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    The EU Clinical Trials Register currently displays   44334   clinical trials with a EudraCT protocol, of which   7366   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2014-005062-30
    Sponsor's Protocol Code Number:NF001
    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:2015-05-08
    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 number2014-005062-30
    A.3Full title of the trial
    Randomized, double-blind, placebo controlled clinical trial to assess the phrenic nerve functional status after periphrenic lidocaine infiltration in lung resection surgery.
    ENSAYO CLINICO PILOTO PARA LA EVALUACIÓN DE LA AFECTACION FUNCIONAL DEL NERVIO FRÉNICO SECUNDARIA A LA INFILTRACION DE LA GRASA PERIFRÉNICA CON LIDOCAINA vs SUERO FISIOLÓGICO.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical trial to assess diaphragm´s function after local anaesthetic infiltration compared to placebo in order to avoid post-surgery pain in patients undergoing thoracic surgery.
    Ensayo clínico para evaluar la función del diafragma después de la infiltración del anestésico local comparado con placebo para evitar el dolor postquirúrgico en pacientes sometidos a cirugía torácica.
    A.4.1Sponsor's protocol code numberNF001
    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 SponsorUniversity Hospital Germans Trias i Pujol
    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 supportUniversity Hospital Germans Trias i Pujol
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity Hospital Germans Trias i Pujol
    B.5.2Functional name of contact pointThoracic Surgery Dept.
    B.5.3 Address:
    B.5.3.1Street AddressCrta Canyet s/n
    B.5.3.2Town/ cityBadalona/Barcelona
    B.5.3.3Post code08916
    B.5.3.4CountrySpain
    B.5.4Telephone number0034934978921
    B.5.5Fax number0034934978843
    B.5.6E-mailcirtoracica.germanstrias@gencat.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 LIDOCAINA INYECTABLE BRAUN 2%
    D.2.1.1.2Name of the Marketing Authorisation holderBRAUN
    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 nameLIDOCAINE
    D.3.4Pharmaceutical form Concentrate for solution for injection/infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPInfiltration
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNlidocaine
    D.3.9.1CAS number 137-58-6
    D.3.9.3Other descriptive nameLIDOCAINE CHLORHYDRATE
    D.3.9.4EV Substance CodeSUB29942
    D.3.10 Strength
    D.3.10.1Concentration unit % percent
    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
    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 placeboInfiltration
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Ipsilateral shoulder pain after thoracotomy for lung resection.
    Dolor de hombro ispsilateral posttoracotomía para resección pulmonar
    E.1.1.1Medical condition in easily understood language
    After performing thoracic surgery the patient usually presents pain in the shoulder in the same side of the surgical incision.
    Después de la cirugía torácica, el paciente suele presentar dolor en el hombro ipsilateral al hemitórax intervenido.
    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 asses, using phrenic nerve electroneurografy, if the periphrenic fat pad infiltration with 10cc 2% lidocaine during lung resection surgery produces a functional alteration of the phrenic nerve and therefore an alteration of the ipsilateral hemidiaphragm motility.
    Evaluar mediante electroneurografía del nervio frénico, si la infiltración de lidocaína al 2% en la grasa perifrénica durante la cirugía de resección pulmonar produce una alteración funcional del nervio frénico y, en consecuencia, se reduce la motilidad del hemidiafragma ipsilateral a la cirugía.
    E.2.2Secondary objectives of the trial
    1- To compare the clinical and spirometric alteration degree produced by the periphrenic fat pad infiltration with 10 cc of 2% lidocaine vs placebo in patients undergoing lung surgery.

    2- To compare pain intensity in both groups
    1. Comparar el grado de afectación clínica y espirométrica generado por la infiltración con lidocaína 2% vs placebo en la grasa periférica en los pacientes intervenidos de cirugía de resección pulmonar.
    2. Comparar la intensidad de dolor en ambos grupos.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -18-85 years old patients undergoing lung resection surgery using postero-lateral thoracotomy.

    -Signed Informed consent of this study
    -Pacientes de 18 a 85 años sometidos a cirugía de resección pulmonar mediante incisión póstero-lateral.
    -El paciente deberá haber firmado un consentimiento informado específico para el presente estudio
    E.4Principal exclusion criteria
    -Inability or contraindication to perform epidural analgesia.
    -Epidural analgesia malfunction intra or post-surgery
    -Neuromuscular diseases, previous shoulder pain or chronic analgesic use
    -Lidocaine allergy
    -Vertebral fractures and/or high spinal cord injuries (C4 or above)
    -Previous diaphragm paralysis of the hemithorax undergoing surgical procedure
    -Inflammatory polyradiculoneuropathies or other neuromuscular diseases.
    -Patients with pacemaker
    -Morbid obesity (BMI>40)
    -Incapacity to understand analogical visual and or verbal pain scales
    -Extended lung resection including chest wall and/or vertebral bodies
    -Pregnancy or lactation
    -Patient refusal to participate
    -Imposibilidad o contraindicación de realizar la punción epidural.
    -Enfermedades neuromusculares, dolor de hombro previo o uso crónico de analgésicos.
    -Alergia a lidocaína
    -Fracturas vertebrales/ lesiones medulares altas (C4 y superiores).
    -Parálisis diafragmática ipsilateral al nervio frénicos evaluado, de cualquier etiología.
    -Polirradiculoneuropatías inflamatorias y otras patologías neuromusculares de base.
    -Portador de marcapasos.
    -Obesidad mórbida ( IMC>40)
    -Imposibilidad de comprensión de las escalas analógica visual (EVA) y/o verbal.
    -Resección de costillas, vértebras u otros componentes óseos de la caja torácica. (En este apartado no se incluye la realización de costotomía controlada previa al acceso a la cavidad pleural).
    -Embarazo o lactancia
    -Negativa del paciente a participar en el estudio
    E.5 End points
    E.5.1Primary end point(s)
    Safety end point: median change of latency (ms) and amplitude (mV) of the registered CMAP (Compound muscle action potential) between basal measure and the one measured after surgery (4-6 hours) in both groups. (Basal measure: intraoperative just before lung resection).
    •Variable de seguridad: cambio en la mediana de la medición de la latencia (ms) y la amplitud (mV) del CMAP (Compound muscle action potential) registrado basal y después de la cirugía (aproximadamente a las 4-6 horas de la infiltración) en ambos grupos de tratamiento. La medición basal se realizará en el acto operatorio, antes de la resección pulmonar.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Four to six hours after the study drug administration
    A las 4-6 horas tras la adminsitración del fármaco en estudio.
    E.5.2Secondary end point(s)
    Efficacy end point: Proportion of patients with an ipsilateral shoulder pain VAS<3 at four hours after the end of surgery in both groups

    Safety end points:
    Median differences in CMAP´s latency and amplitude between basal measure and those measured at 1, 5 and 10 minutes after drug administration and at the end of surgery.
    Median differences in spirometric values (Vital forced capacity, Forced expiratory volume in 1 second and Tiffeneau Index) between pre and post-surgery (4 hours after surgery) in both groups.
    ?Proportion of patients with radiological ipsilateral hemidiaphragm elevation in both groups (within first 12 postoperative hours)
    ?Proportion of patients with pneumonia, atelectasis and/or mechanical ventilation (invasive or non-invasive) within the first 72 postoperative hours.
    Variable de eficacia:
    •Porcentaje de pacientes sin dolor de hombro del lado de la cirugía a las 4 horas tras la cirugía (EVA<3) en ambos grupos de tratamiento.
    Variables de seguridad:
    •Evolución de las medianas de las mediciones de latencia y amplitud del CMAP hasta las 4-6 horas tras la infiltración (1, 5, 10 minutos tras la infiltración y al finalizar la cirugía).
    •Cambios de los valores espirométricos medidos con la Capacidad vital forzada (FVC), el Volumen espiratorio forzado (FEV1) y el Indice de Tiffeneau (IT) pre y post-operatorios (4 horas) en ambos grupos.
    •Porcentaje de pacientes con presencia de elevación del hemidiafragma del lado de la cirugía en ambos grupos valorada por radiografía.
    •Porcentaje de pacientes con neumonía, atelectasia y/o necesidad de ventilación mecánica (invasiva no invasiva) durante el postoperatorio inmediato (primeras 72 horas postquirúrgicas).
    E.5.2.1Timepoint(s) of evaluation of this end point
    Efficacy end point: at four hours after the end of surgery in both groups

    Safety end points:
    Median differences in CMAP´s latency and amplitude between basal measure and those measured at 1, 5 and 10 minutes after drug administration and at the end of surgery.
    Median differences in spirometric values (Vital forced capacity, Forced expiratory volume in 1 second and Tiffeneau Index) between pre and post-surgery (4 hours after surgery) in both groups.
    ?Proportion of patients with radiological ipsilateral hemidiaphragm elevation in both groups (within first 12 postoperative hours)
    ?Proportion of patients with pneumonia, atelectasis and/or mechanical ventilation (invasive or non-invasive) within the first 72 postoperative hours.
    Variable de eficacia: a las 4 horas del final de la cirugía en ambos grupos.

    Variable de seguridad:
    •Evolución de las medianas de las mediciones de latencia y amplitud del CMAP hasta las 4-6 horas tras la infiltración (1, 5, 10 minutos tras la infiltración y al finalizar la cirugía).
    •Cambios de los valores espirométricos medidos con la Capacidad vital forzada (FVC), el Volumen espiratorio forzado (FEV1) y el Indice de Tiffeneau (IT) pre y post-operatorios (4 horas) en ambos grupos.
    •Porcentaje de pacientes con elevación del hemidiafragma del lado de la cirugía en ambos grupos.
    •Porcentaje de pacientes con neumonía, atelectasia y/o necesidad de ventilación mecánica (invasiva no invasiva) durante el postoperatorio inmediato (primeras 72 horas postquirúrgicas).
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 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 months18
    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: 30
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    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 state50
    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
    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 Decision2015-06-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-04-10
    P. End of Trial
    P.End of Trial StatusOngoing
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