Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43874   clinical trials with a EudraCT protocol, of which   7294   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).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2022-000172-19
    Sponsor's Protocol Code Number:DPAM
    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:2022-06-10
    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 number2022-000172-19
    A.3Full title of the trial
    Effect of 0.5% local lidocaine injection on the prevention of acute
    postoperative pain associated with breast surgery
    Efecto de la inyección de lidocaína local al 0.5% en la prevención del dolor
    agudo postoperatorio asociado a la cirugía mamaria
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Prevent pain in the first 24-48h after breast surgery. It is applied by
    injecting with a syringe locally, an anesthetic called lidocaine in the area of
    the surgical scar
    Prevenir el dolor en las primeras 24-48h después de una cirugía de la
    mama. Se aplica inyectando con jeringa a nivel local, un anestésico llamado
    lidocaína en la zona de la cicatriz quirúrgica
    A.3.2Name or abbreviated title of the trial where available
    DPAM
    DPAM
    A.4.1Sponsor's protocol code numberDPAM
    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 SponsorConsorci Sanitari Integral
    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 supportConsorci Sanitari Integral
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationConsorci Sanitari Integral
    B.5.2Functional name of contact pointPurificación Regueiro
    B.5.3 Address:
    B.5.3.1Street AddressJosep Molins, 29-41
    B.5.3.2Town/ cityL´Hospitalet de LLobregat/Barcelona
    B.5.3.3Post code08906
    B.5.3.4CountrySpain
    B.5.4Telephone number+349355312006360
    B.5.6E-mailpuri.regueiro@sanitatintegral.org
    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 Lidocaina Normon 20 mg/ml
    D.2.1.1.2Name of the Marketing Authorisation holderLABORATORIOS NORMON 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.3.1Product nameLIDOCAINE
    D.3.2Product code LIDOCAINE
    D.3.4Pharmaceutical form Concentrate and solvent for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous 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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    The reduction of acute postoperatory pain in female patients diagnosed
    with breast cancer and undergoing surgical treatment is investigated.
    Se investiga la disminución del dolor agudo postoperatorio en pacientes
    mujeres diagnosticadas de cáncer de mama y sometidas a tratamiento
    quirúrgico
    E.1.1.1Medical condition in easily understood language
    Decrease pain after breast surgery in those women diagnosed with
    cancer
    Disminuir el dolor después de la cirugía de mama en aquellas mujeres
    diagnosticadas de cáncer
    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
    1. Demonstrate that intraoperative infiltration of lidocaine at 0.5% in the
    surgical incision, decreases the incidence of acute postoperative pain
    2. Demonstrate that intraoperative infiltration of lidocaine at 0.5%
    decreases the requirements of postoperative analgesia, especially
    opioids
    1. Demostrar que la infiltración intraoperatoria de lidocaína al 0.5% en
    la incisión quirúrgica, disminuye la incidencia de dolor agudo
    postoperatorio
    2. Demostrar que la infiltración intraoperatoria de lidocaína al 0.5%
    disminuye los requerimientos de analgesia postoperatoria,
    especialmente de opiáceos
    E.2.2Secondary objectives of the trial
    -To demonstrate that the intraoperative infiltration of lidocaine at 0.5% in the surgical incision, decreases the incidence of chronic pain
    associated with surgery.
    -To demonstrate that intraoperative infiltration of the surgical incision by lidocaine at 0.5%, decreases the incidence of mobility restriction of the upper extremity ipsilateral to surgery.
    -To assess the incidence of side effects associated with treatment by
    infiltration of the surgical scar with 0.5% lidocaine.
    -To quantify the incidence of acute and chronic postoperative pain after breast surgery in our population.
    -Demonstrate that intraoperative infiltration of the surgical incision by lidocaine 0.5% does not alter the healing of the same
    -Demostrar que la infiltración intraoperatoria de lidocaína al 0.5% en la incisión quirúrgica, disminuye la incidencia de dolor crónico asociado a la cirugía.
    -Demostrar que la infiltración intraoperatoria de la incisión quirúrgica
    mediante lidocaína al 0.5%, disminuye la incidencia de restricción de
    movilidad de la extremidad superior ipsilateral a la cirugía.
    -Evaluar la incidencia de efectos secundarios asociados al tratamiento mediante infiltración de la cicatriz quirúrgica con lidocaína al 0.5%.
    -Cuantificar la incidencia de dolor postoperatorio agudo y crónico tras la cirugía mamaria en nuestra población.
    -Demostrar que la infiltración intraoperatoria de la incisión quirúrgica
    mediante lidocaína al 0.5% no altera la cicatrización de la misma
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Woman over 18 years of age, diagnosed with malignant neoplasm of
    breast, candidate for surgical treatment scheduled in our center, Consorci Sanitari Integral, and who have signed the informed consent
    Mujer mayor de 18 años, diagnosticada de neoplasia maligna de
    mama, candidata a tratamiento quirúrgico programado en nuestro
    centro, Consorci Sanitari Integral, y que hayan firmado el consentimiento informado
    E.4Principal exclusion criteria
    -Allergy to the local anesthetic lidocaine
    -History of breast, thoracic or upper extremity surgery
    -Breast cancer recurrence surgery
    -Preoperative pain of the area to be intervened
    -Previous neurological alteration of the chest wall
    -History of stroke with limb involvement superior ipsilateral to surgery
    -Language difficulty
    -Alergia al anestésico local lidocaína
    -Antecedente de cirugía mamaria, torácica o de extremidad superior
    -Cirugía de recidiva del cáncer de mama
    -Dolor preoperatorio de la zona a intervenir
    -Alteración neurológica previa de la pared torácica
    -Antecedente de accidente cerebrovascular con afectación de la extremidad superior ipsilateral a la cirugía
    -Dificultad idiomática
    E.5 End points
    E.5.1Primary end point(s)
    Acute postoperative pain at 1, 4, 12, 24 and 48h postoperative (VAS
    scale), at rest and in movement with the abduction of the arm > 90º
    Dolor agudo postoperatorio a la 1, 4, 12, 24 y 48h postoperatorias
    (escala EVA), en reposo y en movimiento con la abducción del brazo >
    90º
    E.5.1.1Timepoint(s) of evaluation of this end point
    It will be evaluated at 1,4,12, 24 and 48h postoperative and
    subsequently in the visits in consultation in the month 1,3,6 and 12 after
    surgery
    Se evaluará a la 1,4,12, 24 y 48h postoperatorias y posteriormente en
    las visitas en consulta en el mes 1,3,6 y 12 después de la cirugía
    E.5.2Secondary end point(s)
    -Postoperative analgesia requirements (Paracetamol, NSAIDs, Opiates
    and total amount administered in mg)
    -Complications of the surgical wound (hematoma, infection, seroma,
    dehiscence)
    -Upper extremity mobility (Constant scale)
    -FIGO Stadium
    -Intervention type
    -Reconstruction (prosthesis/flap vs oncoplasty)
    -Duration of intervention
    -Surgeon
    -Anesthetic technique
    -Analgesia required during surgery
    -Complications during surgery
    -Age
    -Weight
    -Height
    -BMI
    -Smoking
    -Alcohol
    -Drugs
    -Comorbidities (Diabetes, HTN)
    -Usual treatment prior to surgery
    -Socioeconomic level
    -Level of studies
    -Requerimientos de analgesia postoperatoria (Paracetamol, AINEs,
    Opiáceos y cantidad total administrada en mg)
    -Complicaciones de la herida quirúrgica (hematoma, infección, seroma, dehiscencia)
    -Movilidad extremidad superior (escala Constant)
    -Estadio FIGO
    -Tipo intervención
    -Reconstrucción (prótesis/colgajo vs oncoplastia)
    -Duración intervención
    -Cirujano
    -Técnica anestésica
    -Analgesia requerida durante la cirugía
    -Complicaciones durante la cirugía.
    -Edad
    -Peso
    -Altura
    -IMC
    -Tabaquismo
    -Alcohol
    -Drogas
    -Comorbilidades (Diabetes, HTA)
    -Tratamiento habitual previo a la cirugía
    -Nivel socioeconómico
    -Nivel de estudios
    E.5.2.1Timepoint(s) of evaluation of this end point
    They will be collected at the first informative visit of the type of surgery
    and the day of the intervention
    Se recogerán en la primera visita informativa del tipo de cirugía y el día
    de la intervención
    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 No
    E.6.5Efficacy No
    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
    grupo control, sin tratamiento
    No treatment in control group
    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 Yes
    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
    It is defined as 12 months after the last patient recruited, so the
    clinical phase is estimated to end in September 2025
    Se define como 12 meses después del último paciente reclutado, por lo
    que la fase clínica se estima que finalice en septiembre del 2025
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    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: 40
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 60
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    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 state128
    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)
    The possibility of repeating treatment in those patients where pain persists in the operated area after the study has been evaluated.
    Se ha valorado la posibilidad de repetir tratamiento en aquellas pacientes donde persiste el dolor en el área operada una vez finalizado el estudio
    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 Decision2022-12-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-11-29
    P. End of Trial
    P.End of Trial StatusOngoing
    For support, Contact us.
    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.

    European Medicines Agency © 1995-Fri May 17 05:57:01 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA