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    Summary
    EudraCT Number:2022-002250-97
    Sponsor's Protocol Code Number:NA
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2022-09-23
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2022-002250-97
    A.3Full title of the trial
    Comparison between periarticular infiltration, pericapsular nerve group block (PENG), and suprainguinal iliaca fascia block on postoperative functional recovery in total hip arthroplasty: a randomized controlled clinical equivalence study
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Equivalence study for a comparison of the impact on postoperative functional recovery in total hip arthroplasty between periarticular infiltration, pericapsular nerve group block (PENG), and suprainguinal iliaca fascia block
    A.4.1Sponsor's protocol code numberNA
    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 SponsorCHU de Liège
    B.1.3.4CountryBelgium
    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 supportCHU de Liège
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCHU de Liège
    B.5.2Functional name of contact pointMichele Carella
    B.5.3 Address:
    B.5.3.1Street AddressDomaine du Sart Tilman B35
    B.5.3.2Town/ cityLiège
    B.5.3.3Post code4000
    B.5.3.4CountryBelgium
    B.5.4Telephone number003242843658
    B.5.6E-mailmcarella@chuliege.be
    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 Naropin
    D.2.1.1.2Name of the Marketing Authorisation holderAspen Pharma Trading Limited
    D.2.1.2Country which granted the Marketing AuthorisationBelgium
    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 Solution for injection/infusion
    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 INNRopivacaine
    D.3.9.3Other descriptive nameRopivacaine hydrochloride
    D.3.9.4EV Substance CodeSUB04264MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number7.5
    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/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
    Total hip arthroplasty surgery
    E.1.1.1Medical condition in easily understood language
    Analgesia and pain relief therapy for total hip replacement surgery
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of our study is to evaluate the equivalence of supra-inguinal fascia iliaca block to pericapsular nerve group block and periarticular infiltration in 2-minute walk test (2MWT) performance at 24 hours after the intervention.
    E.2.2Secondary objectives of the trial
    We expect supra-inguinal fascia iliaca block (SFIB) block to be equivalent to pericapsular nerve group (PENG) block and periarticular infiltration in postoperative functional performance, without motor and quadriceps femoral impairment and with equivalent postoperative analgesia. If the hypothesis is correct, we could propose to integrate SFIB or PENG as first line in the postoperative analgesia strategy for this surgery.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients will be recruited during the preoperative anesthesia consultation.
    They will have to be of age (> 18 years old), classified in the categories American Society of Anesthesiologists (ASA) 1-2-3, admitted for a programmed total hip arthroplasty surgery with spinal anesthesia.
    E.4Principal exclusion criteria
    Excluded from the study are pregnant women, patients with peripheral neuropathy or other severe neurological pathology, chronic pain syndromes, chronic renal insufficiency or severe hepatic insufficiency, allergy to local anaesthetics, major haemostasis disorders or opioid addiction.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint will be the assessment of performance on the 2-minute walking test
    E.5.1.1Timepoint(s) of evaluation of this end point
    At 24 hours after surgery
    E.5.2Secondary end point(s)
    - Consumption of morphine equivalents: oral administration of oxycodone
    - The distance in meters covered in the 2-minute walk test
    - Distance in meters covered in the 6-minute walk test
    - Timed Up-and-Go (TUG) test
    - Numerical rating scale (NRS) of pain

    - Postoperative complications such as:
    1. Orthostatic intolerance
    2. Falls
    3. Postoperative nausea and vomiting
    4. Morphine-related side effects: bladder globe, constipation, dizziness and drowsiness

    - Tampa-scale for the measurement of kinesiophobia
    - Quality-of-Recovery 15-item score (QoR-15) to assess functional recovery

    - Analysis of quadriceps strength before and after the intervention using the dynamometer for isometric contraction

    - Analysis with the Inertial Measurment Units (IMUs) system with accelerometer technology and angular acceleration measurement
    E.5.2.1Timepoint(s) of evaluation of this end point
    - Opioid consumption: first 24 hours postoperatively
    - 2-minute walk test: second postoperative day (D2).
    - Timed Up-and-Go (TUG) test and 6-minute walk test on the first (D1) and second (D2) day after surgery
    - NRS of pain at fixed times: 6h and 12h after surgery, at D1 at 8h, 13h and 18h.

    First 48 hours for postoperative complications
    Tampa-scale for the measurement of kinesiophobia at D2
    Quality-of-Recovery 15-item score (QoR-15) to assess functional recovery on day-2 and day-30
    Analysis of quadriceps strength before and after the intervention using the dynamometer for isometric contraction at D1 and D2
    Analysis with the Inertial Measurment Units (IMUs) system with accelerometer technology and angular acceleration measurement at D1 and D2
    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 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 trial3
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned2
    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
    The end of the trial is reached at the last visit of the last subject at the end of hospitalization and/or day 30 after surgery
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months0
    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: 100
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 119
    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 No
    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 state219
    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 Decision2022-10-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion
    P. End of Trial
    P.End of Trial StatusOngoing
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