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    Summary
    EudraCT Number:2011-001340-29
    Sponsor's Protocol Code Number:IIBSP-LEV-2011-21
    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:2011-07-11
    Trial results View 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 number2011-001340-29
    A.3Full title of the trial
    Effectiveness of Added blocking of radial and median nerves with levobupivacaine in the control of postoperative pain in the rhizarthrosis ambulatory surgery
    Eficacia del bloqueo añadido de los nervios radial y mediano con levobupivacaína en el control del dolor postoperatorio en cirugía ambulatoria de rizartrosis.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Effectiveness of Added blocking of radial and median nerves with levobupivacaine in the control of postoperative pain in the rhizarthrosis ambulatory surgery
    Eficacia del bloqueo añadido de los nervios radial y mediano con levobupivacaína en el control del dolor postoperatorio en cirugía ambulatoria de rizartrosis.
    A.4.1Sponsor's protocol code numberIIBSP-LEV-2011-21
    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 SponsorInstitut de Recerca del Hospital de la Santa Creu i Sant Pau
    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 supportInstitut de Recerca del Hospital de la Santa Creu i Sant Pau
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationInstitut de Recerca del Hospital de la Santa Creu i Sant Pau
    B.5.2Functional name of contact pointRomy Rodríguez
    B.5.3 Address:
    B.5.3.1Street AddressC/ Sant Antoni Maria Claret, 167
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08025
    B.5.3.4CountrySpain
    B.5.4Telephone number349329190501969
    B.5.5Fax number34935537812UK
    B.5.6E-mailRRodriguezMu@santapau.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 CHIROCANE 5mg/ml solución inyectable / concentrado para solución para perfusión
    D.2.1.1.2Name of the Marketing Authorisation holderABBOTT LABORATORIES, 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 Injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPPerineural use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLEVOBUPIVACAINA HIDROCLORURO
    D.3.9.3Other descriptive nameLEVOBUPIVACAINE HYDROCHLORIDE
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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
    Rhizarthrosis
    Rizartrosis
    E.1.1.1Medical condition in easily understood language
    arthrosis at the base of the thumb
    artrosis en la base del pulgar
    E.1.1.2Therapeutic area Diseases [C] - Musculoskeletal Diseases [C05]
    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
    Estudiar la eficacia del bloqueo periférico de los nervios radial y mediano para controlar el dolor tras la cirugía ambulatoria de rizartrosis en el momento de máxima intensidad, esto es, en las primeras 24-48 horas.
    E.2.2Secondary objectives of the trial
    - Evaluar la necesidad de medicación de rescate en ambos grupos.
    - Evaluar la incidencia de náuseas y vómitos, el medicamento y las dosis que de fármaco utilizadas para su tratamiento.
    - Adicionalmente evaluaremos la presencia de bloqueo motor y el momento de la reversión del mismo
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    a) Men and women over 18 years.
    b) Ambulatory Surgery rhizarthrosis.
    c) Acceptance free to participate in the study, with informed consent signed by the patient, tutor or family member.
    a) Hombres o mujeres mayores de 18 años.
    b) Cirugía ambulatoria de rizartrosis.
    c) Aceptación libre de participar en el estudio, con consentimiento informado firmado por el paciente, tutor o familiar responsable.
    E.4Principal exclusion criteria
    a) Patients <18 years.
    b) The patient does not agree to participate in the study.
    c) Allergy to local anesthetics / NSAIDs
    d) Chronic pain treatment.
    e) Neurological diseases
    f) CI local anesthesia.
    a) Pacientes < 18 años.
    b) Que el paciente no acepte participar en el estudio.
    c) Alergia a los anestésicos locales /AINES
    d) Dolor crónico en tratamiento.
    e) Enfermedades neurológicas.
    f) CI anestesia loco-regional.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is to evaluate the pain that will be measured by visual analog scale of pain (VAS). To Determine the maximum VAS and VAS at 24 and 48 hours postoperatively. Besides, to note the time that you have pain and can calculate secondary pain-free period from discharge to home.
    La variable principal a evaluar será el DOLOR medido mediante la escala analógica analógica visual del dolor, (VAS). Se determinará el VAS máximo y el VAS a las 24 y 48 horas del postoperatorio. Además recogeremos la hora en que aparece el dolor, pudiendo calcular secundariamente el período libre de dolor desde el alta a domicilio.
    E.5.1.1Timepoint(s) of evaluation of this end point
    two years
    dos años
    E.5.2Secondary end point(s)
    ? VAS at the time of the call.
    ? maximum VAS.
    ? Time to onset of pain after hospital discharge.
    ? Skipping doses Keral.
    ? Need for rescue analgesia, and total dose used.
    ? Presence of nausea or vomiting, and medication used to control them.
    ? Presence of motor block and time reversal
    ? VAS al momento de recibir la llamada.
    ? VAS máximo.
    ? Hora de inicio de dolor desde el alta hospitalaria.
    ? Omisión de dosis de enantyum.
    ? Necesidad de analgesia de rescate, y dosis total utilizada.
    ? Presencia de náuseas o vómitos y medicamento utilizado para el control de éstos.
    ? Presencia de bloqueo motor y hora de reversión.
    E.5.2.1Timepoint(s) of evaluation of this end point
    two years
    dos años
    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 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 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 Yes
    E.8.1.7.1Other trial design description
    Evaluación ciega por terceros
    Blind evaluation by others persones
    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
    Tratamiento convencional vs. Tratamiento convencional + intervención
    Conventional treatment Versus Conventional treatment + intervention
    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 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
    The last patient finishes the study within 2 days after his/her inclusion
    El último paciente finaliza el estudio al cabo de 2 días tras su inclusión.
    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 months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    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) Yes
    F.1.2.1Number of subjects for this age range: 25
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 25
    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 state50
    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)
    expected normal treatment of that condition
    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 Decision2011-09-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-06-01
    P. End of Trial
    P.End of Trial StatusCompleted
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