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    Summary
    EudraCT Number:2016-005057-21
    Sponsor's Protocol Code Number:PECBRIL2016
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2017-03-31
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2016-005057-21
    A.3Full title of the trial
    A prospective, randomized, parallel comparative clinical trial comparing the safety of perioperative analgesic efficacy of the PEC II block with BRILMA in breast surgery.Version 4, of May 16, 2017
    Ensayo clínico comparativo prospectivo, aleatorizado y paralelo para comparar la seguridad de eficacia analgésica perioperatoria del bloqueo PECII con el BRILMA en cirugía de mama. Versión 4, de 16 de May 2017
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical trial that compares the safety and efficacy of two locoregional anesthetic techniques used on breast cancer surgery called BRILMA and PEC II block
    Ensayo clinico que compara la seguridad y eficacia de dos Tecnicas anestésicas locoregionales en cirugia de cancer de mama llamadas bloqueoBRILMA y PEC II
    A.4.1Sponsor's protocol code numberPECBRIL2016
    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 SponsorHospital Universitario Sant Joan de Reus
    B.1.3.4CountrySpain
    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 supportHospital Universitario Sant Joan de Reus
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHospital Universitario Sant Joan de Reus
    B.5.2Functional name of contact pointServicio de Anestesiologia
    B.5.3 Address:
    B.5.3.1Street AddressAv. Josep Laporte 2
    B.5.3.2Town/ cityReus
    B.5.3.3Post code43204
    B.5.3.4CountrySpain
    B.5.4Telephone number+34977310300
    B.5.6E-mailberthaixaantonieta.rivas@grupsagessa.com
    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.2.1.1.1Trade name Mepivacaina Inyectable Braun 2% Miniplastico
    D.2.1.1.2Name of the Marketing Authorisation holderB. Braun Medical, S.A.
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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 infusion
    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 INNMEPIVACAINE
    D.3.9.1CAS number 96-88-8
    D.3.9.4EV Substance CodeSUB14514MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number10 to 20
    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 Bupivacaina Inyectable Braun 0,5% Miniplastico
    D.2.1.1.2Name of the Marketing Authorisation holderB. Braun Medical, S.A.
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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 infusion
    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 INNBUPIVACAINE
    D.3.9.1CAS number 2180-92-9
    D.3.9.4EV Substance CodeSUB05983MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number2 to 9
    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
    Non-reconstructiva Breast Surgery candidates
    Pacientes candidatas para cirugia de mama no reconstructiva
    E.1.1.1Medical condition in easily understood language
    Parientes that will hace non- reconstructiva breast surgery
    Pacientes a las que se les realizara cirugia de mama no reconstructiva
    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 efficacy and safety of ultrasound-guided BRILMA and PEC II block to reduce peri-operative pain in patients undergoing non reconstructive breast surgery at the University Hospital Sant Joan de Reus
    Comparar la eficacia y seguridad del bloqueo ecoguiado BRILMA con PEC II para disminuir el dolor perioperatorio en las pacientes sometidas a cirugía de mama no reconstructiva en el Hospital Universitario Sant Joan de Reus.
    E.2.2Secondary objectives of the trial
    To compare the analgesic efficacy of the BRILMA and PEC II block during intraoperative period according to the need for administration of opioids based on the variation of vital constants from the moment of the first surgical incision.
    To compare the duration of postoperative analgesic effect of the BRILMA and PEC II block using the Numerical Verbal Scale (EVN).
    To evaluate the safety of BRILMA vs PEC II block, comparing the percentage of complications in each group of patients.
    To assess the degree of satisfaction with regard to postoperative pain in each group of patients.
    Comparar la eficacia analgésica del bloqueo BRILMA y PEC II durante el periodo intraoperatorio según la necesidad de administración de opiáceos en base a la variación de constantes vitales desde el momento de la primera incisión quirúrgica
    Contrastar la duración del efecto analgésico postoperatorio del bloqueo BRILMA y PEC II, mediante la valoración de la Escala Verbal Numérica (EVN).
    Evaluar la seguridad del bloqueo BRILMA vs PEC II, comparando el porcentaje de complicaciones en cada grupo de pacientes.
    Valorar el grado de satisfacción con respecto al dolor postoperatorio en cada grupo de pacientes.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients scheduled for non reconstructive breast surgery.
    Patients age between 18 and 85 years
    Preoperative Surgical risk ASA I to III patients
    Pacientes programadas para cirugia no reconstructiva de mama.
    Edad de la paciente comprendida entre los 18 y 85 años
    Riesgo perioperatorio de las pacientes: ASA I a III.
    E.4Principal exclusion criteria
    Patients scheduled for reconstructive breast surgery.
    Preoperative risk :ASA IV patients.
    Patient weight under 45 Kg or BMI over 40 kg / m2.
    Preoperative Criteria compatible with difficult airway.
    High risk of aspiration of gastric contents.
    Allergy to local anesthetics or other drugs used in the clinical trial.
    Chronic treatment with opioids.
    Local or systemic infection
    Altered platelet funtion and / or hemostasia factors.
    Chronic pain in anterolateral chest portion and/or axila.
    Difficulty to understand the pain valoration scales
    Reluctance or rejection for anesthetic technique.
    Lack of capacity or willingness to participate in the study and to sign the informed consent form.
    Estado físico de la paciente ASA IV.
    Peso de la paciente <45 Kp o IMC >40 Kg/m2.
    Criterios preoperatorios compatibles con vía aérea difícil.
    Alto riesgo de broncoaspiración de contenido gástrico.
    Alergia a anestésicos locales u otros fármacos utilizados en el estudio.
    Tratamiento crónico con opiáceos.
    Infección local y/o generalizada.
    Alteración plaquetaria y/o factores de coagulación.
    Dolor crónico en la región anterolateral del tórax o axila.
    Dificultad para entender las escalas de valoración de dolor.
    Rechazo de técnica anestésica.
    Falta de capacidad o deseo de participar en el estudio y firmar consentimiento informado.
    E.5 End points
    E.5.1Primary end point(s)
    To reduce de Intraaoperative opioid requirements in patients undergoing non reconstructive breast surger . BRILMA or PEC II Block will be done to patients undergoing non reconstructive breast surgery. Anesthetic induction will be carried out without opioids, and intravenous fentanyl will be administered if BRILMA or PEC II Block in uneffective
    Disminuir la necesidades intraaoperatorias de opioides en pacientes sometidas a cirugia de mama no reconstructiva. Se realizara Bloqueo BRILMA o PEC II a las pacientes propuestas para cirugia de mama no reconstructiva. Se realizara inducción anestésica sin opiodes, se administrará fentanilo intravenoso en caso de que bloqueo BRILMA o PEC II no sea eficaz
    E.5.1.1Timepoint(s) of evaluation of this end point
    Intraoperative period
    Periodo intraoperatorio
    E.5.2Secondary end point(s)
    To Compare the requirements of conventional Analgesia in patients with BRILMA and PEC II block during the first 24 hours of postoperative time.
    Assess the analgesic efficacy of BRILMA and PEC II block through Numerica Visual Scale (EVN) EVN considering 0 as absense of pain, 1 or 3 mild pain , 4-6 moderate pain , and over 7 as intense pain
    Comparar los requerimientos de Analgesia convencional en las pacientes a las que se le realizo bloqueo BRILMA y PEC II durante las primeras 24 horas de post operatorio.
    Valorar la eficacia analgesica de Bloqeuo BRILMA y PEC II a través de Escala Visual Numerica (EVN): considerando un EVN 0 la ausencia de dolor, 1 o 3 dolor leve, moderado entre 4 y 6, e intenso mayor a 7
    E.5.2.1Timepoint(s) of evaluation of this end point
    First 24 hours after non-reconstructive Breast Surgery
    Primeras 24 horas posterior a cirugia de mama no recinstructiva
    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 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 Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 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
    the trial will end 24 hours after the surgery one the 100h patient
    el estudio finalizará 24 horas posterior de la cirugía del paciente numero 100
    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: 60
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 40
    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 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 state100
    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
    Ninguno
    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 Decision2017-06-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-05-25
    P. End of Trial
    P.End of Trial StatusOngoing
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