Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44335   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).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2022-000833-18
    Sponsor's Protocol Code Number:PI2021_843_0229
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2022-03-22
    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 ConcernedFrance - ANSM
    A.2EudraCT number2022-000833-18
    A.3Full title of the trial
    Evaluation of the effect of para-sternal block on postoperative respiratory function after cardiac sternotomy surgery.
    Prospective, controlled, randomized, single-blind study with independent evaluation of the judgment criterion
    Evaluation de l’effet du bloc para sternal sur la fonction respiratoire postopératoire après chirurgie cardiaque par sternotomie. Étude prospective, contrôlée, randomisée, en simple aveugle avec évaluation indépendante du critère de jugement
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Evaluation of the effect of para-sternal block on postoperative respiratory function after cardiac sternotomy surgery.
    Prospective, controlled, randomized, single-blind study with independent evaluation of the judgment criterion
    Evaluation de l’effet du bloc para sternal sur la fonction respiratoire postopératoire après chirurgie cardiaque par sternotomie. Étude prospective, contrôlée, randomisée, en simple aveugle avec évaluation indépendante du critère de jugement
    A.3.2Name or abbreviated title of the trial where available
    PARACARD
    A.4.1Sponsor's protocol code numberPI2021_843_0229
    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 Amiens Picardie
    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 supportCHU Amiens
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCHU Amiens Picardie
    B.5.2Functional name of contact pointBoussault A.
    B.5.3 Address:
    B.5.3.1Street Address1 rond point du Pr Cabrol
    B.5.3.2Town/ cityAmiens
    B.5.3.3Post code80054
    B.5.3.4CountryFrance
    B.5.4Telephone number33322 08 83 69369
    B.5.5Fax number33322 08 96 45945
    B.5.6E-mailboussault.annabelle@chu-amiens.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 ROPIVACAINE
    D.2.1.1.2Name of the Marketing Authorisation holderMylan
    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.3.4Pharmaceutical form Solution for injection in vial
    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 INNROPIVACAINE
    D.3.9.1CAS number 84057-95-4
    D.3.9.4EV Substance CodeSUB10382MIG
    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
    pulmonary complications post cardiac surgery
    complications pulmonaires post chirurgie cardiaque
    E.1.1.1Medical condition in easily understood language
    pulmonary complications post cardiac surgery
    complications pulmonaires post chirurgie cardiaque
    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
    Évaluer l’impact d’une anesthésie locorégionale par bloc analgésique de type bloc parasternal sur la fonction respiratoire postopératoire à J1 postopératoire.
    E.2.2Secondary objectives of the trial
    -Évaluer l’impact d’une anesthésie locorégionale par bloc analgésique de type bloc parasternal sur :
    - L’évaluation de la douleur postopératoire à 6, 12, 24, 30 et 48h postopératoire.
    - La fonction pulmonaire à J2 et à 1 mois postopératoire.
    - La douleur postopératoire pendant la kinésithérapie respiratoire dans les 48 heures postopératoires.
    - La douleur postopératoire au repos quotidienne du jour 3 au jour 7 postopératoire.
    - La survenue de complications respiratoires postopératoires dans les 28 jours postopératoires.
    - La durée de ventilation mécanique.
    - La consommation totale de morphinique postopératoire dans les 48h postopératoires.
    - L’évaluation du Lung Injury par dosage de biomarqueur plasmatique.
    - La durée de séjour
    - Incidence de douleur chronique à 3 mois.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -Patients âgés de plus de 18 ans
    - Chirurgie cardiaque élective sous CEC avec sternotomie (remplacement valvulaire, pontage coronarien ou chirurgie combinée avec remplacement valvulaire associé à un pontage coronarien).
    - Consentement éclairé écrit du patient
    E.4Principal exclusion criteria
    - Abord par thoracotomie
    - Abord par mini-sternotomie
    - Dépendance à un médicament opioïde ou médication chronique à un médicament opioïde
    - Utilisation chronique de benzodiazépine (traitement dépresseur respiratoire ou pouvant influer sur la fonction respiratoire postopératoire).
    - Contre-indication ou allergie aux anesthésiques locaux.
    - Chirurgie d'urgence
    - Endocardite infectieuse aiguë
    - Traitement immunosuppresseur ou stéroïdes (prednisone > 0,5mg/kg/jour ou équivalent)
    - SIDA avec un taux de CD4 <200/mm3
    - Trouble auto-immun
    - Receveur de greffe
    - Inclusion dans une autre étude au cours des 30 derniers jours.
    - Grossesse. Les femmes en âge de procréer doivent avoir un test de grossesse HCG urinaire négatif.
    E.5 End points
    E.5.1Primary end point(s)
    Le critère de jugement principal est la variation (Réduction) de la capacité vitale forcée (CVF) postopératoire entre la mesure préopératoire et à J1 postopératoire. La capacité vitale forcée est mesurée par spirométrie SPIROLAB et est exprimée en % de la valeur théorique
    E.5.1.1Timepoint(s) of evaluation of this end point
    D1 post op
    J1 post op
    E.5.2Secondary end point(s)
    • La fonction pulmonaire à J2, 1 mois et 3 mois postopératoire. Les variables mesurées incluent la CVF, le VEMS, le VEMS / CVF, le débit expiratoire de pointe (DEP), le débit expiratoire maximal au point 25 de la CVF (DEM25), DEM50, DEM75, DEM25–75 et le DEM75–85.
    • La douleur postopératoire à 6, 12, 24, 30 et 48 heures postopératoire sera évaluée à l'aide d'une échelle d'évaluation numérique (EN) graduée de 0 à 10. La douleur sera classée comme « nulle » à 0, « légère » de 1 à 3, « modérée » de 4 à 6, « sévère » de 7 à 10.


    • Au cours de la séance de kinésithérapie respiratoire, la douleur postopératoire dans les 48 heures sera évaluée à l’aide de l’EN
    • La douleur postopératoire quotidienne du jour 3 au jour 7 sera évaluée une fois entre 8h et 12h en utilisant l’EN
    • Les complications pulmonaires postopératoires suivantes seront dépistées dans les 28 jours postopératoires et définies selon les critères internationaux (European Perioperative Clinical Outcome definitions) :
    • Durée de ventilation mécanique en heures entre l’arrivée en réanimation et l’extubation orotrachéale.
    • Lung Injury (Dosage sRAGE)
    • Consommation cumulée de morphine ou d'oxycodone pendant 48 heures, exprimée en milligrammes.
    • Durée de séjour définie en jours entre l’entrée en réanimation et la sortie de l’hôpital.
    •
    • La douleur chronique sera évaluée au mois 3 par le questionnaire QCD (questionnaire concis de la douleur)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Several depending o the endoint
    en fonction du critère de jugement
    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 Yes
    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) Yes
    E.7.4Therapeutic use (Phase IV) No
    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 Yes
    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 Yes
    E.8.2.3.1Comparator description
    sans Ropivacaine
    without Ropivacaine
    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.8.4.1Number of sites anticipated in Member State concerned1
    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
    LVLS
    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 months18
    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.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female No
    F.2.2Male No
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients No
    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 state
    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 Decision2022-04-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-05-03
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
    For support, Contact us.
    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
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Sat May 10 00:21:24 CEST 2025 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA