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    Summary
    EudraCT Number:2021-002725-23
    Sponsor's Protocol Code Number:FPS-ROP-2021-03
    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:2021-08-05
    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 number2021-002725-23
    A.3Full title of the trial
    ULTRASOUND-GUIDED ERECTOR SPINAE BLOCKADE AS PART OF MULTIMODAL ANALGESIA IN LUMBOSACRAL SURGERY: A PROSPECTIVE RANDOMISED STUDY.
    BLOQUEO ECOGUIADO DEL ERECTOR ESPINAL COMO PARTE DE LA
    ANALGESIA MULTIMODAL EN LA CIRUGÍA LUMBOSACRA: ESTUDIO
    PROSPECTIVO ALEATORIZADO.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    ULTRASOUND-GUIDED ERECTOR SPINAE BLOCKADE AS PART OF ANALGESIA IN LUMBAR SURGERY.
    BLOQUEO ECOGUIADO DEL ERECTOR ESPINAL COMO PARTE DE LA
    ANALGESIA EN LA CIRUGÍA LUMBAR.
    A.4.1Sponsor's protocol code numberFPS-ROP-2021-03
    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
    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 AddressAvda. Américo Vespucio, Nº15, Edificio S-2
    B.5.3.2Town/ citySeville
    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 Ropivacaína Inibsa 2 mg/ml solución inyectable EFG
    D.2.1.1.2Name of the Marketing Authorisation holderInibsa Hospital S.L.U.
    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 IMPInjection (Noncurrent)
    Intramuscular 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.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 Inibsa 10 mg/ml solución inyectable EFG
    D.2.1.1.2Name of the Marketing Authorisation holderInibsa Hospital S.L.U.
    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 IMPInjection (Noncurrent)
    Intramuscular 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 number3
    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 placeboIntramuscular use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Pain in lumbosacral surgery
    Dolor en Cirugía lumbosacra
    E.1.1.1Medical condition in easily understood language
    Pain in lumbar surgery
    Dolor en cirugía lumbar
    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 analgesic efficacy of ultrasound-guided erector spinae plane blockade (ESPB) at lumbar level with ropivacaine 0.2 % (2 mg/ml) in the control of postoperative pain during 24 hours in patients undergoing lumbosacral surgery compared to ESPB performed with ropivacaine 0.3 % (3 mg/ml) and ESPB performed with Physiological Serum 0.9 %.
    Evaluar la eficacia analgésica del bloqueo ecoguiado del plano del músculo erector de la columna (ESPB) a nivel lumbar con ropivacaína 0.2 % (2 mg/ml) en el control del dolor postoperatorio durante 24 horas en pacientes sometidos a cirugía lumbosacra comparado con ESPB realizado con ropivacaína 0.3 % (3 mg/ml) y ESPB realizado con Suero Fisiológico 0.9 %.
    E.2.2Secondary objectives of the trial
    - To evaluate:
    • The intraoperative analgesic efficacy of ESPB
    • The use of ESPB to reduce the total intraoperative remifentanil dose.
    • The use of ESPB in the reduction of perioperative complications derived from the use of opioids.
    • The safety of the technique in the form of perioperative adverse events.
    • The usefulness of ESPB in early mobilisation without postoperative pain in patients who underwent lumbosacral spine
    • The sensory level achieved by performing the block at the L3 level.
    • A possible association between ESPB with the appearance of motor or sensory alterations at the lower limb level.
    - To determine:
    • The concentration of ropivacaine (0.2 % vs. 0.3 %) at which analgesic efficacy is achieved during the first 24h.
    • The level of patient satisfaction with the anaesthetic technique.
    - Evaluar:
    • La eficacia analgésica intraoperatoria del ESPB.
    • El uso del ESPB para reducir la dosis total de remifentanilo intraoperatorio.
    • El uso del ESPB en la reducción de complicaciones perioperatorias derivadas del uso de opioides.
    • La seguridad de la técnica en forma de eventos adversos perioperatorios.
    • La utilidad del ESPB en la movilización precoz sin dolor postoperatorio de los pacientes intervenidos de columna lumbosacra.
    • El nivel sensitivo alcanzado con la realización del bloqueo a nivel de L3.
    • Una posible asociación entre ESPB con la aparición de alteración motora o sensitiva a nivel de miembros inferiores.
    - Determinar:
    • La concentración de ropivacaína (0.2 % vs 0.3 %) a la que se consigue eficacia analgésica durante las primeras 24h.
    • El nivel de satisfacción del paciente con la técnica anestésica.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Ages between 18 and 75 years.
    - ASA I, II, III patients.
    - Patients with a body mass index (BMI) of less than 35 kg/m2.
    - Patients programmed by both the traumatology and neurosurgery departments of the Hospital Juan Ramón Jiménez for lumbosacral surgery.
    - Informed consent signed by the patient or legal representative to participate in the study.
    - Edades comprendidas entre 18 y 75 años.
    - Pacientes ASA I, II, III.
    - Pacientes con un índice de masa corporal (IMC) menor de 35 Kg/m2.
    - Pacientes programados tanto por el servicio de traumatología como de neurocirugía del Hospital Juan Ramón Jiménez, para cirugía lumbosacra.
    - Consentimiento informado firmado por el paciente o representante legal para participar en el estudio.
    E.4Principal exclusion criteria
    - Patients with psychiatric illness, substance abuse, drug or alcohol dependence, history of chronic pain.
    - Patients with cardiac arrhythmias or pacemakers.
    - Patients with altered coagulation parameters,
    - History of allergy or intolerance to local anaesthetics, morphine or derivatives.
    - Infection in the region of intervention.
    - Surgery for vertebral fractures at lumbar level, surgery for oncological causes and/or previous surgery at lumbar level.
    - Surgeries involving more than 2 lumbar spaces.
    - Pacientes con enfermedades psiquiátricas, abuso de sustancias, dependencia a drogas o alcohol, historia de dolor crónico.
    - Pacientes con arritmias cardiacas o portadores de marcapasos.
    - Pacientes con alteración de los parámetros analíticos de coagulación,
    - Historia de alergia o intolerancia a los anestésicos locales, morfina o derivados.
    - Infección en la región de intervención.
    - Cirugías de fracturas vertebrales a nivel lumbar, intervención por causas oncológicas y/o cirugías previas a nivel lumbosacra.
    - Cirugías que incluyan un número mayor de 2 espacios lumbares.
    E.5 End points
    E.5.1Primary end point(s)
    1.- Determination of the patient's pain at rest using the Visual Analogue Scale (VAS).

    2.- Recording of supplementary analgesia administered by the patient himself through the controlled analgesia pumps, obtaining the total number of boluses of morphine administered.
    1.- Determinación del dolor del paciente en reposo mediante la Escala visual analógica (EVA).

    2.- Registro de la analgesia suplementaria administrada por el propio paciente a través de las bombas de control de analgesia, obteniendo el total de bolos de morfina administrados
    E.5.1.1Timepoint(s) of evaluation of this end point
    1.- Before undergoing surgery, 2 hours after arrival at the Postanaesthesia Recovery Unit and 24 hours post-operatively. (+/- 3 h).

    2.- During the 24-hour follow-up period after surgery.
    1.- Antes de ser sometido a intervención quirúrgica, a las 2 horas de su llegada a la Unidad de Recuperación Postanestésica y a las 24 horas postoperatorias. (+/- 3 h).

    2.- Durante el período de seguimiento de 24 horas después de la cirugía.
    E.5.2Secondary end point(s)
    1.- Intraoperative nociception monitoring through the NOL (nociception level) monitor.
    2.- Total remifentanil dose measured through the data recorded in the remifentanil continuous perfusion pump.
    3.- Concentration of ropivacaine that achieves best analgesic efficacy.
    4.- Complications associated with the use of perioperative opioids.
    Presence of perioperative complications, to evaluate the safety of the technique.
    6.- Determination of the patient's pain in movement using the Visual Analogue Scale (VAS).
    7.- Association of ESPB with motor and/or sensory alterations and as a complementary measure of the safety of the technique.
    8.- Test of hot-cold sensitivity by contact with the patient's skin
    with a cotton swab soaked in alcohol.
    9.- Patient Global Impression of Change Scale (PGIC).
    1.- Monitorización de la nocicepción intraoperatoria a través del monitor NOL (nociception level).
    2.- Dosis total de remifentanilo medido a través de los datos registrados en la bomba de perfusión continua de remifentanilo.
    3.- Concentración de ropivacaína que consigue mejor eficacia analgésica.
    4.- Complicaciones asociadas con el uso de opioides perioperatorios.
    5.- Presencia de complicaciones perioperatorias, para evaluar la seguridad de la técnica.
    6.- Determinación del dolor del paciente en movimiento mediante la Escala visual analógica (EVA).
    7.- Asociación del ESPB con alteración motora y/o sensitiva y como medida complementaria de la seguridad de la técnica.
    8.- Test de sensibilidad frío-calor por contacto con la piel del paciente
    con una torunda de algodón impregnada en alcohol.
    9.- Escala Patient Global Impresión of Change (PGIC).
    E.5.2.1Timepoint(s) of evaluation of this end point
    1.- Its value will be obtained during the intraoperative period in a non-invasive and continuous manner.
    2.- In the intraoperative period.
    3.- From the time the patient undergoes the erector spinae block until the first dose of analgesic rescue is required.
    4.- Perioperative period.
    5.- Perioperative period.
    6.- Before undergoing surgery, 2 hours after arrival at the Post-anaesthesia Recovery Unit and 24 hours post-operatively. (+/- 3 h).
    7.- Before undergoing surgery, 2 hours after arrival at the PACU and 24 hours after surgery (+/- 3 hours).
    8.- 2 hours after arrival at the PACU and 24 hours after surgery (+/- 3 hours).
    9.- Last follow-up visit.
    1.- Se obtendrá su valor durante el intraoperatorio de forma no invasiva y continua.
    2.- En el periodo intraoperatorio.
    3.- Desde que el paciente se le realiza el bloqueo del erector espinal hasta que demanda la primera dosis de rescate analgésico.
    4.- Periodo perioperatorio.
    5.- Periodo perioperatorio.
    6.- Antes de ser sometido a intervención quirúrgica, a las 2 horas de su llegada a la Unidad de Recuperación Postanestésica y a las 24 horas postoperatorias. (+/- 3 h).
    7.- antes de someterse a intervención quirúrgica, a las 2 horas de la llegada a la URPA y a las 24 horas tras intervención quirúrgica (+/- 3 horas).
    8.- A las 2 h de la llegada a la URPA y a las 24 h tras intervención quirúrgica (+/- 3 horas).
    9.- Última visita de seguimiento.
    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 Yes
    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 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) Yes
    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 years1
    E.8.9.1In the Member State concerned months1
    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: 91
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 90
    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 Information not present in EudraCT
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women Yes
    F.3.3.4Nursing women Information not present in EudraCT
    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
    They may participate as long as a legal representative of the subject signs the consent form.
    Podrán participar siempre y cuando un representante legal del sujeto firme el consentimiento.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state181
    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 Decision2021-11-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-11-04
    P. End of Trial
    P.End of Trial StatusOngoing
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