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    Summary
    EudraCT Number:2013-000235-27
    Sponsor's Protocol Code Number:S-20120216
    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:2013-02-19
    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 number2013-000235-27
    A.3Full title of the trial
    Interscalener blockade for surgery on the shoulder, a comparison of two dosing regimens: Fixed intermittent bolus with the possibility of PCA (Patient controlled administration) Vs. continuous infusion with the possibility of PCA.
    Interscalener blokade i forbindelse med skulderkirurgi, en sammenligning mellem to doserings regimer: Fast intermitterende bolus injektion med mulighed for PCA vs. kontinuerlig infusion med mulighed for PCA.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Shoulder nerve blockade for surgery on the shoulder: A comparison of two dosing methods: Fixed limited amounts of local anesthetic injected at fixed times with the possibility of supplementing controlled by the patient Vs. continuous injection of a local anesthetic with the possibility of supplementing controlled by the patient
    Skuldernerve blokade i forbindelse med operation på skulderen: En sammenligning mellem to doserings metoder: Faste afgrænsede mængder lokalbedøvelse indsprøjtet på faste tider med mulighed for supplering styret af patienten vs. konstant indsprøjtning af lokalbedøvelse med mulighed for supplering styret af patienten.
    A.4.1Sponsor's protocol code numberS-20120216
    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 SponsorOdense universitets 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 supportOdense Universitets Hospital
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationOdense Universitets Hospital
    B.5.2Functional name of contact pointOdense Universitets Hospital
    B.5.3 Address:
    B.5.3.1Street AddressSdr Boulevard 29
    B.5.3.2Town/ cityOdense
    B.5.3.3Post code5000
    B.5.3.4CountryDenmark
    B.5.4Telephone number00456666113333
    B.5.6E-mailMichael.Due.Nielsen@rsyd.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 Ropivacain, FreseniusKabi solution for infusion 2mg/ml
    D.2.1.1.2Name of the Marketing Authorisation holderFresenius Kabi
    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 nameRopivacain
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPInfiltration
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNROPIVACAINE
    D.3.9.1CAS number 84057-95-4
    D.3.9.4EV Substance CodeSUB10382MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    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 Yes
    D.3.11.13.1Other medicinal product typeamide-type local anaesthetic
    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
    Shoulder frcture
    Rotator cuff leasion
    Shoulder alluplastic
    Brud på skulderknogler
    Skulder aluplastik
    Rotator cuff læsion
    E.1.1.1Medical condition in easily understood language
    Fracture of the bones in the shoulder
    Leasion af the ligaments inthe shoulder
    Shoulder arthrosis
    Brud på skulderens knogler
    Læsion af skulderens ledbånd
    Gigt i skulderleddet
    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 16.1
    E.1.2Level LLT
    E.1.2Classification code 10002182
    E.1.2Term Analgesia
    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
    To investigater wether we can reduce pain associated with shoulder surgery by changing the adminitration af local anaesthetic in an interscalene catheter from continuous infusion to intermittent bolus injection
    At undersøge om om man kan reducere smerter ved skulderkirurgi ved at ændre doseringen af lokal bedøvelse i et interscalener kateter til intermitterende bolus injektion i stedet for kontinuerlig infusion.
    E.2.2Secondary objectives of the trial
    To investigater wether we can reduce sideeffekts associated with nerveblockade for shoulder surgery by changing the adminitration af local anaesthetic in an interscalene catheter from continuous infusion to intermittent bolus injection
    At undersøge om om man kan reducere bivirkningerne ved nerveblokade til skulderkirurgi ved at ændre doseringen af lokal bedøvelse i et interscalener kateter til intermitterende bolus injektion i stedet for kontinuerlig infusion.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    All patients over 18 years in need of an interscalenecatheter for shoulder surgery (artificial shoulder joint operaton, operations on the shoulder joint's capsule and fracture of the upper arm). ASA class 1-3. (In otherwise healthy patients (1) Pt. With mild systemic disease (2), Pt. With severe systemic disease, (3) Pt. With severe systemic disease, and in the constant life threatening condition (4).
    Alle patienter over 18 år der skal have anlagt interscalenerkateter i forbindelse med skulderkirurgi (kunstig skulderleds operaton, operationer på skulder leddets kapsel og brud på overarmen). ASA klasse 1-3. (I øvrigt Raske patienter (1) Pt. med mild systemisk sygdom(2), Pt. Med svær systemisk sygdom (3) Pt. med svær systemisk sygdom og i konstant livstruende tilstand (4).
    E.4Principal exclusion criteria
    Patients requiring intensive therapy before or after surgery. Incapacitated patients. Patients with known allergy to local anesthetics.
    Patienter der kræver intensiv terapi før eller efter operationen. Inhabile patienter Patienter med kendt allergi overfor lokalbedøvelse.
    E.5 End points
    E.5.1Primary end point(s)
    VAS-score
    VAS-score
    E.5.1.1Timepoint(s) of evaluation of this end point
    Every 8 hours after blokade 48 hours in total
    Hver 8 time i 48 timer.
    E.5.2Secondary end point(s)
    Gender, age, weight, type of operation, opioid consumption per and postoperatively. Number of PCA administered.
    Køn, alder, vægt, operationstype, opioid forbrug per og post operativt. Antal PCA administreret.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Every 8 hours after blokade, 48 hours in total
    Hver 8 time i 48 timer.
    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 No
    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 No
    E.8.2.3Other No
    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 Yes
    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
    Data monitoring
    Data tilsynet
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months6
    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: 20
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 40
    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 Yes
    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 Yes
    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 state60
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 60
    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 Decision2013-02-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-01-29
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-03-22
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