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    Summary
    EudraCT Number:2016-004377-41
    Sponsor's Protocol Code Number:TFP_1-1
    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:2016-10-28
    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 number2016-004377-41
    A.3Full title of the trial
    Regional anaesthesia of the cutaneus nerves of the hip -
    A randomized controlled trial of the transversalis fascia plane block
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Regional anaesthesia of the cutaneus nerves of the hip -
    A randomized controlled trial of the transversalis fascia plane block
    A.4.1Sponsor's protocol code numberTFP_1-1
    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 SponsorDep. Anaesthesia and Intensive Care, Aarhus University 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 supportA.P. Møller og Hustru Chastine Mc-Kinney Møllers Fond til almene Formaal
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAarhus University Hospital
    B.5.2Functional name of contact pointDep. Anaesthesia and Intensive Care
    B.5.3 Address:
    B.5.3.1Street AddressNørrebrogade 44
    B.5.3.2Town/ cityAarhus C
    B.5.3.3Post code8000
    B.5.3.4CountryDenmark
    B.5.4Telephone number+4528782877
    B.5.6E-mailthomas.dahl.nielsen@clin.au.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 Marcain
    D.2.1.1.2Name of the Marketing Authorisation holderAstraZeneca 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.3.1Product nameMarcain
    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 INNBupivacain
    D.3.9.3Other descriptive nameBUPIVACAINE HYDROCHLORIDE
    D.3.9.4EV Substance CodeSUB00902MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2,5
    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 placeboPerineural use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Postoperative pain after hip surgery
    E.1.1.1Medical condition in easily understood language
    Postoperative pain after hip surgery
    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 19.0
    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
    To evaluate the success of the transversals fascia plane (TFP) block in producing cutaneous anesthesia proximal to - and continous with - the area of anesthesia produced by the lateral femoral cutaneous nerve (LFCN) block
    E.2.2Secondary objectives of the trial
    -Evaluating the cutaneous anesthesia after a selective subcostal nerve block
    -Evaluating the cutaneous anesthesia after the TFP block
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Age ≥ 18 years
    - Written informed consent
    - ASA i or II
    -Mentally capable of cooperating during the trial.
    - Understanding and speaking Danish or English.
    E.4Principal exclusion criteria
    - Pre-existing neurological pathology involving the area of investigation
    -Anatomical or mental aspects that would hinder nerve blocks
    - Allergy to local anesthetics
    - Current pregnancy
    - Weight less than 55 kg
    - Request to leave the trial
    - Infection in the area of injection
    E.5 End points
    E.5.1Primary end point(s)
    Success rate of the TFP block with local anesthetic to produce a cutaneous area of anesthesia that is continous with the anesthetized cutaneous area after a LFCN block, compared to placebo.
    E.5.1.1Timepoint(s) of evaluation of this end point
    30 minutes after relevant nerve blocks
    E.5.2Secondary end point(s)
    - Time needed to do the subcostal nerve block
    - Succes rate of ultrasonographic (US) visualization of the subcostal nerve just caudate to the 12th costa
    - Succes rate of US visualization of the subcostal nerve at location where the lateral cutaneous nerve is branching off
    - Success rate of US visualization of the subcostal lateral cutaneous nerve in its course through the external oblique muscle
    -Succes rate of relevant cutaneous anesthesia after subcostal nerve block
    - Succes rate of relevant cutaneous anesthesia after subcostal nerve block produced by the primary injection
    - Extent of the cutaneous area anesthetized after subcostal nerve block
    - Success rate of each of the incisions (cannulated screws, DHS, IM nail, anterior-, anterolateral- lateral- and posterior approach) in being completely covered by the cutaneous anesthesia after subcostal nerve block
    - Success rate of each of the incisions in being partly covered by the cutaneous anesthesia after subcostal nerve block
    -Rate of complete failure for each of the incisions to be covered by any cutaneous anesthesia after subcostal nerve block
    -Success rate of the LFCN block to produce a cutaneous area of anesthesia that is continous with the anesthetized cutaneous area after the subcostal nerve block on day one
    -Success rate of the LFCN block to produce a cutaneous area of anesthesia that is continous with the anesthetized cutaneous area after the subcostal nerve block on day one measured on a vertical line through the greater trochanter
    - Success rate of each of the incisions in being completely covered by the cutaneous anesthesia after subcostal nerve block and LFCN nerve block
    - Time needed to do the TFP block
    -Success rate of the TFP block with local anesthetic to produce a cutaneous area of anesthesia that is continous with the anesthetized cutaneous area after a LFCN block, compared to placebo, measured on a vertical line through the greater trochanter
    - Success rate of each of the incisions in being completely covered by the cutaneous anesthesia after LFCN nerve block and TFP block with local anesthetic, compared to placebo
    - Success rate of each of the incisions in being partly covered by the cutaneous anesthesia after LFCN nerve block and TFP block with local anesthetic, compared to placebo
    -Rate of complete failure for each of the incisions to be covered by any cutaneous anesthesia after LFCN nerve block and TFP block with local anesthetic, compared to placebo
    -Success rate of blockage of the iliohypogastric nerve after TFP block with local anesthetic, compared to placebo
    -Success rate of blockage of the subcostal nerve after TFP block with local anesthetic, compared to placebo
    -Extent of the cutaneous area anesthetized by the TFP block
    E.5.2.1Timepoint(s) of evaluation of this end point
    30 minutes after relevant nerve blocks
    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
    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 months
    E.8.9.1In the Member State concerned days4
    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 Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    F.3.2Patients No
    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 2016-10-28. 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 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 Decision2016-12-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-12-19
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-01-15
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