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    Summary
    EudraCT Number:2017-001122-17
    Sponsor's Protocol Code Number:ISRCTN12771155
    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:2017-06-09
    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 number2017-001122-17
    A.3Full title of the trial
    "ANALGESIC EFFICACY OF INTRADURAL MORPHINE VERSUS INTERCOSTAL
    LEVOBUPIVACAINE IN THE POSTOPERATIVE PERIOD OF MAJOR
    PULMONARY RESECTION BY VIDEOTHORASCOCOPY"
    “EFICACIA ANALGÉSICA DE LA MORFINA INTRADURAL VERSUS LEVOBUPIVACAÍNA INTERCOSTAL EN EL POSTOPERATORIO DE RESECCIÓN PULMONAR MAYOR POR VIDEOTORACOSCOPIA”
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    "ANALGESIC EFFICACY OF INTRADURAL MORPHINE VERSUS INTERCOSTAL
    LEVOBUPIVACAINE IN THE POSTOPERATIVE PERIOD OF MAJOR
    PULMONARY RESECTION BY VIDEOTHORASCOCOPY"
    “EFICACIA ANALGÉSICA DE LA MORFINA INTRADURAL VERSUS LEVOBUPIVACAÍNA INTERCOSTAL EN EL POSTOPERATORIO DE RESECCIÓN PULMONAR MAYOR POR VIDEOTORACOSCOPIA”
    A.3.2Name or abbreviated title of the trial where available
    ISRCTN12771155
    A.4.1Sponsor's protocol code numberISRCTN12771155
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberISRCTN12771155
    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 SponsorSILVIA GONZALEZ SANTOS
    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 supportSILVIA GONZALEZ SANTOS
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSILVIA GONZALEZ SANTOS
    B.5.2Functional name of contact pointSILVIA
    B.5.3 Address:
    B.5.3.1Street AddressSERRANO ANGUITA
    B.5.3.2Town/ citySAN SEBASTIAN
    B.5.3.3Post code20008
    B.5.3.4CountrySpain
    B.5.4Telephone number0034606977281
    B.5.5Fax number0034943007069
    B.5.6E-mailDRA_SGSANTOS@YAHOO.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 Morfina B. Braun 10 mg/ml solución inyectable
    D.2.1.1.2Name of the Marketing Authorisation holderMorfina
    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 nameMorfina B. Braun 10 mg/ml solución inyectable
    D.3.2Product code Morfina B. Braun 10 mg/ml solución inyectable
    D.3.4Pharmaceutical form Solution for injection/infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntrathecal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNMORFINA
    D.3.9.1CAS number 52-26-6
    D.3.9.3Other descriptive nameMORPHINE HYDROCHLORIDE
    D.3.9.4EV Substance CodeSUB14596MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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.2.1.1.1Trade name levobupivacaína hidrocloruro
    D.2.1.1.2Name of the Marketing Authorisation holderCHIROCANE 5 mg/ml solución inyectable y para perfusión
    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 nameCHIROCANE 5 mg/ml solución inyectable y para perfusión
    D.3.2Product code CHIROCANE 5 mg/ml solución inyectable y para perfu
    D.3.4Pharmaceutical form Solution for injection/infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPPerineural use
    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 milligram(s)
    D.3.10.2Concentration typeequal
    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
    Control of the pain in surgery of major resection for videotoracoscopia
    Control del dolor en cirugía de resección mayor por videotoracoscopia (VATS)
    E.1.1.1Medical condition in easily understood language
    Control of the pain in surgery of major resection for videotoracoscopia
    Control del dolor en cirugía de resección mayor por videotoracoscopia (VATS)
    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
    Primary aim: 1. To compare two technologies of anesthesia locorregional to determine that of choice in the control of the postoperatory pain after surgery of major resection videotoracoscópica.
    Objetivo primario:
    1. Comparar dos técnicas de anestesia locorregional para determinar la de elección en el control del dolor postoperatorio tras cirugía de resección mayor videotoracoscópica.
    E.2.2Secondary objectives of the trial
    Secondary aims: 1. To value incident of chronic pain for this type of surgery, 2. To value the adverse effects of the technologies, 3. And to re-evaluate the standards of postoperatory vigilance that the clinical guides of the ASA (Anestesiología's American Company) impose, especially as for the patients to whom one administers morphine intratecal.
    Objetivos secundarios:
    1. Valorar incidencia de dolor crónico en este tipo de cirugía,
    2. Valorar los efectos adversos de las técnicas,
    3. y reevaluar los estándares de vigilancia postoperatoria que las guías clínicas de la ASA (Sociedad americana de Anestesiología) imponen, sobre todo en cuanto a los pacientes a los que se administra morfina intratecal.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patients programmed for pulmonary major resection (lobectomías, bilobectomías or segmentectomías ruled) for videotoracoscopia. Subjects of more than 18 years. Those that grant assent informed to taking part in the study.
    E.4Principal exclusion criteria
    1. Age <18 years, 2. History of abuse of drugs, 3. Patients with chronic pain treated with opioids, 4. Any contraindication for the accomplishment of the blockade intradural or intercostal (hemorrhagic diseases, systemic infections or recent places, allergy to local anesthesics or morphine, SNC's expansive processes, water on the brain or alterations of lumbar column that counter
    indicate the lumbar puncture), 5. Patients who do not want to take part or mentally not competent, 6. And surgeries re-turned to toracotomía.
    E.5 End points
    E.5.1Primary end point(s)
    The principal variable will be: pain in rest and with the cough (0h, 6h, 12h, 24h, 48h, 6 months and 12 months). Valued by the EVN (visual numerical scale) and the quantity of morphine IV (in mg) administered in the postoperative period.
    • La variable principal será: dolor en reposo y con la tos (0h, 6h, 12h, 24h, 48h, 6 meses y 12 meses). Valorado por la EVN (escala visual numérica) y la cantidad de morfina IV (en mg) administrada en el PO.
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 months
    12 meses
    E.5.2Secondary end point(s)
    The secondary variables: level of sedation, nauseas or vomits, pruritus, general satisfaction of the managing of the pain (to the discharge), respiratory complications (atelectasia that needs FBC, pneumonia that needs antibiotic, respiratory insufficiency that needs intubation), cardiac complications (atrial fibrilation, heart atack and congestive heart failure), urinary retention with resounding or impossibility of retreat of urinary probe, day of deambulación, days of hospitable stay, mortality to 90 days
    • Las variables secundarias: nivel de sedación, náuseas o vómitos, prurito, satisfacción general del manejo del dolor (al alta), complicaciones respiratorias (atelectasia que requiera FBC, neumonía que requiera antibiótico, insuficiencia respiratoria que requiera IET), complicaciones cardiacas (ACxFA, IAM, ICC), retención urinaria con resondaje o imposibilidad de retirada de sonda urinaria, día de deambulación, días de estancia hospitalaria, mortalidad a los 90 dias
    E.5.2.1Timepoint(s) of evaluation of this end point
    90 days
    90 dias
    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 No
    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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    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
    LVLS
    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 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: 85
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 51
    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 Yes
    F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2017-06-09. Yes
    F.3.3.2Women of child-bearing potential using contraception Yes
    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 state136
    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 Decision2017-11-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-07-26
    P. End of Trial
    P.End of Trial StatusOngoing
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