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    Summary
    EudraCT Number:2019-005010-19
    Sponsor's Protocol Code Number:HCB/2019/1148
    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:2020-02-21
    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 number2019-005010-19
    A.3Full title of the trial
    Ultrasound-guided Genicular Nerve Block an Analgesic Alternative to LIA for
    Total Knee Arthroplasty. Randomized clinical trial.
    Comparación del bloqueo de los nervios geniculares con ayuda de la ecografía con la infiltración local analgésica en el manejo analgésico de la colocación de protesis total de rodilla: ensayo clínico aleatorizado prospectivo
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Comparison of ultrasound-guided Genicular Nerve Block with local infiltration analgesia for analgesic managment of total Knee Arthroplasty: A prospective, randomized clinical study.
    Comparación del bloqueo de los nervios geniculares con ayuda de la ecografía con la infiltración local analgésica en el manejo analgésico de la colocación de protesis total de rodilla: ensayo clínico aleatorizado prospectivo.
    A.3.2Name or abbreviated title of the trial where available
    RCTGENTKR
    PGENECA
    A.4.1Sponsor's protocol code numberHCB/2019/1148
    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 SponsorHospital Clínic de Barcelona
    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 supportHospital Clínic de Barcelona
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHospital Clínic de Barcelona
    B.5.2Functional name of contact pointAnestesiología y Reanimación
    B.5.3 Address:
    B.5.3.1Street AddressVillaroel 170
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08036
    B.5.3.4CountrySpain
    B.5.4Telephone number34932275558
    B.5.6E-mailCunat@clinic.cat
    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 ROPIVACAINA INIBSA
    D.2.1.1.2Name of the Marketing Authorisation holderLABORATORIOS INIBSA
    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 Solution for 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 INNROPIVACAINE
    D.3.9.1CAS number 84057-95-4
    D.3.9.3Other descriptive nameROPIVACAINE HYDROCHLORIDE
    D.3.9.4EV Substance CodeSUB04264MIG
    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.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 ADRENALINA B.BRAUN
    D.2.1.1.2Name of the Marketing Authorisation holderB.BRAUN
    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 Solution for 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 INNADRENALINE
    D.3.9.1CAS number 51-43-4
    D.3.9.3Other descriptive nameADRENALINE TARTRATE PH. EUR.
    D.3.9.4EV Substance CodeSUB176490
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    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 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: 3
    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 INIBSA
    D.2.1.1.2Name of the Marketing Authorisation holderLABORATORIOS INIBSA
    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 Solution for 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 INNROPIVACAINE
    D.3.9.1CAS number 84057-95-4
    D.3.9.3Other descriptive nameROPIVACAINE HYDROCHLORIDE
    D.3.9.4EV Substance CodeSUB04264MIG
    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.IMP: 4
    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 ADRENALINA B.BRAUN
    D.2.1.1.2Name of the Marketing Authorisation holderB.BRAUN
    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 Solution for 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 INNADRENALINE
    D.3.9.1CAS number 51-43-4
    D.3.9.3Other descriptive nameADRENALINE TARTRATE PH. EUR.
    D.3.9.4EV Substance CodeSUB176490
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.05
    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
    Total knee arthroplasty has become one of the most frequent surgical procedures in the world. Currently models employ high volume local infiltration analgesia (LIA) techniques. The genicular nerve block (GNB) appears as an alternative due to the success that has been obtained in the ablative treatment in pain clinics. The objective of this study is to evaluate the analgesic results of GNB after TKA in comparison with a group that received the usual technique (high volume LIA).
    La artroplastia total de rodilla (ATR) es uno de los procedimientos quirúrgicos más frecuentes en el mundo. Actualmente se emplean técnicas de analgesia de infiltración local de gran volumen (LIA). El bloqueo de los nervios geniculares (GNB) ha aparecido como una alternativa tras el éxito obtenido en el tratamiento ablativo en el dolor crónico. El objetivo es evaluar la analgesia obtenida tras el GNB después de la ATR en comparación con aquellos pacientes que reciben la técnica habitual (LIA).
    E.1.1.1Medical condition in easily understood language
    The genicular nerve block is an alternative to analgesic management in total knee arthroplasty (local infiltration analgesia). The objective is to compare analgesic efficacy of both techniques.
    El bloqueo de los nervios geniculados es una alternativa a la infiltración local analgésica en la artroplastia total de rodilla. El objetivo es comparar la eficacia analgésica de ambas técnicas.
    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
    The main objective is to verify that the ultrasound-guided blockade of the genicular nerves is not inferior in terms of analgesic efficacy in comparison with the LIA in the first 24 hours of the postoperative period of primary TKR and during the first mobilization using the NRS score.
    El objetivo principal es comprobar que el bloqueo ecoguiado de los nervios geniculados es capaz de proporcionar una analgesia no inferior a la obtenida con la LIA en pacientes sometidos a ATR primaria en las primeras 24 horas del postoperatorio y durante la primera movilización utilizando la puntuación NRS.
    E.2.2Secondary objectives of the trial
    The secondary objectives are to evaluate that the consumption of rescue opioids and the range of joint mobility are not inferior in those patients who have received the genicular nerve block in comparison with those who have received the LIA.
    Los objetivos secundarios son comparar que el consumo de opioides de rescate y el rango de movilidad articular son no inferiores en aquellos pacientes que hayan recibido bloqueo de los nervios geniculados respecto a los que hayan recibido la LIA.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Subjects undergoing TKR with informed written consent.
    • ASA physical status I-III
    • BMI 18-40 kg/m2.
    • Todo paciente sometido a artroplastia total primaria de rodilla que de su consentimiento para participar en el estudio.
    • Clasificación de la ASA physical status I-III.
    • IMC 18-40 kg/m2.
    E.4Principal exclusion criteria
    • Patients who refuse the performance of the block or who refuse to give their consent or who do not have the capacity to collaborate with compliance with the protocol.
    • General anesthesia.
    • Age under 18 or over 90 years.
    • Patients who undergo bilateral arthroplasty, revision arthroplasties or prosthetic replacements.
    • Contraindication for peripheral nerve block (local infection, neurological deficit, complex regional syndrome, previous trauma or ipsolateral knee surgery).
    • Systemic infection.
    • Opioid consumption during the last 4 weeks in doses higher than 30 mg oral morphine or equivalent).
    • Patients with hemorrhagic diathesis or coagulopathy (diagnosis by clinical or laboratory history).
    • Patients with allergies to any medication that is part of the protocol (for example, allergy to local anesthetics).
    • Pacientes que rechacen la realización del bloqueo, que se nieguen a dar su consentimiento o que no tengan capacidad para colaborar con el cumplimiento del protocolo.
    • Anestesia general.
    • Edad menor a 18 años o mayor a 90 años.
    • Pacientes que se sometan a artroplastia bilateral, artroplastias de revisión o recambios protésicos.
    • Contraindicación para un bloqueo nervioso periférico (infección local, déficit neurológico, síndrome regional complejo, trauma previo o cirugía en la rodilla ipsilateral).
    • Infección sistémica.
    • Consumo de opioides durante las últimas 4 semanas en dosis mayores a 30 mg de morfina oral o equivalente).
    • Pacientes con diátesis hemorrágica o coagulopatía (diagnóstico por historia clínica o laboratorio).
    • Pacientes con alergias a cualquier medicamento que sea parte del protocolo (por ejemplo, alergia a anestésicos locales).
    E.5 End points
    E.5.1Primary end point(s)
    NRS at 24 hours after surgery.
    NRS a las 24 horas después de la cirugía.
    E.5.1.1Timepoint(s) of evaluation of this end point
    24 hours.
    24 horas.
    E.5.2Secondary end point(s)
    1. NRS at the Post-anesthesia care unit (PACU) after spinal block reversal, evaluated as genuflection of contralateral knee in 90 degrees.
    2. NRS at 12 hours after surgery.
    3. NRS after first mobilization.
    4. Need for rescue opioids and dose of rescue drugs (mg morphine / mg methadone / mg tramadol)
    5. Mobility range (maximum flexion / maximum extension) during the first mobilization.
    1. NRS en la unidad de reanimación post anestésica (URPA) post reversión bloqueo espinal, evaluado como genuflexión de rodilla contralateral en 90 grados.
    2. NRS a las 12 horas después de la cirugía.
    3. NRS posterior a la movilización
    4. Rescate Opioides y dosis de fármacos de rescate (mg morfina/mg metadona/mg tramadol)
    5. Rango movilidad (máxima flexión/máxima extensión) durante la primera exploración
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. After spinal block reversal.
    2. At 12 hours after surgery.
    3. After first mobilization.
    4. During the hospitalization.
    5. During the first mobilization.
    1. Post reversión bloqueo espinal.
    2. A las 12 horas después de la cirugía.
    3. Tras la primera movilización.
    4. Durante la hospitalización.
    5. Durante la primera mobilización.


    1. After spinal block reversal.
    2. At 12 hours after surgery.
    3. After first mobilization.
    4. During the hospitalization.
    5. During the first mobilization.
    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 Yes
    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 No
    E.8.1.3Single blind Yes
    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
    LVLS
    Última entrada en el estudio del último paciente.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months3
    E.8.9.1In the Member State concerned days
    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: 11
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 51
    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.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 Decision2020-08-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-07-29
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2021-04-30
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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
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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