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    Summary
    EudraCT Number:2013-001364-30
    Sponsor's Protocol Code Number:BBH-TQL-LC
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2014-02-12
    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 ConcernedDenmark - DHMA
    A.2EudraCT number2013-001364-30
    A.3Full title of the trial
    Ultrasoundguided transmuscular quadrates lumborum block after elective laparoscopic cholecystectomy. A prospective, randomised clinical trial.
    Ultralydsvejledt Transmuskulær Quadratus Lumborum blokade efter elektiv laparoskopisk cholecystektomi. En prospektiv, randomiseret klinisk undersøgelse.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Ultrasoundguided quadratus lumborum block after removal of the gallbladder. A randomised clinical trial
    Ultralydsvejledt quadratus lumborum blokade efter planlagt fjernelse af galdeblæren. En randomiseret klinisk undersøgelse.
    A.4.1Sponsor's protocol code numberBBH-TQL-LC
    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 SponsorBispebjerg Hospital
    B.1.3.4CountryDenmark
    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 supportBispebjerg Hospital
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBispebjerg Hospital
    B.5.2Functional name of contact pointAfdeling Z
    B.5.3 Address:
    B.5.3.1Street AddressBispebjerg Bakke 23
    B.5.3.2Town/ cityCopenhagen
    B.5.3.3Post code2400 NV
    B.5.3.4CountryDenmark
    B.5.4Telephone number4535312783
    B.5.6E-mailz-afd.bispebjerghospital@regionh.dk
    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 Ropivacain "B.Braun" 7,5 mg/ml
    D.2.1.1.2Name of the Marketing Authorisation holderB.Braun Melsungen AG
    D.2.1.2Country which granted the Marketing AuthorisationDenmark
    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 nameRopivacain "B.Braun" 7,5 mg/ml
    D.3.4Pharmaceutical form Injection
    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 INNRopivacain
    D.3.9.1CAS number 132112-35-7
    D.3.9.3Other descriptive nameROPIVACAINE HYDROCHLORIDE MONOHYDRATE
    D.3.9.4EV Substance CodeSUB22590
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboInjection
    D.8.4Route of administration of the placeboPerineural use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Postoperative pain following laparoscopic cholecystectomy
    Postoperative smerter efter laparoskopisk cholecystektomi
    E.1.1.1Medical condition in easily understood language
    Pain after scopic surgery with removal of the gallbladder
    Smerter efter fjernelse af galdeblæren ved kikkertoperation.
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.1
    E.1.2Level LLT
    E.1.2Classification code 10049890
    E.1.2Term Cholecystolithiasis
    E.1.2System Organ Class 100000004871
    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 ultrasound guided transmuscular quadrates lumborum block with placebo in patients undergoing laparoscopic cholecystectomy. Main objective is pain score sititng up 1 hour after administration of block.
    At undersøge ultralydsvejledt quadratus lumborum blok overfor placebo hos patienter efter laparoskopisk cholecystektomi.
    Primær effektparameter er smerteintensitet i siddende stilling 1 time efter anlæggelse af blokade.
    E.2.2Secondary objectives of the trial
    Opioid consumption
    LOS in recovery
    Pain intensity in prone position
    Opioid forbrug
    Tid i opvågningsafsnittet
    Smerteintensitet i liggende stilling
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients for planned laparoscopic cholecystectomy
    Painscore >= 4 NRS upon arrival in recovery
    Recieved verbal as well as written information about the trial
    Informed consent signed
    Age > 18 yrs
    ASA 1-3
    Patienter til elektiv laparoskopisk cholecystektomi
    Smertescore >= 4 NRS ved ankomst til opvågningsafsnittet
    Modtaget mundtlig såvel som skriftlig information om undersøgelsen
    Informeret samtykke underskrevet
    Alder > 18 år
    ASA 1-3
    E.4Principal exclusion criteria
    Cannot cooperate to the procedure
    Does not speak or understand danish
    Allergy towards the medicine used in the trail
    Large daily consumption of opioids
    Known abuse of alcohol og medication
    Difficult or impossible procedure due to anatomical conditions
    Kan ikke medvirke til proceduren
    Ikke taler eller forstår dansk
    Allergi overfor de anvendte lægemidler i undersøgelsen
    Stort dagligt forbrug af opioider
    Kendt misbrug af alkohol eller medicin
    Vanskelig eller umulig procedure pga anatomiske betingelser
    E.5 End points
    E.5.1Primary end point(s)
    Pain intensity sitting up
    Smerte intensitet i siddende stilling
    E.5.1.1Timepoint(s) of evaluation of this end point
    1 hour after performing the blockprocedure
    1 time efter anlæggelse af blokade
    E.5.2Secondary end point(s)
    Pain intensity in prone position
    Opioid consumption (total)
    Opioid sideeffects
    LOS in recovery
    Smerteintensitet i liggende stilling
    Opioid forbrug (total)
    Opioid bivirkninger
    Opholdstid i opvågningen
    E.5.2.1Timepoint(s) of evaluation of this end point
    15 min, 30 min, 2 h and every hour until discharge to home
    Total consumption until discharge
    Occurence of nausea and/or vomiting
    Time until discharge criteria met in recovery regardless of logistics
    15 min, 30 min, 2 h og hver time indtil udskrivelse til hjemmet
    Totalforbrug af opioid
    Forekomst af kvalme og/eller opkast
    Tid til udskrivningskriterier er tilstede i opvågning uanset logistikken i øvrigt
    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 No
    E.6.6Pharmacokinetic Yes
    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 No
    E.8.1.4Double blind Yes
    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 Yes
    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 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
    Trial ends upon including 30 patients eligible for evaluation.
    Undersøgelsen slutter når der er inkluderet 30 evaluérbare patienter.
    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: 50
    F.1.3Elderly (>=65 years) No
    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 2014-02-12. 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 state50
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 50
    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
    Ingen
    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 Decision2013-07-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-06-24
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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