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   43881   clinical trials with a EudraCT protocol, of which   7295   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:2020-000732-22
    Sponsor's Protocol Code Number:OSTAP
    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:2020-05-25
    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 number2020-000732-22
    A.3Full title of the trial
    Effectiveness comparative study of oblique subcostal transversus abdominis plane block (OSTAP block) versus laparoscopic ports infiltration in patients undergoing elective cholecystectomy.
    Estudio comparativo de la efectividad del bloqueo del plano abdominal del oblicuo a nivel subcostal (bloqueo OSTAP) frente a infiltración de los puertos de laparoscopia en pacientes sometidos a colecistectomía electiva.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Effectiveness comparative study of two anesthetic techniques commonly used in patients undergoing gallbladder surgical removal.
    Estudio comparativo de la efectividad de dos técnicas anestésicas usadas habitualmente en pacientes sometidos a extirpación quirúrgica de la vesícula biliar.
    A.4.1Sponsor's protocol code numberOSTAP
    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 SponsorPablo Rama Maceiras
    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 supportPablo Rama Maceiras
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPablo Rama Maceiras
    B.5.2Functional name of contact pointServicio de Anestesiología y Rea.
    B.5.3 Address:
    B.5.3.1Street AddressC.H.U. A Coruña, C/ Xubias de arriba, 84
    B.5.3.2Town/ cityA Coruña
    B.5.3.3Post code15006
    B.5.3.4CountrySpain
    B.5.4Telephone number+34981178152
    B.5.6E-mailpablo.rama.maceiras@sergas.es
    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 Levobupivacaína Altan 5 mg/ml solución inyectable y para perfusión EFG
    D.2.1.1.2Name of the Marketing Authorisation holderAltan Pharmaceuticals, 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.3.4Pharmaceutical form Solution for injection/infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPRoute of administration not applicable
    Infiltration
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLEVOBUPIVACAINE
    D.3.9.1CAS number 27262-47-1
    D.3.9.4EV Substance CodeSUB08464MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/kg milligram(s)/kilogram
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number5
    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
    Elective cholecystectomy
    Colecistectomía electiva
    E.1.1.1Medical condition in easily understood language
    Gallbladder surgical removal
    Extirpación quirúrgica de la vesícula biliar
    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 compare two commonly used analgesic techniques in anesthesia for laparoscopic cholecystectomy and to assess if there are some differences between them as to the need of use additional analgesic (morphic chloride) in the immediate postoperative period (first 4 postoperative hours)
    Comparar dos técnicas analgésicas empleadas de forma habitual en la anestesia para la colecistectomía laparoscópica y evaluar si existen diferencias entre ellas en cuanto a las necesidades de administración de analgésicos mayores (cloruro mórfico) en el período postoperatorio inmediato (primeras 4 horas postoperatorias).
    E.2.2Secondary objectives of the trial
    (1) To assess postoperative pain intensity, according to Visual Analog Scale (VAS) at rest and with mobilization or cough. Where 0= no pain and 10= the worst imaginable pain, depending on the block method made in the operating room.

    (2) To evaluate the time from patient's recovery admission to the first analgesia request.

    (3) To determine incidence and intensity of postoperative nausea or vomit, as well as antiemetic intake and if there are some differences depending on the block method made.

    (4) To record complications during surgery and postoperatively such as conversion to open surgery (it will imply patient withdrawal), bleeding, infection, or need of reintervention.
    (1) Evaluar la intensidad del dolor postoperatorio, según la Escala Visual Analógica (EVA) en reposo y con la movilización o la tos: 0= no dolor hasta 10 (el peor dolor imaginable) en función del bloqueo realizado en el quirófano

    (2) Evaluar el tiempo transcurrido desde el ingreso del paciente en recuperación hasta la primera demanda de analgesia

    (3) Determinar la incidencia e intensidad de náuseas o vómitos postoperatorios, así como el consumo de antieméticos y si existen diferencias en función del bloqueo realizado

    (4) Recoger las complicaciones surgidas durante la cirugía y en el postoperatorio tales como reconversión a cirugía abierta, imposibilidad de la extubación en quirófano (que supondrá la retirada del paciente del estudio), sangrado, infección, o necesidad de reintervención.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    (1) Age between 18 and 85 years.

    (2) Laparoscopic elective cholecystectomy intervention with planned hospital admission.

    (3) ​ASA Physical Status Classification System < IV
    (1) Edad entre 18 y 85 años.

    (2) intervención de colecistectomía electiva por vía laparoscópica con ingreso hospitalario previsto

    (3) sistema de clasificación de riesgo anestésico ASA < IV
    E.4Principal exclusion criteria
    (1) Patient refusal
    (2) known hypersensitivity to any of the medications used in this study
    (3) opiates chronic use
    (4) epilepsy
    (5) psychomotor delay
    (6) morbid obesity (defined as BMI> 40)
    (7) obstructive sleep apnea syndrome
    (8) presence of a heart rhythm block that requires a pacemaker implant
    (9) liver failure (defined as total preoperative serum bilirubin > 2 mg / dl)
    (10) renal insufficiency (defined as estimated renal glomerular filtration rate ≤ 50 ml / min / 1.73 m2)
    (11) pregnancy
    (12) local skin infection at the puncture site level
    1) Negativa del paciente,
    (2) hipersensibilidad conocida a alguna de las medicaciones empleadas en el estudio,
    (3) uso crónico de opiáceos,
    (4) epilepsia,
    (5) retraso psicomotriz,
    (6) obesidad mórbida (definida como IMC> 40),
    (7) síndrome de apnea obstructiva del sueño,
    (8) presencia de un bloqueo del ritmo cardiaco que requiera el implante de un marcapasos,
    (9) insuficiencia hepática (definida como bilirrubina sérica preoperatoria total >2 mg/dl),
    (10) insuficiencia renal (definida como filtrado glomerular estimado renal ≤ 50 ml/min/1.73 m2),
    (11) embarazo
    (12) infección local en la piel a nivel de las zonas de punción.
    E.5 End points
    E.5.1Primary end point(s)
    - Total morphine dose (mg), required by patients in the period studied.
    - Number of patients who required morphic chloride administration in the period studied.
    - Dosis de morfina total (mg), requerida por los pacientes en el período estudiado.
    - Número de pacientes que requieren adminsitración de cloruro mórfico en el período estudiado
    E.5.1.1Timepoint(s) of evaluation of this end point
    The evaluation of the study endpoints will be carried out in the first four hours of the postoperative period.
    La evaluación de las variables del estudio se realizará en las primeras cuatro horas de postoperatorio.
    E.5.2Secondary end point(s)
    - Postoperative pain intensity, according to Visual Analog Scale (VAS) at rest and with mobilization or cough. Where 0= no pain and 10= the worst imaginable pain.
    - Time from patient's recovery admission to the first analgesia request.
    - Incidence and intensity of postoperative nausea or vomit, as well as antiemetic intake (Ondansetron).
    - Total dose of remifentanil used intraoperatively.
    - The duration of operation in minutes.
    - The duration of the stay in the postoperative Recovery room (in hours) and in the hospital (in days).
    - Complications during surgery and postoperatively such as conversion to open surgery (it will imply patient withdrawal), bleeding, infection, or need of reintervention (it will imply patient withdrawal, as well).
    - La intensidad del dolor postoperatorio, según la la Escala Visual Analógica (EVA) en reposo y con la movilización o la tos (0= no dolor hasta 10= el peor dolor imaginable).
    - El tiempo transcurrido desde el ingreso del paciente en recuperación hasta la primera demanda de analgesia.
    - La incidencia e intensidad de náuseas o vómitos postoperatorios, así como el consumo de antiemético (ondansetrón).
    - La dosis total de remifentanilo empleada en el intraoperatorio.
    - La duración de operación en minutos.
    - La duración de la estancia en la sala de Recuperación postoperatoria (en horas) y en el hospital (en días).
    - Las complicaciones surgidas durante la cirugía y en el postoperatorio, tales como reconversión a cirugía abierta, imposibilidad de la extubación en quirófano (que supondrá la retirada del paciente del estudio), sangrado, infección, o necesidad de reintervención (que también supondrá la retirada del paciente del estudio).
    E.5.2.1Timepoint(s) of evaluation of this end point
    - The VAS will be evaluated at admission; every 30 minutes during the first two postoperative hours and every hour during the staying in the recovery unit.
    - The other variables of the study will be carried out in the first four hours of the postoperative period.
    - Se evaluará la EVA al ingreso; cada 30 minutos durante las dos primeras horas postoperatorias y cada hora durante su estancia en la unidad de recuperación
    - Las demás variables del estudio se realizarán en las primeras cuatro horas de postoperatorio.
    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 Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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 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
    Se comparará el mismo analgésico en diferentes métodos de bloqueo
    Same analgesic will be compared in different ways of block
    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 years1
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    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: 23
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 23
    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 state46
    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)
    Not different from the expected normal treatment of that condition
    No difiere del tratamiento normal esperado para dicha condición
    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 Decision2020-05-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-05-07
    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-Sat May 18 10:28:14 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA