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    Summary
    EudraCT Number:2021-000242-17
    Sponsor's Protocol Code Number:Protocol_PPB_TKA_14012021
    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:2021-01-27
    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 number2021-000242-17
    A.3Full title of the trial
    The effect of the popliteal plexus block on postoperative opioid consumption, pain, muscle strength and mobilization after total knee arthroplasty
    - a randomized, controlled, blinded study
    Effekten af en ny nerveblokade på morfinforbrug, smerter, muskelstyrke og mobilisering efter knæ protese operation - et videnskabeligt lodtrækningsforsøg.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The effect of a new peripheral nerve block, popliteal plexus block, on postoperative opioid use, postoperative pain, muscle strength of the leg and mobilization after total knee replacement surgery - a randomized, controlled, blinded study
    Effekten af en ny nerveblokade på morfinforbrug, smerter, muskelstyrke og mobilisering efter knæ protese operation - et videnskabeligt lodtrækningsforsøg.
    A.4.1Sponsor's protocol code numberProtocol_PPB_TKA_14012021
    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 SponsorRegion Hospital Silkeborg
    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 supportGigtforeningen
    B.4.2CountryDenmark
    B.4.1Name of organisation providing supportSilkeborg Region Hospital
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationRegion Hospital Silkeborg
    B.5.2Functional name of contact pointJohan Kløvgaard Sørensen
    B.5.3 Address:
    B.5.3.1Street AddressFalkevej 1-3
    B.5.3.2Town/ citySilkeborg
    B.5.3.3Post code8600
    B.5.3.4CountryDenmark
    B.5.4Telephone number004528945356
    B.5.6E-mailjoksoe@rm.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 Marcaine
    D.2.1.1.2Name of the Marketing Authorisation holderAspen Nordic
    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.3.4Pharmaceutical 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 INNBUPIVACAINE
    D.3.9.1CAS number 2180-92-9
    D.3.9.4EV Substance CodeSUB05983MIG
    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 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 a total knee arthroplasty surgery
    Postoperativ smerter efter total knæ alloplastik operation
    E.1.1.1Medical condition in easily understood language
    Pain following a total knee replacement surgery
    Smerter efter knæprotese operation.
    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 21.1
    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 aim to evaluate the analgesic effects of three different nerve block regimens (Popliteal Plexus Block + Femoral Triangle Block versus Femoral Triangle Block versus Adductor Canal Block) after primary unilateral total knee arthroplasty (TKA), in order to optimize pain treatment for TKA patients and minimize the use of opioids. We observe TKA patients opioid consumption and pain scores in the period of 24 hours postoperative, while testing their muscle strength and ability to mobilize.
    Vi ønsker at evaluere den smertestillende effekt af 3 forskellige nerveblokade regimer som benyttes til postoperativ smertebehandling efter total knæproteseoperation. Dette gøres for at forbedre smertebehandlingen til disse patienter samt at nedbringe bruges af opioider. Vi vil undersøger patienter i 24 timer efter deres total knæprotese operation, hvor vi måler deres forbrug af opioider og deres smerter samt undersøger deres muskelstyrke og mobiliseringsevne.
    E.2.2Secondary objectives of the trial
    not applicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Scheduled to undergo primary total knee arthroplasty in spinal anesthesia

    Able to perform a Timed Up and Go (TUG) test

    Age > 50 years old

    Ability to give their written informed consent to participating in the study after having fully understood the contents of the study

    American Society of Anesthesiologists (ASA) physical status 1, 2, or 3
    Planlagt til knæprotese operation gennemført under rygmarvsbedøvelse

    Kunne udfører en mobiliseringstest (Timed Up and Go test)

    Alder over 50 år

    Habile til at afgive et informeret skriftlig om deltagelse i forsøget

    Vurdering af følgesygdomme ved American Society of Anesthesiologists (ASA) skal kunne kategoriseres som klasse 1, 2 eller 3.
    E.4Principal exclusion criteria
    Patients who cannot cooperate

    Patients who cannot understand or speak Danish.

    Patients with allergy or intolerance to the medicines used in the study

    Patients with a daily intake of strong opioids (morphine, oxycodone, ketobemidone, methadone, fentanyl)

    Patients suffering from alcohol and/or drug abuse – based on the investigator's assessment

    Diagnosed with chronic central or peripheral neurodegenerative disorders

    Body Mass Index > 40
    Manglende samarbejdsevne

    Manglende kommunikationsevne på dansk

    Overfølsomhed overfor de i studiets anvendte medicinske præparater

    Dagligt indtag af stærke opioider op til operationen

    Stof- eller alkohol misbrugere – vurderet af primær investigator

    Diagnosticeret med betydende perifere eller centrale nervesygdomme

    Body Mass Index > 40
    E.5 End points
    E.5.1Primary end point(s)
    Total opioid consumption in each group, A, B and C (PCA pump and any potential rescue administration, calculated as IV morphine equivalents)
    Total opioid forbrug i hver gruppe, A, B og C (målt ved smertepumpen sammenlagt med eventuel andet administreret opioid i ækvivalent morfin dosis
    E.5.1.1Timepoint(s) of evaluation of this end point
    At 24 hours after surgery, defined as 24 hours after time of final suture
    24 timer efter operationen, defineret som 24 timer efter tidspunktet for anlæggelse af sidste sutur
    E.5.2Secondary end point(s)
    Total opioid consumption in each group, A, B and C (PCA pump and any potential rescue administration, calculated as IV morphine equivalents)

    Post-block Maximum Voluntary Isometric Contraction (MVIC) by knee extension, calculated as a percentage of the Pre-block baseline value

    Post-block MVIC by ankle plantarflexion, calculated as a percentage of the Pre-block baseline value

    Post-block MVIC by ankle dorsiflexion, calculated as a percentage of the Pre-block baseline value

    Muscle strength of knee extension, graded by Manual Muscle Test (MMT)

    Muscle strength of ankle plantarflexion, graded by MMT

    Muscle strength of ankle dorsiflexion, graded by MMT

    Time (seconds) to perform Times Up and Go (TUG) test

    Worst pain during TUG gradet by Numeric Rating Scale (NRS)

    Postoperative pain intensity (NRS) at rest analyzed using a linear mixed model with the inclusion of all time points

    Postoperative pain scores (NRS) at 90 degrees active flexion of the knee analyzed using a linear mixed model with the inclusion of all time points.
    Total opioid forbrug i hver gruppe, A, B og C (målt ved smertepumpen sammenlagt med eventuel andet administreret opioid i ækvivalent morfin dosis

    Post-blok Maximum Voluntary Isometric Contraction (MVIC) ved knæ ekstension, beregnet som procent af præblok baseline værdien.

    Post-blok MVIC ved ankel plantarfleksion, beregnet som procent af præblok baseline værdien.

    Post-blok MVIC ved ankel dorsifleksion, beregnet som procent af præblok baseline værdien.

    Muskel styrke vurdering af knæ ekstension ved Manuel Muskel Test (MMT)

    Muskel styrke vurdering af ankel plantarfleksion ved MMT

    Muskel styrke vurdering af ankel dorsifleksion ved MMT

    Tiden for at gennemfører Timed Up and Go (TUG) test

    Værste oplevede smerter under TUG testen

    Postoperative smerte i hvile analyseret ved linær mixed model

    Postoperativ smerte ved 90 graders fleksion af knæleddet, analyseret ved linær mixed model
    E.5.2.1Timepoint(s) of evaluation of this end point
    Total opioid consumption is 12 hours after time of final suture

    MVICs are testet prior to nerve block procedure (preoperative) and 60 minutes after nerve block procedure (preoperative)

    Muscle strength tests by MMT are performed prior to nerve block (preoperative) and 60 minutes after nerve block procedure (peroperative) and postoperative 5 hours after time of final suture

    TUG test and worst pain during TUG is performed 5 hours after time of final suture

    Postoperative pain at rest and during 90 degrees of knee flexion is obtained preoperativ, before peripheral nerve block procedure, and at 2, 5, 7, 20 and 24 hours after time of final suture
    Total opioid forbrug måles 12 timer efter operationen, defineret som 12 timer efter tidspunktet for anlæggelse af sidste sutur

    MVIC målingerne gøre før nerveblokade proceduren (præoperativt) og 60 minutter efter nerveblokade proceduren (præoperativt)

    MMT gøres før nerveblokade proceduren (præoperativt) og 60 minutter efter nerveblokade proceduren (præoperativt) samt 5 timer efter tiden for anlæggelse af den sidste sutur (postoperativt)

    TUG testen samt smerteangivelse under TUG gøres 5 timer efter anlæggelse af den sidste sutur (postoperativt)

    Postoperativ smerte score i hvile og ved 90 graders fleksion af knæleddet angives før nerveblokade proceduren (præoperativt) samt postoperativt 2, 5, 7, 20 og 24 timer efter tiden for anlæggelsen af den 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 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 Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial3
    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
    The trial will end when 165 patiens are included in the trial and data collection is completed
    Forsøget stopper når 165 patienter er inkluderet og data er indsamlet.
    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 months
    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: 45
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 120
    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 state165
    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)
    After participation the patients follows the standard treatment programme set by the orthopedic surgeon. This often includes daily doses of paracetamol, Ibumetin and oxycodone for a shorter period. After hospital discharge, the patients are followed by the orthopedic surgeon in the orthopedics outpatient clinic.
    Efter deltage overgår patienterne til at følge standard smertebehandlingsplan ordineret af ortopædkirurgen. Denne indeholder ofte dagligt indtag af paracetamol, ibumentin og oxycodon tabletter i en begrænset tidsperiode. Efter udskrivelse fra hospitalet bliver patienten fulgt af ortopædkirurgen gennem ambulante kontrolbesøg.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation Department of Clinical Medicine - Anesthesiology, Aarhus University Hospital
    G.4.3.4Network Country Denmark
    G.4 Investigator Network to be involved in the Trial: 2
    G.4.1Name of Organisation Department of Anesthesia, Gentofte Hospital
    G.4.3.4Network Country Denmark
    G.4 Investigator Network to be involved in the Trial: 3
    G.4.1Name of Organisation Department of Anesthesia, Centre of Head and Orthopedics, Rigshospitalet
    G.4.3.4Network Country Denmark
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2021-03-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-03-11
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2023-06-26
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