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    The EU Clinical Trials Register currently displays   44334   clinical trials with a EudraCT protocol, of which   7366   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:2019-003590-25
    Sponsor's Protocol Code Number:NL
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2020-06-15
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2019-003590-25
    A.3Full title of the trial
    a Randomized controlled trial for epidural Analgesia for Pain relief after lumbar Interlaminar Decompressive spine surgery - RAPID
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Epidural analgesia after back surgery
    A.3.2Name or abbreviated title of the trial where available
    RAPID
    A.4.1Sponsor's protocol code numberNL
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    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 Bupivacaïne HCl 0,125% / Sufentanil 50 µg flacon à 50 ml
    D.2.1.1.2Name of the Marketing Authorisation holderStichting Apotheek Haarlemse Ziekenhuizen
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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 nameBupivacaine
    D.3.2Product code Sufentanil
    D.3.4Pharmaceutical form Suspension for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntrathecal use
    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 placeboSuspension for injection
    D.8.4Route of administration of the placeboIntrathecal use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Lumbar spinal stenosis
    Lumbale kanaalstenose
    E.1.1.1Medical condition in easily understood language
    Lumbar spinal stenosis
    wervelkanaalvernauwing
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level LLT
    E.1.2Classification code 10041595
    E.1.2Term Spinal stenosis lumbar
    E.1.2System Organ Class 100000004859
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine whether epidural analgesia is superior to placebo, in reducing pain (measured in NRS) in patients after open lumbar decompression surgery.
    Onderzoeken of intra-operatieve epidurale pijnstilling superieur is aan een placebo in het verminderen van pijn bij patiënten die een interlaminaire decompressie ondergaan en of dit lijdt tot minder post-operatief opioïd gebruik in de eerste 48 uur na OK
    E.2.2Secondary objectives of the trial
    To determine whether epidural analgesia leads to a reduction in cumulative opioid use until 48 hours postoperatively
    To determine whether epidural analgesia leads to higher patient satisfaction than placebo.
    To determine whether epidural analgesia leads to shorter hospital stay.
    To determine whether epidural analgesia leads to less adverse events.
    Onderzoeken of epidurale pijnstilling zorg voor minder morfinegebruik post-operatief, betere patiënttevredenheid, korter ziekenhuisverblijf en minder complicaties
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -Indication for open interlaminar decompressive lumbar spine surgery.
    -Age over 18 years.
    -Psychosocially, mentally, and physically able to fully comply with this study protocol.
    -Informed consent prior to this study.
    - indicatie voor open lumbale interlaminaire decompressie
    - leeftijd boven 18jaar
    - Psychosociaal, mentaal en fysiek in staat te voldoen aan het studieprotocol
    - toestemmingsverklaring getekend
    E.4Principal exclusion criteria
    -Pre-operative opiod use
    -Previous radiotherapy at the intended surgical level.
    -(Progressive) motor failure and/or anal sphincter disorders which urges instant intervention.
    -Active spinal infection.
    -Immature bone (ongoing growth).
    -Pregnancy.
    -Contra-indications for anesthesia or surgery.
    - Pre-operatief opioid gebruik
    - Eerdere radiotherapie in het te opereren gebied
    - Neurolgische uitval welke leidt tot spoedinterventie
    - Spinale infectie
    - Immatuur bot
    - zwangerschap
    - contra-indicaties anesthesie of operatie
    E.5 End points
    E.5.1Primary end point(s)
    Postoperative pain scores (NRS)
    Postoperatieve pijnscores
    E.5.1.1Timepoint(s) of evaluation of this end point
    recovery entry, recovery exit, 2, 4, 6, 12, 24 and 48 hours postoperative
    binnenkomst uitslaapkamer, vertrek uitslaapkamer, 2, 4, 6, 12, 24 en 48 uur postoperatief
    E.5.2Secondary end point(s)
    Total postoperative opioid consumption at 48 hours postoperatively with interim measurements at 2, 4, 6, 12 and 24 hours. Patient satisfaction (measured by QoR-40), hospital stay in days, number of adverse events.
    Totale postoperatieve opioid gebuik 48 uur postoperatie, patiënttevredenheid, duur ziekenhuisopname, aantal complicaties
    E.5.2.1Timepoint(s) of evaluation of this end point
    opioid consumption: 48 hours postoperatively with interim measurements at 2, 4, 6, 12 and 24 hours.
    patient satisfaction: 24 hours after surgery
    Hospital stay in days
    adverse events 30 days after surgery
    Opioïd gebruik 48 uur
    patiënttevredenheid, 24 uur postOK
    ziekenhuisverblijf in dagen
    Complicaties eerste 30 dagen na OK
    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 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
    30 days after last patiënt included and treated
    30 dagen na laatste inclusie
    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 months
    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: 34
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 34
    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 state34
    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)
    no further treatment
    geen verdere behandeling
    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 Decision2020-06-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-06-15
    P. End of Trial
    P.End of Trial StatusOngoing
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