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    Summary
    EudraCT Number:2014-004601-32
    Sponsor's Protocol Code Number:SM4-UG-14
    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:2014-10-29
    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 ConcernedDenmark - DHMA
    A.2EudraCT number2014-004601-32
    A.3Full title of the trial
    The Effect of Local Anesthetic Volume within the Adductor Canal on Quadriceps Function Evaluated by Electromyography:
    A Randomized, Observer-Masked, Placebo-Controlled Study in Volunteers.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The Effect of Local Anesthetic Volume within the Adductor Canal on Quadriceps Function Evaluated by Electromyography:
    A Randomized, Observer-Masked, Placebo-Controlled Study in Volunteers.
    A.4.1Sponsor's protocol code numberSM4-UG-14
    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 SponsorGentofte Hospital
    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 supportGentofte Hospital
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUlrik Grevstad
    B.5.2Functional name of contact pointGentofte Hospital, Dept. of anaest.
    B.5.3 Address:
    B.5.3.1Street AddressKildegårdsvej 28
    B.5.3.2Town/ cityHellerup
    B.5.3.3Post code2900
    B.5.3.4CountryDenmark
    B.5.4Telephone number004538673892
    B.5.6E-mailulrik.grevstad@hotmail.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 Lidokain SAD
    D.2.1.1.2Name of the Marketing Authorisation holderAmgros I/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 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 INNLIDOCAINE
    D.3.9.3Other descriptive nameLIDOCAINE
    D.3.9.4EV Substance CodeSUB08507MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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
    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
    Healthy volunteers.
    Results will be used for optimizing the treatment of post-operative pain after total knee arthroplasty
    E.1.1.1Medical condition in easily understood language
    knee replacement
    E.1.1.2Therapeutic area Diseases [C] - Musculoskeletal Diseases [C05]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.1
    E.1.2Level SOC
    E.1.2Classification code 10022891
    E.1.2Term Investigations
    E.1.2System Organ Class 10022891 - Investigations
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    We do not know the optimal volume for the ACB and we find it relevant to investigate to what extent and which parts of the quadriceps muscle gets affected when different volumes of a local anesthetic are injected into the adductor canal. Selective affection of the different components of the femoral quadriceps muscle can be assessed by non-invasive EMG record-ings. Further, the quadriceps femoris muscle strength will be evaluated by measuring the MVIC following the different volumes. The EMG recordings will be voluntary (vEMG) meas-ured during MVIC and stimulated (sEMG). sEMG is measured during transcutaneous electri-cal stimulation of the femoral nerve.
    The healthy volunteers will not gain from this study but it is our firm belief that the obtained knowledge can help future TKA patients as we hope to come closer in answering the ques-tion; “what is the optimal volume for the ACB?” — Thereby, enabling us to provide pain relief with fewer side effects and adverse events.
    We do not know the optimal volume for the ACB and we find it relevant to investigate to what extent and which parts of the quadriceps muscle gets affected when different volumes of a local anesthetic are injected into the adductor canal. Selective affection of the different components of the femoral quadriceps muscle can be assessed by non-invasive EMG record-ings. Further, the quadriceps femoris muscle strength will be evaluated by measuring the MVIC following the different volumes. The EMG recordings will be voluntary (vEMG) meas-ured during MVIC and stimulated (sEMG). sEMG is measured during transcutaneous electri-cal stimulation of the femoral nerve.
    The healthy volunteers will not gain from this study but it is our firm belief that the obtained knowledge can help future TKA patients as we hope to come closer in answering the ques-tion; “what is the optimal volume for the ACB?” — Thereby, enabling us to provide pain relief with fewer side effects and adverse events.
    E.2.2Secondary objectives of the trial
    not applicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Age > 18 years old
    • Subjects who gave their written informed consent to participating in the study after having fully understood the contents of the protocol and re-strictions.
    • ASA 1
    • Male
    • BMI 18–30
    • Physical exercise 1-3 hours/week
    E.4Principal exclusion criteria
    • Subjects who cannot cooperate with the study.
    • Subjects who cannot understand or speak Danish.
    • Subjects with allergy to the medicines used in the study.
    • Subjects suffering from alcohol and/or drug abuse – based on the inves-tigator's opinion.
    • Pathology or previous surgery or trauma to the lower limb.
    • Intense exercise 24 h before the tests
    • Intake of any analgesics 24 h prior to baseline measurements.
    E.5 End points
    E.5.1Primary end point(s)
    • Difference between ACB-groups, one hour post-block, in amplitude of the rectified vEMG signal from the vastus medialis, expressed as percentage of the pre-block value.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Pre block and one hour post-block
    E.5.2Secondary end point(s)
    • Difference between ACB-groups, one hour post-block, in amplitude of the rectified vEMG signal from the vastus lateralis, expressed as percentage of the pre-block value.
    • Difference between groups, one hour post-block, in MVIC expressed as percentage of the pre-block value
    • Difference between ACB-groups, one hour post-block, in amplitude of the rectified sEMG signal from the vastus medialis, expressed as percentage of the pre-block value.
    • Difference between ACB-groups, one hour post-block, in amplitude of the rectified sEMG signal from the vastus lateralis, expressed as percentage of the pre-block value.
    • Correlation between volume and MVIC. MVIC expressed as a percentage of the pre-block value.
    • Difference in proportions between ACB-groups having an affection of both the saphe-nous nerve and the vastus medialis (but no other components of the quadriceps femoris muscle), one hour post block evaluated by EMG. (see below for establishment of the cut-off point for affected/not affected:
    E.5.2.1Timepoint(s) of evaluation of this end point
    Pre block and one hour post block
    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 Yes
    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 Yes
    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 trial5
    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 years0
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days2
    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: 20
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female No
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    F.3.2Patients No
    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 state20
    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 Decision2014-12-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-01-07
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-01-21
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