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    Summary
    EudraCT Number:2021-003679-32
    Sponsor's Protocol Code Number:984
    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:2021-11-17
    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 number2021-003679-32
    A.3Full title of the trial
    Erector spinae plane block for reduction of early postoperative pain scores and opioid use in lumbar spinal fusion surgery, a prospective double-blinded
    randomized placebo controlled trial
    Erector spinae plane blok voor het verminderen van vroege postoperatieve pijnscores en opiaatgebruik in lumbale spinale fusiechirurgie, een prospectieve, dubbelblinde, gerandomiseerde, placebo-gecontroleerde trial
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Research into the effect of local anesthetic as additional pain relief after surgery on the lower back
    Onderzoek naar de werking van lokale verdoving als aanvullende pijnbestrijding na operatie aan de onderrug
    A.3.2Name or abbreviated title of the trial where available
    RCT-ESPB
    RCT-ESPB
    A.4.1Sponsor's protocol code number984
    A.5.4Other Identifiers
    Name:ClinicalTrials.govNumber:NCT05345249
    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 SponsorSint Maartenskliniek
    B.1.3.4CountryNetherlands
    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 supportSint Maartenskliniek
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSint Maartenskliniek
    B.5.2Functional name of contact pointClinical Trial Information
    B.5.3 Address:
    B.5.3.1Street AddressHengstdal 3
    B.5.3.2Town/ cityUbbergen
    B.5.3.3Post code6574NA
    B.5.3.4CountryNetherlands
    B.5.4Telephone number+31243272593
    B.5.6E-maili.vandewijgert@maartenskliniek.nl
    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 Ropivacaine HCl
    D.2.1.1.2Name of the Marketing Authorisation holderFresenius Kabi Nederland B.V.
    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 nameRopivacaine HCl
    D.3.2Product code RVG104944
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPPerineural 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 placeboInjection/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
    Patients planned to undergo elective lumbar spinal fusion surgery with a dorsal surgical approach
    Patiënten gepland voor electieve lumbale spinale fusiechirurgie met een dorsale chirurgische benadering
    E.1.1.1Medical condition in easily understood language
    Operation on the lower back
    Operatie aan de onderrug
    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 the study is to evaluate the analgesic effect of ESPB on early postoperative pain after lumbar spinal fusion surgery.
    Het primaire doel van het onderzoek is om het analgetische effect van het ESPB te evalueren op vroege postoperatieve pijn na lumbale spinale fusiechirurgie.
    E.2.2Secondary objectives of the trial
    The secondary objectives are to assess the effect of ESPB on:
    - Acceptability of pain;
    - Opioid use in cumulative morphine equivalent dose (MEQ) in the postoperative care unit and in the first 24 hours after surgery;
    - Opioid side effects such as nausea, vomiting and use of anti-emetics in the postoperative care unit and in the first 24 hours after surgery;
    - Time to first opioid use/request;
    - Length of hospital stay;
    - Pain intensity on postoperative admission days, before discharge from hospital, and after 30 days;
    - Opioid use 30 days after surgery;
    - Quality of recovery on postoperative day 1 and before discharge;
    - Complications up to 30 days postoperative.
    Secundaire doelen zijn om het effect van ESPB te onderzoeken op de volgende variabelen:
    - acceptabel zijn van pijn,
    - pijnintensiteit tijdens ziekenhuisopname en na 30 dagen,
    - opiaatgebruik tijdens ziekenhuisopname en na 30 dagen,
    - opiaat bijwerkingen en gebruik van anti-emetica in de eerste 24 uur na operatie,
    - tijd tot eerste opiaatgebruik/-verzoek,
    - opnameduur in ziekenhuis,
    - kwaliteit van herstel op de eerste postoperatieve dag en bij ontslag,
    - complicaties tot 30 dagen postoperatief.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    In order to be eligible to participate in this study, a subject must meet all of the following criteria:
    - Age ≥ 18 years;
    - Patients planned for elective lumbar spinal fusion surgery with a dorsal surgical approach;
    - 1-4 level spine fusion surgery;
    - Written informed consent.
    Om in aanmerking te komen als deelnemer voor de studie, moeten de deelnemers aan alle volgende criteria voldoen:
    - Leeftijd ≥ 18 jaar;
    - Patiënten gepland voor electieve lumbale fusiechirurgie met een dorsale chirurgische benadering;
    - Operatie omhelst 1-4 fusieniveaus;
    - Geschreven informed consent
    E.4Principal exclusion criteria
    • A Body Mass Index (BMI) > 40 kg/m²;
    • ASA physical health classification > 3;
    • Patients who will undergo spine surgery involving more than 4 levels of fusion, scoliosis surgery;
    • Patients who will undergo minimally invasive surgery
    • Patients who will undergo circumferent spine surgery;
    • Patients with an active, local infection or systemic infection;
    • Patients with an allergy to one or more medications used in the study;
    • Patients with any contraindication to a regional anesthetic technique;
    • Kidney- or liver failure inhibiting the systemic use of paracetamol and/or NSAIDs;
    • Acute surgeries;
    • Patients with a history of drugs or alcohol abuse;
    • Pregnancy;
    • Cognitive impairment.
    - Body Mass Index (BMI) > 40kg/m2;
    - ASA-classificatie >3;
    - Operatie omhelst meer dan 4 niveaus van fusie;
    - Scoliose chirurgie;
    - Patiënten die minimaal-invasieve chirurgie ondergaan;
    - Patiënten die circumferente wervelchirurgie ondergaan;
    - Patiënten met een actieve, lokale infectie of systemische infectie;
    - Patiënten met een allergie voor één of meerdere medicaties gebruikt in de studie;
    - Patiënten met een contra-indicatie voor regionale analgesie technieken;
    - Nier- of leverfalen die gebruik van paracetamol en/of NSAIDs beperken;
    - Acute operaties;
    - Patiënten met een voorgeschiedenis van drugs of alcoholmisbruik;
    - Zwangerschap;
    - Cognitieve beperking.
    E.5 End points
    E.5.1Primary end point(s)
    The main study parameter of this study is the early pain intensity in the postoperative care unit after emergence from general anesthesia. Pain
    scores will be measured using NRS, a scale ranging from 0 to 10 (0 meaning no pain at all; 10 being the worst pain ever experienced). The
    NRS will be asked by a trained nurse not earlier than one hour after the patient emerges from general anesthesia in the PACU. The patient must
    have a Richmond Agitation-Sedation Scale (RASS) of 0 to minus 1 in order to determine NRS. If a patient is asleep, no NRS is measured until
    patient is awake.
    De primaire studieparameter is de vroege pijnintensiteit in de postoperatieve care unit na ontwaken van algehele anesthesie. Pijnscores worden gemeten met NRS, een schaal die loopt van 0 tot 10 (0 = geen pijn, 10 = ergste pijn ooit ervaren). De NRS wordt gevraagd door een getrainde verpleegkundige niet eerder dan één uur nadat de patiënt wakker wordt van algehele anesthesie op de PACU. De patiënt moet hiervoor een RASS-score van 0 tot -1 hebben voordat NRS bepaald kan worden. Als een patiënt slaapt, wordt geen NRS gemeten totdat patiënt wakker is.
    E.5.1.1Timepoint(s) of evaluation of this end point
    After emergence from general anesthesia. The NRS will be asked by a trained nurse not earlier than one hour after the patient emerges from
    general anesthesia in the PACU. The patient must have a Richmond Agitation-Sedation Scale (RASS) of 0 to minus 1 in order to determine NRS. If a patient is asleep, no NRS is measured until patient is awake.
    De NRS wordt gevraagd na ontwaken van algehele anesthesie, minstens 1 uur hierna, wanneer patiënt een RASS-score van 0 tot -1 is gescoord
    en patiënt niet slaapt.
    E.5.2Secondary end point(s)
    - Acceptability of pain (yes/no);
    - Opioid use in cumulative morphine equivalent (MEQ) dose in the postoperative care unit and in the first 24 hours after surgery, extracted
    from the EMF and PCIA pump (MEQ, dose);
    - Presence of opioid side effects: nausea, vomiting and use of antiemetics in the postoperative care unit and in the first 24 hours after
    surgery (yes/no);
    - Time to first opioid use/request (minutes);
    - Length of hospital stay (days);
    - Pain intensity on postoperative admission days, before discharge from hospital, and after 30 days (NRS for pain; 0-10);
    - Opioid use 30 days after surgery (yes/no, dose);
    - Quality of recovery (QoR) using the QoR-15 questionnaire7 (Dutch version QoR-15; 0-150) on postoperative day 1 and before discharge;
    - Complications up to 30 days postoperative.
    Secundaire uitkomstmaten zijn acceptabel zijn van pijn, pijnintensiteit tijdens ziekenhuisopname en na 30 dagen, opiaatgebruik tijdens
    ziekenhuisopname en na 30 dagen, opiaat bijwerkingen en gebruik van anti-emetica in de eerste 24 uur na operatie, tijd tot eerste opiaatgebruik/-verzoek, tijd tot eerste mobilisatie, opnameduur in ziekenhuis, kwaliteit van herstel op de eerste postoperatieve dag en bij ontslag, complicaties tot 30 dagen postoperatief.
    E.5.2.1Timepoint(s) of evaluation of this end point
    see E.5.2.
    zie E.5.2.
    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 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
    Last measurement last subject > day 30 after treatment last subject
    Laatste meting laatste proefpersoon
    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: 38
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 38
    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 2021-11-17. Yes
    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 state76
    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)
    Normal treatment will be provided
    Normale behandeling wordt gecontinueerd
    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 Decision2021-11-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-11-25
    P. End of Trial
    P.End of Trial StatusOngoing
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