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    The EU Clinical Trials Register currently displays   43881   clinical trials with a EudraCT protocol, of which   7295   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:2011-004167-68
    Sponsor's Protocol Code Number:CHJTMP_01/2011
    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:2012-01-19
    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 number2011-004167-68
    A.3Full title of the trial
    Comparación de bloqueo TAP (abordaje cuadrado lumbar) versus bloqueo femoral para analgesia postoperatoria de artroplastia parcial de cadera, ambos guiados con ultrasonidos
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Evaluación de la eficacia de los analgesicos postoperatorios en pacientes mayores de 65 años sometidos a operación por fractura de cadera
    A.3.2Name or abbreviated title of the trial where available
    TAP
    BLOQUEO TAP VS BLOQUEO FEMORAL
    A.4.1Sponsor's protocol code numberCHJTMP_01/2011
    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 SponsorMARIA TERESA PARRAS MALDONADO
    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 supportMINISTERIO SANIDAD Y POLITICA SOCIAL
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMARIA TERESA PARRAS MALDONADO
    B.5.2Functional name of contact pointFRANCISCO MANUEL LUQUE MARTINEZ
    B.5.3 Address:
    B.5.3.1Street AddressAVDA. EJERCITO ESPAÑOL, 10
    B.5.3.2Town/ cityJAEN
    B.5.3.3Post code23007
    B.5.3.4CountrySpain
    B.5.4Telephone number+34953008077
    B.5.6E-mailfranciscom.luque.exts@juntadeandalucia.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 levobupivacaine
    D.2.1.1.2Name of the Marketing Authorisation holderCHIROCANE 2.5MG/ML SOLUCION INYECTABLE/CONCENTRADO PARA SOLUCION PARA PERFUSION
    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 nameCHIROCANE
    D.3.2Product code LEVOBUPIVACAINA
    D.3.4Pharmaceutical form Solution for injection/concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntradural use (Noncurrent)
    Intrabursal use
    Posterior juxtascleral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 27262-48-2
    D.3.9.2Current sponsor codeLEVOBUPIVACAINE HYDROCHLORIDE
    D.3.9.3Other descriptive nameLEVOBUPIVACAINE HYDROCHLORIDE
    D.3.9.4EV Substance CodeSUB02904MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number0.65 to 1.25
    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 levobupivacaine
    D.2.1.1.2Name of the Marketing Authorisation holderCHIROCANE 2.5MG/ML SOLUCION INYECTABLE/CONCENTRADO PARA SOLUCION PARA PERFUSION
    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 nameCHIROCANE
    D.3.2Product code LEVOBUPIVACAINA
    D.3.4Pharmaceutical form Solution for injection/concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntradural use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 27262-48-2
    D.3.9.2Current sponsor codeLEVOBUPIVACAINE HYDROCHLORIDE
    D.3.9.3Other descriptive nameLEVOBUPIVACAINE HYDROCHLORIDE
    D.3.9.4EV Substance CodeSUB02904MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number0.65 to 1.25
    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
    104 patients will be randomized to each of the two groups to apply TAP or femoral block, after which they were placed in lateral decubitus position and proceed to the performance of spinal anesthesia. The group will perform TAP TAP block with 30 ml of levobupivacaine 0.125% and the femoral group perform femoral block, levobuivacaína injecting 10 ml of 0.25%. Both blocks will be guided by ultrasound.
    104 pacientes serán asignados de forma aleatoria a cada uno de los dos grupos, para aplicarles un bloqueo TAP o femoral, tras el cual se les colocará en posición decubito lateral y se procederá a la realización de la anestesia intradural. Al grupo TAP se le realizará el bloqueo TAP con 30 ml de levobupivacaina 0,125% y al grupo Femoral se le realizará el bloqueo femoral, inyectando 10 ml de levobuivacaína 0,25%. Ambos bloqueos serán guiados con ultrasonidos.
    E.1.1.1Medical condition in easily understood language
    104 patients will be assigned to two different groups, to apply different types of anesthesia. Both will be guided by ultrasound.
    104 pacientes serán asignados a dos grupos diferentes, para aplicarles diferentes tipos de anestesia. Ambos serán guiados con ultrasonidos.
    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 evaluate effectiveness of postoperative analgesic in TAP block versus femoral block in hip fracture
    Evaluar la eficacia analgésica postoperatoria del bloqueo TAP versus bloqueo femoral en pacientes mayores de 65 años sometidos a artroplastia parcial por fractura de cadera.
    E.2.2Secondary objectives of the trial
    - To analyze the necessity of postoperative analgesic
    - To value the effectiveness of block between both group
    - To compare their stay in URPA
    - To value the satisfaction in the patient
    - Analizar la necesidad de analgesia de rescate postcirugía.
    - Valorar la eficacia del bloqueo sensitivo y motor en ambos grupos.
    - Comparar la duración de su estancia en URPA.
    - Valorar el grado de satisfacción del paciente con la técnica realizada.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    inclusion criteria:
    - Sing of consent
    - More than 65 years old
    - ASA clasification (I-III) for anestesic risk
    - Hip fracture with parcial arthroplasty surgical treatment
    Criterios de inclusión:
    - Firma del consentimiento del paciente o tutor para participar en el estudio.
    - Pacientes mayores de 65 años
    - Riesgo anestésico determinado por la clasificación ASA: I-III.
    - Fractura intracapsular de cadera en la que se indique tratamiento quirúrgico mediante artroplastia parcial de cadera.
    E.4Principal exclusion criteria
    exclusion criteria:
    - Anestesic allergy
    - Mental illness
    - Periferic neuropathy
    - Intradural anesthetic contraindication
    Criterios de exclusión:
    - Alergia conocida a los anestésicos locales tipo amida.
    - Enfermedad mental que impida colaborar con la cumplimentacion de cuestionarios.
    - Neuropatía periférica.
    - Contraindicación para realizar anestesia intradural
    E.5 End points
    E.5.1Primary end point(s)
    After the surgery and the patient extubated, will move into the recovery room post-anesthesia (PACU).
    Una vez finalizada la cirugía y extubado el paciente, se trasladará a la unidad de reanimación post-anestesia (URPA).
    E.5.1.1Timepoint(s) of evaluation of this end point
    In PACU the patient will pass the EVA survey to analyze the degree of pain.
    En URPA se le pasará al paciente la encuenta EVA para analizar el grado de dolor.
    E.5.2Secondary end point(s)
    At 24 hours reflects the degree of patient satisfaction.
    A las 24 horas se recogerá el grado de satisfacción del paciente.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Satisfaction Survey
    Encuesta de satisfacción
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety No
    E.6.5Efficacy No
    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 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
    At 24 hours after admission the patient.
    A las 24 horas del ingreso del paciente.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    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: 104
    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 state104
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 0
    F.4.2.2In the whole clinical trial 104
    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)
    There will be no special treatment derived from this study
    No se hará ningun tratamiento especial derivados de este estudio
    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 Decision2012-04-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-07-28
    P. End of Trial
    P.End of Trial StatusOngoing
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