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    Summary
    EudraCT Number:2014-004207-78
    Sponsor's Protocol Code Number:ProtokolSB1
    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:2014-11-19
    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 number2014-004207-78
    A.3Full title of the trial
    Comparison of the effect of saphenous block with plain bupivacaine vs. protracted bupivacaine mixture as a supplement to continuos sciatic catheter after major ankle and foot surgery: a randomized study


    Sammenligning af effekten af saphenusblokade med bupivacain vs. protraheret bupivacainblanding som supplement til kontinuert ischiadicusblokade efter stor ankelkirurgi
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Post-operative pain treatment of patients after major ankle and foot surgery by comparing a nerve block with plain local anesthetic to a new
    protracted mixture of local anesthetics.
    Smertedækning af patienter efter stor ankel- og fodkirurgi vha. sammenligning af nervebedøvelse med almindelig lokalbedøvelse i forhold til en ny længerevirkende lokalbedøvelsesblanding
    A.4.1Sponsor's protocol code numberProtokolSB1
    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.4.1Name of organisation providing supportGrosserer L.F. Foghts fond
    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 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 Dexagalen
    D.2.1.1.2Name of the Marketing Authorisation holderGALENpharma GmbH
    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 nameDexagalen
    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 INNDEXAMETHASONE SODIUM PHOSPHATE
    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
    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 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 three types of major ankle and hind foot surgery: (1) total ankle arthroplasty, (2) ankle arthrodesis or (3) subtalar arthrodesis
    Postoperative smerter efter tre typer af stor ankel- og bagfodskirurgi: (1) ankelalloplastik, (2) ankelartrodese eller (3) subtaloartrodese.
    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 17.1
    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 17.1
    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 17.1
    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 investigate whether addition of the adjuvant
    dexamethasone to bupivacaine-adrenaline can prolong the analgesic
    effect of the saphenous block compared to plain bupivacaine-adrenaline
    in patients after major ankle and hind foot surgery.
    Hovedformålet er at undersøge om tilsætning af dexamethason til bupivacain-adrenalin kan forlænge den analgetiske virkningsvarighed af saphenusblokaden i forhold til ren bupivacain-adrenalin hos patienter efter stor ankel- og bagfodskirurgi.
    E.2.2Secondary objectives of the trial
    - Compare the cumulated opioid consumption during the first 48 hours after surgery
    - Compare pain scores during the first 48 hours after surgery
    - Investigate the localization of the pain during the first 48 hours after surgery

    - Sammenligne det kumulerede opioidforbrug 48 timer postoperativt
    - Sammenligne smertescore 48 timer postoperativt
    - Undersøge lokalisering af smerter de første 48 timer postoperativt

    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 or (3) subtalar 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 eller (2) ankelartrodese (ikke-artroskopisk) eller (3) subtaloartrodese
    - 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
    - BMI > 35
    - Pregnancy
    - 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
    - BMI >35
    - Graviditet
    - Dagligt forbrug af opioider
    - Koagulationsforstyrrelser
    - Infektion sv.t. indstiksstedet eller systemisk infektion
    E.5 End points
    E.5.1Primary end point(s)
    Duration of the saphenous nerve block with plain vs. protracted
    bupivacaine mixture registered as the time until the first dose of
    morphine is taken, and when the pain score is above 3 and located to
    the frontal or medial side of the ankle. Morphine is administered
    intravenously by a patient controlled pump, (PCA - Patient Controlled
    Analgesia), which will give a specific dose when the patient pushes the
    button. The patients will be thoroughly instructed in the use of the pump prior to the operation and the importance of scoring their pain and indicating the localization if they want to take a dose of morphine is underlined.
    Virkningsvarighed af n. saphenusblokade med plain vs. protraheret bupivacainblanding registreret som tiden indtil første dosis morfin, hvor patienten angiver smertescore større end numeric rating scale (NRS) score 3 og lokalisering af værste smerte til for- eller inderside af ankelleddet. Der anvendes intravenøs patientkontrolleret smertebehandling, Patient Controlled Analgesia (PCA), hvor patienten kobles til en smertepumpe med morfin, som indgiver en bestemt dosis, når patienten trykker på knappen. Patienterne instrueres før operationen grundigt i, hvornår de skal tage morfin og vigtigheden af, at de samtidig scorer deres smerter på NRS samt angiver lokaliseringen af smerterne.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The timepoint for the primary end point is the exact time where the first bolus of morphine is taken by the patient. This timepoint is registered by the PCA pump and will be within the first 48 hours after surgery.
    Tidspunktet for evaluering af det primære effektmål er det præcise tidspunkt hvor patienten første gang tager en bolus morfin. Dette tidspunkt registreres af PCA pumpen og vil være indenfor de første 48 timer.
    E.5.2Secondary end point(s)
    - Cumulated opioid consumption registered by the PCA pump
    - Pain score on the NRS (Numeric ranking scale) with values from 0 to 10. Pain scoring is done at rest because the patient's leg is elevated on a Kirschner splint. It is the maximal pain since the last score, which is evaluated.
    - Pain localization
    - Test of sensory blockade of the peroneal, tiabial and saphenous nerve. The sensory blockade of the peroneal nerve is tested on the dorsal side
    of the toes and the tibial nerve on the plantar side of the toes. The
    saphenous territory at the medial side of the lower leg is covered in
    a cast, and therefore the orthopaedist will make a small window in the
    cast to enable testing.

    - Kumuleret opioidforbrug ved PCA pumpe
    - Smertescore med NRS med værdier fra 0 til 10, hvor 0 er ingen smerte og 10 er den værst tænkelige smerte. Smertescoring foretages i hvile, da patienten ligger med benet eleveret på Kirschnerskinne. Det er den maksimale smerte i perioden siden sidste scoring, som registreres.
    - Smerternes lokalisering
    - Test af sensorisk blokade af n. peroneus, n. tibialis og n. saphenus. Sensorisk blokade af n. peroneus testes med is på dorsalsiden af tæerne og tilsvarende testes n. tibialis på plantarsiden af tæerne. N. saphenus’ innervationsområde på medialsiden af crus er dækket af gipsbandagering, men ortopædkirurgerne laver et vindue i gipsen for at muliggøre sensorisk test af n. saphenus.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Cumulated opioid consumption is registered 48 hours after surgery
    Pain score, pain localization and sensory tests are performed at regular time intervals: Arrival at and departure from the Perioperative Section and 6, 12, 24, 30, 36, 42 and 48 hours after surgery.
    Kumuleret opioidforbrug registreres 48 timer efter operationen.
    Smertescore, smertelokalisering samt sensorisk test foretages på følgende tidspunkter: Ankomst til samt afgang fra Perioperativt Afsnit og 6, 12, 24, 30, 36, 42 og 48 timer postoperativt.
    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 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.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 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 months5
    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: 20
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    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 state40
    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
    Ingen
    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 Decision2015-01-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-11-07
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-12-16
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
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