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    Summary
    EudraCT Number:2015-002169-50
    Sponsor's Protocol Code Number:Parav20150511
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2015-09-07
    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 ConcernedSweden - MPA
    A.2EudraCT number2015-002169-50
    A.3Full title of the trial
    The analgesic effect of local anaesthetic only compared to local anaesthetic
    with adjunct of short acting opioid and adrenaline in a continuous
    paravertebral block for analgesia after VATS – a prospective randomised
    study.
    Analgetisk effekt av lokalanestetika enbart jämfört med lokalanestetika
    med tillsats av kortverkande opioid och adrenalin i en kontinuerlig
    paravertebral blockad för smärtlindring efter VATS – en prospektiv
    randomiserad studie.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Does the addition of a short-acting morphine and epinephrine to a
    continuous infusion of local anaesthetic improve pain treatment when
    continuously infused in a paravertebral block after lung surgery?
    Utvärdering om kontinuerlig infusion av en blandning av läkemedlen
    levobupivakain, sufentanil och adrenalin i en paravertebral kateter ger
    bättre smärtlindring och återhåmtning efter video-assisterad
    thorakoskopisk kirurgi än infusion av enbart levobupivakain.
    A.4.1Sponsor's protocol code numberParav20150511
    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 SponsorInstitution for Clinical Science, Karolinska Institutet
    B.1.3.4CountrySweden
    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 supportnone, academic research supported by Department of
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDepartment of Thoracic Surgery, Karolinska
    B.5.2Functional name of contact pointMark Larsson
    B.5.3 Address:
    B.5.3.1Street AddressThoraxkliniken N10:03
    B.5.3.2Town/ cityStockholm
    B.5.3.3Post code171 76
    B.5.3.4CountrySweden
    B.5.4Telephone number46(0)8517 70 914
    B.5.6E-mailmark.larsson@karolinska.se
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleComparator
    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 Chirocaine
    D.2.1.1.2Name of the Marketing Authorisation holderAbbVie AB
    D.2.1.2Country which granted the Marketing AuthorisationSweden
    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 Infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOther use (Noncurrent)
    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 RoleComparator
    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 Sufenta
    D.2.1.1.2Name of the Marketing Authorisation holderJanssen-Cilag AB
    D.2.1.2Country which granted the Marketing AuthorisationSweden
    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 Infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOther use (Noncurrent)
    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 RoleComparator
    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 mylan
    D.2.1.1.2Name of the Marketing Authorisation holderMylan AB
    D.2.1.2Country which granted the Marketing AuthorisationSweden
    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 Infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOther use (Noncurrent)
    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
    The analgesic effects of continuous paravertebral infusion of two
    analgesic mixtures after Video-Assisted Thoracoscopic Surgery (VATS).
    Den analgetiska effekten av kontinuerlig paravertebral infusion av två
    olika blandningar av smärtstillande läkemedel efter video-assisterad
    thorakoskopisk kirurgi (VATS).
    E.1.1.1Medical condition in easily understood language
    Pain treatment with two different mixtures of pain medication after lung
    surgery.
    Smärtbehandling med två olika blandningar av smärtstillande läkemedel
    efter lung kirurgi.
    E.1.1.2Therapeutic area Body processes [G] - Physiological processes [G07]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To test the hypothesis that the addition of sufentanil and epinephrine to levobupivacaine in continuous paravertebral block will increase its analgesic potency, resulting in better pain relief and enhanced recovery after Video-Assisted Thoracoscopic Surgery despite the lower total levobupivacaine dose administered.
    Denna studie syftar till att klarlägga om en blandning av lokalbedövningsmedel, kortverkande morfinpreparat och adrenalin ger bättre smärtlindring än en blandning av lokalbedövningsmedel och koksalt i en kontinuerlig infusion via en paravertebral kateter efter video assisterad thorax kirurgi.
    E.2.2Secondary objectives of the trial
    Cumulative 8-hourly NRS after 72 hours.
    Postoperative NRS every 8 hours for 72 hours.
    Postoperative NRS in ambulation twice daily for 72 hours.
    Postoperative recovery according to PQRS at 72 hours, 1 week and 3
    months compared to preoperative values.
    Time until able to perform activities of daily living.
    Time to eat and drink.
    Time to walk unaided.
    Time to GI-function.
    Day of discharge and discharge time
    Pre- and postoperative spirometry
    Plasma levels of stress markers 1, 12 and 36 hours postoperatively
    compared to preoperative values
    Summerade värdet av var 8:e timmes NRS skattning
    Post operativ NRS var 8:e timme under 72 timmar
    Post operativ NRS vid gång två ganger dagligen under 72 timmar
    Post operativ återhämtning enligt PQRS vid 72 timmar, 1 vecka och 3
    månader jämfört med pre operativa PQRS värden
    Tid till att kunna genomföra dagliga aktiviteter
    Tid til intag av mat och dryck
    Tid till att kunna gå utan stöd
    Tid till återkomst av tarm motilitet
    Utskrivningsdag och –tid
    Pre- och post operativ spirometri
    Plasma koncentrationer av stress markörer 1,12 och 36 timmar efter
    kirurgi jämfört med pre operative värden
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Age 20 to 75 years
    • ASA (American Society of Anesthesiologists) Physical Status Class 2-3
    • Informed consent
    • Ålder 20 till 75 år
    • ASA (American Society of Anesthesiologists) Physical Status Class 2-3
    • Samtycke efter skriftlig och muntlig information
    E.4Principal exclusion criteria
    • Allergy to local anaesthetic
    • Pronounced hepatic disease
    • Psychiatric disease or any psychoactive medication
    • Cognitive disturbance and/or inability to understand written and/or
    oral instructions
    • History of chronic pain or chronic pain medication
    • Överkänslighet mot lokalbedövningsmedel
    • Grav leversvikt
    • Känd psykisk sjukdom eller pågående behandling med psykofarmaka
    • Nedsatt kognitiv förmåga och/eller oförmåga att förstå skrivna
    och/eller muntliga instruktioner
    • Långvarig smärta eller pågående behandling med läkemedel mot
    långvarig smärta
    E.5 End points
    E.5.1Primary end point(s)
    Cumulated intravenous PCA morphine consumption at 72 hours.
    Totala intravenösa morfindosen som administrerats via PCA pump over
    72 timmar.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Evaluation of rescue analgesic requirement at 72 hours.
    Utvärdering av totala behovet av rescue smärtmedicinering vid 72
    timmar.
    E.5.2Secondary end point(s)
    • Cumulated NRS score every 8 hours at 72 hours
    • PQRS score at 72 hours, 1 week and 3 months
    • NRS at rest at all time points
    • Morphine consumption at all time points
    • Cumulated NRS in ambulation twice daily
    • NRS in ambulation twice daily
    • Incidence of nausea and/or vomiting at any time during 72 hours
    • Incidence of sedation at any time during 72 hours
    • Incidence of pruritis at any time during 72 hours
    • Spirometry pre- and postoperatively
    • Plasma levels of stress markers 1, 12 and 36 hours postoperatively
    compared to preoperative values
    • Sammanräknade NRS värdet föralla 8-timmars värden vid 72 timmar
    • PQRS score vid 72 timmar, 1 vecka och 3 månader
    • NRS vid alla tidpunkter
    • Morfinbehov vid alla tidpunkter
    • Sammanräknad NRS score från NRS värdering vid gang två ganger om
    dagen
    • NRS vid gång två ganger om dagen
    • Förekomst av illamående och/eller kräkning under studiens 72
    timmar
    • Förekomst av sedering under studiens 72 timmar
    • Förekomst av klåda under studiens 72 timmar
    • Spirometri pre- och post operativt
    • Plasma koncentrationer av stress markörer 1, 12 och 36 timmar efter
    kirurgi jämfört med pre operativa värden
    E.5.2.1Timepoint(s) of evaluation of this end point
    • NRS scoring at 8-hour intervals for 72 hours
    • NRS scoring in ambulation twice daily for 72 hours
    • Incidence of sedation, nausea or pruritis during 72 hours of the study
    • PQRS assessment 1- 14 days preoperatively, in the recovery room at
    40 minutes postoperatively; 72 hours, 1 week, and 3 months after
    surgery
    • Spirometry preoperatively and at day 1 postoperatively
    • NRS score var 8:e timme under 72 timmar
    • NRS score vid gång två gånger dagligen
    • Förekomst av sedering, illamående eller klåda under studiens 72
    timmar
    • PQRS bedömning 1-14 dagar fore kirurgi, på uppvakningsavdelningen
    40 minuter efter avslutad kirurgioch 72 timmar, 1 vecka och 3 månader
    efter kirurgi
    • Spirometri pre operativt och dag 1 post operativt
    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 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 No
    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
    Three months after LVLS in follow-up by telephone contact
    Tre månader efter LVLS genom uppföljning via telefon.
    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 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 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 state60
    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 Decision2015-12-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-10-22
    P. End of Trial
    P.End of Trial StatusOngoing
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