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    The EU Clinical Trials Register currently displays   44334   clinical trials with a EudraCT protocol, of which   7366   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2015-004119-19
    Sponsor's Protocol Code Number:2015-005-M
    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:2016-02-22
    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 number2015-004119-19
    A.3Full title of the trial
    Femoral Nerve Blockage in Proximal Femoral Fractures in patients of 65 years of age or older, a Randomised Controlled Trial
    Nervus Femoralis Blokkade in Proximale Femurfracturen in patiënten van 65 jaar of ouder, een Gerandomiseerd Onderzoek
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Nerve blockage in patients with a hip fracture.
    Zenwblokkade in patiënten met een heupfractuur.
    A.3.2Name or abbreviated title of the trial where available
    Femoral Nerve Blockage in Proximal Femoral Fractures
    Nervus Femoralis Blokkade in Proximale Femurfracturen
    A.4.1Sponsor's protocol code number2015-005-M
    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 SponsorReinier de Graaf 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 supportReinier de Graaf Hospital
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationReinier de Graaf Hospital
    B.5.2Functional name of contact pointNina Mathijssen
    B.5.3 Address:
    B.5.3.1Street AddressReinier de Graafweg 5
    B.5.3.2Town/ cityDelft
    B.5.3.3Post code2625 AD
    B.5.3.4CountryNetherlands
    B.5.4Telephone number00310152603718
    B.5.5Fax number00310152604029
    B.5.6E-mailn.mathijssen@rdgg.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 Chirocaine 5mg/ml
    D.2.1.1.2Name of the Marketing Authorisation holderAbbVie 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.3.1Product nameChirocaine 5mg/ml
    D.3.2Product code RVG 24618
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPPerineural 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 No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection
    D.8.4Route of administration of the placeboPerineural use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Pain in patients with a proximal femoral fracture.
    Pijn in patiënten met een proximale femurfractuur.
    E.1.1.1Medical condition in easily understood language
    Pain in patients with a hip fractuur.
    Pijn in patiënten met een gebroken heup.
    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 objective of this study is to determine the clinical outcomes of ultrasound guided femoral nerve blockage using intermitting shots of levobupivacaine, in patients with hip fractures and to compare these results with placebo injections.
    The primary objective is to investigate if femoral nerve blockage leads to a decrease in pain and a decrease in complications (delirium, nausea, vomiting, obstipation, hypotension, urinary retention, and respiratory depression). This will be measured with the raw pain intensity difference up to 4 hours after the femoral block. The percentage of patiënts with and without complications will be recorded. Next we will record every individual complication.
    Met deze studie zullen de klinische consequenties worden onderzocht van intermitterende toediening van levobupivacaïne rond de femoraalzenuw vergeleken met placebo injecties.
    Primair zal middels deze studie worden bepaald of blokkade van de nervus femoralis leidt tot pijn verlaging en vermindering van het aantal complicaties. Dit zal worden uitgedrukt in exacte verschillen in pijn intensiteit tot 4 uur na de injectie. Het aantal complicaties zal per complicatie en per patiënt worden gescoord.
    het verlagen van de pijn
    E.2.2Secondary objectives of the trial
    The secondary objectives of this study include the pain measured with NRS on multiple moments before and after surgery, the amount of analgesics used (paracetamol, non-steroid anti-inflammatory drugs and opioids), length of hospital stay, post-operative mobility status and subsequent discharge location.
    De secundaire onderzoekspunten van deze studie zijn de pijn op basis van de NRS schaal op meerdere punten pre- en postoperatief, het gebruik van andere pijnstillers (paracetamol, NSAID's en opioïden), ligduur, post-operatieve mobiliteit en de ontslaglocatie.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    In order to be eligible to participate in this study, a subject must meet all of the following criteria:
    - Proven proximal femoral fracture (trochanteric, head and neck fractures)
    - Normal lower extremity anatomy and neurovascular examination
    - NRS pain score of ≥4 at admission
    - Aged 65 or older
    Om mee te kunnen doen aan deze studie, zal een proefpersoon aan de volgende eisen moeten voldoen:
    - Bewezen proximale femurfractuur (pertrochantair, mediale en laterale collumfractuur).
    - Niet afwijkende anatomie en neurovasculair onderzoek van de onderste extrimiteiten
    - NRS pijn score van ≥4 bij opname
    - 65 jaar of ouder
    E.4Principal exclusion criteria
    A potential subject who meets any of the following criteria will be excluded from participation in this study:
    - Cognitive impairment; previous diagnosed with dementia or MMSE ≤ 22
    - Delirium at inclusion
    - No good understanding of the Dutch language
    - Known hypersensitivity to local anaesthetics or morphine
    - Multi-trauma patients
    - Pre injury use of opioids
    - Pre injury bedridden or wheelchair bound patients
    Een potentiëel proefpersoon die aan een van de volgende citeria voldoet zal worden uitgesloten van deelname:
    - Cognitieve stoornis; gediagnosticeerd met dementie of een MMSE ≤ 22
    - Delier bij inclusie
    - Onvoldoende begrip van de Nederlandse taal
    - Bekende overgevoeligheid voor locale anaesthesie of morfine
    - Multi traumata
    - Gebruik van opioïden voor het trauma
    - Rolstoel of bed gebonden patiënten
    E.5 End points
    E.5.1Primary end point(s)
    Raw pain intensity difference (PID) up to 4 hours after femoral nerve blockage. The raw PID was calculated as the change from baseline NRS for each measurement in time. The PID will be calculated from the first measured Numeric Rating Scale (NRS) (worst pain in the hour before the femoral nerve blockage).
    NRS for pain will be measured using a 11-point scale ranging from 0 (no pain) to 10 (worst pain imaginable) at admission (before randomization), 1 hour, 2 hours and 4 hours after femoral nerve blockage.
    The percentage of patiënts with and without complications will be recorded. Next we will record every individual complication.
    e primaire uitkomst zal het klinisch relevante verschil in de pijnintensiteit (op basis van exacte verandering in NRS) 4 uur na het nervus femoralis blok. Het exacte pijnverschil is berekend middels het pijn intensiteitsverschil (PID) in de tijd. De PID zal berekend worden als het verschil vanaf de eerst gemeten Numeric Rating Scale (NRS) (de heftigste pijn in het uur voor het femoraalblock).
    De NRS voor pijn zal een 11-punts schaal zijn, van geen pijn (NRS 0), tot de ergst denkbare pijn (NRS 10).
    Complicaties zullen per losse complicatie worden bijgehouden (delier, misselijkheid, braken, obstipatie, hypotensie, urineretentie en respiratoire depressies). Daarnaast zal er gescoord worden welke patiënten wel en welke geen complicatie hebben gehad.
    E.5.1.1Timepoint(s) of evaluation of this end point
    After a patient is included a baseline painscore will be measured (heaviest pain in previous hour). Painscore questionnaires will be repeated at 4 hours and will be recorded as the raw pain intensity difference.
    If the patient is transferred to the nursing room, the nurse of the department will screen the patient daily for possible complications.
    From the first day of admission nurses will daily take a DOS (delirium observation scale). When a delirium is suspected with the DOS a CAM (confussion assessment method) will be conducted.
    Na inclusie zal de baseline pijnscore worden gemeten (heftigste pijn in uur voor het inclusie). De pijnscore wordt na 4 uur herhaald en dit verschil is het exacte pijnverschil.
    Als de patiënt naar de afdeling wordt gebracht zal de verpleegkundige de patiënt dagelijks blijven screenen voor mogelijke complicaties.
    Vanaf de eerste de eerste dag van opname zal de verpleegkundige een DOS (delirium observation scale) bijhouden. Bij een vermoeden op een delier via de DOS zal CAM (confussion assessment method) worden afgenomen om dit te bevestigen of uit te sluiten.
    E.5.2Secondary end point(s)
    The amount of opioid use.
    Pre and postoperative NRS for pain
    Post-operative mobility
    Het opioidgebruik
    De pre- en postoperatieve pijscore (NRS)
    Postoperatieve mobiliteit
    E.5.2.1Timepoint(s) of evaluation of this end point
    Painscore questionnaires will be repeated at 1 hour, 2 hours, 6 hours and every consecutive 6 hours until surgery. For the use of rescue analgesics the electronic dossier of the patient will be reviewed.
    If the patient is transferred to the nursing room, the nurse of the department will daily measure NRS for pain
    After surgery, the NRS for pain is measured twice by the researcher. Furthermore, the cumulated ambulation score (CAS) is monitored daily during the first three postoperative days by the researcher who is blinded.
    Pijnscores zullen 1, 2, 6, en elke 6 uur na het femoraalblok tot aan de operatie worden afgenomen. Het elektronisch patiëntendossier zal worden geraadpleegd voor de hoeveelheid pijnstilling.
    Na de operatie zal de NRS tweemaal daags worden geobjectiveerd op de afdeling. Postoperatieve mobiliteitsscores zullen dagelijks worden bijgehouden middels de Cumulted Ambulation Score (CAS) voor de eerste 3 postoperatieve dagen.
    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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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 Yes
    E.8.2.3Other No
    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
    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 months
    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) No
    F.1.2.1Number of subjects for this age range: 0
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 84
    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 Yes
    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 Yes
    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 state84
    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
    Geen
    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 Decision2016-02-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-04-25
    P. End of Trial
    P.End of Trial StatusOngoing
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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