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    Summary
    EudraCT Number:2017-001708-31
    Sponsor's Protocol Code Number:Protokol_PPB_ACL_21042017
    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:2017-04-25
    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 number2017-001708-31
    A.3Full title of the trial
    The effect of the popliteal plexus block on postoperative pain after reconstruction of the anterior cruciate ligament
    Effekten af plexus popliteus blokade til postoperativ smertebehandling efter rekonstruktion af forreste korsbånd
    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 repair of the anterior cruciate ligament in the knee.
    Effekten af en ny teknik til at bedøve de nerver, som er involveret i smerter efter reparation af det forreste korsbånd i knæet.
    A.4.1Sponsor's protocol code numberProtokol_PPB_ACL_21042017
    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 support A.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 pointDepartment of Anesthesia
    B.5.3 Address:
    B.5.3.1Street AddressNørrebrogade 44, bldg. 21, 1st fl.
    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-adrenalin 5 mg/ml + 5 mikrogram/ml
    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-adrenalin
    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 HYDROCHLORIDE
    D.3.9.3Other descriptive nameMarcain
    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.3.8INN - Proposed INNEPINEPHRINE
    D.3.9.1CAS number 51-43-4
    D.3.9.3Other descriptive nameAdrenaline
    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.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Postoperative pain after reconstruction of the anterior cruciate ligament
    Postoperative smerter efter rekonstruktion af forreste korsbånd
    E.1.1.1Medical condition in easily understood language
    Pain after repair of the anterior cruciate ligament in the knee
    Smerter efter reparation af forreste korsbånd i knæet
    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 LLT
    E.1.2Classification code 10078191
    E.1.2Term Anterior cruciate ligament reconstruction
    E.1.2System Organ Class 100000021343
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The main objective of this pilot study is to investigate the effect of the popliteal plexus block (PPB) as a supplement to femoral triangle block (FTB) after reconstruction of the anterior cruciate ligament.
    Formålet med dette pilotstudie er at undersøge effekten af plexus popliteus blokade (PPB) som supplement til trigonum femoralis blokade (FTB) efter rekonstruktion af forreste korsbånd
    E.2.2Secondary objectives of the trial
    The secondary objectives of the pilot study are: testing of the set-up for the following randomized clinical trial (RCT), length of observation periods, test methods, data collection for the power estimation for the RCT.
    Sekundære formål: afprøve set-up for det efterfølgende randomiserede, kontrollerede studie (RCT), længde på observationsperioder, testmetoder, indsamling af data til styrkeberegning til RCT.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Patients undergoing ACL reconstruction on one of the two trial sites
    - Age ≥ 18
    - ASA I-III
    - Informed consent
    - Patienter indstillet til ACL rekonstruktion på et af de to forsøgscentre
    - Alder ≥ 18 år
    - ASA I-III
    - Informeret samtykke
    E.4Principal exclusion criteria
    - Patients unable to cooperate
    - Patients not able to speak Danish or with other communication problems
    - Pregnancy
    - Contraindication towards any medical product used in the study
    - Preoperatively reduced sensation on the medial and lateral part of the lower leg
    - Patients with diabetes requiring medical treatment
    - Preoperative intake of opioids (dosed > once daily)
    - ACL revision
    - Manglende evne til at samarbejde
    - Manglende danskkundskaber eller andre former for kommunikationsproblemer
    - Graviditet
    - Allergi over for lægemidler som anvendes i undersøgelsen
    - Præoperativ nedsat sensorik sv.t. mediale og laterale crus
    - Patienter med behandlingskrævende diabetes
    - Patienter i præoperativt opioid behandling (doseret > 1 gang dagligt)
    - ACL revision
    E.5 End points
    E.5.1Primary end point(s)
    The effect of the PPB evaluated as the percentage of patients with postoperative pain NRS >3 dropping in pain score to NRS ≤ 3 after the PPB

    Effekten af PPB målt som andelen af patienter med postoperative smerter NRS >3, som efter anlæggelse af PPB falder til NRS ≤ 3.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Pain scores (NRS) are evaluated 15, 30, 45 and 60 minutes after the PPB.
    Smertescore (NRS) 15, 30, 45 og 60 minutter efter anlæggelse af PPB.
    E.5.2Secondary end point(s)
    1) The percentage of patients with FTB reporting pain (NRS >3) not localized to the graft donor site in the observation period
    2) Onset time for PPB
    3) The effect of the PPB on cutaneous sensation on the lateral part of the lower leg (pinprick test)
    4) The effect of the PPB on muscle strength (dorsal flexion and plantar flexion in the ankle joint, measured with a handheld dynamometer)
    1) Andelen af patienter med FTB, som i observationsperioden får smerter (NRS >3), som ikke er graft smerter
    2) Anslagstid af PPB
    3) Påvirkning af sensorik på laterale crus efter anlæggelse af PPB (pinprick test)
    4) Påvirkning af muskelkraft efter PPB (dorsal fleksion og plantar fleksion i ankelleddet, målt med et håndholdt dynamometer)

    E.5.2.1Timepoint(s) of evaluation of this end point
    1) Pain scores: 15, 30, 45 and 60 minutes after t0 (t0 = arrival at the PACU)
    2) Time from withdrawal of the needle until patient reports NRS ≤ 3)
    3) Sensory test: Baseline, 30 and 60 minutes after PPB
    4) Muscle strength: Baseline, 60 minutes after PPB
    1) Smertescore (NRS): 15, 30, 45 og 60 minutter efter t0 (t0 = ankomst til PACU)
    2) Tiden fra udtrækning af blokadenål og til patienten angiver NRS ≤ 3
    3) Sensorisk test: baseline, 30 og 60 minutter efter anlæggelse af PPB
    4) Muskelkraft: baseline, 60 minutter efter anlæggelse af PPB
    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 Yes
    E.6.13.1Other scope of the trial description
    Pilot study. Testing of the set-up, length of observation period and tests methods and collection of data for the power estimation.
    Pilotstudie. Afprøvning af set-up, længde af observationsperioder og testmetoder, indsamling af data til styrkeberegningen.
    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 No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Pilotstudie
    Pilot study
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    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 months8
    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: 100
    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 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 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)
    Patients will follow the standard of care after having completed the observation period.
    Patienterne vil efter afslutning af observationsperioden følge afdelingens standardbehandling
    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 Decision2017-06-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-05-16
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-12-04
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