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    The EU Clinical Trials Register currently displays   43873   clinical trials with a EudraCT protocol, of which   7293   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2018-001025-20
    Sponsor's Protocol Code Number:ROPIOBES_HULP_2018
    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:2018-05-21
    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 number2018-001025-20
    A.3Full title of the trial
    COMPARISON OF POSTOPERATIVE ANALGESIA OF INTRAPERITONEAL NEBULIZED ROPIVACAIN BEFORE AND AFTER LAPAROSCOPIC GASTRIC BY-PASS IN OBESITY SURGERY
    COMPARACIÓN DE LA ANALGESIA POSTOPERATORIA DE LA ROPIVACAÍNA NEBULIZADA INTRAPERITONEAL ANTES Y DESPUÉS DEL BY-PASS GÁSTRICO LAPAROSCÓPICO EN CIRUGÍA DE OBESIDAD
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    STUDY TO COMPARE THE POSTOPERATIVE ANALGESIA OF INTRAPERITONEAL NEBULIZED ROPIVACAIN BEFORE AND AFTER LAPAROSCOPIC GASTRIC BY-PASS SURGERY IN OBESITY PATIENTS
    ESTUDIO PARA COMPARAR LA ANALGESIA POSTOPERATORIA DE LA ROPIVACAÍNA NEBULIZADA INTRAPERITONEAL ANTES Y DESPUÉS DE CIRUGÍA DE BY-PASS GÁSTRICO LAPAROSCÓPICO EN PACIENTES CON OBESIDAD
    A.4.1Sponsor's protocol code numberROPIOBES_HULP_2018
    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 SponsorServicio de Anestesiología y Reanimación del Hospital Universitario La Paz
    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 supportServicio de Anestesiología y Reanimación del Hospital Universitario La Paz
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUCICEC
    B.5.2Functional name of contact pointHOI TONG
    B.5.3 Address:
    B.5.3.1Street AddressPaseo de la Castellana 261, Hospital Universitario La Paz. edificio Maternidad, 2ª planta. UCICEC
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28046
    B.5.3.4CountrySpain
    B.5.4Telephone number34912071466
    B.5.5Fax number34912071466
    B.5.6E-mailhoi.tong@idipaz.es
    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 Ropivacaína Inibsa
    D.2.1.1.2Name of the Marketing Authorisation holderInibsa
    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 Injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntraperitoneal use
    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.3.9.4EV Substance CodeSUB10382MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number7.5
    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 Ropivacaína Inibsa
    D.2.1.1.2Name of the Marketing Authorisation holderInibsa
    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 Injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntraperitoneal use
    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.3.9.4EV Substance CodeSUB10382MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number7.5
    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
    Post-surgical pain after gastric bypass surgery in obese patients
    Dolor postquirúrgico tras cirugía de by-pass gástrico en pacientes obesos
    E.1.1.1Medical condition in easily understood language
    Dolor postquirúrgico tras cirugía de by-pass gástrico en pacientes obesos
    Dolor tras la cirugía de bypass gástrico en pacientes con obesidad.
    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 postoperative pain score (using visual analogue scale, VAS) in the two groups once the patient arrives at the post-anesthetic recovery unit (immediate postoperative VAS).
    Comparar la puntuación del dolor postoperatorio (mediante escala visual analógica, VAS) en los dos grupos una vez que el paciente llega a la unidad de recuperación post-anestésica (VAS postoperatorio inmediato).
    E.2.2Secondary objectives of the trial
    - Determine if there is a difference in the VAS at 3, 6 and 24 hours.
    - Determine if there is a difference in morphine consumption during the first 24 hours.
    - Determine if there is a difference in the incidence of nausea and vomiting during the first 24 hours.
    - Determine if there is a difference in the presence of pain referred to the shoulder during the first 24 hours.
    - Determine if there are differences in the beginning of oral tolerance, ambulation and length of hospital stay.
    - Determine if there are cardiovascular complications in any of the groups during the first 48 hours.
    - Determine if there are differences in inflammatory markers at 24 hours.
    - Determinar si existe diferencia en las VAS a las 3, 6 y 24 horas.
    - Determinar si existe diferencia en el consumo de morfina durante las primeras 24 horas.
    - Determinar si existe diferencia en la incidencia de náuseas y vómitos durante las primeras 24 horas.
    - Determinar si existe diferencia en la presencia de dolor referido al hombro durante las primeras 24 horas.
    - Determinar si existen diferencias en el inicio de la tolerancia oral, deambulación y tiempo de estancia hospitalaria.
    - Determinar si existen complicaciones cardiovasculares en alguno de los grupos durante las primeras 48 horas.
    - Determinar si existen diferencias en los marcadores inflamatorios a las 24 horas.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Patients programmed for laparoscopic Roux-Y gastric bypass surgery
    - Age between 18 and 80 years old
    - Informed consent
    - BMI ≥ 35 kg / m2
    - That he agrees to participate in the study by signing the informed consent.
    - Pacientes programados para cirugía de Bypass gástrico laparoscópico en Y de Roux
    - Edad entre los 18 y los 80 años
    - Consentimiento informado cumplimentado
    - IMC ≥ 35 kg/m2
    - Que acepte participar en el estudio firmando el consentimiento informado.
    E.4Principal exclusion criteria
    - Reconversion to open surgery
    - Allergy known to local anesthetics
    - Psychiatric alterations that prevent the clinical evaluation of pain
    - Previous history of chronic pain of any type with habitual opioid use
    - Severe cardiovascular disease (NYHA ≥ III): CHF, arrhythmias, decompensated cardiomyopathies.
    - Treatment with class III antiarrhythmics (amiodarone, sotalol).
    - IRC stadium 3 or more.
    - Child-Pugh hepatic dysfunction class B or C.
    - Previous gastrointestinal surgery.
    - Acute porphyria
    - If the surgery is reconverted to open, the patient will be excluded from the study.
    - Reconversión a cirugía abierta
    - Alergia conocida a anestésicos locales
    - Alteraciones psiquiátricas que impidan la evaluación clínica del dolor
    - Historia previa de dolor crónico de cualquier tipo con consumo habitual de opioides
    - Enfermedad cardiovascular severa (NYHA ≥ III): ICC, arritmias, miocardiopatías descompensadas.
    - Tratamiento con antiarrítmicos clase III (amiodarona, sotalol).
    - IRC estadio 3 o más.
    - Disfunción hepática Child-Pugh clase B o C.
    - Cirugía gastrointestinal previa.
    - Porfiria aguda
    - Si la cirugía se reconvierte a abierta, el paciente quedará excluido del estudio.
    E.5 End points
    E.5.1Primary end point(s)
    To compare the postoperative pain score (using visual analogue scale, VAS) in the two groups once the patient arrives at the post-anesthetic recovery unit (immediate postoperative VAS).
    Comparar la puntuación del dolor postoperatorio (mediante escala visual analógica, VAS) en los dos grupos una vez que el paciente llega a la unidad de recuperación post-anestésica (VAS postoperatorio inmediato).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Immediate post-operative
    Post-operatorio inmediato
    E.5.2Secondary end point(s)
    - Determine if there is a difference in the VAS at 3, 6 and 24 hours.
    - Determine if there is a difference in morphine consumption during the first 24 hours.
    - Determine if there is a difference in the incidence of nausea and vomiting during the first 24 hours.
    - Determine if there is a difference in the presence of pain referred to the shoulder during the first 24 hours.
    - Determine if there are differences in the beginning of oral tolerance, ambulation and length of hospital stay.
    - Determine if there are cardiovascular complications in any of the groups during the first 48 hours.
    - Determine if there are differences in inflammatory markers at 24 hours.
    - Determinar si existe diferencia en las VAS a las 3, 6 y 24 horas.
    - Determinar si existe diferencia en el consumo de morfina durante las primeras 24 horas.
    - Determinar si existe diferencia en la incidencia de náuseas y vómitos durante las primeras 24 horas.
    - Determinar si existe diferencia en la presencia de dolor referido al hombro durante las primeras 24 horas.
    - Determinar si existen diferencias en el inicio de la tolerancia oral, deambulación y tiempo de estancia hospitalaria.
    - Determinar si existen complicaciones cardiovasculares en alguno de los grupos durante las primeras 48 horas.
    - Determinar si existen diferencias en los marcadores inflamatorios a las 24 horas.
    E.5.2.1Timepoint(s) of evaluation of this end point
    At 3,6, 24 and 48 hours post-surgical.
    A las 3, 6, 24 y 48 horas post-quirúrgicas
    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 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) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Ropivacaina intraperitoneal post-quirúrgica
    post-surgical intraperitoneal Ropivacaine
    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
    LVLS
    Última visita programada del último paciente del estudio.
    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 months6
    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: 100
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 Yes
    F.3.3.1Women of childbearing potential not using contraception Yes
    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 state110
    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)
    The expected normal treatment of that condition
    El habitual para esta condición
    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 Decision2018-05-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-05-24
    P. End of Trial
    P.End of Trial StatusOngoing
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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