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    Summary
    EudraCT Number:2022-000559-35
    Sponsor's Protocol Code Number:0
    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:2022-07-15
    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 number2022-000559-35
    A.3Full title of the trial
    COMPLICATIONS AND DEGREE OF TOLERANCE OF THE ADMINISTRATION OF LOCAL ANESTHESIA IN DIAGNOSTIC / THERAPEUTIC THORACOCENTESIS PROCEDURES
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Differences (complications and degree of tolerance) in the use of three different drugs for pleural anesthesia in pleural procedures
    A.4.1Sponsor's protocol code number0
    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 SponsorNone
    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 supportSEPAR
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHospital Clinico Universitario Valladolid
    B.5.2Functional name of contact pointBlanca De Vega
    B.5.3 Address:
    B.5.3.1Street AddressRamon y cajal s/n
    B.5.3.2Town/ cityValladolid
    B.5.3.3Post code47001
    B.5.3.4CountrySpain
    B.5.6E-mailblancadevegasanchez@gmail.com
    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.2.1.2Country 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 namemepivacaine 2%
    D.3.4Pharmaceutical form Solution for injection/infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPInfiltration
    Intrapleural 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.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.2.5The 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 name1% lidocaine hydrochloride
    D.3.4Pharmaceutical form Solution for injection/infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPInfiltration
    Intrapleural 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.IMP: 3
    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.2.5The 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 name1% lidocaine hydrochloride solution + 8.4% sodium bicarbonate (ratio 10:1)
    D.3.2Product code 645705
    D.3.4Pharmaceutical form Solution for injection/infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPInfiltration
    Intrapleural 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
    There is no consensus about the most appropriate local anesthetic, and 1% mepicavain and 2% lidocaine uses can be postulated indistinctly. This project was born with the intention of highlighting the level of anesthesia achieved, the side effects and the safety profile of the use of 1% mepivacaine, 2% lidocaine or 1% lidocaine solution + 8.4% sodium bicarbonate (ratio 10 :1 ml) to achieve local anesthesia in basic pleural intervention.
    E.1.1.1Medical condition in easily understood language
    There is no consensus on the drug to be used to achieve pleural anesthesia prior to pleural procedures
    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 analyze the efficacy of local anesthesia achieved prior to performing diagnostic and therapeutic pleural techniques, comparing the use of 1% lidocaine (undiluted), 2% mepivacaine (undiluted) and 1% lidocaine solution + sodium bicarbonate 8 .4% (ratio 10:1 ml), as well as secondary effects directly derived from the administration of said drugs and the total dose administered to achieve correct anesthesia.
    E.2.2Secondary objectives of the trial
    a. To know the drug with the highest safety profile for use in pleural techniques.
    b. To know the minimum dose necessary for adequate anesthesia prior to performing pleural techniques.
    c. Degree of patient satisfaction in relation to the analgesia achieved after carrying out the diagnostic or therapeutic technique.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    a. Informed consent signature
    b. > 18 years old
    c. Performance of basic pleural interventional procedures (diagnostic / therapeutic thoracocentesis and placement of endothoracic drainage)
    d. Hemodynamic stability and prior therapeutic indication of the need for basic pleural techniques.
    E.4Principal exclusion criteria
    a. lack of informed consent
    b. severe hemodynamic disturbance
    c. Known allergy to any of the anesthetic drugs used: hypersensitivity to lidocaine and/or amide-type local anesthetics
    Presence of any of the following conditions: Cardiogenic shock, Severe cardiac conduction dysfunction, Decompensated heart failure, Degenerative nerve disease, under 18 years old
    F. refusal to participate by the patient
    g. procedures performed for life-threatening reasons
    h. Need for advanced pleural interventional procedures (pleural biopsy, tunneled pleural drainage, thoracoscopy, etc.)
    E.5 End points
    E.5.1Primary end point(s)
    • • Anthropometric data (sex, age, weight and height)
    • • Type of procedure performed (diagnostic/ therapeutic thoracocentesis)
    • • Type of gauge used (Fr)
    • • Volume of pleural liquid extracted (expressed in ml)
    • • Biochemical characteristics of the extracted pleural fluid
    • • Vital signs before and after the procedure (systolic blood pressure, diastolic blood pressure, heart rate and saturation measured by pulse oximetry)
    • • amount of anesthetic drug used for proper anesthesia (expressed in ml)
    • • Immediate complications.
    E.5.1.1Timepoint(s) of evaluation of this end point
    • • Anthropometric data (sex, age, weight and height)
    • • Type of procedure performed (diagnostic/ therapeutic thoracocentesis)
    • • Type of gauge used (Fr)
    • • Volume of pleural liquid extracted (expressed in ml)
    • • Biochemical characteristics of the extracted pleural fluid
    • • Vital signs before and after the procedure (systolic blood pressure, diastolic blood pressure, heart rate and saturation measured by pulse oximetry)
    • • amount of anesthetic drug used for proper anesthesia (expressed in ml)
    • • Immediate complications.

    Data will be colleted during three consecutive months, and after this the data analyse will be carry on
    E.5.2Secondary end point(s)
    • • Anatomical location of the pleural effusion
    • • amount (ultrasound measurement expressed in mm of the distance between the parietal pleura and the visceral pleura immediately prior to the procedure)
    E.5.2.1Timepoint(s) of evaluation of this end point
    • • Immediate complications.

    Data will be colleted during three consecutive months, and after this the data analyse will be carry on
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 No
    E.8.2.4Number of treatment arms in the trial3
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned13
    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
    In the absence of complications, the patient will be discharged from the interventional pulmonology unit and their participation in the study will end after the procedure.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    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: 100
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 100
    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 state200
    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)
    In the absence of complications, the patient will be discharged from the interventional pulmonology unit and their participation in the study will end. There is not any post trial treatment
    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 Decision2022-07-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-07-08
    P. End of Trial
    P.End of Trial StatusOngoing
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