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    The EU Clinical Trials Register currently displays   44293   clinical trials with a EudraCT protocol, of which   7351   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2017-000068-14
    Sponsor's Protocol Code Number:HIP/FUSION#2
    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:2017-04-18
    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 number2017-000068-14
    A.3Full title of the trial
    Postoperative analgesia after elective hip surgery - effect of obturator nerve blockade
    Postoperativ analgesi efter elektiv hoftekirurgi – effekt af nervus obturatorius-blokade
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Pain treatment after planned hip surgery - effect of peripheral blockade of the obturator nerve
    Smertebehandling efter planlagt hoftekirurgi - effekt af perifer nerveblokade af nerven nervus obturatorius
    A.3.2Name or abbreviated title of the trial where available
    HIP/FUSION#2
    A.4.1Sponsor's protocol code numberHIP/FUSION#2
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03064165
    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 SponsorInstitut for Klinisk Medicin, Aarhus Universitet
    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 supportGraduate School of Health, Aarhus University
    B.4.2CountryDenmark
    B.4.1Name of organisation providing supportDirektør Bønnelycke og Hustru fru Grethe Bønnelyckes Foundation
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationElective Surgery Center
    B.5.2Functional name of contact pointNiels Dalsgaard Nielsen
    B.5.3 Address:
    B.5.3.1Street AddressFalkevej 1-3
    B.5.3.2Town/ citySilkeborg
    B.5.3.3Post code8600
    B.5.3.4CountryDenmark
    B.5.4Telephone number+4522838334
    B.5.6E-mailnielsdn@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
    D.2.1.1.2Name of the Marketing Authorisation holderAstraZeneca
    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.3.4Pharmaceutical form 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
    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 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
    No specific medical condition is investigated. The objective of the
    trial is to investigate a method for postoperative analgesia after elective hip surgery.
    Der undersøges ikke en specifik medicinsk tilstand. Studiets formål er at undersøge en metode til smertebehandling efter elektiv hoftekirurgi.
    E.1.1.1Medical condition in easily understood language
    No specific medical condition is investigated. The objective of the
    trial is to investigate a method for pain treatment after planned hip surgery.
    Der undersøges ikke en specifik medicinsk tilstand. Studiets formål er at undersøge en metode til smertebehandling efter planlagt hoftekirurgi.
    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 19.1
    E.1.2Level LLT
    E.1.2Classification code 10068084
    E.1.2Term Anesthesia procedure
    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 estimate the effect of obturator nerve blockade on postoperative opioid consumption 0-12 hours after total hip replacement.
    Estimering af effekten af nervus obturatorius-blokade på det postoperative opioidforbrug 0-12 timer efter total hoftealloplastik.
    E.2.2Secondary objectives of the trial
    To estimate the effect of obturator nerve blockade on:
    - Postoperative opioid consumtion 12-18 hours after total hip replacement
    - Postoperative pain at rest and during passive movement after total hip replacement.
    - Pain during ambulation after total hip replacement.
    - Time to first opioid dose after total hip replacement.
    - Postoperative nausea and vomiting after total hip replacement.
    - The length of stay at post anesthesia care unit after total hip replacement.
    - The length of admission after total hip replacement.
    - The patients ability to be mobilized after total hip replacement.
    - The patients quality of sleep the first night after total hip replacement.

    To estimate the duration of spinal anaesthesia aftertotal hip replacement.
    Estimering af effekten af nervus obturatorius-blokade på:
    - Opioidforbruget 12-18 timer efter total hoftealloplastik.
    - Postoperativ smerte ved passiv bevægelse og i hvile efter total hoftealloplastik.
    - Smerte under mobilisering efter total hoftealloplastik.
    - Tiden til første opioiddosis efter total hoftealloplastik.
    - Postoperativ kvalme og opkastning efter total hoftealloplastik.
    - Varigheden af opholdet på observationsafsnit efter total hoftealloplastik.
    - Indlæggelsens varighed efter total hoftealloplastik.
    - Patientens evne til mobilisering efter total hoftealloplastik.
    - Patientens søvnkvalitet den første postoperative nat efter total hoftealloplastik.

    Estimering af varigheden af spinalanæstesi efter total hoftealloplastik.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Patients for primary hip replacement in spinal anesthesia
    - Age >= 18 years
    - American Society of Anesthesiologists physical status classification score I-III
    - Informed consent
    - Patienter indstillet til primær hoftealloplastik i spinalanæstesi
    - Alder ≥ 18 år
    - American Society of Anesthesiologists physical status classification score (ASA) I-III
    - Informeret samtykke
    E.4Principal exclusion criteria
    - Lacking the ability to corporate
    - Lacking the ability to speak danish
    - Planned discharge on the same day of surgery
    - Neuropathy of the lower extremities
    - Contraindications for NonSteroidal Anti-Inflammatory Drugs (NSAID)
    - Contraindications for dexamethasone
    - Chronic opioid demanding pain
    - Pregnancy
    - Allergy towards the IMP
    - Active treatment with amiodarone
    - Active treatment with verapamil
    - Active treatment with corticosteroids
    - Manglende evne til samarbejde
    - Manglende danskkundskaber
    - Patienter i sammedags-forløb (udskrives samme dag som operationen)
    - Neuropati i underekstremiteter
    - Kontraindikationer for non-steroide antiinflammatoriske lægemidler (NonSteroidal Anti-Inflammatory Drugs; NSAID)
    - Kontraindikationer for dexamethason
    - Kroniske opioidkrævende smerter
    - Graviditet
    - Overfølsomhed for det anvendte lægemiddel
    - Aktuel behandling med amiodaron
    - Aktuel behandling med verapamil
    - Aktuel behandling med kortikosteroider
    E.5 End points
    E.5.1Primary end point(s)
    Cumulated dose of opioid 0-12 hour after total hip replacement.
    Summeret dosis af opioid 0-12 timer efter total hoftealloplastik.
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 hours after completion of total hip replacement
    12 timer efter afslutning af total hoftealloplastik
    E.5.2Secondary end point(s)
    1: Cumulated dose of opioid 12-18 hours after total hip replacement.
    2: Pain at rest at time of examination (numeric rating scale)
    3: Pain at passive hip fleksion to 90 degrees (numeric rating scale)
    4: Maksimal pain during ambulation on the day of operation
    5: Time from completion of surgery to first dose of opioid
    6: Intensity of nausea on time of examination (numeric rating scale)
    7: Incidences og emesis 0-18 hours after total hip replacement.
    8: Cumulated dose of ondansetron 0-18 hours after total hip replacement.
    9: Cumulated dose of droperidol 0-18 hours after total hip replacement.
    10: Length of stay on post anesthesia care unit after completion of total hip replacement.
    11: Length of stay on hospital after completion of total hip replacement.
    12: Ability to ambulate 5 hours after total hip replacement
    13: Control with operated extremity during ambulation 5 hours after total hip replacement.
    14: Self-reported sleep quality the first night after total hip replacement
    15: Duration og spinal anesthesia after total hip replacement.
    1: Summeret opioid-dosis fra 12-18 timer efter operationens afslutning
    2: Smerte i hvile på undersøgelsestidspunktet (numerisk vurderingsskala)
    3: Smerte ved passiv fleksion af hoften til 90 grader (numerisk vurderingsskala)
    4: Værste smerte under mobilisering på operationsdagen
    5: Tid til fra afslutningen af total hoftealloplastik til første dosis opioid
    6: Intensitet af kvalme på undersøgelsestidspunkt (numerisk vurderingsskala)
    7: Antallet af opkastninger de første 18 timer efter total hoftealloplastik.
    8: Summeret dosis af ondansetron de første 18 timer efter total hoftealloplastik.
    9: Summeret dosis af droperidol de første 18 timer efter total hoftealloplastik.
    10: Varighed af postoperativt ophold på observationsafsnit efter total hoftealloplastik.
    11: Varighed af ophold på hospital efter total hoftealloplastik.
    12: Evne til mobilisering 5 timer efter operationens afslutning
    13:Kontrol med opererede ben ved mobilisering 5 timer efter operationens afslutning
    14: Selvvurderet søvnkvalitet første postoperative nat efter total hoftealloplastik
    15: Varighed af spinalanæstesi efter total hoftealloplastik
    E.5.2.1Timepoint(s) of evaluation of this end point
    1, 5, 7-10, 14: 24 hours after completion of total hip replacement
    2, 3, 6: 1, 2, 5, 7 and 24 hours after completion of total hip replacement
    4, 12, 13: 5 hours after completion of total hip replacement
    11: After discharge from hospital
    15: Every 15 minutes after arrival on post anaesthesia care unit.
    1, 5, 7-10, 14: 24 timer efter afslutning af total hoftealloplastik
    2, 3, 6: 1, 2, 5, 7 and 24 timer efter afslutning af total hoftealloplastik
    4, 12, 13: 5 timer efter afslutning af total hoftealloplastik
    11: Efter udskrivelse fra sygehus
    15: Hvert 15. minut efter ankomst til opvågningsafsnit
    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 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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months3
    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: 30
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 30
    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 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 2017-04-18. 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 state60
    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
    Comment regarding fields F.1.2.1 and F.1.3.1: The total number of
    subjects in this study is 60 persons on or above the age of 18. The
    correct value for each of the above mentioned fields should therefore
    be "0-60".
    Ingen
    Kommentar til felterne F.1.2.1 og F.1.3.1: The totale antal
    forsøgspersoner i studiet er 60 personer på eller over 18 år. Den
    korrekte værdi for de ovennævnte felter burde derfor være "0-60".
    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 Decision2017-05-24
    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 trial2018-06-08
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