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    Summary
    EudraCT Number:2016-005246-31
    Sponsor's Protocol Code Number:ANEST01
    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:2017-02-10
    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 number2016-005246-31
    A.3Full title of the trial
    Analgesic effectiveness of ultrasound-guided bilateral Transversus Abdominis Plane (TAP) block technique for laparoscopic radical prostatectomy: a prospective, randomized, simple-blind study
    Eficacia analgésica del bloqueo TAP bilateral ecoguiado para cirugía de prostatectomía radical laparoscópica: estudio comparativo, prospectivo, aleatorizado, simple ciego.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Analgesic effectiveness of ultrasound-guided bilateral Transversus Abdominis Plane (TAP) block technique for laparoscopic radical prostatectomy surgery
    Eficacia analgésica del bloqueo TAP bilateral ecoguiado para cirugía de prostatectomía radical laparoscópica
    A.3.2Name or abbreviated title of the trial where available
    Analgesic effectiveness of ultrasound-guided bilateral TAP block technique for PRL
    Eficacia analgésica del bloqueo TAP bilateral ecoguiado para cirugía de PRL
    A.4.1Sponsor's protocol code numberANEST01
    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 SponsorComplexo Hospitalario Universitario de Pontevedra
    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 supportComplexo Hospitalario Universitario de Pontevedra
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationComplexo Hospitalario Universitario de Pontevedra
    B.5.2Functional name of contact pointServicio de Anestesia
    B.5.3 Address:
    B.5.3.1Street AddressHospital de Montecelo Mourente s/n
    B.5.3.2Town/ cityPontevedra
    B.5.3.3Post code36071
    B.5.3.4CountrySpain
    B.5.4Telephone number+34986800511
    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 Levobupivacaina
    D.2.1.1.2Name of the Marketing Authorisation holderlevobupivacaine
    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 nameLevobupivacaine
    D.3.4Pharmaceutical form Solution for injection/infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPPerineural use
    Infiltration
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNlevobupivacaine
    D.3.9.3Other descriptive namelevobupivacaine
    D.3.10 Strength
    D.3.10.1Concentration unit % percent
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.25
    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
    Patients scheduled for elective laparoscopic radical prostatectomy surgery
    Pacientes programados para cirugía de prostatectomía radical laparoscópica
    E.1.1.1Medical condition in easily understood language
    Patients scheduled for elective laparoscopic radical prostatectomy surgery
    Pacientes programados para cirugía de prostatectomía radical laparoscópica
    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
    Evaluate the effectiveness of the US-guided bilateral TAP block tecnique as part of a multimodal analgesic plan that reduces the postoperative pain in the laparoscopic radical prostatectomy surgery compared with the IV conventional analgesia
    Evaluar la eficacia del bloqueo TAP bilateral ecoguiado como parte de una estrategia de analgesia multimodal que disminuya el dolor postoperatorio en la cirugía de prostatectomía radical laparoscópica comparada con la analgesia IV convencional.
    E.2.2Secondary objectives of the trial
    Not applicable
    No aplicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - ASA physical status I-III
    - Male
    - Aged 18-90 years
    - Scheduled for elective laparoscopic radical prostatectomy
    - Able to provide written informed consent
    -ASA I-III
    -Varón
    -Edad de 18-90 años
    -Programados para cirugía de prostatectomía radical laparoscópica
    -Capaces de firmar el consentimiento informado
    E.4Principal exclusion criteria
    - Unable to provide written informed consent
    - Unable to understand the Visual Analog Scale (VAS) for pain
    - Allergy to local anesthetic agents or other drug of the study
    - Preoperative chronic dependence upon opioid medication
    - Contraindication for TAP block: Coagulopathy, use of anticoagulant drugs or infection of the point of injection
    -Incapaz de firmar el consentimiento informado-
    -Incapaz de comprender la escala visual analógica EVA de dolor
    -Alérgico a anestésicos locales u otros fármacos del estudio
    -Dependencia crónica a Opioides
    -Contraindicación para el bloqueo TAP: coagulopatía, uso de fármacos anticoagulantes, infección en el punto de inyección.
    E.5 End points
    E.5.1Primary end point(s)
    - Decrease the intensity of postoperative pain after laparoscopic radical prostatectomy surgery, measured with the VAS scale
    -Reducción de la intensidad del dolor postoperatorio después de cirugía de prostatectomía radical laparoscópica medido mediante escala EVA
    E.5.1.1Timepoint(s) of evaluation of this end point
    First 48 hours of postoperative period
    Primeras 48 horas del postoperatorio
    E.5.2Secondary end point(s)
    - Increase the time to first request for rescue analgesia in the postoperative period
    - Decrease postoperative nausea and vomiting
    - Decrease postoperative opioid consumption
    -Incrementar el tiempo requerido hasta el primer rescate analgésico en el periodo postoperatorio.
    -Disminuir las náuseas y vómitos postoperatorios.
    -Dismunuir el consumo de opioide postoperatorio.
    E.5.2.1Timepoint(s) of evaluation of this end point
    First 48 hours of postoperative period
    Primeras 48 horas postoperatorias.
    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 Yes
    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 Yes
    E.8.2.3.1Comparator description
    Conventional iv analgesic therapy
    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 months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months6
    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: 56
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 56
    F.2 Gender
    F.2.1Female No
    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 state56
    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 Decision2017-03-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-03-16
    P. End of Trial
    P.End of Trial StatusOngoing
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