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    The EU Clinical Trials Register currently displays   38177   clinical trials with a EudraCT protocol, of which   6271   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2016-000050-36
    Sponsor's Protocol Code Number:BERTHOUD-GIRARD-SAPB
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2016-05-04
    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 ConcernedFrance - ANSM
    A.2EudraCT number2016-000050-36
    A.3Full title of the trial
    Evaluation de l’efficacité analgésique d’un bloc du muscle grand dentelé dans la chirurgie valvulaire par thoracotomie, en comparaison avec un cathéter intra-cicatriciel, au CHU de Dijon. Essai clinique randomisé, contrôlé, monocentrique
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Comparaison de deux prises en charge de la douleur après chirurgie cardiaque par thoracotomie
    A.3.2Name or abbreviated title of the trial where available
    SAPB thoraco
    A.4.1Sponsor's protocol code numberBERTHOUD-GIRARD-SAPB
    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 SponsorCHU de DIJON
    B.1.3.4CountryFrance
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCHU de DIJON
    B.5.2Functional name of contact pointChef de projets recherche
    B.5.3 Address:
    B.5.3.1Street Address14 rue Paul Gaffarel
    B.5.3.2Town/ cityDIJON
    B.5.3.3Post code21079
    B.5.3.4CountryFrance
    B.5.4Telephone number038029315333
    B.5.5Fax number038029369033
    B.5.6E-mailcatherine.renaud@chu-dijon.fr
    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 Lévobupivacaïne
    D.2.1.1.2Name of the Marketing Authorisation holderABBVIE
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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 nameLévobupivacaïne
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPInfiltration
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLévobupivacaïne
    D.3.9.1CAS number 27262-48-2
    D.3.9.3Other descriptive nameLEVOBUPIVACAINE HYDROCHLORIDE
    D.3.9.4EV Substance CodeSUB02904MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1.25
    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
    Chirurgie valvulaire
    E.1.1.1Medical condition in easily understood language
    Chirurgie cardiaque
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level LLT
    E.1.2Classification code 10036286
    E.1.2Term Post-operative pain
    E.1.2System Organ Class 100000004863
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Déterminer si la réalisation d’un bloc du muscle grand dentelé échoguidé après la fermeture chirurgicale, améliore l’efficacité de l’analgésie postopératoire des patients bénéficiant d’une chirurgie valvulaire par thoracotomie et mini-thoracotomie droite, en comparaison avec l’analgésie obtenue par un cathéter intra-cicatriciel.
    E.2.2Secondary objectives of the trial
    1- Amélioration de la réhabilitation respiratoire, des échanges gazeux et diminution des pneumopathies post opératoire
    2- ,Diminution de la durée de séjour en réanimation et à l’hôpital
    3- Diminution des scores de sédation
    4- Diminution des effets secondaires liés aux morphiniques
    5- Diminution des douleurs chroniques à 4 mois
    6- Diminution des infections liées à l’utilisation d’un cathéter
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Personne ayant donné son consentement écrit
    - Patients majeurs
    - Patients subissant une chirurgie cardiaque valvulaire par thoracotomie ou mini thoracotomie droite
    - Patients subissant une chirurgie programmée
    E.4Principal exclusion criteria
    - Adulte protégé
    - Personne non affiliée à un régime de sécurité sociale
    - Femme enceinte ou allaitante
    - Patients déjà inclus dans l’étude
    - Patients subissant une deuxième chirurgie cardiaque ou plus par thoracotomie
    - Patients porteurs d’une infection locale ou d’une infection généralisée à type de bactériémie
    - Patients présentant une hypersensibilité aux anesthésiques locaux, aux opiacés, ou à la dexaméthasone ou à l'un des excipients présents dans les spécialités utilisées
    - Patients atteints d’une dysfonction cognitive préopératoire
    - Prise chronique de morphiniques ou d’anti-inflammatoires stéroïdiens et non-stéroïdiens à fortes doses
    - Prise chroniques d’antiépileptiques et d’antidépresseurs
    - Patients atteints d’une insuffisance hépatique sévère dont le score est supérieur ou égal à un Child Pugh B
    - Patients mineurs
    - Patients présentant une intoxication aiguë ou surdosage avec des produits dépresseurs du système nerveux central (alcool, hypnotiques, autres analgésiques…)
    - Patients présentant une hypotension sévère
    E.5 End points
    E.5.1Primary end point(s)
    Evaluation de la consommation de morphine, exprimée en milligramme, en post-opératoire, 48 heures après l’extubation.
    E.5.1.1Timepoint(s) of evaluation of this end point
    48 heures après l'extubation
    E.5.2Secondary end point(s)
    - Score de douleur mesurée grâce à l’échelle visuelle analogique
    - Délai entre la fin de la titration de morphine et le premier bolus de morphine par PCA
    - Mesure de la PaO2, de la saturation en oxygène et de la PaCO2 sur une gazométrie artérielle en post-opératoire (H+6 de l’extubation puis à J1 et à J2 de la chirurgie)
    - Nombre de pneumopathie post opératoire documentées
    - Durée du séjour post-opératoire en réanimation et en Centre Hospitalier (exprimée en jours)
    - Score de Ramsay (H+6 de l’extubation puis toutes les 12H pendant 48 heures) : évaluation de la sédation
    - Nombre de nausées, vomissements et rétention aigue d’urine survenant dans les 48 heures après extubation
    - Evaluation de la douleur chronique post opératoire (à 4 mois) grâce au questionnaire DN4
    E.5.2.1Timepoint(s) of evaluation of this end point
    jusqu'à 4 mois après l'intervention
    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) Yes
    E.8.2.2Placebo No
    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
    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 months22
    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: 41
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 41
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2016-05-04. Yes
    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 state82
    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 Decision2016-04-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-03-10
    P. End of Trial
    P.End of Trial StatusOngoing
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