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    Summary
    EudraCT Number:2014-003343-35
    Sponsor's Protocol Code Number:CR-TFB-2014/502
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2014-08-06
    Trial results View 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 ConcernedDenmark - DHMA
    A.2EudraCT number2014-003343-35
    A.3Full title of the trial
    The effect of saphenous nerve and obturator nerve block combined with systemic high dose glucocorticoid versus local infiltration analgesia combined with a systemic high dose glucocorticoid on opioid consumption and pain after total knee arthroplasty.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The effect of saphenous nerve and obturator nerve block combined with intravenous given glucocorticoid compared with infiltration of local anesthetic in the tissue around the knee joint combined with intravenous given glucocorticoid, on opioid consumption and pain after total knee arthroplasty.
    A.3.2Name or abbreviated title of the trial where available
    Prolonged combined block after total knee arthroplasty
    A.4.1Sponsor's protocol code numberCR-TFB-2014/502
    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 SponsorThomas Fichtner Bendtsen
    B.1.3.4CountryDenmark
    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 supportHospital of Silkeborg
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHospital of Silkeborg
    B.5.2Functional name of contact pointCentre of Elective Surgery
    B.5.3 Address:
    B.5.3.1Street AddressFalkevej 3
    B.5.3.2Town/ citySilkeborg
    B.5.3.3Post code8600
    B.5.3.4CountryDenmark
    B.5.4Telephone number004525883172
    B.5.6E-mailcharlotte.runge@aarhus.rm.dk
    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 Dexamethason Krka
    D.2.1.1.2Name of the Marketing Authorisation holderKRKA, tovarna zdravil, d.d., Novo mesto
    D.2.1.2Country which granted the Marketing AuthorisationSlovenia
    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 Concentrate for 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 INNdexamethasone
    D.3.9.1CAS number 312-93-6
    D.3.9.3Other descriptive nameDEXAMETHASONE PHOSPHATE
    D.3.9.4EV Substance CodeSUB01612MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number4
    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 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 Ropivacain
    D.2.1.1.2Name of the Marketing Authorisation holderFresenius Kabi AB
    D.2.1.2Country which granted the Marketing AuthorisationDenmark
    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 Concentrate for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPPeriarticular use
    Perineural 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 number2
    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: 3
    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 Toradol
    D.2.1.1.2Name of the Marketing Authorisation holderRoche A/S
    D.2.1.2Country which granted the Marketing AuthorisationDenmark
    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 Concentrate for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    Periarticular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNKETOROLAC TROMETAMOL
    D.3.9.1CAS number 74103-07-4
    D.3.9.4EV Substance CodeSUB02835MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30
    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: 4
    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 adrenalin
    D.2.1.1.2Name of the Marketing Authorisation holderTakeda Pharma A/S
    D.2.1.2Country which granted the Marketing AuthorisationDenmark
    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 Concentrate for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPPeriarticular use
    Perineural use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNadrenalin
    D.3.9.1CAS number 51-43-4
    D.3.9.3Other descriptive nameEPINEPHRINE
    D.3.9.4EV Substance CodeSUB06568MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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
    D.8.4Route of administration of the placeboPeriarticular use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    The medical condition to be examined in this study is the first postoperative period after total knee replacement with a view to pain management.
    E.1.1.1Medical condition in easily understood language
    The medical condition to be examined in this study is the first time after total knee replacement with a view to pain management.
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.1
    E.1.2Level LLT
    E.1.2Classification code 10038286
    E.1.2Term Regional nerve block
    E.1.2System Organ Class 100000004865
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The aim is to investigate the effect of combined saphenous nerve and obturator nerve block with a mixture of local analgesics; ropivacaine and adrenaline, compared with combined local infiltration analgesia in the tissue around the knee joint both methods combined with systemic high dose glucocorticoid on opioid consumption after total knee arthroplasty.
    E.2.2Secondary objectives of the trial
    Secondarily it is to investigate the effect of combined saphenous nerve and obturator nerve blockade compared with local infiltration analgesia in the tissue around the knee joint both methods combined with a systemic high dose glucocorticoid on pain and block duration after total knee arthroplasty.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Age> 50 years
    • Patients set to cemented Total knee arthroplasty in spinal block
    • ASA 1-3
    E.4Principal exclusion criteria
    • Patients who can not cooperate with the investigation
    • Patients who have given written informed consent to participate in the study after having understood the contents of the protocol and limitations fully
    • Patients who do not understand or speak Danish
    • Patients receiving immunosuppressive therapy
    •Patients receiving glucocorticoid daily
    • Patients with a treatment-dependent diabetes mellitus
    • Patients with known neuropathy in the lower limbs
    • Allergy to those used in the study drugs
    • Alcohol and / or drug abuse - the investigator's opinion
    • Patients who can not tolerate NSAIDs
    • Fixed several times daily consumption of strong opioids (morphine, ketogan,
    Oxynorm, methadone, fentanyl)
    E.5 End points
    E.5.1Primary end point(s)
    • Consumption of opioid from 0 to 20 hours postoperatively, via patient-controlled analgesia-(PCA) pump. The patient is instructed to self-administer a dose when NRS (numeric rating scale) > 3 at rest.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Time 20 hours postoperatively
    E.5.2Secondary end point(s)
    • The total consumption of opioid from time 0 to 24 hours postoperatively , at the PCA pump .
    • Pain Score with NRS - with values from 0 to 10, with 0 being no pain and 10 being the worst pain imaginable, by passive flexion of the knee joint from 0-90 degrees time 2 , 6, 20 and 24 hours postoperatively .
    • Reported pain Score at rest at time 2, 6 , 20 and 24 hours postoperatively . Where highest score since last score recorded.
    • Time of initial postoperative opioid-required pain breakthrough ( NRS > 3 at rest) reported by the patient
    • Nausea Score with NRS (numeric rating scale ) - with values from 0 to 10, where 0 is no nausea and 10 being the worst nausea time 2, 6, 20, 24 hours postoperatively .
    • Number of vomiting between 0- 20 hours and 0-24 hours postoperatively .
    • Consumption of Ondansetron between 0-20 hours and 0-24 hours postoperatively .
    •Reporting of dizziness at time 2, 6, 20 and 24 hours postoperatively. Recording whether the dizziness is preventing mobilization.
    • Duration of stay (length of stay , LOS ) in the observation unit (post anesthesia care unit , pacu). The end time for the LOS in PACU recorded at the time when the patient meets DASAIMs (Danish Society of Anaesthesiology and Intensive Therapy) printing criteria - regardless of Pacu 's logistics in general.
    • Discharge time from the hospital or maximum 60 hour postoperatively.
    • Mobilization and Function:
    • Preoperatively isometric tests of muscle strength in the hip adductors by a handheld dynamometer before and 30 minutes after performed nerve blockades. The patient performed 4-10 measurements with a 30 second break in between each measurement. The difference between the highest value for the test before and after nerve block is calculated.
    Time where the patient first time are mobilize to walk postoperatively with crutches or support from nurses.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1-2 hours preoperatively evaluation:
    - Pain score at rest and pain at passively flexion of the knee
    - Nausea Score
    - Isometric tests
    Time 2., 6., 20., 24. hours postoperatively evaluation:
    - Pain score at rest and pain at passively flexion of the knee
    - Nausea Score
    - dizziness
    Time 20 and 24 hours postoperatively evaluation:
    - Number of vomiting
    - Consumption of Ondansetron
    - Total consumption of opioid

    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 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 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 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
    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 months14
    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: 10
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 64
    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 state74
    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 Decision2014-10-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-08-27
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-12-15
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