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    Summary
    EudraCT Number:2020-001215-24
    Sponsor's Protocol Code Number:7-190320
    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:2020-03-30
    Trial 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 number2020-001215-24
    A.3Full title of the trial
    The effect of subpectineal obturator nerve block on opioid consumption and pain after hip arthroscopy
    A double-blind randomized, controlled trial
    Effekten af subpectineal obturatorius nerveblokade på opioidforbrug og smerter efter hofteartroskopi
    En dobbeltblindet randomiseret, kontrolleret undersøgelse
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The effect of subpectineal obturator nerve block on opioid consumption and pain after hip arthroscopy
    Effekten af subpectineal obturatorius nerveblokade på opioidforbrug og smerter efter kikkertoperation af hoften.
    A.4.1Sponsor's protocol code number7-190320
    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 supportDen Videnskabelige Forskningsfond Regionshospitalet Horsens
    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 pointThomas Fichtner Bendtsen
    B.5.3 Address:
    B.5.3.1Street AddressPalle Juul-Jensens Blvd. 99
    B.5.3.2Town/ cityAarhus N
    B.5.3.3Post code8200
    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 holderAspen Pharma
    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 Concentrate and solvent for 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
    D.3.9.1CAS number 2180-92-9
    D.3.9.4EV Substance CodeSUB05983MIG
    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.3.11 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 placeboConcentrate for solution for injection/infusion
    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
    Postoperative pain after hip arthroscopy

    Postoperative smerter efter hofte artroskopi
    E.1.1.1Medical condition in easily understood language
    Pain after hip arthroscopy
    Smerter efter kikkertoperation af hoften
    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 21.0
    E.1.2Level LLT
    E.1.2Classification code 10080604
    E.1.2Term Hip arthroscopy
    E.1.2System Organ Class 100000004848
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The purpose of the trial is to assess the analgesic effect of preoperatively placed active or placebo subpectineal obturatorius nerve block for elective primary hip arthroscopy.
    The primary objective of the study is to investigate morphine consumption
    Formålet med studiet er at vurdere analgetisk effekt af præoperativt anlagt aktiv eller placebo subpectineal obturatorius nerveblokade til elektiv primær hofteartroskopi
    Forsøgets primære mål er at undersøge morfinforbrug
    E.2.2Secondary objectives of the trial
    The secondary goals are to investigate pain and morphine side effects.
    Det sekundære mål er at undersøge smerter og morfinbivirkninger.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Set for elective primary hip arthroscopy by one single orthopedic surgeon
    • Scheduled general anesthesia with Propofol and Remifentanil
    • ASA I-III
    • Patient ≥ 18 years
    • Informed consent
    • Planlagt primær hofteartroskopi af en og samme ortopæd kirurg
    • Planlagt generel anæstesi med Propofol og Remifentanil
    • ASA I-III
    • Patient ≥ 18 år
    • Informeret samtykke
    E.4Principal exclusion criteria
    • Inability to cooperate
    • Unable to speak and/or understand Danish or other forms of communication problems
    • Allergy to local analgesics used in the study (Marcain + Adrenaline).
    • Lack of tolerance to both Morphine and Oxycodone
    • Chronic pain with daily opioid consumption (dosed > 1day)
    • Treatment with antipsychotics
    • Known abuse of alcohol or medication
    • Previous hip surgery
    • Pregnancy.
    • Manglende evne til at samarbejde
    • Kan ikke tale og/eller forstå dansk eller andre former for kommunikationsproblemer
    •Allergi over for anvendte lokalanalgetika i undersøgelsen (Marcain + Adrenalin).
    • Mangel på tolerance over for både Morfin og Oxycodon
    • Kronisk smerte med daglig opioidforbrug (doseret> 1 dag)
    • Behandling med antipsykotika
    • Kendt misbrug af alkohol eller medicin
    • Tidligere hofteoperation
    • Graviditet.
    E.5 End points
    E.5.1Primary end point(s)
    Cumulated opioid consumption by PCA pump (patient controlled analgesia) for the first 180 min in PACU (Post operative care unit) after primary hip arthroscopy for patients with active or placebo subpectineal obturatorius nerve block.
    Kumuleret opioidforbrug ved PKA-pumpe (patient kontrolleret analgesi) i de første 180 min i PACU (opvågningsafsnittet) efter primær hofteartroskopi for patienter med aktiv eller placebo subpectineal obturatorius nerveblokade.
    E.5.1.1Timepoint(s) of evaluation of this end point
    180 min after arrival to PACU
    180 efter ankomst til PACU
    E.5.2Secondary end point(s)
    • Pain score (NRS 0-10, where 0 is no pain and 10 the worst possible pain) in the hip at rest assessed upon arrival at PACU and then every 30 min. the next 180 min. where the patient remains in the PACU.
    • Pain score (NRS 0-10) in the hip at activity (flexion of the hip joint to 45 degrees) assessed upon arrival at the PACU and then every 30 minutes. the next 180 min. where the patient remains in the PACU.
    • Nausea score assessed on a scale (none, light, moderate, pronounced) assessed upon arrival at PACU and then every 30 min. the next 180 min. where the patient remains in the PACU.
    • Number of vomiting in the first 180 min. the patient is in the PACU.
    • Duration of stay (LOS) measured in minutes in PACU. The end time for LOS on the Observation section is recorded at the time the patient meets DASAIM's criteria for discharge from the PACU. After the first 180 min in the PACU, this is assessed every 30 min where the patient remains in the PACU.
    • Total morphine consumption in PACU during the first 180 min in PACU.
    • The force of the hip adductor muscles on the operated lower extremities is tested with a dynamometer after 180 min.
    • Patient satisfaction with the pain management at the time of discharge (NRS 0-10, where 0 is very dissatisfied and 10 is very satisfied).
    •Smertescore (NRS 0-10, hvor 0 er ingen smerte og 10 den værst tænkelige smerte) i hoften i hvile vurderet ved ankomst til PACU og derefter hvert 30. min. de næste 180 min. hvor patienten forbliver i PACU.
    •Smertescore (NRS 0-10) i hoften ved aktivitet (fleksion i hofteleddet til 45 grader) vurderet ved ankomst til PACU og derefter hvert 30. min. de næste 180 min. hvor patienten forbliver i PACU.
    •Kvalmescore vurderet på en skala (ingen, let, moderat, udtalt) vurderet ved ankomst til PACU og derefter hvert 30. min. de næste 180 min. hvor patienten forbliver i PACU.
    •Antal af opkastninger de første 180 min. patienten er i PACU.
    •Varighed af ophold (LOS) målt i minutter i PACU. Sluttiden for LOS på Observationsafsnittet registreres på det tidspunkt, hvor patienten opfylder DASAIMs kriterier for udskrivelse fra PACU. Efter de første 180 min i PACU vurderes dette hvert 30. min hvor patienten forbliver i PACU.
    •Samlet morfinforbrug i PACU i løbet af de første 180 min i PACU.
    •Kraften i hofteadductormusklerne på den opererede underekstremiteter testes med et dynamometer efter 180 min.
    •Patienttilfredshed med smertebehandlingen på udskrivelsestidspunktet (NRS 0-10, hvor 0 er meget utilfreds og 10 er meget tilfreds).
    E.5.2.1Timepoint(s) of evaluation of this end point
    Assessed upon arrival at PACU and then every 30 min. the next 180 min. where the patient remains in the PACU. (Time 0, 30, 60, 90, 120, 150, 180 min)
    Vurderet ved ankomst til PACU og derefter hvert 30. min. de næste 180 min. hvor patienten forbliver i PACU. (Til tiden 0, 30, 60, 90, 120, 150, 180 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 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 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 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
    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 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: 35
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 5
    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 2020-03-30. Yes
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women Yes
    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
    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 Decision2020-04-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-05-12
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2021-06-18
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