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    Summary
    EudraCT Number:2012-002704-41
    Sponsor's Protocol Code Number:SM2-UG12
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2012-07-11
    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 number2012-002704-41
    A.3Full title of the trial
    Effect of Adductor-Canal-Blockade on postoperative pain, ability to walk and morphine consumption after total knee arthroplasty: A randomised
    study
    Effekten af Adductor-Kanal-Blokade vs placebo på smerter, gangfunktion og morfinforbrug efter total knæalloplastik som led i en multimodal
    smertebehandling
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Effect of Adductor-Canal-Blockade on pain, ability to walk and morphine consumption after total knee arthroplasty
    Effekten af Adductor-Kanal-Blokade vs placebo på smerter, gangfunktion og morfinforbrug efter total knæalloplastik som led i en udvidet smertebehandling
    A.4.1Sponsor's protocol code numberSM2-UG12
    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 SponsorRigshospitalet
    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 supportProfessor Joergen Berg Dahl
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGentofte Hospital, department of Anaesthesia
    B.5.2Functional name of contact pointClinical Trial Informations
    B.5.3 Address:
    B.5.3.1Street AddressNiels Andersens Vej 65
    B.5.3.2Town/ cityHellerup
    B.5.3.3Post code2900
    B.5.3.4CountryDenmark
    B.5.4Telephone number+4539773977
    B.5.6E-mailulrik.grevstad@hotmail.com
    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 Ropivacaine
    D.2.1.1.2Name of the Marketing Authorisation holderFresenius Kabi AB
    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 nameRopivacaine
    D.3.4Pharmaceutical form Solution for 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.3.9.1CAS number 98717-15-8
    D.3.9.3Other descriptive nameROPIVACAINE HYDROCHLORIDE
    D.3.9.4EV Substance CodeSUB04264MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSuspension for injection
    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
    Treatment of postoperative pain in patients after total knee arthroplasty
    Behandling af postoperative smerter hos patienter, der har gennemgået
    total knæalloplastik
    E.1.1.1Medical condition in easily understood language
    Treatment of postoperative pain in patients after total knee arthroplasty
    Behandling af smerter hos patienter, der har fået indsat et nyt knæled
    E.1.1.2Therapeutic area Diseases [C] - Musculoskeletal Diseases [C05]
    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
    Treatment of postoperative pain after total knee arthroplasty
    Behandling af postoperative smerter hos patienter, der har gennemgået total knæalloplastik
    E.2.2Secondary objectives of the trial
    no secondary objectives
    ingen sekundære objectives
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Age > 30 and < 85 years
    - Total knee arthroplasty in spinal anaesthesia at Gentofte Hospital
    - Informed consent
    - ASA 1-3
    - BMI >18 and <40
    • Alder > 30 år og < 85 år
    • Patienter indstillet til total knæalloplastik i spinal anæstesi
    • Patienter, som har givet deres skriftlige informerede samtykke til at
    deltage i undersøgelsen efter at have forstået denne.
    • ASA 1-3
    • BMI > 18 og < 40
    E.4Principal exclusion criteria
    - Unable to corporate.
    - Unable to speak or understand Danish
    - Allergy to ropivacaine
    - Known medical or alcohol-abuse
    - Known peripheral neuopathy
    - Daily consumption af strong opioids
    - Pregnancy
    - Patienter som ikke kan samarbejde til undersøgelsen.
    - Patienter som ikke forstår eller taler dansk.
    - Allergi over for de i undersøgelsen anvendte stoffer.
    - Alkohol- og/eller medicinmisbrug – efter investigators skøn.
    - Kendte føleforstyrrelser i underekstremiteterne.
    - Dagligt forbrug af stærke opioider
    - Graviditet

    E.5 End points
    E.5.1Primary end point(s)
    Difference between groups in pain intensity during active 45 degrees knee flexion - 24 hours after surgery, measured on VAS (0-100)
    Forskellen i smertescore (VAS) ved aktiv 45 graders fleksion af
    knæleddet til tiden 24 timer efter sidste sutur
    E.5.1.1Timepoint(s) of evaluation of this end point
    24 hours after last suture
    24 timer efter sidste sutur
    E.5.2Secondary end point(s)
    - Difference between groups (VAS measured at rest as AUC 0-24 hours)
    at time points: 2, 4, 6, 8, 24 hours postoperatively.
    - Difference between groups (VAS measured at 45 degrees active knee
    flexion as AUC 0-24 hours) at time points: 2, 4, 6, 8, 24 postoperative
    hours.
    - Time to perform a TUG (Timed Up and Go) test 24 hours after surgery.
    - Difference between groups in cumulated morphine consumption, first
    24 hours. Morphine administered as PCA.
    - Difference between groups in mean nausea-score at time 2, 4, 6, 8, 24
    postoperative hours.
    - Difference between
    -Forskellen i smertescore (VAS) i hvile målt som AUC 0-24 timer efter
    sidste sutur. AUC på baggrund af målinger til tiderne 2, 4, 6, 8 og 24
    timer efter sidste sutur.
    -Forskellen i smertescore (VAS) ved aktiv 45 graders fleksion af
    knæleddet målt som AUC 0-24 timer efter sidste sutur. AUC på baggrund
    af målinger til tiderne 2, 4, 6, 8 og 24 timer efter sidste sutur.
    -Tiden til TUG-test 24 timer efter sidste sutur.
    -Kumuleret morfinforbrug de første 24 timer postoperativt,
    administreret som patientkontrolleret smertebehandling (bolus 2,5 mg
    i.v., lock-out tid 10 minutter).
    -Graden af kvalme til tiderne 2, 4, 6, 8 og 24 timer, beregnet som
    gennemsnitsværdien for hele perioden.
    -Kumuleret forbrug af antiemetika de første 24 timer postoperativt.
    E.5.2.1Timepoint(s) of evaluation of this end point
    2, 4, 6, 8 and 24 hours after last suture
    2, 4, 6, 8 og 24 timer efter sidste sutur
    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 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 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 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
    We plan to include 100 patients - study drug/placebo will be given 1, 7, 15 and 23 hours after last suture and LPLV is 8 hours after last injection of study drug/placebo.
    we planlægger at inkludere 100 patienter, der vil modtage medicin 1, 7, 15 og 23 timer efter sidste sutur. LPLV er 8 timer efter sidste injektion.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months0
    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: 80
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    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 2012-07-11. 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 state100
    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)
    Standard treatment after total knee arthroplasty
    Standard behandling efter total knæalloplastik
    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 Decision2012-07-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-09-18
    P. End of Trial
    P.End of Trial StatusOngoing
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