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    Summary
    EudraCT Number:2021-005508-37
    Sponsor's Protocol Code Number:PI2021_843_0197
    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:2021-10-20
    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 number2021-005508-37
    A.3Full title of the trial
    Evaluation of plasma concentrations of intravenous lidocaine and epidural ropivacaine when used in combination in major abdominal surgery
    Évaluation des concentrations plasmatiques de la lidocaïne intra veineuse et de la ropivacaïne utilisée par voie péridurale lors de leur association dans les chirurgies abdominales majeures.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Évaluation des concentrations plasmatiques de la lidocaïne intra veineuse et de la ropivacaïne utilisée par voie péridurale lors de leur association dans les chirurgies abdominales majeures.
    Évaluation des concentrations plasmatiques de la lidocaïne intra veineuse et de la ropivacaïne utilisée par voie péridurale lors de leur association dans les chirurgies abdominales majeures.
    A.3.2Name or abbreviated title of the trial where available
    LARA
    LARA
    A.4.1Sponsor's protocol code numberPI2021_843_0197
    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-Picardie
    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 pointProject manager
    B.5.3 Address:
    B.5.3.1Street AddressDRCI, CHU AMIENS-PICARDIE
    B.5.3.2Town/ cityAMIENS
    B.5.3.4CountryFrance
    B.5.6E-mailDRCI-Projets@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 LIDOCAINE AGUETTANT 10 mg/ml
    D.2.1.1.2Name of the Marketing Authorisation holderLABORATOIRE AGUETTANT
    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 nameLIDOCAINE
    D.3.4Pharmaceutical form Injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous 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.IMP: 2
    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 ALTAN
    D.2.1.1.2Name of the Marketing Authorisation holderALTAN PHARMA LIMITED
    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 nameROPIVACAINE
    D.3.4Pharmaceutical form Injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPEpidural 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
    major abdominal surgery
    chirurgie abdominale majeure
    E.1.1.1Medical condition in easily understood language
    major abdominal surgery
    chirurgie abdominale majeure
    E.1.1.2Therapeutic area Diseases [C] - Digestive System Diseases [C06]
    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 assess the plasma concentrations of lidocaine and ropivacaine during the combination of perimedullary anesthesia and intravenous lidocaine during major abdominal surgery.
    d’évaluer les concentrations plasmatiques de lidocaïne et de ropivacaïne lors de l’association d’une anesthésie périmédullaire et de lidocaïne intra veineuse au cours d’une chirurgie abdominale majeure.
    E.2.2Secondary objectives of the trial
    look for unwanted side effects associated with local anesthetics.
    rechercher les effets secondaires indésirables liées aux anesthésiques locaux.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Patient undergoing major abdominal surgery with laparotomy
    - Age ≥ 18 years
    - Patient(e) bénéficiant d’une chirurgie abdominale majeure avec laparotomie
    - Age ≥ 18 ans
    E.4Principal exclusion criteria
    - Major abdominal surgery by laparoscopic route
    - Contraindication to the installation of a thoracic PDA
    - Contraindication to IV lidocaine
    - Contraindication to ropivacaine: allergy to LA, acute porphyria
    - Major hepatectomy with clamping
    - Chirurgie abdominales majeures par voie coelioscopique
    - Contre-indication à la pose d’une APD thoracique
    - Contre-indication à la lidocaïne IV
    - Contre-indication à la ropivacaïne : allergie aux AL, porphyrie aigüe
    - Hépatectomie majeure avec clampage
    E.5 End points
    E.5.1Primary end point(s)
    the plasma concentration of ropivacaine and lidocaine outside the safety range at different times of treatment. For lidocaine, the plasma safety range is 1.4 to 6 mg/ml, neurotoxicity appears from 15mg/ml, cardiotoxicity from 21 mg/ml.
    For ropivacaine, the usual total venous concentration not to be exceeded is around 2.2 microg.ml-1
    la concentration plasmatique de ropivacaïne et de lidocaïne en dehors de l’intervalle de sécurité aux différents temps de la prise e charge. Concernant la lidocaïne, l’intervalle de sécurité plasmatique est de 1,4 à 6 mg/ml, la neurotoxicité apparait à partir de 15mg/ml, la cardiotoxicité à partir de 21 mg/ml.
    Pour la ropivacaïne, la concentration veineuse totale habituelle à ne pas dépasser se situe aux alentours de 2,2 microg.ml-1
    E.5.1.1Timepoint(s) of evaluation of this end point
    48 hours
    48 heurs
    E.5.2Secondary end point(s)
    Investigation of clinical systemic toxicity to local anesthetics within 48 hours postoperatively
    Recherche de toxicité systémique clinique aux anesthésiques locaux dans les 48 heures post-opératoires
    E.5.2.1Timepoint(s) of evaluation of this end point
    48 hours
    48 heurs
    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 No
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    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
    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 months12
    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: 35
    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 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 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
    néant
    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 Decision2021-12-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-11-19
    P. End of Trial
    P.End of Trial StatusCompleted
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