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    Summary
    EudraCT Number:2019-002858-23
    Sponsor's Protocol Code Number:PI2019_843_0051
    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:2019-07-29
    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 number2019-002858-23
    A.3Full title of the trial
    Serratus plain block versus paravertebral block versus serratus plain block and paravertebral block for postoperative pain following thoracoscopic surgery
    Comparaison des Blocs Nerveux Serratus versus Para-vertébral versus Serratus et Para-vertébral pour l’Analgésie Post-opératoire après Chirurgie par Vidéo-Thoracoscopie
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Serratus plain block versus paravertebral block versus serratus plain block and paravertebral block for postoperative pain following thoracoscopic surgery
    Comparaison des Blocs Nerveux Serratus versus Para-vertébral versus Serratus et Para-vertébral pour l’Analgésie Post-opératoire après Chirurgie par Vidéo-Thoracoscopie
    A.3.2Name or abbreviated title of the trial where available
    THORACOSCOPIC
    THORACOSCOPIC
    A.4.1Sponsor's protocol code numberPI2019_843_0051
    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 AddressCHU Amiens-Picardie
    B.5.3.2Town/ cityAmiens
    B.5.3.3Post code80054
    B.5.3.4CountryFrance
    B.5.4Telephone number333 2208 83 85
    B.5.5Fax number333 2208 96 45
    B.5.6E-mailmattoug.salah@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 KABI 2 mg/ml, solution injectable en ampoule
    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.3.1Product nameROPIVACAÏNE
    D.3.2Product code N01BB09
    D.3.4Pharmaceutical form Injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOther use (Noncurrent)
    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 KABI 7,5 mg/ml, solution injectable en ampoule.
    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.3.1Product nameROPIVACAINE
    D.3.4Pharmaceutical form Injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPNot mentioned (Noncurrent)
    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 infusion
    D.8.4Route of administration of the placeboOther use (Noncurrent)
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    postoperative pain following thoracoscopic surgery
    douleur postopératoire après une chirurgie thoracoscopique
    E.1.1.1Medical condition in easily understood language
    postoperative pain following thoracoscopic surgery
    douleur postopératoire après une chirurgie thoracoscopique
    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 efficiency of serratus plain block versus paravertebral block versus serratus plain block and paravertebral block for postoperative pain following thoracoscopic surgery
    comparer l’efficacité de l’analgésie postopératoire précoce en fonction des différentes modalités d’analgésie locorégionale per-opératoire chez les patients opérés par thoracoscopie (sans écartement des côtes)
    E.2.2Secondary objectives of the trial
    are to compare between the 3 groups:
    • The visual analog scale: END at rest and postoperative cough at H1, H3, H6, D1, D2, D3, and at discharge from hospital.
    • Postoperative opioid consumption
    • Failure rate of locoregional analgesia evaluated in the operating room
    • Respiratory morbidity (duration of drainage, hospitalization and rate of pneumonitis)
    • Evaluation of postoperative chronic pain in control consultation at 6 months of intervention
    sont de comparer entre les 3 groupes :
    • L’échelle visuelle analogique : END au repos et à la toux post opératoire à H1, H3, H6, J1, J2, J3, et à la sortie d’hospitalisation.
    • Consommation de morphiniques post-opératoire
    • Taux d’échec de l’analgésie locorégionale évalué au bloc opératoire
    • Morbidité respiratoire (durée de drainage, d’hospitalisation et taux de pneumopathies)
    • Evaluation des douleurs chroniques post opératoires en consultation de contrôle à 6 mois de l’intervention
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Patient over 18 years old
    - video-assisted thoracospic surgery with 3 trocars,
    - Patient adulte majeur (≥18 ans)
    - Geste chirurgical réalisé par thoracoscopie exclusive 3 trocarts
    E.4Principal exclusion criteria
    - Minor patient
    - Refusal of locoregional analgesia
    - Patient with a history of chronic pain under opioids or patients with impossible pain assessment
    - Substance addiction
    - Surgical procedure with thoracic nerve damage (especially pleural abrasion)
    - Thoracotomy surgical procedure, assisted video mini-thoracotomy
    - Contraindication to locoregional analgesia (allergy, skin condition)
    - Patient mineur
    - Refus de l’analgésie locorégionale
    - Patient aux antécédents de douleurs chroniques sous morphiniques ou patients avec évaluation de la douleur impossible
    - Toxicomanie
    - Geste chirurgical avec atteinte nerveuse thoracique (notamment abrasion pleurale)
    - Geste chirurgical par thoracotomie, mini-thoracotomie vidéo assistée
    - Contre-indication à la réalisation d’une analgésie locorégionale (allergie, état cutané)
    E.5 End points
    E.5.1Primary end point(s)
    Pain visual analog scale (VAS) at cougthing evaluated at H0 following thoracoscopic surgery
    l’Echelle Numérique Décimale (END) à la toux évaluée par le personnel infirmier de salle de réveil (SSPI) à l’arrivée en SSPI (H0).
    E.5.1.1Timepoint(s) of evaluation of this end point
    day 1
    jour 1
    E.5.2Secondary end point(s)
    Analog visual scale: END at rest and at postoperative cough at H1, H3, H6, D1, D2, D3, and at discharge from hospital, informed according to the usual computer protocol of the establishment by a qualified nurse state, in the recovery room and in the thoracic surgery department.
    • Use of opioid therapies during the period of hospitalization
    • Failure rate of locoregional analgesia assessed in SSPI
    • Duration of thoracic drainage.
    • Duration of hospitalization.
    • Respiratory morbidity - rate of pneumonitis.
    • Evaluation of postoperative chronic pain in control consultation at 6 months of intervention using the following secondary endpoints:
    Evaluation of the pain by NDS and DN4 + NeuPSIG (neuropathic pain) scale and evaluation of the consumption of antalgic therapies
    • Echelle visuelle analogique : END au repos et à la toux post opératoire à H1, H3, H6, J1, J2, J3, et à la sortie d’hospitalisation, renseignée selon le protocole habituel informatique de l’établissement par une infirmière diplômée d’état, en salle de réveil et dans le service de chirurgie thoracique.
    • Consommation de thérapeutiques morphiniques durant la durée de l’hospitalisation
    • Taux d’échec de l’analgésie locorégionale évalué en SSPI
    • Durée de drainage thoracique.
    • Durée d’hospitalisation.
    • Morbidité respiratoire – taux de pneumopathies.
    • Evaluation des douleurs chroniques post opératoires en consultation de contrôle à 6 mois de l’intervention à l’aide des critères de jugement secondaires suivants :
    • Evaluation de la douleur par échelle END et DN4 + NeuPSIG (douleurs neuropathiques) et évaluation de la consommation de thérapeutiques antalgiques.
    E.5.2.1Timepoint(s) of evaluation of this end point
    day 1, 2, 3 and at 6 months
    J1, J2, J3 et à 3 mois
    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 No
    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 No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial3
    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 years2
    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: 120
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 36
    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 state156
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 156
    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 Decision2019-09-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-11-20
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2023-02-23
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