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    Summary
    EudraCT Number:2013-004013-41
    Sponsor's Protocol Code Number:AUH-TFB-SSPS-3
    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:2014-02-13
    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 number2013-004013-41
    A.3Full title of the trial
    Supra Sacral Parallel Shift - ultrasound/MR image fusion guided lumbosacral plexus block
    Supra Sacral Parallel Shift - ultralyd/MR billedfusionsvejledt plexus lumbosacralis blokade
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Supra Sacral Parallel shift - ultrasound/magnetic resonance image fusion guided block of the lumbosacral nervous plexus
    Supra Sacral Parallel Shift - ultralyd/magnetisk resonans billedfusionsvejledt blokade af lænde- og korsbensregionens nervefletværk
    A.3.2Name or abbreviated title of the trial where available
    SSPS - US/MR image fusion guided lumbosacral plexus block
    SSPS - UL/MR billedfusionsvejledt plexus lumbosacralis blokade
    A.4.1Sponsor's protocol code numberAUH-TFB-SSPS-3
    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 Fichnter 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 supportThe A.P. Møller Foundation
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationThomas Fichtner Bendtsen
    B.5.2Functional name of contact pointClinical Trial Information - SSPS
    B.5.3 Address:
    B.5.3.1Street AddressDep. of Anaesthesiology and Intensive Care Medicine, Aarhus University Hospital, Nørrebrogade 44
    B.5.3.2Town/ cityAarhus C
    B.5.3.3Post codeDK-8000
    B.5.3.4CountryDenmark
    B.5.4Telephone number+4551542997
    B.5.6E-mailtfb@dadlnet.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 Lidokain-adrenalin 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 IMPIntramuscular use
    Perineural 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 number20
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNAdrenaline
    D.3.9.3Other descriptive nameADRENALINE
    D.3.9.4EV Substance CodeSUB15951MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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 Dotarem
    D.2.1.1.2Name of the Marketing Authorisation holderGUERBET - Vicare Medical 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 Injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    Intravenous use
    Perineural use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNGADOTERIC ACID
    D.3.9.1CAS number 72573-82-1
    D.3.9.4EV Substance CodeSUB07865MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mmol/ml millimole(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.5
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    E.1.1.1Medical condition in easily understood language
    Hip surgery anaesthesia and peri-operative hip pain treatment.
    Bedøvelse til hoftekirurgi og peri-operativ behandling af hoftesmerter.
    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 18.0
    E.1.2Level LLT
    E.1.2Classification code 10054710
    E.1.2Term Postoperative hip pain
    E.1.2System Organ Class 100000004863
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level PT
    E.1.2Classification code 10051060
    E.1.2Term Hip surgery
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The main objective of the trial is to complete a randomized, double blinded, controlled trial with a single injection block of the lower part of the lumbar plexus (L2, L3, L4) and the upper part of the sacral plexus (L4, L5, S1) with regard to proximal analgesia of the femoral nerve, the obturator nerve, the lumbosacral trunk and the S1 spinal nerve with ultrasound/MR image fusion guided Supra Sacral Parallel Shift-technique versus ultrasound guided Supra Sacral Parallel shift-technique by estimating sensory block of the terminal nerves innervation in healthy volunteers.
    Det primære formål med projektet er at gennemføre en randomiseret, dobbeltblindet kontrolleret undersøgelse af blokade med én injektion af den nedre del af plexus lumbalis (L2, L3, L4) og den øvre del af plexus sacralis (L4, L5, S1) med henblik på proksimal analgesi af nervus femoralis, nervus obturatorius, truncus lumbosacralis og spinalnerve S1 med ultralyd/MR-billedfusion vejledt Supra Sacral Parallel Shift-teknik versus ultralydvejledt Supra Sacral Parallel Shift-teknik ved at estimere sensorisk blokade af de terminale nervers innervationsområder i raske, frivillige forsøgspersoner.
    E.2.2Secondary objectives of the trial
    The secondary objective of the trial is to estimate time for preparation of the block, time for and discomfort during the block injection, injection site and depth of block needle, mean arterial blood pressure, sensory block of the terminal nerves innervation, calculate cost-effectiveness, and examine the distribution of local anesthetics surrounding the lumbosacral nerves with MRI for ultrasound/MR image fusion guided Supra Sacral Parallel Shift-technique versus ultrasound guided Supra Sacral Parallel shift-technique in healthy volunteers.
    Det sekundære formål med projektet er at estimere og sammenligne forberedelsestid før blokaden, tid for og ubehag ved blokadeanlæggelsen, indstikssted og dybde af blokadenålen, plasma lidokain, middelarterierlt blodtryk, sensorisk blokade af de nævnte nervers terminale nervers innervationsområder og epidural spredning af lokalanalgetikum efter blokadeanlæggelse, beregne cost-effectiveness samt undersøge udbredelsen af lokalanalgetikum omkring de nævnte lumbosacrale nerver vurderet med MRI for SSPS teknik vejledt af ultralyd/MR billedfusion sammenlignet med SSPS teknik vejledt af ultralyd i raske, frivillige forsøgspersoner.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Age ≥ 18 years
    • Volunteer who has given their written and oral informed consent to participate in the study after fullly understanding the content and the limitations of the protocol.
    • Normal healthy person (American Society of Anesthesiology Classification, ASA I)
    • Alder ≥ 18 år
    • Forsøgspersoner som har givet deres skriftlige og mundtlige informerede samtykke til at deltage i undersøgelsen efter at have forstået protokollens indhold og begrænsninger fuldt ud
    • Normal rask person (American Society of Anesthesiology Classification, ASA I)
    E.4Principal exclusion criteria
    • Volunteers not able to cooperate for the study
    • Volunteers not able to understand or speak Danish
    • Daily use of analgesics
    • Allergy against the medicines used in the study
    • Drug abuse - according ti the investigator's estimation
    • Alcohol consumption larger than the recommendations of the Danish National Board of Health
    • Contraindication for MRI scanning including pregnancy
    • Volunteers in who nerve blocks are not possible due to technical reasons
    • Volunteers who are incompetent, eg. surrogate consent is not accepted
    • Forsøgspersoner som ikke kan samarbejde til undersøgelsen
    • Forsøgspersoner som ikke forstår og taler dansk
    • Daglig forbrug af analgetikum
    • Allergi over for de i undersøgelsen anvendte stoffer
    • Medicinmisbrug – efter investigators skøn
    • Større alkoholforbrug end Sundhedsstyrelsens retningslinjer, dvs. > 14 genstande ugentligt for mænd og > 7 genstande ugentligt for kvinder
    • Kontraindikation mod MRI skanning inklusive graviditet
    • Forsøgspersoner, hvor det, på grund af tekniske forhold, ikke er muligt at anlægge blokaderne
    • Inhabile patienter, dvs. at der ikke kan benyttes stedfortrædende samtykke
    E.5 End points
    E.5.1Primary end point(s)
    Success rate (SR) of block of the clinical relevant lumbosacral nerves that innervate the hip joint capsule estimated as significant motor block of the obturator nerve (L2-L3, hip adduction), the femoral nerve (L3-L4, knee extension) and the lumbosacral trunk (L4-L5, hip medial rotation) at the time T = 40 minutes. A motor block is a proxy marker of a sensory block.
    Succesrate (SR) af nerveblokade af de klinisk relevante lumbosacrale nerver, der innerverer hofteledskapslen estimeret som signifikant motorisk blokade af nervus obturatorius (L2-L3, hofteadduktion), nervus femoralis (L3-L4, knæekstension), truncus lumbosacralis (L4-L5, hofte medialrotation) til tiden T = 40 minutter. En motorisk blokade er proksy markør for sensorisk blokade.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Time (T) = 40 minutes after the nerve block.
    Tiden (T) = 40 minutter efter anlæggelse af nerveblokade.
    E.5.2Secondary end point(s)
    • Plasma-lidocaine after the nerve block
    • Time for preparation measured in seconds from placement of the study participant on the bed until the end of the pre-ultrasoundscanning
    • Time for placement of the block measured in seconds from the placement of the ultrasound transducer on the skin until the block needle is pulled out after injection of local anesthetics
    • Injectionsite in the skin in reference to the sagittal midline
    • Depth of the block needle in reference to the injectionsite
    • Discomfort during block placement measured with Numeric rating scale (NRS)
    • Mean arterial pressure after the block
    • Cost-effectiveness estimeret estimated as extra expense per extra successful nerve block (incremental cost-effetctiveness ratio, ICER)
    • Sensor block (cold, warm, touch, pain) of the femoral nerve (L2, anteriorly on thigh) and of the cutane femoral lateral nerve (L2, laterally on thigh) after the block
    • Perineural spread of local anesthetics with contrast estimated with T1- and T2-weighted and DWI MRI scanning after the block for the spinal nerves L2-S1, the femoral nerve, the obturator nerve, the cutane femoral lateral nerve, and the lumbosacral trunk.
    • Epidural spread of local anesthetics with contrast estimated with T1- and T2-weighted and DWI MRI scanning after the block.
    • Plasma-lidokain efter blokadeanlæggelse
    • Forberedelsestid (FT) i sekunder (s) fra anbringelse af forsøgspersonen på lejet indtil afslutning af pre-ultralydscanning
    • Anlæggelsestid (AT) i sekunder (s) fra anbringelse af ultralydtransduceren på huden indtil bloknålen er blevet trukket ud
    • Indstikssted i huden i forhold til den sagittale midtlinje målt i centimeter (cm)
    • Dybde af blokadenålen i forhold til indstiksstedet i huden målt i centimeter (cm)
    • Ubehag ved blokadeanlæggelse (vurderet med Numeric rating scale, NRS) efter hver blokade
    • Middle arterielt blodtryk efter blokadeanlæggelse
    • Cost-effectiveness estimeret som inkrementel cost-effectiveness ratio (ICER) estimeret som ekstra udgift per ekstra succesfuld nerveblokade
    • Sensorisk blokade (kulde, varme, berøring, smerte) af nervus femoralis (L2, midt på lårets forside) og nervus cutaneus femoris lateralis (L2, midt på lateralsiden af låret) efter blokadeanlæggelse
    • Perineural spredning af lokalanalgetikum med kontrast vurderet med T1-, T2- og DWI-vægtet MRI skanning efter blokadeanlæggelse for spinalnerverne L2-S1, nervus femoralis, nervus obturatorius, nervus cutaneus femoris lateralis og truncus lumbosacralis.
    • Epidural spredning af lokalanalgetikum med kontrast vurderet med T1- og T2- og DWI-vægtet MRI skanning efter blokadeanlæggelse.
    E.5.2.1Timepoint(s) of evaluation of this end point
    • Plasma-lidocaine: 0, 5, 10, 20, 40, 60 og 90 minutes after the nerve block
    • Time for preparation: when the block needle penetrates the skin for the first time
    • Time for placement of the block: when the block needle is pulled out after injection of local anesthetics
    • Injectionsite: immediately after the block
    • Depth of block needle: immediately after the block
    • Discomfort: immediately after the block
    • Mean arterial pressure: 5 minutes after the block
    • Cost-effectiveness: after the trial is finished
    • Sensor block: 30 minutes after the block
    • Perineural spread of local anesthetics: 60 minutes after the block
    • Epidural spread of local anesthetics: 60 minutes after the block.
    • Plasma-lidokain: 0, 5, 10, 20, 40, 60 og 90 minutter efter blokadeanlæggelse
    • Forberedelsestid (FT) i sekunder (s): når blokadenålen perforerer huden første gang
    • Anlæggelsestid (AT) i sekunder (s): når nålen er trukket ud efter injektion af lokalbedøvelsesmiddel
    • Indstikssted: umiddelbart efter blokadeanlæggelsen
    • Dybde af blokadenålen: umiddelbart efter blokadeanlæggelsen
    • Ubehag ved blokadeanlæggelse: umiddelbart efter hver blokade
    • Middle arterielt blodtryk: 5 minutter efter blokadeanlæggelse
    • Cost-effectiveness: efter forsøget er afsluttet
    • Sensorisk blokade: 30 efter blokadeanlæggelse
    • Perineural spredning af lokalanalgetikum: 60 minutter efter blokadeanlæggelse
    • Epidural spredning af lokalanalgetikum: 60 minutter efter blokadeanlæggelse
    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 Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Cost-effectiveness of the US-guided and the US/MR image fusion guided technique, respectively.
    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 No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    En anden teknik til at placere den samme medicin.
    Another technique to place the same medicinal product.
    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
    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 months2
    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: 26
    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 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 state26
    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.
    Ikke relevant.
    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 Decision2014-02-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-09-18
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-11-08
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