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    Summary
    EudraCT Number:2013-000846-20
    Sponsor's Protocol Code Number:ANE-INTRA-2013
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2013-04-09
    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 number2013-000846-20
    A.3Full title of the trial
    Comparison of the effects of bupivacain or levobupivacain on cerebral oxigenation during intradural anesthesia in elderly patients who undergo major orthopaedic surgery for hip replacement
    Efecto sobre la oxigenación cerebral de la utilización de bupivacaína o levobupivacaína durante la anestesia intradural en el paciente anciano sometido a cirugía ortopédica mayor por fractura de fémur
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Comparison of the effects of bupivacain or levobupivacain on cerebral oxigenation during intradural anesthesia in elderly patients who undergo hip replacement surgery
    Efecto sobre la oxigenación cerebral de la utilización de bupivacaína o levobupivacaína durante la anestesia intradural en el paciente anciano sometido a cirugía por fractura de fémur
    A.4.1Sponsor's protocol code numberANE-INTRA-2013
    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 SponsorFundació Parc Taulí
    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 supportFundació Parc Taulí
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFundació Parc Taulí
    B.5.2Functional name of contact pointOficina de Recerca
    B.5.3 Address:
    B.5.3.1Street AddressParc Taulí nº 1
    B.5.3.2Town/ citySabadell
    B.5.3.3Post code08208
    B.5.3.4CountrySpain
    B.5.6E-mailafarre@tauli.cat
    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 BUPIVACAÍNA HIPERBÁRICA BRAUN 0,5% MINIPLASCO
    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.3.1Product nameBupivacaine
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    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 milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number7 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.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 CHIROCANE 0,625 mg/ml solución para perfusión
    D.2.1.1.2Name of the Marketing Authorisation holderAbbvie Farmaceutica, S.L.U.
    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.3.1Product namelevobupivacaine
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLEVOBUPIVACAINE
    D.3.9.1CAS number 27262-47-1
    D.3.9.4EV Substance CodeSUB08464MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number7 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
    Intradural anaesthesia
    Anestesia intradural
    E.1.1.1Medical condition in easily understood language
    Anestesia
    Anestesia
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10002091
    E.1.2Term Anaesthesia
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The main objective is to assess the effect of bupivacaine or levobupivacaine on peroperatory regional cerebral oximetry during anaesthesia in elderly patients undergoing hip replacement surgery
    El objetivo principal será evaluar el efecto sobre la oximetría regional cerebral peroperatoria (SrO2) de la utilización de bupivacaína o de levobupivacaína en la anestesia intradural en el paciente anciano sometido a cirugía ortopédica mayor por fractura de fémur
    E.2.2Secondary objectives of the trial
    Compare between patients treated with bupivacaine or levobupivacaine the following parameters:
    1. Change in cognitive function after surgery
    2. Hemodynamic changes induced by anaesthetic blockade and administration of vasoconstrictor drugs during anaesthesia
    3. Characteristics of sensorial and motor blockade induced by intradural anaesthesia
    4. Degree of intrasurgical bleeding
    5. Changes in renal function
    6. Clinical complications during hospitalization
    7. Mortality after 30 days
    Comparar:
    1. La modificación de la función cognitiva respecto de los valores preoperatorios.
    2. Los cambios hemodinámicos inducidos por bloqueo anestésico y la administración de fármacos vasoconstrictores durante la anestesia.
    3. Las características de los bloqueos sensorial y motor producidos por la anestesia intradural.
    4. El grado de sangrado intraoperatorio
    5. Los cambios en la función renal respecto de los valores del preoperatorio.
    6. Las complicaciones clínicas hasta el alta hospitalaria
    7. Mortalidad a treinta días
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patients older than 70 years old who undergo major orthopaedic surgery for hip replacement and will receive intradural anaesthesia
    2. Patients who give their informed consent to participate in the study
    1. Pacientes ancianos mayores de 70 años que van a ser sometidos a cirugía ortopédica mayor por fractura de fémur tributarios de anestesia intradural.
    2. Que hayan otorgado su consentimiento informado a participar en el estudio
    E.4Principal exclusion criteria
    1. Patients allergic to anaesthetic drugs to be used in the protocol
    2. Patients with severe aortic estenosis
    3. Patients who refuse the anaesthetic technique
    4. Patients with severe cognitive impairment previous to the intervention (defined by a score in the Pfeiffer test of 8-10 errors)
    5. Any condition that, in the investigator's opinion, could pose a risk to the patient
    11. Pacientes alérgicos a los anestésicos locales empleados
    2. Pacientes con estenosis aórtica severa.
    3. Rechazo de la técnica anestésica por parte del paciente.
    4. Puntuación test de Pfeiffer previa a la intervención quirúrgica: 8-10 errores (deterioro cognitivo severo)
    5. Pacientes en los que se considere que la participación en el estudio puede suponer un perjuicio clínico, en opinión del médico responsable del cuidado del paciente.
    E.5 End points
    E.5.1Primary end point(s)
    Proportion of intraoperative time with a decrease or cerebral regional saturation (SrO2), of at least 20% with respect to baseline values
    La variable principal del estudio será el porcentaje de tiempo intraoperatorio en el que se detecta un descenso de la saturación regional cerebral O2 (SrO2) del 20% con respecto a los valores basales
    E.5.1.1Timepoint(s) of evaluation of this end point
    During the surgery
    Dirante la cirugí
    E.5.2Secondary end point(s)
    ? Change in cognitive function after 5 or 7 days with respect to preoperative function, measured by means of the Pfeiffer cognitive test
    ? La modificación de la función cognitiva al cabo de 5 a 7 días de la intervención quirúrgica respecto de los valores preoperatorios, valorada mediante el número de errores en el test cognitivo de Pfeiffer (SPMSQ).
    E.5.2.1Timepoint(s) of evaluation of this end point
    Measured at day 5 or 7 post-surgery
    Valorado al dia 5 ó 7 post cirugía
    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 No
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic Yes
    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 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) 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
    LVLP
    UVUP
    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 months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    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) No
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 56
    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 Information not present in EudraCT
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    F.3.3.3Pregnant women Information not present in EudraCT
    F.3.3.4Nursing women Information not present in EudraCT
    F.3.3.5Emergency situation Information not present in EudraCT
    F.3.3.6Subjects incapable of giving consent personally Information not present in EudraCT
    F.3.3.7Others Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state56
    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)
    Non applicable
    No aplica
    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 Decision2013-06-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-03-23
    P. End of Trial
    P.End of Trial StatusCompleted
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