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    Summary
    EudraCT Number:2019-004813-15
    Sponsor's Protocol Code Number:VERSPLASMA
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2020-09-07
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2019-004813-15
    A.3Full title of the trial
    Serum concentrations of ropivacaine after unilateral pectoral nerve block type II (Pecs II) in breast cancer surgery
    Serumconcentraties van ropivacaine na unilaterale Pecs II block in borstkankerchirurgie
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Detection of the amount of local anesthesia absorbed by the blood after a regional breast analgesia technique for breast cancer surgery.
    Bepalen van de mate waarin locale verdoving geabsorbeerd wordt in de bloedbaan na een regionale borstwandverdoving bij borstkankerchirurgie.
    A.3.2Name or abbreviated title of the trial where available
    Pecs Serum 2020
    Pecs Serum 2020
    A.4.1Sponsor's protocol code numberVERSPLASMA
    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 SponsorAZ Turnhout
    B.1.3.4CountryBelgium
    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 supportBARA
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAZ Turnhout
    B.5.2Functional name of contact pointBarbara Versyck
    B.5.3 Address:
    B.5.3.1Street AddressSteenweg op Merksplas 44
    B.5.3.2Town/ cityTurnhout
    B.5.3.3Post code2300
    B.5.3.4CountryBelgium
    B.5.4Telephone number+3214406571
    B.5.6E-mailbarbara.versyck@azturnhout.be
    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 Ropivacaine Fresenius Kabi 5mg/ml
    D.2.1.1.2Name of the Marketing Authorisation holderFresenius Kabi
    D.2.1.2Country which granted the Marketing AuthorisationBelgium
    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.3.2Product code N01BB09
    D.3.4Pharmaceutical form 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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    The aim of this study is to quantify peak and mean venous serum concentrations of ropivacaine after ultrasound guided Pecs II block with 2.5mg/kg ropivacaine diluted to 30ml.
    Het doel van dit onderzoek is om de piek- en gemiddelde veneuze serumconcentraties van ropivacaïne te kwantificeren na Pecs II-blok met echografie met 2,5 mg / kg verdunde ropivacaïne tot 30 ml.
    E.1.1.1Medical condition in easily understood language
    We want to investigate in what amount the injected local anesthesia of a Pecs II block drains away to the bloodstream and if that amount reaches the maximum allowed dose or not.
    We willen onderzoeken in welke hoeveelheid de geïnjecteerde lokale anesthesie van een Pecs II-blok wegvloeit naar de bloedbaan en of die hoeveelheid de maximaal toegestane dosis overschrijdt of niet.
    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 aim of this study is to quantify peak and mean venous serum concentrations of ropivacaine after ultrasound guided Pecs II block with 2.5mg/kg ropivacaine diluted to 30ml.
    Het doel van dit onderzoek is om de piek- en gemiddelde veneuze serumconcentraties van ropivacaïne te kwantificeren na Pecs II-blok met echografie met 2,5 mg / kg verdunde ropivacaïne tot 30 ml.
    E.2.2Secondary objectives of the trial
    Not applicable
    Niet van toepassing
    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: (1) Age 18 or older (2) BMI between 17 and 35kg/m2, (3) scheduled for elective unilateral mastectomy or tumorectomy with sentinel node resection or axillary clearance, and (4) written informed consent.
    Om in aanmerking te komen om deel te nemen aan dit onderzoek, moet een proefpersoon aan alle volgende criteria voldoen: (1) Leeftijd 18 of ouder (2) BMI tussen 17 en 35kg / m2, (3) gepland voor electieve unilaterale mastectomie of tumorectomie met schildwachtklierresectie of okselevidemment, en (4) schriftelijke geïnformeerde toestemming.
    E.4Principal exclusion criteria
    Patients with (1)known allergies or sensitivity to local anaesthesia, or with (2) a BMI less than 17 or more than 35 kg/m2, (3) who are pregnant, (4) who have renal (GFR < 60ml/min) and/or hepatic impairment (end-stage liver disease that compromises normal hepatic drug metabolism) will be excluded. Given our inclusion and exclusion criteria, minors and subjects not capable of giving informed consent will be excluded from participation in the study.
    Patiënten met (1) bekende allergieën of gevoeligheid voor lokale anesthesie, of met (2) een BMI lager dan 17 of meer dan 35 kg / m2, (3) die zwanger zijn, (4) die nier hebben (GFR <60ml / min) ) en / of leverinsufficiëntie (eindstadium leverziekte die het normale metabolisme van de lever in gevaar brengt) zullen worden uitgesloten. Gezien onze opname- en uitsluitingscriteria zullen minderjarigen en personen die geen geïnformeerde toestemming kunnen geven, worden uitgesloten van deelname aan het onderzoek.
    E.5 End points
    E.5.1Primary end point(s)
    The aim of this study is to quantify peak and mean venous serum concentrations of ropivacaine after a Pecs II block with 2.5mg/kg ropivacaine diluted to 30ml.
    Het doel van dit onderzoek is om de piek- en gemiddelde veneuze serumconcentraties van ropivacaïne te kwantificeren na een Pecs II-blok met 2,5 mg / kg verdunde ropivacaïne tot 30 ml.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Ten blood samples will be obtained. Two blood samples will be obtained immediately after placement of the Pecs II block as one of these sample will be used to determine albumin and alpha-1-glycoprotein levels. The eight other blood sample will be obtained at 10, 20, 30, 45, 60, 90 and 120 minutes and at 4 hours after performing the Pecs II block.
    Er zullen tien bloedstalen worden verkregen. Twee bloedstalen worden direct na plaatsing van het Pecs II-blok verkregen, omdat een van deze stalen zal worden gebruikt om albumine- en alfa-1-glycoproteïne gehalten te bepalen. De acht andere bloedstalen wordt verkregen na 10, 20, 30, 45, 60, 90 en 120 minuten en 4 uur na het uitvoeren van het Pecs II-blok.
    E.5.2Secondary end point(s)
    Not applicable
    Niet van toepassing
    E.5.2.1Timepoint(s) of evaluation of this end point
    Not applicable
    Niet van toepassing
    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 Yes
    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 Yes
    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 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 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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned 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: 10
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    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 Yes
    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)
    equal to standard of care
    gelijk aan het standaard protocol
    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 Decision2021-03-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-01-18
    P. End of Trial
    P.End of Trial StatusOngoing
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