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    Summary
    EudraCT Number:2020-004872-17
    Sponsor's Protocol Code Number:IC2020-04
    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:2020-12-11
    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 number2020-004872-17
    A.3Full title of the trial
    A Double-blind Randomized non-inferiority Trial of erector spinae block (ESP) versus paravertebral block (PVB) before Breast Cancer Surgery: Effects on acute Postoperative Pain
    Essai clinique randomisé de non-infériorité, multicentrique en double aveugle, évaluant l’effet du bloc érecteur (ESP) versus bloc paravertébral (BPV) sur la douleur aiguë après chirurgie carcinologique du sein
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Effect of erector spinae block versus para paravertebral block on acute postoperative pain before breast cancer surgery
    Effet du bloc érecteur versus bloc paravertébral sur la douleur aiguë après chirurgie carcinologique du sein
    A.3.2Name or abbreviated title of the trial where available
    ER-One
    ER-One
    A.4.1Sponsor's protocol code numberIC2020-04
    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 SponsorINSTITUT CURIE
    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 supportPHRC-K19-037
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationINSTITUT CURIE
    B.5.2Functional name of contact pointIsabelle TURBIEZ
    B.5.3 Address:
    B.5.3.1Street Address35 rue Dailly
    B.5.3.2Town/ citySAINT-CLOUD
    B.5.3.3Post code92210
    B.5.3.4CountryFrance
    B.5.4Telephone number33147 11 16 59
    B.5.6E-maildrci.promotion@curie.fr
    D. IMP Identification
    D.IMP: 1
    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.2.1.2Country 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.3.2Product code Chlorhydrate de Ropivacaïne
    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 nameChlorhydrate de Ropivacaïne
    D.3.9.4EV Substance CodeSUB10382MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/kg milligram(s)/kilogram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number3
    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
    Nervous Block erector spinae plane (ESP) or paravertebral block (PVB) preoperatively in women with breast adenocarcinoma without metastasis or breast in situ adenocarcinoma to by treated either by breast-conserving surgery with axillary dissection, either by modified radical mastectomy with or without axillary or lymph node dissection.
    Bloc nerveux érecteur ou paravertébral juste avant chirurgie chez des patientes présentant un adénocarcinome mammaire infiltrant non métastatique ou adénocarcinome mammaire in situ à traiter soit par chirurgie mammaire conservatrice avec curage axillaire, soit par mastectomie radicale avec ou sans geste axillaire.
    E.1.1.1Medical condition in easily understood language
    Local anesthetic before breast cancer surgery
    Anesthésie locale avant chirurgie pour cancer du sein
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level LLT
    E.1.2Classification code 10003034
    E.1.2Term Application site anesthesia
    E.1.2System Organ Class 100000004867
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level HLT
    E.1.2Classification code 10006290
    E.1.2Term Breast and nipple neoplasms malignant
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Assessment of the percentage of patients needed morphine with ESP block or PVB during the first two postoperative hours in the Post-Anesthesia Care Unit (PACU).
    Évaluation du pourcentage de patientes ayant besoin de morphine avec bloc ESP ou BPV pendant les deux premières heures postopératoires dans la Salle de Surveillance Post-Interventionnelle (SSPI).
    E.2.2Secondary objectives of the trial
    1.Evaluation of the total morphine consumption (IV titration in mg) in the PACU.
    2.Evaluation of the consumption of Remifentanil in the Operating Room in µg during the period from incision to the last stitch .
    3.Evaluation of the Visual Analogic Scale (VAS) (no pain=0, worst pain=10): VAS at arrival in the PACU, VAS every 30 min in the PACU, VAS at 4 and 24 hours. Pain scores will be evaluated at rest and after shoulder movement.
    4.Percentage of patients with nausea or vomiting over 24 hours.
    5.Evaluation of the complications and side effects of each block.
    6.Post-operative distribution of diminished cold sensation on the nipple line (ice cube test) in the PACU.
    7.Evaluation of postoperative quality of recovery score: the QoR-15 before surgery and 24h after surgery
    8.Anaesthesiologist & patient satisfaction after regional anesthesia technique with a scale from 0 to 10 (not at all satisfactory=0; very satisfactory=10).
    9.Consumption of antalgic drugs over 24 hours.
    1.Évaluation de la consommation totale de morphine (titration IV en mg) en SSPI.
    2.Évaluation de la consommation de Rémifentanil en salle d'opération en µg pendant la période de l'incision jusqu'au dernier point de suture
    3.Évaluation de l'échelle visuelle analogique (EVA) (pas de douleur = 0, pire douleur = 10) : EVA à l'arrivée en SSPI, EVA toutes les 30 min en SSPI; EVA à 4 et 24 h
    4.Évaluation de l'incidence des nausées et vomissements sur 24 h.
    5.Évaluation des complications et des effets secondaires de chaque bloc.
    6.Distribution post-opératoire de la diminution de la sensation de froid sur la ligne mamelonnaire en SSPI.
    7.Évaluation de la qualité postopératoire du score de récupération : le QoR-15 avant la chirurgie et 24 h après la chirurgie.
    8.Satisfaction des patients et des anesthésistes après la technique d'anesthésie locorégionale avec une échelle de 0 à 10 (pas du tout satisfaisant = 0, très satisfaisant = 10).
    9.Consommation d’antalgiques sur 24 h
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Woman with breast adenocarcinoma without metastasis or breast in situ adenocarcinoma (with or without breast reconstruction by prosthesis) to by treated:
    - either by breast-conserving surgery with axillary dissection,
    - either by modified radical mastectomy with axillary dissection
    - either by modified radical mastectomy with lymph node dissection
    - either by modified radical mastectomy without axillary
    2.Patients aged between 18 and 85 years old.
    3.ASA class 1, 2 or 3 (Physical Status Classification System of American Society of Anesthesiologists (ASA)).
    4.Signed informed consent form.
    5.Patient able to answer self-assessment questionnaires (sufficient understanding of evaluations and in French).
    6.Patient affiliated to the health care insurance.

    There is no prohibition for people to take part simultaneously in another research and there is no exclusion cause at the end of the research period.
    1.Femme présentant un adénocarcinome mammaire infiltrant non métastatique ou adénocarcinome mammaire in situ à traiter (avec ou sans reconstruction mammaire immédiate par prothèse) :
    - soit par chirurgie mammaire conservatrice avec curage axillaire,
    - soit par mastectomie totale avec curage axillaire
    - soit par mastectomie totale avec ganglion sentinelle
    - soit par mastectomie totale sans geste axillaire.
    2.Patients âgés de 18 ans à 85 ans.
    3.Classe 1, 2 ou 3 de l'ASA (Système de classification de l'état physique de l'American Society of Anesthesiologists (ASA)).
    4.Formulaire de consentement éclairé signé.
    5.Patiente capable de répondre aux questionnaires d’autoévaluation (compréhension suffisante des évaluations et du français).
    6.Patiente affiliée à un régime d’assurance maladie (bénéficiaire ou ayant droit).

    Il n’y a pas d’interdiction pour les personnes de participer simultanément à une autre recherche et il n’y a pas de période d’exclusion prévue à l’issue de la recherche.
    E.4Principal exclusion criteria
    1.Preoperative consumption of opioid in the patient's current médications within three months before inclusion.
    2.Ipsilateral breast surgery during 3 months prior to the inclusion.
    3.Allergy to local anaesthetics and morphine and NSAID.
    4.Local skin inflammation at the puncture area.
    5.Bilateral breast surgery planned at inclusion.
    6.Major immediate ipsilateral breast reconstruction by using tissue flap procedure (example: latissimus dorsi flap, DIEP, TRAM…).
    7.Any contra-indication or patient’s refusal for regional anesthesia.
    8.Male subjects.
    9.Pregnant woman or breastfeeding.
    10.B blocker medication.
    11.Patient already participating in an analgesia protocol that may interfere with the pain assessment criteria.
    12.Patient deprived of liberty or under legal protection.
    13.Inability to undergo medical monitoring of the trial for geographical, social or psychological reasons.
    1.Consommation préopératoire d'opioïdes dans le traitement habituel de la patiente et dans les 3 mois précédant l’inclusion.
    2.Chirurgie mammaire homolatérale dans les 3 mois précédant l’inclusion.
    3.Allergie et/ou intolérance aux anesthésiques locaux, à la morphine et aux AINS.
    4.Inflammation locale de la peau au niveau de la zone de ponction.
    5.Chirurgie mammaire bilatérale prévue au moment de l’inclusion.
    6.Reconstruction mammaire homolatérale immédiate majeure, par lambeau (exemple : grand dorsal, DIEP, TRAM...)
    7.Toute contre-indication ou refus de la patiente pour une anesthésie régionale.
    8.Sujets masculins.
    9.Femme enceinte ou en période d’allaitement.
    10.Médicament bloquant B.
    11.Patiente participant déjà à un protocole d’analgésie pouvant interférer sur les critères d’évaluation de la douleur.
    12.Personnes privées de liberté ou sous tutelle (y compris la curatelle).
    13.Impossibilité de se soumettre au suivi médical de l'essai pour raisons géographique, sociale ou psychique.
    E.5 End points
    E.5.1Primary end point(s)
    The main hypothesis of this study is to demonstrate that the percentage of patients needed morphine during the first two postoperative hours in the ESP group is no worse than in the PVB group by more than 20%. The rational to choose this objective as primary objective is to show a non-inferiority of ESP versus PVB on acute postoperative pain.
    L'hypothèse principale de cette étude est de démontrer que le pourcentage de patientes ayant besoin de morphine au cours des deux premières heures postopératoires dans le groupe ESP n'est pas supérieur de plus de 20% à celui observé dans le groupe BPV. Le rationnel de choisir cet objectif comme objectif principal est de montrer une non-infériorité de l'ESP par rapport au BPV sur la douleur postopératoire aiguë.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Primary end point : 2 hours
    Critère principal : 2 heures
    E.5.2Secondary end point(s)
    1.Postoperative morphine consumption: the rational for this objective is to show the efficacy of ESP block in breast surgery according low consumption of opioid, thus improving the patients’ pain outcomes and the related side effects.
    2.Consumption of remifentanil in the Operating Room (OR) in µg during the period from the surgical incision to the end of the surgical dissection (consumption of remifentanil during this period / patient weight / duration of the period).
    3.Acute early postoperative pain at rest. The rational for such an objective is to show efficacy of the ESP block on breast surgery. The pain will be assessed by the Visual Analogic Scale (VAS) (no pain=0, worst pain=10): VAS at arrival in the PACU, VAS every 30 minutes in the PACU, VAS at 4 and 24 hours. Pain scores will be evaluated at rest and after shoulder movement.
    4.Percentage of nausea or vomiting in patients over 24 hours: the rational for this objective is to show the efficacy low consumption of opioid, thus improving the patients’ related side effects.
    5.Complications and side effects of each block.
    6.Post-operative distribution of diminished cold sensation on the nipple line (ice cube test) in the PACU.
    7.Evaluation of postoperative quality of recovery score: the QoR-15 before surgery and 24 hours after surgery. Quality of recovery after anesthesia is an important measure of the early postoperative health status of patients. The QoR-15 provides a valid evaluation of this recovery. The validation of the French version of the scale is published.
    8.Anaesthesiologist (conditions for performing the block) and patient (pain) satisfaction just after regional anesthesia technique with a scale from 0 to 10 (not at all satisfactory=0; very satisfactory=10).
    9.Total dose of antalgic drugs (over 24 hours).
    1.Consommation postopératoire de morphine: la raison de cet objectif est de montrer l'efficacité du bloc ESP en chirurgie mammaire en fonction d'une faible consommation de morphine, améliorant ainsi la douleur des patientes et les effets secondaires associés.
    2.Consommation de Rémifentanil en salle d'opération en µg pendant la période allant de l'incision chirurgicale à la fin de l’intervention chirurgicale (consommation de Rémifentanil pendant cette période / poids de la patiente / durée de la période).
    3.Douleur postopératoire précoce aiguë au repos et après mouvement de l'épaule. La justification d'un tel objectif est de montrer l'efficacité du bloc ESP sur la chirurgie mammaire. La douleur sera évaluée par l’échelle visuelle analogique (EVA) (pas de douleur = 0, pire douleur = 10) : EVA à l'arrivée en SSPI, EVA toutes les 30 minutes en SSPI, EVA à 4 et 24 heures. Les scores de douleur seront évalués au repos et à la mobilisation.
    4.Pourcentage de patientes ayant présenté des nausées et vomissements sur 24 heures : la raison d'être de cet objectif est de montrer l'efficacité d'une faible consommation d'opioïdes, améliorant ainsi les effets secondaires liés aux patientes.
    5.Complications et effets secondaires de chaque bloc.
    6.Distribution post-opératoire de la diminution de la sensation de froid sur la ligne mamelonnaire (test avec un glaçon) en SSPI.
    7.Évaluation de la qualité postopératoire du score de récupération: le QoR-15 avant la chirurgie et 24 heures après la chirurgie. La qualité de la récupération après anesthésie est une mesure importante de l'état de santé postopératoire précoce des patientes. Le QoR-15 fournit une évaluation valide de cette récupération. La validation de la version française de l'échelle est publiée.
    8.Satisfaction des patientes (douleur ressentie) et des anesthésistes (conditions de réalisation du bloc) juste après la technique d'anesthésie régionale avec une échelle de 0 à 10 (pas du tout satisfaisant = 0, très satisfaisant = 10).
    9.Doses totales d’antalgiques consommés sur 24 heures.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1.Postoperative morphine consumption: 2 hours
    2.Consumption of remifentanil: during the period from the surgical incision to the end of the surgical dissection
    3.VAS every 30 min in the PACU, VAS at 4 and 24 hours
    4.Nausea or vomiting in patients: 24 hours
    5.Complications and side effects : 30 days
    6.Cold sensation : 15 minutes
    7.QoR-15: 24 hours
    8.Anaesthesiologist and patient satisfaction: 30 minutes
    9.Total dose of antalgic drugs: 24 hours
    1.Consommation postopératoire de morphine: 2 heures
    2.Consommation de Rémifentanil : période allant de l'incision chirurgicale à la fin de l’intervention chirurgicale
    3.EVA toutes les 30 min en SSPI, EVA à 4 et 24 heures
    4.Nausées et vomissements sur 24 heures
    5.Complications et effets secondaires : 30 jours
    6.Sensation de froid : 15 minutes
    7.QoR-15 : 24 heures
    8.Satisfaction des patientes et anesthésistes : 30 minutes
    9.Doses totales d’antalgiques : 24 heures
    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 Yes
    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) 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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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.8.2.4Number 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 concerned5
    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
    LPLV
    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 months25
    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: 192
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 100
    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 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 state292
    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)
    Follow up at 30 days after postoperative block
    Suivi 30 jours après la réalisation du bloc.
    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 Decision2021-02-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-03-18
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2023-07-14
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