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    Summary
    EudraCT Number:2018-002842-35
    Sponsor's Protocol Code Number:2018/07
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2018-08-28
    Trial results View 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 number2018-002842-35
    A.3Full title of the trial
    Interest of parasternal block to prevent hypertensive and tachycardia episodes during sternotomy in patients undergoing coronary artery bypass graft
    Intérêt d’un bloc parasternal en injection unique dans la prévention des épisodes d’hypertension et de tachycardie lors d’une sternotomie chez des patients opérés d’un pontage aorto-coronarien
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The benefit of local anesthesia at the sternum in patients with coronary surgery
    Intérêt d'une anesthésie locale de la paroi thoracique chez des patients opérés d’un pontage coronarien
    A.3.2Name or abbreviated title of the trial where available
    PARA
    PARA
    A.4.1Sponsor's protocol code number2018/07
    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 SponsorCMC Ambroise Paré
    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 supportCMC Ambroise Paré
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCMC Ambroise Paré
    B.5.2Functional name of contact pointEquipe Recherche Clinique
    B.5.3 Address:
    B.5.3.1Street Address25-27 Boulevard Victor Hugo
    B.5.3.2Town/ cityNeuilly-sur-Seine
    B.5.3.3Post code92200
    B.5.3.4CountryFrance
    B.5.4Telephone number+33146415079
    B.5.5Fax number+33146415086
    B.5.6E-mailrecherche@clinique-a-pare.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 KABI 7,5 mg/ml
    D.2.1.1.2Name of the Marketing Authorisation holderFRESENIUS KABI FRANCE
    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
    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.3.9.3Other descriptive nameROPIVACAINE HYDROCHLORIDE
    D.3.9.4EV Substance CodeSUB04264MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2.5
    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 placeboInfiltration
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    coronary artery bypass graft
    pontage aorto-coronarien
    E.1.1.1Medical condition in easily understood language
    coronary surgery
    pontage coronarien
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10038286
    E.1.2Term Regional nerve block
    E.1.2System Organ Class 100000004865
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Show that the preoperative realization of a parasternal block reduces the posology of remifentanil administered during sternotomies
    Montrer qu’un bloc parasternal préopératoire permet de diminuer la posologie de rémifentanil administré au cours des sternotomies
    E.2.2Secondary objectives of the trial
    Evaluate the effect of parasternal block on :
    1. Hemodynamic response
    2. Dose of hypnotic (propofol) and analgesic (remifentanil) drugs during surgery
    3. Inflammatory response
    4. Pain level during extubation
    5. Complications
    Evaluer l’influence du bloc parasternal préopératoire sur :
    1. La réponse hémodynamique.
    2. La consommation d’hypnotiques (propofol) et de morphiniques (rémifentanil) per-opératoire
    3. La réponse inflammatoire
    4. La douleur post-opératoire au moment de l’extubation
    5. Le taux de complications
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - 18 Years and older
    - Patients undergoing coronary artery bypass graft requiring sternotomy other than re-interventions and combined surgeries
    - Consent for participation
    - Affiliation to the french social security system
    - Âgés de plus de 18 ans
    - Programmés pour un pontage aorto-coronarien nécessitant une sternotomie, ré-interventions et chirurgies combinées exclues
    - Ayant donné leurs consentements de participation conformément à la réglementation
    - Bénéficiant d'un régime de sécurité sociale
    E.4Principal exclusion criteria
    - Pregnant or breastfeeding women
    - Patients under protection of the adults (guardianship, curator or safeguard of justice)
    - Communication difficulties or neuropsychiatric disorder
    - Neuropathic disease
    - Constitutional coagulation disorders
    - Kidney insufficiency
    - Sensitivity to nonsteroidal anti-inflammatory drugs
    - Hypersensitivity to local anaesthetics
    - Chronic use of opioid analgesics
    - Corticosteroid treatment or immunosuppressive therapy
    - Autoimmune disease
    - Chronic pain syndrome or fibromyalgia
    - Emergency cardiac surgery
    - Hypovolemia
    - Femmes enceintes ou allaitant
    - Patients sous tutelle, sous curatelle ou sous sauvegarde de justice
    - Patients présentant une gêne à la communication ou des troubles neuropsychiques
    - Patients présentant une neuropathie périphérique
    - Patients ayant des troubles de la coagulation constitutionnels
    - Patients présentant une altération de la fonction rénale
    - Patients ayant une intolérance aux anti-inflammatoires non stéroïdiens
    - Patients ayant un antécédent d’allergie aux anesthésiques locaux
    - Patients ayant une consommation chronique de morphinique
    - Patients sous traitement aux corticoïdes ou immunodépresseurs
    - Antécédent de maladie auto-immune
    - Patients ayant des syndromes douloureux chroniques ou souffrants de fibromyalgie
    - Patients devant bénéficier d’une chirurgie cardiaque en urgence
    - Patients en état d’hypovolémie
    E.5 End points
    E.5.1Primary end point(s)
    Maximal dose of remifentanil required to maintain hemodynamic parameters (arterial blood pressure and heart rate) in the appropriate values during intubation, skin incision, sternotomy and sternal retractor setup
    Dose maximale de rémifentanil nécessaire pour assurer le maintien de la tension artérielle et de la fréquence cardiaque dans les valeurs recommandées lors de l’intubation, l’incision cutanée, la sternotomie et la mise en place des écarteurs sternaux
    E.5.1.1Timepoint(s) of evaluation of this end point
    Intraoperative period : from intubation to sternal retractor setup
    Période peropératoire : de l'intubation jusqu'à la mise en place des écarteurs sternaux
    E.5.2Secondary end point(s)
    1. Measure of hemodynamic parameters (arterial blood pressure and heart rate) and patient state index (PSi)
    2. Dose of propofol and remifentanil administered during surgery
    3. Serum concentrations of cytokines
    4. Numeric scale of pain, ranging from 0 to 10 (0 = no pain, 10= worst possible pain), during extubation
    5. Complication rate :
    - Complications related to parasternal block (wrong distribution of the local anesthetic, infection at injection site, rhythm disorders caused by intravascular injection of the local anesthetic)
    - Post-operative complications (acute respiratory distress syndrome, pneumopathy, kidney failure, hypertension)
    1. Mesure des variables hémodynamiques (Fréquence Cardiaque, FC ; Pression Artérielle Systolique, PAS ; Pression Artérielle Diastolique, PAD ; et Pression Artérielle Moyenne, PAM) et de l’indice de l’état du patient (PSi)
    2. Dose moyenne horaire de propofol et de rémifentanil correspondant à la dose totale de propofol ou de rémifentanil utilisée en per-opératoire divisée par la durée de l’intervention
    3. Dosage des cytokines
    4. L’évaluation de la douleur au moment de l’extubation utilise une Echelle Numérique (EN) de 0 (pas de douleur) à 10 (extrêmement douloureux)
    5. Recueil d'éventuelles complications :
    - Complications pouvant être liées à la réalisation du bloc (mauvaise distribution du bloc parasternal, infection du site d'injection, survenue de troubles du rythme liés à une injection intravasculaire de l'agent anesthésique)
    - Complications post-opératoires (défaillance respiratoire, pneumopathie, insuffisance rénale, hypertension)
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. Intraoperative period : from the start of general anesthesia maintenance, i.e. PSi within the 25-50 range, to the fifth minute after sternal retractor setup (refers to criteria 1)
    2. Intraoperative period : from induction of anesthesia to skin closure (refers to criteria 2)
    3. At induction of anesthesia, at the arrival in intensive care, at day 1, day 2, day 3, day 5 and day 7 at the time of the morning blood collection (refers to criteria 3)
    4. During extubation (refers to criteria 4)
    5. 7 days after surgery (refers to criteria 5)
    1. Période peropératoire : une fois le patient endormi (défini par une valeur du PSi comprise entre 25 et 50) et jusqu’à la 5ème minute après la mise en place des écarteurs sternaux (en relation avec le critère 1)
    2. Période peropératoire : à partir de l’induction de l’anesthésie et jusqu'à la fermeture cutanée (en relation avec le critère 2)
    3. A l'induction de l'anesthésie, à l’arrivée en réanimation, à J1, J2, J3, J5 et J7 au moment des bilans sanguins du matin (en relation avec le critère 3)
    4. Au moment de l'extubation (en relation avec le critère 4)
    5. 7 jours après l'intervention (en relation avec le critère 5)
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy Yes
    E.6.4Safety No
    E.6.5Efficacy No
    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
    After cytokine assay : after the last visit of the last subject, the plasma collection will be sent to the analysis laboratory in order to measure the cytokines.
    Après le dosage des cytokines : après la dernière visite du dernier patient les échantillons de plasma seront envoyés au laboratoire d'analyse afin de doser les cytokines.
    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) Yes
    F.1.2.1Number of subjects for this age range: 15
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 15
    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 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 2018-08-28. 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 state30
    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
    Aucun
    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 Decision2018-11-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-09-17
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-11-07
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