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    Summary
    EudraCT Number:2016-000608-27
    Sponsor's Protocol Code Number:ProtokolSB2
    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:2016-02-16
    Trial results View 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 number2016-000608-27
    A.3Full title of the trial
    The effect of subsartorial saphenous block on postoperative pain following major ankle and hind foot surgery
    Effekten af subsartorial saphenusblokade på postoperative smerter efter stor ankel- og bagfodskirurgi
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The effect of anesthetizing the small nerve to the ankle joint on postoperative pain following major ankle surgery
    Effekten af at bedøve af den lille nerve til ankelleddet på smerterne efter stor ankelkirurgi
    A.4.1Sponsor's protocol code numberProtokolSB2
    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 pointDep. Anaesthesia and Intensive Care
    B.5.3 Address:
    B.5.3.1Street AddressNørrebrogade 44, building 21
    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 RoleComparator
    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
    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 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.3.8INN - Proposed INNEPINEPHRINE
    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.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
    Post-operative pain after four types of major ankle and hind foot surgery:
    (1) total ankle arthroplasty, (2) ankle arthrodesis, (3) subtalar arthrodesis or (4) triple arthrodesis
    Postoperative smerter efter fire typer af stor ankel- og bagfodskirurgi:
    (1) ankelalloplastik, (2) ankelartrodese, (3) subtaloartrodese eller (4) tripleartrodese
    E.1.1.1Medical condition in easily understood language
    Patients' pains after major ankle and foot surgery defined as a total ankle replacement or a fusion of the joint.
    Patienternes smerter efter stor ankel- og bagfodskirurgi defineret som
    indsættelse af kunstigt ankelled eller stivgørende operation af leddet.
    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 19.0
    E.1.2Level LLT
    E.1.2Classification code 10003396
    E.1.2Term Arthroplasty NOS
    E.1.2System Organ Class 100000004865
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level LLT
    E.1.2Classification code 10016962
    E.1.2Term Foot arthrodesis
    E.1.2System Organ Class 100000004865
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level LLT
    E.1.2Classification code 10002540
    E.1.2Term Ankle arthrodesis
    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
    The main objective is to conduct a prospective, randomized, controlled, double-blinded trial to compare subsartorial saphenous block with bupivacaine-adrenaline vs. placebo to investigate the effect of a saphenous block as a supplement to a continious sciatic catheter on postoperative pain following major ankle surgery.
    Formålet med undersøgelsen er at gennemføre en prospektiv, randomiseret, kontrolleret, dobbeltblindet sammenligning af éngangsblokade af n. saphenus subsartorialt midt på låret med henholdsvis placebo og bupivacain-adrenalin for at undersøge effekten af saphenusblokade som supplement til ischiadicusblokade efter stor ankel- og bagfodskirurgi.
    E.2.2Secondary objectives of the trial
    Sensory test of the infrapatellar branch as a proxy marker for analgesia of the saphenous nerve.
    Sensorisk test af r. infrapatellaris som proxymarkør for analgesi af n. saphenus.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Elective ankle or hind foot surgery either (1) total ankle arthroplasty, (2) ankle arthrodesis (3) subtalar arthrodesis, (4) triple arthrodesis
    - Age ≥ 18
    - ASA I-III
    - Informed consent both orally and in writing after the patient has fully
    understood the protocol and its limitations.
    - Elektiv bagfods- og/eller ankelkirurgi enten (1) ankelalloplastik, (2) ankelartrodese (ikke-artroskopisk), (3) subtaloartrodese eller (4) tripleartrodese
    - Alder ≥ 18 år
    - ASA I-III
    - Mundtligt og skriftligt informeret samtykke til deltagelse i
    undersøgelsen efter at have forstået protokollens indhold og
    begrænsninger fuldt ud
    E.4Principal exclusion criteria
    - Communication problems or dementia
    - Allergies to any medical product used in the study
    - Neuropathy of the sciatic or femoral nerve prior to the operation
    - Morbus Charcot-Marie-Tooth disease, diabetic neuropathy, peripheral
    vascular disease
    - Daily use of opioids
    - Coagulation disorders
    - Infection at the site of injection or systemic infection
    - Kommunikationsproblemer eller demens
    - Allergi overfor lægemidler anvendt i undersøgelsen
    - Præoperativ n. ischiadicus eller n. femoralis neuropati
    - Præoperativ nedsat kraft eller sensorik i operationsekstremiteten
    - Morbus Charcot-Marie-Tooth, diabetisk neuropati, svær perifer
    vaskulær sygdom
    - Dagligt forbrug af opioider
    - Koagulationsforstyrrelser
    - Infektion sv.t. indstiksstedet eller systemisk infektion
    E.5 End points
    E.5.1Primary end point(s)
    The frequency of patients who report significant pain at rest (NRS > 3)
    Frekvensen af patienter som rapporterer betydende hvilesmerter (NRS > 3)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Pain scores are evaluated 8 times during the 2 hours observation period.

    The observation period starts when the surgery is completed. This time is noted in the electronic patient file = t0

    The test times are:
    At arrival at the Perioperative Section and at t = 30 min, t = 60 min t = 75 min, t = 90 min, t = 105 min, t = 120 min

    Smertescoring foretages 8 gange i løbet af den to timers observationsperiode.

    Observationsperioden starter ved kirurgiafslutning. Dette tidspunkt er noteret i den elektroniske patientjournal = t0

    Testtidspunkterne er:
    Ved ankomst til perioperativt afsnit og til t = 30 min, t = 60 min t = 75 min, t = 90 min, t = 105 min, t = 120 min
    E.5.2Secondary end point(s)
    Sensory testing of the infrapatellar branch. The skin is tested in an area from the medial femoral condyle to the midline between the apex of patella and the tibial tuberosity.

    Sensorisk test af r. infrapatellaris. Huden testes i et område fra mediale femurkondyl til midtlinjen mellem apex patella og tuberosita tibia.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Sensory testing is conducted when the patient reports significant pain (NRS >3)

    If the patient does not experience any pain during the observation period, sensory testing is conducted at the end of the observation period, t = 120 min
    Sensorisk test udføres når patienten rapporterer betydende smerter (NRS > 3)

    Hvis patienten ikke oplever smerter i løbet af observationsperioden, udføres sensorisk test ved afslutning af observationsperioden, t = 120 min
    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 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 months9
    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: 9
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 9
    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 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 2016-02-16. 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 state18
    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)
    None
    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 Decision2016-03-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-04-05
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-02-28
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