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    Summary
    EudraCT Number:2013-003684-54
    Sponsor's Protocol Code Number:ACLS
    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:2014-01-23
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2013-003684-54
    A.3Full title of the trial
    Analgesic efficacy of saphenous nerve blockade for outpatient knee anterior cruciate ligament surgery
    De effectiviteit van locale verdoving van de nervus saphenus
    voor pijnbestrijding bij kruisbandoperaties op het dagcentrum
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Analgesic efficacy a nerve blockade in the mid thigh for outpatient knee anterior cruciate ligament surgery
    De effectiviteit van locale verdoving van een zenuw die loopt langs het dijbeen voor pijnbestrijding bij kruisbandoperaties op het dagcentrum
    A.4.1Sponsor's protocol code numberACLS
    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 SponsorAcademic Medical Center Amsterdam
    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 supportAcademic Medical Center Amsterdam
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAcademic Medical Center
    B.5.2Functional name of contact pointWerner ten Hoope
    B.5.3 Address:
    B.5.3.1Street AddressMeibergdreef 9
    B.5.3.2Town/ cityAmsterdam
    B.5.3.3Post code1100 DD
    B.5.3.4CountryNetherlands
    B.5.4Telephone number310205669111
    B.5.6E-mailw.tenhoope@amc.uva.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 Chirocaine
    D.2.1.1.2Name of the Marketing Authorisation holderAstraZeneca
    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 nameChirocaine
    D.3.2Product code SUB02904MIG
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPPerineural use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLEVOBUPIVACAINE
    D.3.9.1CAS number 27262-47-1
    D.3.9.3Other descriptive nameChirocaine
    D.3.9.4EV Substance CodeSUB08464MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number75
    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
    Mid thigh saphenous nerve block with levobupivacain, as compared to femoral nerve block, in patients undergoing anterior cruciate ligament surgery
    Saphenus blokkade in het bovenbeen met levobupivacaine, in vergelijking met een nervus femoralisblokkade, bij patiënten voor voorste kruisbandchirurgie in dagbehandeling
    E.1.1.1Medical condition in easily understood language
    Nerve block for preventing postoperative pain in patients undergoing anterior cruciate ligament surgery in daycare
    Zenuwblokkade in het bovenbeen voor postoperatieve pijnstilling na een operatie aan de voorste kruisband in dagbehandeling
    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
    Readiness to discharge in hours and according to Post-Anesthetic Discharge Scoring System (PADSS)
    Klaar voor ontslag in uren en PADDS-score
    E.2.2Secondary objectives of the trial
    - VAS score
    - Overall Benefit of Analgesia Score (OBAS)
    - Lysholm score
    - SF-12
    - Sensory blockade extent
    - Time to rescue analgesic (morphine postoperatively)
    - Total analgesic consumption (telephone interview)
    - Time to mobilization (telephone interview)
    - Knee function will be done by the Knee Society 6 weeks after surgery
    - Incidence of falls or near falls
    - VAS-score
    - OBAS score
    - Lysholm score
    - SF12
    - Duur sensorische blokkade
    - Tijd tot rescue medicatie
    - Totale pijnstillingconsumptie
    - Tijd tot mobiliseren
    - Kniefunctie
    - Valincidentie
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Informed consent, age 18-65 years, ASA status I - III, rupture of the anterior cruciate ligament.
    Toestemmingsverklaring, leeftijd 18-65 jaar, ASA I- III, ruptuur van de voorste kruisband
    E.4Principal exclusion criteria
    Inability to perform written informed consent, contraindication for regional anesthesia, contraindication for general anesthesia, allergy against local anesthetics, BMI > 35, pre-existing diagnosed neuropathy of the operated leg, ingestion of strong opioids, pregnancy or breastfeeding status. History of significant cardiovascular disease (MI, CVA, peripheral vascular disease)
    Niet bij machte toestemmingsverklaring te tekenen, contraindicatie voor regionale en algehele anesthesie, allergie voor lokale anetshetica, BMI > 35, pre-existente neuropathie van het te opereren been, gebruik van sterke opiaten, zwangerschap of borstvoeding, voorgeschiedenisvan cardiovasculaire ziekte (MI, CVA, perifere vaatziekten)
    E.5 End points
    E.5.1Primary end point(s)
    Shortening of readiness to discharge in hours (20%)
    Eerder klaar voor ontslag in uren (20%)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Post-operatively on day of surgery
    Postoperatief op de dag van chirurgie
    E.5.2Secondary end point(s)
    The secundary endpoints are expected to be at least as effective compared to the control group
    Alle secundare eindpunten worden verwacht in ieder geval net zo effectief te zijn vergeleken met de controle groep
    E.5.2.1Timepoint(s) of evaluation of this end point
    - VAS score hourly until discharge, and on the morning and evening of the first postoperative day (telephone interview) together with OBAS on first postoperative day).
    -Overall Benefit of Analgesia Score (OBAS), determined on the day of surgery, and the first postoperative day.[23]
    D 0:
    - KOOS-, IKDC questionnaire, SF12- Sensory blockade extent one hour postoperatively (focusing on concomitant blockade of the saphenous or femoral nerve).
    - Time to rescue analgesic (morphine postoperatively)
    - Total analgesic consumption (telephone interview)
    - Time to mobilization (telephone interview)
    D1- OBAS (telephone interview)
    - Knee function will be done by the Knee Society 6 weeks after surgery
    - Incidence of falls or near falls 6 weeks
    - WOMAC, SF-12
    - VAS scoren uur tot ontslag, en op de ochtend en de avond van de eerste dag postoperatief (telefonisch interview) samen met OBAS op de eerste dag na de operatie).
    Overall voordeel van analgesie score (OBAS), bepaald op de dag van de operatie, en de eerste dag na de operatie. [23]
    D 0:
    - IKDC-, KOOS vragenlijst, SF12-Sensory blokkade mate een uur postoperatief (gericht op gelijktijdige blokkade van de saphenous of femorale zenuw).
    - Tijdsduur tot analgeticum (morfine postoperatief)
    - Totaal pijnstillende verbruik (telefonisch interview)
    - Tijdsduur tot mobilisatie (telefonisch interview)
    D1 OBAS (telefonisch interview)
    - Knie-functie zal worden gedaan door de Knee Society 6 weken na de operatie
    - Incidentie van vallen of in de buurt als 6 weken
    -, SF-12
    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 No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    compared with a femoral nerve blockade
    E.8.2.4Number of treatment arms in the trial2
    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 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
    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 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: 50
    F.1.3Elderly (>=65 years) No
    F.1.3.1Number of subjects for this age range: 0
    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 state50
    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
    Geen
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2014-03-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-01-20
    P. End of Trial
    P.End of Trial StatusOngoing
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