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    Summary
    EudraCT Number:2021-002712-30
    Sponsor's Protocol Code Number:FPS-SMG-2021-02
    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:2021-07-29
    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 number2021-002712-30
    A.3Full title of the trial
    PHASE III, RANDOMISED, DOUBLE-BLIND, CLINICAL TRIAL TO DETERMINE THE ROLE OF MAGNESIUM SULPHATE IN ADDUCTOR CANAL BLOCK IN ARTHROSCOPIC KNEE SURGERY
    ENSAYO CLÍNICO FASE III, ALEATORIZADO, DOBLE CIEGO PARA DETERMINAR EL PAPEL DEL SULFATO DE MAGNESIO EN EL BLOQUEO CANAL ADUCTOR EN CIRUGÍA ARTROSCÓPICA DE RODILLLA
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    CLINICAL TRIAL TO DETERMINE HOW A TYPE OF MAGNESIUM SULPHATE ANALGESIA WORKS IN ARTHROSCOPIC KNEE SURGERY
    ENSAYO CLÍNICO PARA DETERMINAR CÓMO FUNCIONA UN TIPO DE ANALGESIA CON SULFATO DE MAGNESIO EN CIRUGÍA ARTROSCÓPICA DE RODILLLA
    A.4.1Sponsor's protocol code numberFPS-SMG-2021-02
    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 SponsorFUNDACIÓN PÚBLICA ANDALUZA PROGRESO Y SALUD
    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 supportFundación Andaluza Beturia para la Investigación en Salud –FABIS
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFUNDACIÓN PÚBLICA ANDALUZA PROGRESO Y SALUD
    B.5.2Functional name of contact pointPAULA CALLEJO GARCÍA
    B.5.3 Address:
    B.5.3.1Street AddressAvenida Américo Vespucio n°15 Edificio s-2
    B.5.3.2Town/ citySevilla
    B.5.3.3Post code41092
    B.5.3.4CountrySpain
    B.5.6E-mailgestionensayosclinicos.fps@juntadeandalucia.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 MAGNESIUM SULPHATE ALTAN
    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.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPPerineural use
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Pain in arthroscopic anterior cruciate ligament reconstruction surgery.
    Dolor en la cirugía de reconstrucción del ligamento cruzado anterior por vía artroscópica.
    E.1.1.1Medical condition in easily understood language
    Pain after knee surgery
    Dolor tras cirugía de rodilla
    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 the efficacy of Magnesium Sulphate via perineural route in prolonging analgesia when administered as an adjuvant to the local anaesthetic Ropivacaine in arthroscopic anterior cruciate ligament reconstruction surgery.
    Evaluar la eficacia del Sulfato de Magnesio vía perineural en la prolongación de la analgesia cuando se administra como adyuvante del anestésico local Ropivacaína en la cirugía de reconstrucción del ligamento cruzado anterior vía artroscópica.
    E.2.2Secondary objectives of the trial
    - To assess the speed at which anaesthetic block is established.
    - To measure the depth of regional anaesthesia.
    - To determine the analgesic efficacy of the block in the immediate postoperative period, as well as during the first 24 hours at home after hospital discharge.
    - To assess the safety of the technique, in the form of perioperative adverse events.
    - To determine the level of patient satisfaction.
    - Valorar la velocidad de instauración del bloqueo anestésico.
    - Medir la profundidad de la anestesia regional.
    - Determinar la eficacia analgésica del bloqueo en el postoperatorio inmediato, así como durante las primeras 24 horas en el domicilio tras el alta hospitalaria.
    - Valorar la seguridad de la técnica, en forma de eventos adversos perioperatorios.
    - Determinar el nivel de satisfacción del paciente.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Patients scheduled for anterior cruciate ligament reconstruction surgery via arthroscopy.
    - ASA I and II patients of both sexes.
    - Age between 18 and 60 years.
    - Signed informed consent form agreeing to participate in the study.
    - Pacientes programados para cirugías de reconstrucción del ligamento cruzado anterior vía artroscópica.
    - Pacientes ASA I y II de ambos sexos.
    - Edad comprendida entre los 18 y los 60 años.
    - Consentimiento informado firmado aceptando participar en el estudio.
    E.4Principal exclusion criteria
    - ASA III or IV patients.
    - Patients with expected difficult airway.
    - Patients with the presence of predictive criteria for failed ventilation with supraglottic devices.
    - Allergy or intolerance to local anaesthetics, morphine or derivatives, magnesium sulphate.
    - Diabetes mellitus with last control of glycosylated haemoglobin greater than 7%.
    - Patients with neuromuscular diseases.
    - Patients with previous treatment with corticoids or calcium antagonists.
    - Patients with difficulty in understanding the information related to the study and in collaborating in the assessment of pain.
    - Patients with major psychiatric pathology in DSM-V.
    - Pregnancy and/or breastfeeding.
    - Pacientes ASA III o IV.
    - Pacientes con vía aérea difícil prevista.
    - Pacientes con presencia de criterios predictores de ventilación fallida con dispositivos supraglóticos.
    - Alergia o intolerancia a los anestésicos locales, morfina o derivados, Sulfato de Magnesio.
    - Diabetes mellitus con último control de Hemoglobina glicosilada mayor a 7%.
    - Pacientes con enfermedades neuromusculares.
    - Pacientes con tratamiento previo con corticoides o antagonistas del calcio.
    - Pacientes con dificultad para comprender la información relacionada con el estudio y para colaborar en la valoración del dolor.
    - Pacientes con patología psiquiátrica mayor en DSM-V.
    - Embarazo y/o lactancia materna.
    E.5 End points
    E.5.1Primary end point(s)
    Time in minutes from the time the patient receives the adductor canal block until the first analgesic rescue dose is demanded.
    Tiempo en minutos transcurrido desde que el paciente se le realiza el bloqueo del canal aductor hasta que demanda la primera dosis de rescate analgésico.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Clinical follow-up period
    Periodo de seguimiento clínico
    E.5.2Secondary end point(s)
    - Speed of onset of anaesthetic blockade.
    - Intraoperative nociception monitoring via the NOL (nociception level) monitor.
    - Anaesthetic depth.
    - Visual Analogue Scale (VAS)
    - Total number of boluses of morphine requested by the patient.
    - Adverse effects.
    - Overall patient satisfaction with treatment (PGIC scale).
    - Tiempo en minutos desde la realización de la inyección hasta la instauración del bloqueo analgésico.
    - Monitorización de la nocicepción intraoperatoria a través del monitor NOL (nociception level).
    - Profundidad anestéstica
    - Escala Visual Analógica (EVA).
    - Cantidad total de bolos de morfina demandados por el paciente.
    - Eventos adversos.
    - Satisfacción general del paciente con el tratamiento (Escala PGIC).
    E.5.2.1Timepoint(s) of evaluation of this end point
    - From injection to establishment of analgesic blockade.
    - During the intraoperative period.
    - Clinical follow-up period
    - Before undergoing surgery and clinical follow-up period.
    - Clinical follow-up period.
    - Clinical follow-up period.
    - At the end of the clinical follow-up
    - Desde la realización de la inyección hasta la instauración del bloqueo analgésico.
    - Durante el periodo intraoperatorio.
    - Periodo de seguimiento clínico.
    - Antes de someterse a la intervención y durante el periodo de seguimiento clínico.
    - Periodo de seguimiento clínico.
    - Periodo de seguimiento clínico.
    - Al final del seguimiento 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 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) Yes
    E.7.4Therapeutic use (Phase IV) No
    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 Yes
    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) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial3
    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 visita 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 months
    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: 131
    F.1.3Elderly (>=65 years) No
    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 Yes
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Informed consent shall be given by the subject's legal representative, provided that the latter does not have the capacity to give it.
    El consentimiento informado será otorgado por el representante legal del sujeto siempre que este último no tenga la capacidad de realizarlo.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state131
    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 Decision2021-10-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-10-01
    P. End of Trial
    P.End of Trial StatusOngoing
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