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    Summary
    EudraCT Number:2015-001559-55
    Sponsor's Protocol Code Number:15/022U
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2015-04-30
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2015-001559-55
    A.3Full title of the trial
    Quality of analgesia after interscalene block with 5 mL of bupivacaine 0.25% and 10 mL of Exparel® (133 mg) vs. 15 mL of 0.25% bupivacaine after arthroscopic shoulder surgery
    Analgesie kwaliteit na een interscaleen blok met 5 mL bupivacaine 0.25% en 10 mL Exparel® (133 mg) versus 15 mL 0.25% bupivacaine, na een arthroscopisch rotator cuff herstel van de schouder.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Amount of pain reduction after a nerve block with 5 mL of bupivacaine 0.25% and 10 mL of Exparel® (133 mg) versus 15 mL of 0.25% bupivacaine after arthroscopic shoulder surgery
    Pijn vermindering na een zenuw blokkade met 5 mL bupivacaine 0.25% en 10 mL Exparel® (133 mg) versus 15 mL 0.25% bupivacaine, na een kijkoperatie van de schouder.
    A.3.2Name or abbreviated title of the trial where available
    Exparel-interscalene block study
    Exparel-interscaleen blok studie
    A.4.1Sponsor's protocol code number15/022U
    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 SponsorZiekenhuis Oost-Limburg, Departement of Anesthesia
    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 supportZiekenhuis Oost-Limburg, department of anesthesia
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationZiekenhuis Oost-Limburg
    B.5.2Functional name of contact pointDepartment of Anesthesia
    B.5.3 Address:
    B.5.3.1Street AddressSchiepen Bos 6
    B.5.3.2Town/ cityGenk
    B.5.3.3Post code3600
    B.5.3.4CountryBelgium
    B.5.4Telephone number3289325305
    B.5.6E-mailcatherine@nysora.com
    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 Exparel (liposomal bupivacaine)
    D.2.1.1.2Name of the Marketing Authorisation holderPacira pharmaceuticals
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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 nameExparel liposomal bupivacaine
    D.3.4Pharmaceutical form Injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPPerineural use
    Infiltration
    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 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 Marcaine 0.5%
    D.2.1.1.2Name of the Marketing Authorisation holderAstraZeneca
    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.3.1Product nameMarcaine 0.5% (bupivacaine)
    D.3.4Pharmaceutical form Injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPPerineural use
    Infiltration
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Postoperative pain after arthroscopic shoulder surgery
    E.1.1.1Medical condition in easily understood language
    pain after surgery of the shoulder
    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
    This study is designed to compare the level and duration of pain control of 10 mL of Exparel® (133 mg) injected after 5 mL 0.25% bupivacaine and 15 mL of 0.25% bupivacaine alone for interscalne brachial plexus block. We hypothesize that level and duration of pain control of 5 mL 0.25% bupivacaine and 10 mL of Exparel® (133 mg) will exceed that of 15 mL of bupivacaine 0.25% alone for ISBPB.
    Primary outcome measures are:
    Total opioid consumption up to 72 h post surgery
    Time to first pain medicine request made by the patient
    E.2.2Secondary objectives of the trial
    Secondary outcome measures are:
    Numeric rating scores for pain on 0-10 scale (NRS)
    Overall Benefit of Analgesia Score (OBAS)
    Modified Brief Pain Inventory Scale (MBPI)
    Onset and duration of sensory block
    Onset and duration of motor block
    Duration of postoperative care unit stay
    Time to discharge home
    Incidence of postoperative nausea or vomiting through the first postoperative week (Postoperative Nausea and Vomiting (PONV) Intensity scale)
    Sleep quality and duration through the first postoperative week
    Patient satisfaction with pain control
    Functionality of operated arm
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    ● Dutch or English speaking adults
    ● 18 years or older ASA I-III physical class
    ● Scheduled for elective arthroscopic shoulder surgery
    E.4Principal exclusion criteria
    ● History of allergy to a local anesthetic
    ● Baseline neurological deficit
    ● Medical condition that would make it difficult to assess sensory distribution or communicate with our staff
    ● Recent history (< 3 months) of drug or alcohol abuse
    ● Concomitant opioid therapy
    ● Preexisting coagulation disorder
    ● Infection at the injection site
    ● Pregnancy
    E.5 End points
    E.5.1Primary end point(s)
    Total opioid consumption up to 72 h post surgery
    Time to first pain medicine request made by the patient
    E.5.1.1Timepoint(s) of evaluation of this end point
    1h, 2h, 24h, 48h, 72h and 1 week postoperatively
    E.5.2Secondary end point(s)
    Numeric rating scores for pain on 0-10 scale (NRS)
    Overall Benefit of Analgesia Score (OBAS)
    Modified Brief Pain Inventory Scale (MBPI)
    Onset and duration of sensory block
    Onset and duration of motor block
    Duration of postoperative care unit stay
    Time to discharge home
    Incidence of postoperative nausea or vomiting through the first postoperative week (Postoperative Nausea and Vomiting (PONV) Intensity scale)
    Sleep quality and duration through the first postoperative week
    Patient satisfaction with pain control
    Functionality of operated arm
    E.5.2.1Timepoint(s) of evaluation of this end point
    1h, 2h, 24h, 48h, 72h and 1 week postoperatively
    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 Yes
    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) Yes
    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 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) Yes
    E.8.2.2Placebo No
    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
    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: 30
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 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)
    post clinical trial care is not different from the expected normal treatment of the condition
    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 Decision2015-05-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-05-08
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-03-31
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