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    Summary
    EudraCT Number:2020-004697-21
    Sponsor's Protocol Code Number:PENG-CAD
    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:2020-10-16
    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 number2020-004697-21
    A.3Full title of the trial
    RANDOMIZED AND CONTROLLED PHASE IV CLINICAL TRIAL ON THE ANALGESIC EFFECTIVENESS OF THE COMBINED BLOCKADE (PENG -PERICAPSULAR NERVE GROUP- AND THE FEMORAL LATERAL CUTANEOUS NERVE) IN THE HIP FRACTURES OF THE ELDERLY. COMPARATIVE STUDY BETWEEN LEVOBUPIVACAINE AND ROPIVACAINE.
    ENSAYO CLÍNICO FASE IV, ALEATORIZADO Y CONTROLADO SOBRE LA EFICACIA ANALGÉSICA DEL BLOQUEO COMBINADO (PENG -PERICAPSULAR NERVE GROUP- Y DEL NERVIO CUTANEO LATERAL FEMORAL) EN LAS FRACTURAS DE CADERA DEL ANCIANO. ESTUDIO COMPARATIVO ENTRE LEVOBUPIVACAÍNA Y ROPIVACAÍNA.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    RANDOMIZED AND CONTROLLED PHASE IV CLINICAL TRIAL ON THE ANALGESIC EFFECTIVENESS OF THE COMBINED BLOCKADE (PENG -PERICAPSULAR NERVE GROUP- AND THE FEMORAL LATERAL CUTANEOUS NERVE) IN THE HIP FRACTURES OF THE ELDERLY. COMPARATIVE STUDY BETWEEN LEVOBUPIVACAINE AND ROPIVACAINE.
    ENSAYO CLÍNICO FASE IV, ALEATORIZADO Y CONTROLADO SOBRE LA EFICACIA ANALGÉSICA DEL BLOQUEO COMBINADO (PENG -PERICAPSULAR NERVE GROUP- Y DEL NERVIO CUTANEO LATERAL FEMORAL) EN LAS FRACTURAS DE CADERA DEL ANCIANO. ESTUDIO COMPARATIVO ENTRE LEVOBUPIVACAÍNA Y ROPIVACAÍNA.
    A.4.1Sponsor's protocol code numberPENG-CAD
    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 SponsorInstituto de Investigación Biomédica de Salamanca
    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 supportInstituto de Investigación Biomédica de Salamanca
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSCReN-UICEC CAUSA/IBSAL
    B.5.2Functional name of contact pointÁrea de Ensayos Clínicos
    B.5.3 Address:
    B.5.3.1Street AddressPaseo de San Vicente
    B.5.3.2Town/ citySalamanca
    B.5.3.3Post code37007
    B.5.3.4CountrySpain
    B.5.4Telephone number+349232911005779
    B.5.6E-mailricardo.lopez@scren.es
    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 Levobupivacaína Altan 7,5 mg/ml solución inyectable y para perfusión E F G
    D.2.1.1.2Name of the Marketing Authorisation holderAltan Pharmaceuticals, 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 nameLevobupivacaína
    D.3.4Pharmaceutical form Solution for injection/infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntraarterial 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/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 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 Altan 2 mg/ml solución para perfusión EFG
    D.2.1.1.2Name of the Marketing Authorisation holderAltan Pharmaceuticals 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 nameRopivacaína
    D.3.4Pharmaceutical form Solution for injection/infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntraarterial 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 number2
    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
    Most appropriate anesthetic technique for surgery of hip fracture in the elderly
    Técnica anestésica más adecuada para la cirugía de la fractura de cadera del anciano
    E.1.1.1Medical condition in easily understood language
    Most appropriate anesthetic technique for surgery of hip fracture in the elderly
    Técnica anestésica más adecuada para la cirugía de la fractura de cadera del anciano
    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 23.0
    E.1.2Level PT
    E.1.2Classification code 10020100
    E.1.2Term Hip fracture
    E.1.2System Organ Class 10022117 - Injury, poisoning and procedural complications
    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 analgesic efficacy of both local anesthetics in the regional block of hip fracture surgery.
    Comparar la eficacia analgésica de ambos anestésicos locales en el bloqueo regional de la cirugía de fractura de cadera.
    E.2.2Secondary objectives of the trial
    • To describe the behavior of this combined technique in hip fractures, establishing the latency of initiation and duration of analgesia.
    • To describe the secondary effects derived from the combined technique described.
    • To validate in our population, especially in patients with cognitive impairment, the usefulness of the chosen analgesic scales.
    • Describir el comportamiento de dicha técnica combinada en las fracturas de cadera, estableciendo latencia de inicio y duración de la analgesia.
    • Describir los efectos secundarios derivados de la técnica combinada descrita.
    • Validar en nuestra población, sobre todo en los pacientes con deterioro cognitivo, la utilidad de las escalas analgésicas elegidas.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • The patient will have to voluntarily sign and understand the informed consent that will be provided in writing.
    • Patients over 65 years of age, with a hip fracture, who are going to be operated on at the Salamanca University Assistance Complex (CAUSA).
    • El paciente tendrá que firmar voluntariamente y entender el consentimiento informado que se le proporcionará por escrito.
    • Pacientes mayores de 65 años, con fractura de cadera, que vayan a ser intervenidos en el Complejo Asistencial Universitario de Salamanca (CAUSA).
    E.4Principal exclusion criteria
    • Rejection of the technique.
    • Allergy to any of the drugs.
    • Coagulation disorders.
    • Local infections instead of puncture.
    • Vascular prostheses at the femoral level.
    • Rechazo de la técnica.
    • Alergia a alguno de los fármacos.
    • Alteraciones de la coagulación.
    • Infecciones locales en lugar de punción.
    • Prótesis vasculares a nivel femoral.
    E.5 End points
    E.5.1Primary end point(s)
    • Complications during surgery that in the opinion of the investigator invalidate the results of the study
    • Complicaciones durante la cirugía que a juicio del investigador invaliden los resultados del estudio
    E.5.1.1Timepoint(s) of evaluation of this end point
    After surgery
    Tras la cirugía
    E.5.2Secondary end point(s)
    • Lack of collaboration or inability in the evaluation of the pain scales used in the study.
    • Falta de colaboración o incapacidad en la evaluación de las escalas de dolor empleadas en el estudio.
    E.5.2.1Timepoint(s) of evaluation of this end point
    At any time during the clinical trial
    En cualquier momento durante el ensayo clínico
    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 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
    Until completing the number of patients, 108. A rhythm of 15 patients/month is calculated, which means a planned completion in April 2021.
    Hasta completar el número de pacientes, 108. Se calcula un ritmo de 15 pacientes/mes, lo que supone una finalización prevista en Abril de 2021.
    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 months7
    E.8.9.1In the Member State concerned 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: 108
    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 state108
    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)
    None
    Ninguno
    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 Decision2020-12-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-10-05
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2021-12-01
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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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