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    Summary
    EudraCT Number:2020-000135-47
    Sponsor's Protocol Code Number:21/103
    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:2021-08-31
    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 number2020-000135-47
    A.3Full title of the trial
    Analgesic efficacy of erector spinae plane block in lumbar spine surgery: a prospective, randomized and double blind study.
    ANALGESIA POSTOPERATORIA MEDIANTE EL BLOQUEO BILATERAL DEL PLANO DEL MÚSCULO ERECTOR ESPINAL EN CIRUGÍA DE COLUMNA LUMBAR: ESTUDIO PROSPECTIVO, ALEATORIZADO Y DOBLE CIEGO
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Analgesic efficacy of a regional tecnique (erector spinae plane block) in lumbar spine surgery
    Eficacia analgésica de una técnica regional (bloqueo del plano del erector espinal) en cirugía de columna lumbar
    A.3.2Name or abbreviated title of the trial where available
    BEE trial
    A.4.1Sponsor's protocol code number21/103
    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 Universitario Fundación Alcorcón
    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 Universitario Fundación Alcorcón
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHospital Universitario Fundación Alcorcón
    B.5.2Functional name of contact pointDepartment of Anesthesiology
    B.5.3 Address:
    B.5.3.1Street AddressCalle Budapest 1
    B.5.3.2Town/ cityAlcorcón
    B.5.3.3Post code28922
    B.5.3.4CountrySpain
    B.5.6E-maildianarocio.zamudio@salud.madrid.org
    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 Levobupivacaine
    D.2.1.1.2Name of the Marketing Authorisation holderFresenius Kabi
    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/infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPInfiltration
    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
    The analgesic efficacy of erector spinae plane block in lumbar spine surgery. Infiltration of local anesthetic in this plane may lower postoperative pain.
    La eficacia analgésica del bloqueo del plano del erector espinal en cirugía de columna lumbar. El uso de anestésicos locales en este plano podría ayudar a disminuir el dolor postoperatorio.
    E.1.1.1Medical condition in easily understood language
    Postoperative pain after spine surgery
    Dolor postoperatorio tras cirugía de columna 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 campare 24h morphine consumption between patients that received erector spinae plane block and patients that did not receive any regional technique.
    Comparar el consumo de morfina durante las 24 primeras horas del postoperatorio de cirugía de columna, entre pacientes que recibieron el bloqueo del plano del erector espinal y aquellos que no recibieron ninguna técnica regional.
    E.2.2Secondary objectives of the trial
    To compare between the groups:
    - Morphine consumption throughout hospital stay
    - VAS scores
    - Time to first mobilisation
    - Time to firt sitting
    - Time to first standing
    - Hospital stay
    Entre los objetivos secundarios se encuentran determinar el consumo de morfina durante todo el período de ingreso postoperatorio, la intensidad del dolor postoperatorio mediante una escala visual analógica (EVA), el tiempo transcurrido desde la cirugía hasta primera movilización, sedestación y bipedestación, y el tiempo de estancia hospitalaria postoperatoria
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Patients older than 18 years
    - American society Status classification (ASA) I-III
    - Elective spine surgery up to 4 spaces.
    - Primary surgery and reinterventions
    1) Pacientes mayores de 18 años 2) Pacientes con clasificación ASA I-III 3) Cirugía electiva de columna lumbar entre 1 y 4 espacios 4) Cirugías primarias y reintervenciones.
    E.4Principal exclusion criteria
    - Urgent surgery
    - Infection in site of surgery
    - Allergy to local anesthetics, opioids u other analgesics used in the trial.
    - Contraindications for regional technique
    - Patient refusal
    - Absence of informed consent
    - Surgical complication that may interfer with adequate pain assessment
    1) Cirugía urgente; 2) Pacientes con proceso infeccioso en la zona quirúrgica; 3) Alergia a anestésicos locales, opioides u otros fármacos utilizados en el estudio; 4) presencia de contraindicaciones para la realización de anestesia regional; 5) rechazo del paciente a participar en el estudio 6) ausencia de consentimiento informado; y 7) complicación quirúrgica en el postoperatorio inmediato que impidan una adecuada valoración del paciente (ej. hemorragia con necesidad de reintervención, delirium, dolor en dermatomas relacionados con malposición de elementos quirúrgicos, etc.).
    E.5 End points
    E.5.1Primary end point(s)
    First 24h morphine consumption
    Consumo de morfina durate las primeras 24h del postoperatorio
    E.5.1.1Timepoint(s) of evaluation of this end point
    24h
    A las 24 horas del postoperatorio
    E.5.2Secondary end point(s)
    To compare between the groups:
    - Morphine consumption throughout hospital stay
    - VAS scores
    - Time to first mobilisation
    - Time to firt sitting
    - Time to first standing
    - Hospital stay
    Comparar entre los grupos:
    - Consumo de morfina durante el ingreso hospitalario
    - EVA al ingreso, 30 min, 2, 6,24 y 48 h.
    - Tiempo hasta primera movilización, sedestación y bipedestación (según día de ingreso)
    - Estancia hospitalaria
    E.5.2.1Timepoint(s) of evaluation of this end point
    During hospital stay
    Durante el ingreso hospitalario
    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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    No other regional technique
    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
    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: 50
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 50
    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 state100
    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 Decision2021-11-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-10-28
    P. End of Trial
    P.End of Trial StatusOngoing
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