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    Summary
    EudraCT Number:2015-001033-24
    Sponsor's Protocol Code Number:1234
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-06-08
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2015-001033-24
    A.3Full title of the trial
    The management of post-operative pain nia patients undergoing cardiac surgery mini - invasive minithoracotomy : Randomized trial
    La gestione del dolore post-operatorio nei pazienti sottoposti a chirurgia cardiaca mini-invasiva in minitoracotomia: studio randomizzato
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The management of post-operative pain nia patients undergoing cardiac surgery mini - invasive minithoracotomy
    La gestione del dolore post-operatorio nei pazienti sottoposti a chirurgia cardiaca mini-invasiva in minitoracotomia
    A.3.2Name or abbreviated title of the trial where available
    post-operative pain nia patients undergoing cardiac surgery mini - invasive minithoracotomy
    dolore post-operatorio nei pazienti sottoposti a chirurgia cardiaca mini-invasiva in minitoracotomia
    A.4.1Sponsor's protocol code number1234
    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 SponsorAOU CITTA' DELLA SALUTE E DELLA SCIENZA DI TORINO
    B.1.3.4CountryItaly
    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 supportAOU CITTA' DELLA SALUTE E DELLA SCIENZA
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAOU CITTA' DELLA SALUTE E DELLA SCIENZA
    B.5.2Functional name of contact pointANESTESIA E RIANIMAZIONE 1
    B.5.3 Address:
    B.5.3.1Street AddressC.SO BRAMANTE 88
    B.5.3.2Town/ cityTORINO
    B.5.3.3Post code10126
    B.5.3.4CountryItaly
    B.5.4Telephone number0116336129
    B.5.5Fax number0116336129
    B.5.6E-maildpasero@cittadellasalute.to.it
    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 ROPIVACAINA KABI - 10 MG/ML SOLUZIONE INIETTABILE 5 FIALE IN PP DA 10 ML
    D.2.1.1.2Name of the Marketing Authorisation holderFRESENIUS KABI ITALIA S.R.L.
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 nameRopivacaina
    D.3.2Product code 1
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMP
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor code1
    D.3.9.3Other descriptive nameRopivacaine hydrochloride monohydrate
    D.3.10 Strength
    D.3.10.1Concentration unit % (W/V) percent weight/volume
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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 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 MORFINA CLORIDRATO MONICO - 20 MG/ML SOLUZIONE INIETTABILE 5 FIALE 1 ML
    D.2.1.1.2Name of the Marketing Authorisation holderMONICO S.P.A.
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 nameMorfina Cloridrato Monico
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMP
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor code2
    D.3.9.3Other descriptive namemorphine hydrochloride
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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
    The management of postoperative pain in patients undergoing cardiac surgery minimally invasive minithoracotomy : randomized
    La gestione del dolore post-operatorio nei pazienti sottoposti a chirurgia cardiaca mini-invasiva in minitoracotomia: studio randomizzato
    E.1.1.1Medical condition in easily understood language
    post-operative pain nia patients undergoing cardiac surgery mini - invasive
    dolore post-operatorio nei pazienti sottoposti a chirurgia cardiaca mini-invasiva
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10043491
    E.1.2Term Thoracotomy
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Assess whether the use of the technique of locoregional analgesia with catheter reduces the consumption of opioid analgesics expressed as equivalent dose for pain control for patients operated with approach of minimally invasive surgery in minithoracotomy , compared to those treated with standard analgesia ( administration intravenous ) .
    Valutare se l¿utilizzo della tecnica di analgesia locoregionale con cateterino riduca il consumo di farmaci analgesici espressi come oppioidi dose equivalenti per il controllo del dolore dei pazienti operati con approccio di chirurgia mini-invasiva in minitoracotomia, rispetto a quelli trattati con analgesia standard (somministrazione endovenosa).
    E.2.2Secondary objectives of the trial
    1. Reduce the time of mechanical ventilation
    2. Reduction of ICU stay
    3. Shorter hospital stay
    1. Riduzione del tempo di ventilazione meccanica
    2. Riduzione dei tempi di degenza in terapia intensiva
    3. Riduzione dei tempi di degenza ospedaliera
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Age = 18 years
    2. Patients undergoing cardiac surgery minimally invasive minithoracotomy .
    1. Età = 18 anni
    2. Pazienti sottoposti a chirurgia cardiaca mini-invasiva in minitoracotomia.
    E.4Principal exclusion criteria
    1. Patients allergic to analgesics or anesthetics
    2. Patients who have not given their consent to participate in the study
    3. Patients with psychiatric disorders because it would prevent the feedback postoperative
    4. Patients operated under emergency
    5. Patients on ECMO ( extracorporeal circulation )
    1. Pazienti allergici a farmaci analgesici o anestetici
    2. Pazienti che non abbiano dato il consenso alla partecipazione allo studio
    3. Pazienti con disturbi psichiatrici perché impedirebbero le valutazioni post-operatorie
    4. Pazienti operati in regime di urgenza
    5. Pazienti in ECMO (circolazione extracorporea)
    E.5 End points
    E.5.1Primary end point(s)
    - Entro le 24 ore
    - Entro le 48 ore
    - Entro le 72 ore
    a. Riduzione livelli medi NRS del dolore
    b. Riduzione del consumo di altri farmaci antidolorifici supplementari
    c. Miglioramenti dal punto di vista respiratorio (riduzione tempi di intubazione, riduzione infezioni vie respiratorie)
    d. Riduzione degenza in terapia intensiva
    e. Riduzioni tempi di ospedalizzazione
    E.5.1.1Timepoint(s) of evaluation of this end point
    - Within 24 hours
    - Within 48 hours
    - Within 72 hours
    a. Reduction in average levels of pain NRS
    b . Reduction in use of other pain medications additional
    c . Improvements in terms of respiratory (reduction intubation times , reducing respiratory infections )
    d. Reduction ICU stay
    and . Reductions in hospitalization time
    E.5.2Secondary end point(s)
    1. Reduce the time of mechanical ventilation
    2. Reduction of ICU stay
    3. Shorter hospital stay
    1. Riduzione del tempo di ventilazione meccanica
    2. Riduzione dei tempi di degenza in terapia intensiva
    3. Riduzione dei tempi di degenza ospedaliera
    E.5.2.1Timepoint(s) of evaluation of this end point
    within 48 hours
    entro le 48 ore
    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 Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence Yes
    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 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.8.2.4Number 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.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States No
    E.8.5.1Number of sites anticipated in the EEA1
    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 Information not present in EudraCT
    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 years1
    E.8.9.1In the Member State concerned months12
    E.8.9.1In the Member State concerned days36
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months12
    E.8.9.2In all countries concerned by the trial days36
    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: 55
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 5
    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 state60
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 60
    F.4.2.2In the whole clinical trial 60
    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)
    subjects will still be managed as previstio from normal clinical practice
    i soggetti verranno comunque gestiti come previstio dalla normale pratica clinica
    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 Decision2015-12-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-01-25
    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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