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    Summary
    EudraCT Number:2019-004089-16
    Sponsor's Protocol Code Number:15/19
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2020-05-28
    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 number2019-004089-16
    A.3Full title of the trial
    Comparison between mid-axillary ultrasound-guided transversus abdominis plane (TAP) block and local wound infiltration for postoperative analgesia in laparoscopic radical prostatectomy. Impact on early discharge.
    Comparación de la analgesia postoperatoria entre el bloqueo transversus abdominis plane (TAP) mediante abordaje medioaxilar y la infiltración local de las heridas quirúrgicas en las prostatectomías radicales por laparoscopia (PRL). Impacto en el alta temprana postoperatoria (Programa ERAS).
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Comparison of the efficacy of two analgesic techniques for pain control in prostate surgery by laparoscopic approach
    Comparación de la eficacia de dos técnicas analgésicas para el control del dolor en la cirugía de próstata mediante abordaje laparoscópico
    A.4.1Sponsor's protocol code number15/19
    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 pointAna Tejedor Navarro
    B.5.3 Address:
    B.5.3.1Street AddressAv. Jacint Verdaguer, 90
    B.5.3.2Town/ citySant Joan Despi
    B.5.3.3Post code08970
    B.5.3.4CountrySpain
    B.5.4Telephone numberEspañ9355312007265
    B.5.6E-mailana.tejedor@hotmail.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.2.1.1.1Trade name Ropivacaine
    D.2.1.1.2Name of the Marketing Authorisation holderB. BRAUN MELSUNGEN AG
    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 nameRopivacaine
    D.3.4Pharmaceutical form Solution for solution for injection
    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 INNROPIVACAINE
    D.3.9.1CAS number 84057-95-4
    D.3.9.4EV Substance CodeSUB10382MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number7.5
    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
    Prostate cancer
    Cáncer de próstata
    E.1.1.1Medical condition in easily understood language
    Prostate cancer
    Cáncer de próstata
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10060862
    E.1.2Term Prostate cancer
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Evaluation of the effectiveness of postoperative analgesia through local infiltration of surgical wounds with respect to the transversus abdominis plane block.
    Evaluación de la efectividad de la analgesia postoperatoria tras la infiltración local de las heridas quirúrgicas respecto el bloqueo transversus abdominis plane.
    E.2.2Secondary objectives of the trial
    - Length of in-hospital stay
    - Evaluation time to intake
    - Evaluation time to the first flatus
    - Evaluation time to sitting position
    - Evaluation time to perambulation
    - Evaluación de la estancia hospitalaria
    - Evaluación del inicio de la tolerancia oral
    - Evaluación del inicio del peristaltismo
    - Evaluación del inicio de la sedestación
    - Evaluación del inicio de la deambulación
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Informed consent form signed and dated, and willingness and ability
    to accomplish the protocol requirements
    2. Histologically confirmed prostate adenocarcinoma
    3. Candidate for radical surgery by laparoscopic approach
    4. Age> 18 years
    5. Feasibility of performing regular monitoring
    1. Consentimiento informado firmado y fechado, y disposición y
    capacidad para cumplir con los requisitos del procolo
    2. Adenocarcinoma de próstata confirmado histológicamente
    3. Paciente candidato a cirugía radical via laparoscópica
    4. Edad >18 años
    5. Viabilidad de realización de un seguimiento regular
    E.4Principal exclusion criteria
    1. Patients who do not agree to participate in the study
    2. History of allergy to local anesthetics and opioid
    3. Patients in chronic opioid treatment
    4. Age <18 years
    1. Pacientes que no acepten participar en el estudio
    2. Historia de alergia a anestésicos locales y opiáceos
    3. Pacientes en tratamiento crónico de opioides
    4. Edad<18 años
    E.5 End points
    E.5.1Primary end point(s)
    Assessment of acute postoperative pain
    Valoración del dolor agudo postoperatorio
    E.5.1.1Timepoint(s) of evaluation of this end point
    Assessment of acute postoperative pain at 1 hour, at 2 hours, at 3 hours, at 4 hours, at 6 hours, at 12 hours, at 18 hours, at 24 hours, at 36 hours and at 48 hours after the end of the surgery
    Valoración del dolor agudo postoperatorio a la 1 hora, 2 hora, 3 hora, 4 hora, 6 hora, 12 hora, 18 hora, 24 hora, 36 hora y 48 hora tras haber finalizado la cirugía
    E.5.2Secondary end point(s)
    - Evaluation of the first flatus
    - Assessment of the start intake
    - Assessment of the start sitting
    - Assessment of the start perambulation
    - Record the numer of days hospitalized
    - Valoración del inicio del peristaltismo
    - Valoración del inicio de la tolerancia oral
    - Valoración del inicio de la sedestación
    - Valoración del inicio de la deambulación
    - Registro de la estancia hospitalaria
    E.5.2.1Timepoint(s) of evaluation of this end point
    - Evaluation of the first flatus during the stay in the post-anaesthetic care unit and in the conventional hospitalization ward.
    - Assessment of the start intake during the stay in the post-anaesthetic care unit and in the conventional hospitalization ward.
    - Assessment of the start sitting position during the stay in conventional hospitalization ward.
    - Assessment of the start perambulation during the stay in conventional hospitalization ward.
    - Record the number of days hospitalized after hospital discharge
    - Valoración del inicio del peristaltismo durante su estancia en la unidad de reanimación postanestésica y en la planta
    - Valoración del inicio de la tolerancia oral durante su estancia en la unidad de reanimación postanestésica y en la planta
    - Valoración del inicio de la sedestación durante su estancia en la planta
    - Valoración del inicio de la deambulación durante su estancia en la planta
    - Registro de la estancia hospitalaria al ser dado de alta del hospital
    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 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 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 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 No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Queremos comparar la eficacia analgésica de dos técnicas diferentes con el mismo mkedicamento
    We want to compare the analgesic efficacy of two different techniques with the same medication
    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
    UVUP
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    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: 10
    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 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)
    Expected normal treatment
    Práctica clínica habitual
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2020-05-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-04-30
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2022-06-26
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