Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43857   clinical trials with a EudraCT protocol, of which   7284   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).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2018-000089-12
    Sponsor's Protocol Code Number:HIP/FUSION#4
    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:2018-03-12
    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 number2018-000089-12
    A.3Full title of the trial
    Effect and safety of the iliopsoas plane block in healthy volunteers
    Effekt og sikkerhed af iliopsoas plane blok hos raske forsøgspersoner
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Effect and safety of a new nerve block - the iliopsoas plane block - for treatment of pain after major hip surgery in healthy volunteers
    Effekt og sikkerhed af et nyt nerveblok - iliopsoas plane blok - til behandling af smerter efter stor hoftekirurgi hos raske forsøgspersoner
    A.3.2Name or abbreviated title of the trial where available
    HIP/FUSION#4
    A.4.1Sponsor's protocol code numberHIP/FUSION#4
    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 supportLippmann Foundation
    B.4.2CountryDenmark
    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.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCenter for Planlagt Kirurgi, Regionshospitalet Silkeborg
    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 codeDK-8600
    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 Lidokain-adrenalin SAD
    D.2.1.1.2Name of the Marketing Authorisation holderAmgros I/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.3.4Pharmaceutical 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 INNLIDOCAINE HYDROCHLORIDE
    D.3.9.3Other descriptive nameLidocaine hydrochloride
    D.3.9.4EV Substance CodeSUB88133
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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 number50
    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 Dotarem
    D.2.1.1.2Name of the Marketing Authorisation holderVicare Medical 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.3.4Pharmaceutical 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 INNGADOTERIC ACID
    D.3.9.1CAS number 72573-82-1
    D.3.9.4EV Substance CodeSUB07865MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number279.3
    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 20.0
    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 investigate, whether the iliopsoas plane block affects the muscle strength of the quadriceps femoris muscle.
    At undersøge, om iliopsoas plane block påvirker muskelstyrken af musculus quadriceps femoris.
    E.2.2Secondary objectives of the trial
    To estimate:
    - the effect of the iliopsoas plane block on the strength of the adductor muscles of the thigh.
    - the effect of the iliopsoas plane block on sensitivity in the dermatome of the lateral cutaneous femoral nerve.
    - the effect of the iliopsoas plane block on sensitivity in the dermatome of the femoral nerve.
    - if the injection from the iliopsoas plane block spreads in the whole iliopsoas plane.
    - if the injection from the iliopsoas plane block spreads to the space between the pectineus and the external obturator muscles.
    - if the injection from the iliopsoas plane block spreads superficial to the iliopsoas muscle.
    - if the injection from the iliopsoas plane block spreads intraarticularly in the hip joint.
    - if the injection from the iliopsoas plane block spreads to the posterior part of the hip joint capsule
    - if / how often the injection from the iliopsoas plane block is inside the iliopectineal bursa medial to the target area.
    At estimere:
    - effekten af iliopsoas plane block på muskelstyrken af lårets adduktormuskulatur.
    - effekten af iliopsoas plane block på sensitiviteten i dermatomet fra nervus cutaneus femoris lateralis.
    - effekten af iliopsoas plane block på sensitiviteten i dermatomet fra nervus femoralis.
    - om injektionen fra iliopsoas plane block spreder sig til hele iliopsoas plane.
    - om injektionen fra iliopsoas plane block spreder sig til rummet mellem musculus pectineus og musculus obturatorius externus.
    - om injektionen fra iliopsoas plane block spreder sig superficielt for musculus iliopsoas.
    - om injektion fra iliopsoas plane block spreder sig intraartikulært i hofteledet
    - om injektion fra iliopsoas plane block spreder sig til den posteriore hofteledskapsel
    - om/hvor hyppigt injektion fra IPB rammer bursa iliopectinea medialt for målområdet
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Age ≥ 18 years
    - American Society of Anesthesiologists physical status classification score (ASA) I-II
    - Informed consent
    - Alder ≥ 18 år
    - American Society of Anesthesiologists physical status classification score (ASA) I-II
    - Informeret samtykke
    E.4Principal exclusion criteria
    - Lacking the ability to corporate
    - Lacking the ability to speak danish
    - Known neuropathy of the lower extremities
    - Chronic opioid demanding pain
    - Consumption of more than 14 resp. 21 units of alcohol/week for women resp. men.
    - Overweight (Body mass index (BMI) > 25 kg/m2)
    - Claustrofobia
    - Pregnancy
    - Allergy towards the used medicines
    - Daily consumption of medicine apart from oral contraceptives.
    - Manglende evne til samarbejde
    - Manglende danskkundskaber
    - Kendt neuropati i underekstremiteter
    - Kroniske opioidkrævende smerter
    - Alkolholforbrug over 14 hhv. 21 genstande/uge for kvinder hhv. mænd
    - Overvægt (Body mass index (BMI) > 25 kg/m2)
    - Klaustrofobi
    - Graviditet
    - Overfølsomhed for de anvendte lægemidler
    - Dagligt forbrug af medicin fraset oral antikonception
    E.5 End points
    E.5.1Primary end point(s)
    Change of maximal force of knee extension from baseline to after nerve blockade.
    Ændring i maksimal styrke ved knæ-ekstension fra baseline til efter nerveblokade.
    E.5.1.1Timepoint(s) of evaluation of this end point
    1 hour after nerve blockade
    1 time efter anlæggelse af nerveblokade
    E.5.2Secondary end point(s)
    1: Change of maximal force of hip adduction from baseline to after nerve blockade.
    2: Change of maximal force of knee extension from baseline to after nerve blockade in the leg, where local anaesthetics are injected compared to the control leg.
    3: Change of maximal force of hip adduction from baseline to after nerve blockade in the leg, where local anaesthetics are injected compared to the control leg.
    4: Change of sensibility in the dermatome of the lateral femoral cutaneous nerve.
    5: Change of sensibility in the dermatome of the femoral nerve.
    6: Spread of contrast in the iliopsoas plane
    7: Spread of contrast to the space between the pectinous and the external obturator muscles.
    8: Spread of contrast to the superficial side of the iliopsoas muscle.
    9: Intraarticular spread of contrast to the hip joint
    10: Spread og contrast to the posterior side of the hip joint capsule.
    11: Contrast in the iliopectineal bursa
    1: Ændringen i muskelstyrke af femurs adduktorer fra før til efter blokadeanlæggelse på det ben, hvor der er injiceret lokalanæstesi.
    2: Ændringen i muskelstyrke af musculus quadriceps fra før til efter blokadeanlæggelse på det ben, hvor der er injiceret lokalanæstesi sammenlignet med det ben, hvor der ikke er injiceret lokalanæstesi.
    3: Ændringen i muskelstyrke af femurs adduktorer fra før til efter blokadeanlæggelse på det ben, hvor der er injiceret lokalanæstesi sammenlignet med det ben, hvor der ikke er
    injiceret lokalanæstesi.
    4: Ændring i sensibilitet over laterale femur sv.t. nervus cutaneus femoris lateralis’ dermatom.
    5: Ændring i sensibilitet over proksimale mediale hjørne af patella sv.t. nervus femoralis’ dermaton.
    6: Spredning af kontrast i iliopsoas plane
    7: Spredning af kontrast til rummet mellem musculus pectineus og musculus obturatorius externus
    8: Spredning af kontrast superficielt for musculus iliopsoas
    9: Spredning af kontrast intraartikulært i hofteledet
    10: Spredning af kontrast over bagsiden af hofteledskapsel
    11: Forekomst af kontrast i bursa iliopectinea
    E.5.2.1Timepoint(s) of evaluation of this end point
    1-5: 1 hour after nerve blockade.
    6-10: Evaluated by MRI-scan 5-60 minutes after nerve blockade.
    1-5: 1 time efter anlæggelse af nerve blokade.
    6-10: Undersøges vha. MR-skanning 5-60 minutter efter anlæggelse af nerve blokade.
    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 Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    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 Yes
    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 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
    LVLS
    Sidste patients sidste besøg
    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 months5
    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: 22
    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 Yes
    F.3.2Patients No
    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 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 state22
    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 Decision2018-04-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-04-24
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-06-10
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Wed Apr 24 16:13:24 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA