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    Summary
    EudraCT Number:2013-004649-18
    Sponsor's Protocol Code Number:13001
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2014-01-17
    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 number2013-004649-18
    A.3Full title of the trial
    The effect of phrenic nerve block on postoperative shoulder pain in patients for liver resection – a double blinded randomised controlled trial.
    Effekten af nervus phrenicus blok som postoperativ smertebehandling af skuldersmerter ved leverkirurgi – et dobbeltblindet randomiseret studie
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The effect of phrenic nerve block on postoperative shoulder pain in patients for liver resection – a double blinded randomised controlled trial.
    Effekten af nervus phrenicus blok som postoperativ smertebehandling af skuldersmerter ved leverkirurgi – et dobbeltblindet randomiseret studie
    A.4.1Sponsor's protocol code number13001
    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 SponsorJens Hilligsø
    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 supportDepartment of Gastroenterology
    B.4.2CountryDenmark
    B.4.1Name of organisation providing supportDepartment of Anaesthesiology
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDepartment of Gastroenterology, Rigshospitalet
    B.5.2Functional name of contact pointDep. of Gartroenterology
    B.5.3 Address:
    B.5.3.1Street AddressBlegdamsvej 9
    B.5.3.2Town/ cityKøbenhavn Ø
    B.5.3.3Post code2100
    B.5.3.4CountryDenmark
    B.5.4Telephone number+4535452122
    B.5.6E-mailjens.hillingsoe@regionh.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 Ropivacain "Fresenius Kabi" 7,5 mg/ml
    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 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 INNROPIVACAINE
    D.3.9.1CAS number 84057-95-4
    D.3.9.4EV Substance CodeSUB10382MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number7.5
    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
    Posteoperative shoulder pain following open liver resection surgery

    .
    Postoperative skuldersmerter efter åben kirurgisk leverresektion.
    E.1.1.1Medical condition in easily understood language
    Pain in the shoulder following surgery to the liver.
    Smerter i skulderen efter åben leverkirurgi
    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 LLT
    E.1.2Classification code 10024717
    E.1.2Term Liver tumor
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To explore whether the use of ultrasound guided phrenic nerve block can reduce the postoperative pain in the shoulder after liver resection. The intervention is directed postoperative to the patients experiencing novel right sided shoulder pain.
    At undersøge og klarlægge hvorvidt en højresidig ultralydsvejledt nerveblokade af nervus phrenicus, har effekt på de akutte postoperative højresidige skuldersmerter, der hyppigt observeres i forbindelse med åben leverkirurgi. Interventionen gennemføres postoperativt og kun på de patienter der har nyopståede højresidige skuldersmerter.
    E.2.2Secondary objectives of the trial
    To evaluate lung function in relation to a unilateral phrenic nerve block.
    To evaluate duration of liver resection surgery in relation to postoperative pain in the shoulder.
    At undersøge påvirkningen af lungefunktionen I relation til anlæggelse af unilateralt nervus phrenicus blok.
    At undersøge sammenhængen mellem varigheden af leverresektionskirurgien og graden af postoperative højresidige skuldersmerter.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Age above 18.
    Patients scheduled for liver resection.
    Ability to giive informed consent.
    .
    Alder over 18 år.
    Gennemgå planlagt åben leverresektion.
    Være i stand til at give informeret samtykke
    E.4Principal exclusion criteria
    Participation in another clinical trial, dealing with pain or management of pain, which could affect this trial, evaluated by the investigator.
    Inability to talk and understand danish
    Drug or alcohol abuse
    Pregnancy
    Congestive heart failure (NYHA class III-IV), or other serious heart disease.
    Chronic obstructive lung disease, moderate or severe degree, or other significant lung disease
    Chronic or acute shoulder pain prior to surgery.
    Body Mass Index above 35.
    Infection at the site of the injection
    Allergy to ropivacaine

    Postoperativ:
    Shoulder pain score < 6 assessed on the numeric rating scale (0-10), 15 minutes after arrival in postanaesthetic care unit (PA CU).
    Insufficient epidural analgesia, or lack of epidural analgesia.
    Inability to visualize nervus phrenicus with sonography.
    Cerebral confusion, postoperative delirium or other medical condition hindering study intervention.
    Presence of an investigator with intervention competence is not available.
    Deltagelse i et andet klinisk forsøg, der omhandler smerter eller smertebehandling der vurderes af investigator at kunne påvirke det aktuelle studie.
    Patienter som ikke forstår eller taler dansk.
    Alkohol- og/eller medicinmisbrug – efter investigators skøn.
    Graviditet*(se nedenfor).
    Hjerteinsufficiens (NYHA klasse III-IV), eller anden alvorlig hjertyesygdom.
    Kronisk obstruktiv lungelidelse i moderat eller svær grad, eller anden betydende lungesygdom.
    Kroniske eller akutte skuldersmerter.
    Body Mass Index (BMI) over 35 kg/m2
    Infektion i området hvor blok skal anlægges.
    Allergi overfor ropivacain.

    Postoperativ eksklusion (forhindrende randomisering):
    Ingen eller højresidige skuldersmerter med NRS < 6, vurderet 15 minutter (0-30 minutter) efter ankomst i det Perioperative Terapi Afsnit (POTA).
    Dysfungerende eller manglende epidural analgesi vurderet af investigator.
    Sonografiske forhold der ikke tillader sikker erkendelse af nervus prenicus på højre side.
    Cerebral konfusion, opvågningsdelir eller anden postoperativ tilstand der forhindrer medvirken til studieinterventionen.
    Investigator med blokadekompetence er indisponibel.
    E.5 End points
    E.5.1Primary end point(s)
    Reduction in pain score of a minimum of 3 NRS ( =numerical rating scale 0-10) points when baseline pain score is compared to pain score after 1st intervention.
    Reduktion i højresidige skuldersmerter vurderet med NRS (numerical rating scale 0-10), sammenlignet med skuldersmerterne umiddelbart inden intervention (baseline) ligeledes vurderet med NRS.
    E.5.1.1Timepoint(s) of evaluation of this end point
    15 minutes after 1st intervention.
    Opgjort 15 minutter efter 1. intervention.
    E.5.2Secondary end point(s)
    Reduction in pain score of a minimum of 3 NRS points, when pain score just prior to the 1st intervention (baseline) is compared to pain score after 1st intervention or 2nd intervention.
    Lung function evaluated with spirometry (FEV1, FVC og VC) just prior to 1st intervention (baseline), compared to lung function after 1st intervention or 2nd intervention.
    Lung function evaluated with arterial blood gas (paO2, paCO2) just prior to 1st intervention (baseline), compared to lung function after 1st intervention or 2nd intervention.
    Duration of surgery compared to shoulderpain just prior to 1st intervention.
    Number of included patients with a pain score (NRS) between 0 and 3 after 1st intervention or 2nd intervention.
    Number of included patients with respiratory affection, if defined as this in the medical chart.
    Number of included patients treated with opioid and the amount of used opioid in morphine equivalence.
    Prevalence of respiratory og cardiovascular events until discharge when defined as this in medical chart and prevalence of readmission obtained from the Danish National Hospital Registry.
    Reduktion i højresidige skuldersmerter vurderet med NRS, sammenlignet med smerter umiddelbart inden intervention (baseline) ligeledes vurderet med NRS.
    Lungefunktionen vurderet ved sammenligning af spirometri (FEV1, FVC og VC) udført umiddelbart inden 1. intervention (baseline).
    Lungefunktionen vurderet ved sammenligning af blodgasanalyse, vurderet på indhold af oxygen og carbondioxid (begge målt i kPa) udtaget umiddelbart inden 1. intervention (baseline).
    Varigheden af det kirurgiske indgreb (målt i minutter), sammenholdt med højresidige skuldersmerter umiddelbart postoperativt (baseline).
    Andel af patienter med NRS mellem 0 og efter 1. og 2. intervention.
    Andel af samtlige primært inkluderede patienter med respiratoriske påvirkning, defineret som dette enten i EWS (Early Warning Score) eller via lægeligt journalnotat.
    Andel af samtlige inkluderede patienter der modtager opioider, samt mængden heraf i morfin-ækvivalenter.
    Forekomst af lunge og kredsløbshændelser under indlæggelsen via lægejournalen, samt forekomst af genindlæggelser, indhentet via landspatientregistret, i den samlede samtykkende forsøgsgruppe.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Pain score 2, 5, 10, 60 minutes and 24h after 1st intervention and 2, 5, 10 and 15 minutes after 2nd intervention.
    Lung function (arterial blood gas and spirometry) just prior to 2nd intervention (15 minutes after 1st intervention), 60 minutes after 1st intervention and 15 minutes after 2nd intervention.
    Respiratory og cardiovascular affection within 24 hours postoperative.
    Pain score (NRS) between 0 and 3 evaluated 5 and 15 minutes after 1st intervention or 2nd intervention
    Number of included patients with respiratory affection within the first 24 hours.
    Respiratory og cardiovascular events until discharge when defined as this in medical chart and prevalence of readmission within 30 days after inclusion.
    Smertescore registreret 2, 5, 10, 60 minutter og 24 timer efter 1. intervention og 2, 5, 10 og 15 minutter efter 2. intervention.
    Lungefunktion (arteriel blodgas og spirometri) målt umidddelbart inden 2. intervention (15 minutter efter 1. intervention) , 15 minutter efter 2. intervention og 60 minutter efter 1. intervention.
    Respiratoriske påvirkning i de første 24 timer postoperativt.
    NRS mellem 0 og 3 vurderet 5 og 15 minutter efter 1. og 2. intervention.
    Morfin-ækvivalenter de første 24 timer.
    Lunge og kredsløbshændelser under indlæggelse og genindlæggelser inden for de første 30 dage.
    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 No
    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 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 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
    Når sidste af de 30 patienter er inkluderet.
    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 months6
    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: 15
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 15
    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 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 2014-01-17. 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 state30
    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
    ingen
    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 Decision2014-01-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-02-21
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2017-09-01
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