femoralis blokkade met achterste kapselinfiltratie versus voorste en achterste kapselinfiltratie na totale knie prothese.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Comparison of nerveblock and local infiltration block in the knee after total knee replacement.
    Vergelijking van zenuwblokkade versus lokale infiltratie in de knie na totale knieprothese.
    A.3.2Name or abbreviated title of the trial where available
    LiFeAnKeR
    LiFeAnKeR
    A.4.1Sponsor's protocol code numberNL51548.100.14
    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 SponsorSt. Lucas Andreas Hospital
    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 supportSt. Lucas Andreas Hospital
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSt. Lucas Andreas Hospital
    B.5.2Functional name of contact pointAnesthesiology
    B.5.3 Address:
    B.5.3.1Street AddressJan Tooropstraat 164
    B.5.3.2Town/ cityAmsterdam
    B.5.3.3Post code1061 AE
    B.5.3.4CountryNetherlands
    B.5.4Telephone number0031020510 8911
    B.5.6E-mailm.vogel@slaz.nl
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleComparator
    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 ropivacaine HCl
    D.2.1.1.2Name of the Marketing Authorisation holderFresenius Kabi Nederland B.V.
    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.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPPeriarticular use
    Perineural use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNropivacaine
    D.3.9.1CAS number 132112-35-7
    D.3.9.2Current sponsor codenon
    D.3.9.3Other descriptive nameROPIVACAINE HYDROCHLORIDE MONOHYDRATE
    D.3.9.4EV Substance CodeSUB22590
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCLONIDINE
    D.3.9.1CAS number 4205-90-7
    D.3.9.4EV Substance CodeSUB06730MIG
    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 No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 ropivacaine
    D.2.1.1.2Name of the Marketing Authorisation holderFresenius Kabi Nederland
    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 infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPPeriarticular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNropivacaine
    D.3.9.1CAS number 132112-35-7
    D.3.9.3Other descriptive nameROPIVACAINE HYDROCHLORIDE MONOHYDRATE
    D.3.9.4EV Substance CodeSUB22590
    D.3.10 Strength
    D.3.10.1Concentration unit Ci/mg curie(s)/milligram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number300
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNepinephrine
    D.3.9.1CAS number 51-43-4
    D.3.9.3Other descriptive nameEPINEPHRINE
    D.3.9.4EV Substance CodeSUB06568MIG
    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 No
    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
    patienst requiring total knee replacement for non-inflammatory osteoarthritis of the knee
    patient die een totale knieprothese krijgen in verband met gonarthrose van de knie
    E.1.1.1Medical condition in easily understood language
    patients undergoing total knee replacement surgery for osteoarthrosis of the knee
    patienten die een totale knie prothese krijgen in verband met arthrose van de knie.
    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
    Identifying the optimal analgesia technique for patients undergoing a total knee replacement giving the best functional outcome.
    Vaststellen van de optimale analgesietechniek voor patienten die een totale knieprothese krijgen die de beste functionale outcome geeft.
    E.2.2Secondary objectives of the trial
    - NRS pain score in rest from the day of surgery until day 3 post surgery
    - NRS pain score in flexion exercise from the day of surgery until day 3 post surgery
    - NRS pain score postoperatively when walking
    - range of motion with flexion and extension during 3 postoperative days
    - length of stay in hospital
    - side-effects
    Pijnscore (NRS) postoperatief in rust tot en met derde postoperatieve dag (drie maal per
    dag) Waarbij NRS 0=geen pijn en NRS 10=maximale pijn.
    •Pijnscore (NRS) postoperatief bij flexieoefening tot en met de derde postoperatieve dag
    (eenmaal per dag)
    •Pijnscore (NRS) postoperatief tijdens lopen (indien mogelijk, een maal per dag)
    •Bewegingsrange flexie en extensie (graden) gedurende drie dagen
    •Ziekenhuisopnameduur (dagen)
    •Bijwerkingen
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients 18 years and older who are scheduled for a TKA with spinal anesthesia.
    - age above 18 years
    - mentally competent
    - eligible for TKA
    - informed consent
    Patiënten boven de 18 jaar voor TKP onder spinaal anesthesie zullen worden benaderd om deel te nemen aan de studie.
    •ouder dan 18 jaar
    •wilsbekwaam
    •op wachtlijst voor TKP
    •informed consent
    E.4Principal exclusion criteria
    -contra indication for spinal anesthesia (severe aortic stenosis, severely compromised cardiac function)
    - infection at interspace of spinal injection
    - allergy to used medicine
    - repeat TKA
    - all previous surgeries concerning arthrotomy
    - participation in other research protocol
    contra-indicatie voor spinale anesthesie:aortaklepstenose en ernstig verminderde hartfunctie
    •infectie op insteekplaats spinaal
    •allergie voor de toe te dienen medicatie
    •re-operatie knie
    •alle ingrepen waarbij eerder een arthrotomie is verricht
    •overgevoeligheid voor de gebruikte medicatie
    •deelname aan andere studie


    E.5 End points
    E.5.1Primary end point(s)
    -Opioid consumption measured by mg of morphine i.v. used daily (every morning at 10.00 am)
    -Mobilization measured by Modified Iowa Levels of Assistance Scale (MILAS)
    •Opiaatconsumptie (aantal mg morfine, iedere ochtend aflezen om 10.00 uur)
    •Modified Iowa Levels of Assistance Scale (MILAS).
    E.5.1.1Timepoint(s) of evaluation of this end point
    day of surgery, postoperative during hospital stay
    dag van de operatie en elke dag tijdens ziekenhuisopname
    E.5.2Secondary end point(s)
    - NRS pain score in rest from the day of surgery until day 3 post surgery
    - NRS pain score in flexion exercise from the day of surgery until day 3 post surgery
    - NRS pain score postoperatively when walking
    - range of motion with flexion and extension during 3 postoperative days
    - length of stay in hospital
    - side-effects
    •Pijnscore (NRS) postoperatief in rust tot en met derde postoperatieve dag (drie maal per
    dag) Waarbij NRS 0=geen pijn en NRS 10=maximale pijn.
    •Pijnscore (NRS) postoperatief bij flexieoefening tot en met de derde postoperatieve dag
    (eenmaal per dag)
    •Pijnscore (NRS) postoperatief tijdens lopen (indien mogelijk, een maal per dag)
    •Bewegingsrange flexie en extensie (graden) gedurende drie dagen
    •Ziekenhuisopnameduur (dagen)
    •Bijwerkingen
    E.5.2.1Timepoint(s) of evaluation of this end point
    day of operation, postoperative during hospital stay
    dag van de operatie en elke dag tijdens ziekenhuisopname
    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 Yes
    E.6.6Pharmacokinetic No
    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 Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    andere injectieplaats (femoralisblok versus lokale infiltratie)
    other site of injection( femoral nerve block versus local infiltration)
    E.8.2.4Number of treatment arms in the trial2
    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
    LVLS
    laatste meting laatste proefpersoon
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    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: 30
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 60
    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 state90
    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)
    Normal treatment of that condition will be provided
    Normale behandeling zal worden geleverd.
    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 Decision2015-04-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-03-31
    P. End of Trial
    P.End of Trial StatusOngoing
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