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    Summary
    EudraCT Number:2012-004554-28
    Sponsor's Protocol Code Number:SM3_UG_12
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-12-17
    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 number2012-004554-28
    A.3Full title of the trial
    Effect of Adductor-Kanal-Blokade vs femoralis-Blokade on muskelstyrke, mobility and smerter with high smerte responders 1. and 2. postoperative day after total knæalloplastik
    Effekten af Adductor-Kanal-Blokade vs Femoralis-Blokade på muskelstyrke, mobilitet og smerter hos high pain responders 1. og 2. postoperative døgn efter total knæalloplastik
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A comparison of two nerve blockade - adductor Channel Blockade vs. Femoral Blockade - on muscle strength, mobility and pain in patients with severe pain first or 2 days after insertion of artificial knees "
    En sammenligning af to nerveblokader – Adductor Kanal Blokade vs. Femoralis Blokade - på muskelstyrke, mobilitet og smerter, hos patienter med kraftige smerter 1. eller 2. døgn efter indsættelse af kunstigt knæ”
    A.4.1Sponsor's protocol code numberSM3_UG_12
    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 supportRigshospitalet
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationRigshospitalet
    B.5.2Functional name of contact pointDepartment of Anaestesia 4231, HOC
    B.5.3 Address:
    B.5.3.1Street AddressBlegdamsvej 9
    B.5.3.2Town/ cityCopenhagen
    B.5.3.3Post code2100
    B.5.3.4CountryDenmark
    B.5.4Telephone number+45 35459502
    B.5.5Fax number+4535459502
    B.5.6E-mailjorgen.berg.dahl@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
    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
    D.3.2Product code N01BB09
    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.3.8INN - Proposed INNRopivacaine Hydrochloride
    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 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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution 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 after a total knee replacement
    Behandling af postoperativ smertebehandling efter total knæalloplastik
    E.1.1.1Medical condition in easily understood language
    Treatment of postoperative pain after a total knee replacement
    Smertebehandling af patienter der har fået udskiftet et knæ.
    E.1.1.2Therapeutic area Diseases [C] - Musculoskeletal Diseases [C05]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10036236
    E.1.2Term Postoperative pain relief
    E.1.2System Organ Class 100000004865
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    We want to investigate the effect of Adducter-canal - blockade(AKB) vs. Femoral blockade(FB) on muscle strength, mobility and pain in patients with intense pain (VAS> 60) at the active 45-degree flexion of the knee joint 1-2. postoperative days after TKA, despite division standard pain.

    Our hypothesis is that AKB has fewer side effects in the form of reduced muscle strength and / or mobilization effort than FB, but has an analgesic effect that is not significantly different from FB
    Vi ønsker at undersøge effekten af AKB vs. FB på muskelstyrke, mobilitet og smerter hos patienter med intense smerter (VAS>60) ved aktiv 45 graders fleksion af knæleddet 1-2. postoperative døgn efter TKA, trods afdelingens standard smertebehandling.

    Vores hypotese er, at AKB har færre bivirkninger i form af nedsat muskelstyrke og/eller mobiliseringsbesvær end FB, men har en smertestillende effekt, der ikke adskiller sig væsentligt fra FB.
    E.2.2Secondary objectives of the trial
    Not applicable
    Not Applicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Age more or egual 30 years and less or egual 85 years
    Patients who have undergone a total knee replacement within 3 days (2.postoperative days included) and VAS scores> 60 in 45 degree active knæfleksion, despite conventional pain management.
    Patients who have given written informed consent to participate in the study after having understood this.
    ASA 1-3
    BMI> 18 and <40
    Alder højere eller lig med 30 år og mindre eller lig med 85 år
    Patienter der har gennemgået TKA indenfor 3 døgn (2.postoperative døgn inkluderet) og scorer VAS>60 under 45 graders aktiv knæfleksion, trods konventionel smertebehandling.
    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
    Patients who can not cooperate with the investigation.
    • Patients who do not understand or speak Danish.
    • Allergy to those used in the study drugs.
    • Alcohol and / or drug abuse - the investigator's opinion.
    • Known sensory disturbances in the lower limbs.
    • Pregnancy
    Ensure that women of childbearing potential are not pregnant prior to study entry by carrying out a pregnancy test before enrollment.
    • 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.
    • Graviditet
    Det sikres, at fertile kvinder, ikke er gravide inden indtræden i forsøget ved at der foretages en graviditetstest inden inklusionen.
    E.5 End points
    E.5.1Primary end point(s)
    The change in muscle strength, Maximum Voluntary Isometric Contraction (MVIC) of the quadriceps femoris muscle measured before and 2 hours after the blockade construction. The change compared between the two groups
    Ændringen i muskelstyrke, Maximum Voluntary Isometric Contraction (MVIC) af quadriceps femoris muskulaturen målt før og 2 timer efter blokadeanlæggelsen. Ændringen sammenlignes mellem de to grupper.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Before and 2 hours after the blockade
    Før og 2 timer efter blokade anlæggelse
    E.5.2Secondary end point(s)
    The change in muscle strength, MVIC, the adductor muscles measured before and 2 hours after the blockade construction. The change compared between the two groups.
    The change in the time it takes to complete a TUG-test, performed before and 2 hours after the blockade construction. The change compared between the two groups.
    The change in pain score, VAS, at rest, measured before and 2 hours after the blockade construction. The change compared between the two groups.
    The change in pain score, VAS, by passive 45 degree flexion of the knee joint measured before and 2 hours after the blockade construction. The change compared between the two groups.
    The change in the highest pain score VAS in TUG test measured before and 2 hours after blockade construction. The change compared between the two groups.
    Ændringen i muskelstyrke, MVIC, af adductor muskulaturen målt før og 2 timer efter blokadeanlæggelsen. Ændringen sammenlignes mellem de to grupper.
    Ændringen i tiden det tager at gennemføre en TUG-test, foretaget før og 2 timer efter blokadeanlæggelsen. Ændringen sammenlignes mellem de to grupper.
    Ændringen i smertescore, VAS, i hvile, målt før og 2 timer efter blokadeanlæggelsen. Ændringen sammenlignes mellem de to grupper.
    - Ændringen i smertescore, VAS, ved passiv 45 graders fleksion af knæleddet målt før og 2 timer efter blokadeanlæggelsen. Ændringen sammenlignes mellem de to grupper.
    Ændringen i den højeste smertescore, VAS, under TUG-testen målt før og 2 timer efter blokadeanlæggelsen. Ændringen sammenlignes mellem de to grupper.
    E.5.2.1Timepoint(s) of evaluation of this end point
    TUG test before and two hours after the Blockade.
    Painscore (VAS) when resting before and 2 hours after the blockade
    Painscore (VAS) when passive 45 degree flexion of the knee joint before and 2 hours after the blockade
    TUG test før og 2 timer efter blokadeanlæggelse.
    Smertescore (VAS) i hvile og 2 timer efter blokadeanlæggelse
    Smertescore(VAS) ved passiv flektion af knæledet før og efter blokadeanlæggelse
    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) Yes
    E.7.4Therapeutic use (Phase IV) No
    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 50 patients - studydrug will be given 24 to 48 hours after surgery and last visit is 8 hours after studydrug is given.
    We planlægger at inkludere 50 patinter - studydrug bliver givet mellem 24 og 48 timer efter operationen - last visit er 8 timer efter at studydrug er givet.
    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 months1
    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: 40
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 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)
    Normal treatmen for pain after a total knee replacement
    Standard smertebehandling efter en 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 Decision2012-11-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-12-18
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-11-22
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    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
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