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    Summary
    EudraCT Number:2017-002921-39
    Sponsor's Protocol Code Number:9859
    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:2018-01-12
    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 number2017-002921-39
    A.3Full title of the trial
    Comparison of motor blockade duration in the context of scheduled caesarean section with spinal anaesthesia : hyperbaric Prilocaïne versus hyperbaric Bupivacaïne.
    Comparaison de la durée du bloc moteur au cours de césariennes programmées sous rachianesthésie : Prilocaïne Hyperbare versus Bupivacaïne Hyperbare
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Comparison of two anaesthetics used in scheduled caesarean section in terms of post anaesthesia immobilisation duration : hyperbaric Prilocaïne versus hyperbaric Bupivacaïne.
    Comparaison de deux anesthésiques lors de césariennes programmées en termes de durée d'immobilisation post-anesthésie : Prilocaïne Hyperbare versus Bupivacaïne Hyperbare
    A.3.2Name or abbreviated title of the trial where available
    Césarcaïne
    Césarcaïne
    A.4.1Sponsor's protocol code number9859
    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 SponsorUniversity hospital of Montpellier
    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 supportUniversity hospital of Montpellier
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity Hospital of Montpellier
    B.5.2Functional name of contact pointVerchère Anne
    B.5.3 Address:
    B.5.3.1Street AddressDRI- Pav 32 - 39 avenue Charles Flahault
    B.5.3.2Town/ cityMontpellier
    B.5.3.3Post code34295
    B.5.3.4CountryFrance
    B.5.4Telephone number0033467330812
    B.5.5Fax number0033467339172
    B.5.6E-maila-verchere@chu-montpellier.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 BARITEKAL® (Prilocaïne)
    D.2.1.1.2Name of the Marketing Authorisation holderNORDIC PHARMA SAS
    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 nameBARITEKAL®
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntrathecal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPRILOCAINE
    D.3.9.1CAS number 721-50-6
    D.3.9.4EV Substance CodeSUB10041MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 BUPIVACAINE MYLAN 20 mg/4 ml, solution injectable pour voie intra rachidienne en ampoule
    D.2.1.1.2Name of the Marketing Authorisation holderLaboratoire MYLAN
    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 nameBUPIVACAINE
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntrathecal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNBupivacaine
    D.3.9.1CAS number 18010-40-7
    D.3.9.3Other descriptive nameANHYDROUS BUPIVACAINE HYDROCHLORIDE
    D.3.9.4EV Substance CodeSUB71293
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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
    Caesarean section anaesthesia
    anesthésie de césarienne
    E.1.1.1Medical condition in easily understood language
    Caesarean section anaesthesia
    anesthésie de césarienne
    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
    To compare the duration of the motor blockade after spinal anaesthesia with Bupivacaine or Prilocaine in the context of scheduled C-sections (time between the anaesthesia and the Bromage score = 0)
    comparer la durée de bloc moteur après rachianesthésie à la Bupivacaïne Hyperbare ou à la Prilocaïne Hyperbare au cours de césariennes programmées (temps entre l’injection de la rachianesthésie et le retour à un score de Bromage à 0).
    E.2.2Secondary objectives of the trial
    1) superior sensitivity level 15mn after injection (cold test)
    2) Néosynéphrine injected quantity to correct hypotensions (arterial pressure < 90/60mmHg or nausea or vomiting)
    3) newborn APGAR score at birth
    4) delay between injection and incision
    5) surgery duration (time between incision and last suture)
    6) post-operatoire necessity for complementary anaesthetic
    7) delay before the first dose of emergency analgesic
    8) pos-operative pain
    9) delay before the patient is back to her room
    10) presence/absence of post-lumbar ponction syndrome
    11) patient's satisfaction survey at 24h (ENS between 0 and 10)
    12) surgeon's satisfaction survey at the end of the surgery about the spinal anaesthesia (ENS between 0 and 10)
    1) Le niveau sensitif supérieur obtenu 15 minutes après injection (test au froid)
    2) La quantité de Néosynéphrine injectée pour corriger les hypotensions (tension artérielle inférieure à 90/60mmHg ou apparition de nausées ou vomissements)
    3) Le Score d’APGAR des nouveaux nés à la naissance
    4) Le délai entre l’injection et l’incision
    5) La durée d’intervention (délai entre incision et dernier point chirurgical)
    6) La nécessité de compléments anesthésiques peropératoire
    7) Le délai avant la première dose d’analgésique de secours
    8) La douleur postopératoire
    9) Le délai de retour en chambre
    10) La recherche de syndrome post ponction lombaire
    11) La recherche de Troubles neuro-sensoriels dans les 24 heures post-opératoire
    12) Score de Satisfaction de la patiente à H24 (ENS entre 0 et 10)
    13) Score de satisfaction du chirurgien en fin d’intervention sur la rachianesthésie (ENS entre 0 et 10)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Scheduled C-section
    - Eutocic pregnancy
    - Non-multiple pregnancy
    - Age : over 18-years-old
    - Height : between 155cm and 175cm
    - Patient affiliated or beneficiary of healthcare protection
    - Signature of consent form
    - Césarienne programmée
    - Grossesse eutocique
    - Grossesse non multiple
    - Age : 18 ans et plus
    - Taille : entre 155 et 175 cm
    - Patients affiliés ou bénéficiaires d'un régime de Sécurité Sociale
    - Signature du consentement de la patiente
    E.4Principal exclusion criteria
    - Underage patient
    - Pathological pregnancy
    - Multiple pregnancy
    - Emergency C-section
    - Patient not speaking french
    - Patient refusal
    - spinal anaesthesia contraindication :
    .Cutaneous infection at the injection point
    .Sepsis
    .Coagulation disorder
    .Lumbar equipment at needle-puncture site
    - Prilocaïne contraindication :
    .Allergy to Prilocaine or other amide local anaesthetic, or allergy to any excipient of BARITEKAL®
    .Severe cardiac conduction abnormality
    .Severe anaemia
    .Decompensated heart failure
    .Cardiogenic and hypovolemic shock
    .Congenital or acquired methemoglobinemia
    .Concomitant treatment by blood thinner
    .Methemoglobinemia contributing factors (Dapsone, Cotrimoxazole, antimalarial treatments, nitroprusside, nitrates, nitrofurane, oxyde nitrique, 8-hydrosiquinoleine, phenacetin, phenazorydine, resercine)
    - Bupivacaïne contraindication :
    .Allergy to local amide anesthetic
    .IV local anaesthesia
    - Patiente mineure
    - Grossesse pathologique
    - Grossesse multiple
    - Césarienne en Urgence
    - Patiente ne comprenant pas le français
    - Refus de la patiente
    - Contre-indications à la rachianesthésie :
    .Infection cutanée locale au point de ponction
    .Septicémie
    .Trouble de la coagulation
    .Présence de matériel lombaire au niveau du point de ponction
    - Contre-indications à la Prilocaïne
    .Une hypersensibilité au chlorhydrate de prilocaïne, à d'autres anesthésiques locaux de type amide ou à l'un des excipients entrant dans la composition.
    .Des anomalies sévères de la conduction cardiaque.
    .Une anémie sévère.
    .Une insuffisance cardiaque décompensée.
    .Un choc cardiogénique et hypovolémique.
    .Une méthémoglobinémie congénitale ou acquise.
    .Un traitement concomitant par anticoagulants.
    .Facteurs favorisant de Méthémoglobinémie : Usage concomittant de Dapsone, Cotrimoxazole, antipaludéens, nitroprusside, nitrates, nitrofurane, oxyde nitrique, 8-hydrosiquinoleine, phenacetin, phenazorydine, resercine
    - Contre-indications à la Bupivacaïne :
    .Hypersensibilité connue aux anesthésiques locaux à liaison amide.
    .Anesthésie régionale par voie intraveineuse.
    E.5 End points
    E.5.1Primary end point(s)
    Motor blockade duration measure by Bromage score
    Durée du bloc moteur mesuré par le score de bromage
    E.5.1.1Timepoint(s) of evaluation of this end point
    every 15mn from the begining of the anaesthesia until the score reaches 0
    toutes les 15 minutes depuis le debut de l'anesthésie jusqu'à l'obtention d'un score de 0
    E.5.2Secondary end point(s)
    1) Sensory level (cold test)
    2) Quantoty of Neosynephrine needed to correct the hypotensions (arterial pressure < 90/60mmHg, nausea, vomitting)
    3) delay between the spinal anaesthesia and the first incision
    4) newborn APGAR score
    5) duration of the intervention
    6) pain level (Visual Analog Scale VAS)
    7) delay between spinal anaesthesia and the first injection of second line analgesic
    8) delay before the patient is back to her chamber
    9) Presence of neurosensory disorders
    10) Presence of post lumbar puncture syndrome
    11) patient's satisfaction (simple numerical scale)
    12) surgeon's satisfaction about the spinal anaesthesia (simple numerical scale from 0 to 10)
    1) Le niveau sensitif supérieur (test au froid)
    2) La quantité de Néosynéphrine injectée pour corriger les épisodes hypotensifs (tension artérielle inférieure à 90/60mmHg ou apparition de nausées ou vomissements)
    3) Le délai entre l’injection de la rachianesthésie et l’incision chirurgicale
    4) Le Score d’APGAR des nouveaux nés donné par le pédiatre
    5) La durée d’intervention
    6) Mesure la douleur par EVA
    7) Le délai entre la rachianesthésie et la première injection d’antalgique de deuxième ligne
    8) Le délai de retour en chambre
    9) La recherche de Troubles neuro-sensoriels
    10) La recherche de syndrome post ponction lombaire
    11) Le score de Satisfaction de la patiente (ENS entre 0 et 10)
    12) Le score de satisfaction du chirurgien sur la rachianesthésie (ENS entre 0 et 10)
    E.5.2.1Timepoint(s) of evaluation of this end point
    1) at 5, 10 and 15mn after the injection of the anaesthetic and at the end of the intervention
    2) when the patient leaves the service
    3) at the time of the first cut
    4) at birth
    5) time between the first incision and the last stiches
    6) when arriving and leaving the post anesthesia care units (PACU) and at H24
    7) At the injection of the second line analgesic
    8) When the patient is back to her room
    9) in the 24h after surgery
    10) at H24
    11) at H24
    12) at the end of the surgery
    1) à 5, 10 et 15 minutes après l’injection de l’AL et en fin d’intervention
    2) à la fin de la prise en charge de la patiente dans le service
    3) au moment de la première incision
    4) à la naissance
    5) délai entre incision et dernier point chirurgical
    6) à l’arrivée et en sortie de Salle de Surveillance Post-Interventionnelle (SSPI) et à H24
    7) à l'injection de l'antalgique de deuxième ligne
    8) quand la patiente est de retour en chambre
    9) dans les 24 heures post-opératoires
    10) à H24
    11) à H24
    12) en fin d’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 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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 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) 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 No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned2
    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 months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial 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: 50
    F.1.3Elderly (>=65 years) No
    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 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 Yes
    F.3.3.4Nursing women Yes
    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 state50
    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 Decision2017-12-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-12-05
    P. End of Trial
    P.End of Trial StatusOngoing
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