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    Summary
    EudraCT Number:2017-005180-40
    Sponsor's Protocol Code Number:Protocol_PPB_TKA_31122017
    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:2018-01-08
    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 number2017-005180-40
    A.3Full title of the trial
    The effect of the popliteal plexus block on postoperative pain after total knee arthroplasty - a randomized, controlled, double-blinded study
    Effekten af plexus popliteus blokade på postoperative smerter efter total knæalloplastik – et randomiseret, kontrolleret, dobbeltblindet studie
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The effect of a new technique for anesthetizing the nerves involved in pain after knee replacement
    Effekten af en ny teknik til at bedøve de nerver, som er involveret i smerter efter indsættelse af kunstigt knæled
    A.4.1Sponsor's protocol code numberProtocol_PPB_TKA_31122017
    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 SponsorAarhus University 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 supportA.P. Møller og Hustru Chastine Mc-Kinney Møllers Fond til almene Formaal 

    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAarhus University Hospital
    B.5.2Functional name of contact pointOperation og Intensiv Nord
    B.5.3 Address:
    B.5.3.1Street AddressNørrebrogade 44, Bygning 21, 1. sal
    B.5.3.2Town/ cityAarhus C
    B.5.3.3Post code8000
    B.5.3.4CountryDenmark
    B.5.4Telephone number+4551542997
    B.5.6E-mailtfb@dadlnet.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 Marcain-adrenaline
    D.2.1.1.2Name of the Marketing Authorisation holderAstraZeneca A/S
    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 nameMarcain-adrenaline 5 mg/ml + 5 mikrogram/ml
    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.3.9.3Other descriptive nameBUPIVACAINE HYDROCHLORIDE
    D.3.9.4EV Substance CodeSUB00902MIG
    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.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 51-43-4
    D.3.9.3Other descriptive nameEPINEPHRINE
    D.3.9.4EV Substance CodeSUB06568MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(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.IMP: 2
    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 Dexamethasone
    D.2.1.1.2Name of the Marketing Authorisation holderKRKA
    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 nameDexamethasone
    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.3.9.3Other descriptive nameDEXAMETHASONE SODIUM PHOSPHATE
    D.3.9.4EV Substance CodeSUB01615MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number4.37
    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 posterior pain after total knee arthroplasty
    Postoperativ posterior smerte efter total knæalloplastik
    E.1.1.1Medical condition in easily understood language
    Pain after total knee replacement
    Smerter efter indsættelse af kunstigt knæled
    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 20.0
    E.1.2Level PT
    E.1.2Classification code 10023469
    E.1.2Term Knee arthroplasty
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10002325
    E.1.2Term Anesthesia local
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10036236
    E.1.2Term Postoperative pain relief
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the analgesic effect of the popliteal plexus block (PPB) as a supplement to a femoral triangle block (FTB) after total knee arthroplasty (TKA)
    At undersøge den analgetiske effekt af plexus popliteus blokade som supplement til trigonum femoralis blokade efter total knæalloplastik
    E.2.2Secondary objectives of the trial
    To evaluate the effect of the popliteal plexus block (PPB) in relation to opioid consumption, effect on sensory function and motor strength and to assess the onset time of the PPB. Furthermore, we aim to assess the number of patients who require a PBB as a supplement to a FTB.
    At undersøge effekten af plexus popliteus blokade på opioidforbrug, på sensorisk og motorisk funktion samt at vurdere anslagstiden af PPB. Desuden er formålet at evaluere andelen af patienter, der har brug for et PPB som supplement til FTB.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Male or female at least 50 years of age at screening
    - Scheduled to undergo primary total knee arthroplasty in spinal anaesthesia
    - Normal sensory function at the lateral part of the thigh and lower leg
    - American Society of Anesthesiologists (ASA) physical status 1, 2, or 3
    - Able to provide informed consent
    - Alder ≥ 50 år
    - Primær total knæalloplastik i spinalanæstesi
    - ASA 1,2 eller 3
    - Normal sensorisk funktion på lateralsiden af lår og underben
    - Informeret samtykke
    E.4Principal exclusion criteria
    - Unable to cooperate and follow the study protocol
    - Communication problems
    - Allergic towards any medical product administered in the study
    - Diabetes requiring medical treatment
    - Pregnancy (a pregnancy test will be conducted on all women of childbearing potential prior to inclusion in the study. A positive test result will result in exclusion from the study)
    - Preoperative opioid treatment (dosed > once daily)
    - Manglende evne til at samarbejde og følge protokollen
    - Kommunikationsproblemer
    - Allergi over for lægemidler som anvendes i undersøgelsen
    - Behandlingskrævende diabetes
    - Graviditet (Kvinder i den fertile alder vil få foretaget en graviditetstest for inklusion og vil blive ekskluderet ved positivt resultat)
    - Patienter i præoperativ opioid behandling (doseret > 1 gang dagligt)
    E.5 End points
    E.5.1Primary end point(s)
    Success of the PPB is defined as the proportion of patients with significant postoperative pain (NRS > 3) after FTB, who drop in pain score to NRS ≤ 3 after PPB and maintain NRS ≤ 3 without any opioids until 60 minutes after PPB.
    PPB succes er defineret som andelen af patienter med signifikante postoperative smerter (NRS > 3) efter FTB, som falder i smertescore til NRS ≤ 3 efter PPB og opretholder NRS ≤ 3 uden opioider indtil 60 minutter efter PPB.
    E.5.1.1Timepoint(s) of evaluation of this end point
    After placement of the PPB, pain scores (NRS) are registered every 5 minutes until 15 minutes after PPB placement. Pain scores are registered again 30 min, 45 min and 60 min after PPB.
    Smertescore (NRS) registreres hvert 5. minut indtil 15 minutter efter PPB anlæggelse. Herefter registreres smertescore til tiderne 30 min, 45 min og 60 minutter efter PPB.
    E.5.2Secondary end point(s)
    1) Onset time of the PPB (defined as the time from withdrawal of the block needle and until the patient reports NRS ≤ 3. Maximal onset time is defined as 60 min)
    2) The effect of the PPB on cutaneous sensation on the lateral aspect of the lower leg (pinprick test)
    3) The effect of PPB on isometric muscle strength of the dorso- and plantar flexors of the ankle joint (handheld dynamometer test)
    4) Cumulated opioid consumption from 0-4 hours
    5) Cumulated opioid consumption from 4-24 hours
    6) Pain scores
    7) Pain localization
    8) The number of patients experiencing significant pain (NRS > 3) as a proportion of all patients with FTB
    1) Anslagstid af PPB (anslagstid er defineret som tiden fra tilbagetrækning af nålen og indtil patienten rapporterer NRS ≤ 3. Maksimal anslagstid er per definition 60 min)
    2) Effekten af PPB på sensorisk funktion på lateralsiden af crus (nålepriktest)
    3) Effekten af PPB på isometrisk muskelstyrke af ankelleddets dorso- og plantarfleksorer (test med håndholdt dynamometer)
    4) Kumuleret opioidforbrug fra 0-4 timer
    5) Kumuleret opioidforbrug fra 4-24 timer
    6) Smertescore
    7) Smertelokalisering
    8) Antallet af patienter som oplever signifikant smerte (NRS > 3) ud af alle patienter med FTB
    E.5.2.1Timepoint(s) of evaluation of this end point
    1) Pain scores every 5 min until 15 min after PPB and then every 15 min until 60 min after PPB
    2) Baseline and 2 hrs after PPB
    3) Baseline and 2 hrs after PPB
    4) 0-4 hrs, registered from the electronic patient record (EPJ)
    5) 4-24 hrs, registered from the EPJ
    6) For subjects receiving a PPB: 2, 4 and 24 hrs after PPB. For subjects not receiving a PPB: 24 hrs after the end of the primary observation period (POP)
    7) NRS > 3: when significant pain is reported during POP; 15 and 60 min after PPB; at any increase in NRS score at any time during the 60 min after PPB; 2, 4 and 24 hrs after PPB.
    NRS ≤ 3: at the follow-up visit 24 hrs after the end of the POP
    8) POP: 3-hour period starting at the return of completely normal cutaneous sensation after spinal anesthesia.
    1) Smertescore hvert 5. min indtil 15 min efter PPB og herefter hvert 15. min indtil 60 min efter PPB
    2) Baseline og 2 timer efter PPB
    3) Baseline og 2 timer efter PPB
    4) 0-4 timer, registreret fra den elektroniske patientjournal (EPJ)
    5) 4-24 timer, registreret fra EPJ
    6) For patienter som modtager PPB: 2, 4 og 24 timer efter PPB. For patienter som ikke modtager PPB: 24 timer efter afslutningen af den primære observationsperiode (POP)
    7) NRS > 3: når signifikant smerte rapporteres i løbet af POP; 15 og 60 min efter PPB; ved enhver stigning i NRS i løbet de første 60 min efter PPB; 2,4 og 24 timer efter PPB.
    NRS ≤ 3: ved follow-up besøg 24 timer efter afslutning af POP
    8) POP: 3-timers periode som starter ved komplet normalisering af sensorik efter spinalanæstesien.
    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 No
    E.6.4Safety No
    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.6.13.1Other scope of the trial description
    The scope of the trial is to assess the effect of the popliteal plexus block (PPB) as a supplement to femoral triangle block (FTB). All patients will receive a FTB with 10 ml Marcain-adrenaline with the addition of 0.5 ml Dexamethasone. The FTB will cover the pain from the anterior part of the knee joint. Patients who despite FTB report NRS > 3 in the primary observation period will receive the study treatment: a PPB with either 10 ml Marcain-adrenaline or 10 ml saline according to randomization
    Målet med studiet er at undersøge effekten af plexus popliteus blokade (PPB) som supplement til en trigonum femoralis blokade (FTB). Alle patienter får anlagt FTB med 10 ml Marcain-adrenalin tilsat 0.5 ml Dexamethason. FTB vil dække de anteriore knæsmerter. Patienter, som trods FTB rapporterer NRS > 3 i den primære observationsperiode, vil modtage forsøgsbehandlingen: PPB med enten 10 ml Marcain-adrenalin eller 10 ml saltvand i henhold til randomiseringen.
    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 No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned2
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months11
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months11
    E.8.9.2In all countries concerned by the trial 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: 10
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 60
    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 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 state70
    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)
    Patients will follow the standard of care after having completed the primary observation period defined as a 3-hour period starting at the return of completely normal cutaneous sensation after spinal anesthesia. One follow-up visit will be conducted after 24 hours, and after that the patient has completed participation in the trial.
    Patienterne vil følge afdelingens standardbehandling efter, at de har gennemført den primære observationsperiode, defineret som en 3-timers periode, der starter ved komplet normalisering af sensorik efter spinalanæstesien. Efter 24 timer foretages et opfølgende besøg, og herefter har patienten afsluttet forsøget.
    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 Decision2018-02-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-02-05
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2018-08-23
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