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    Summary
    EudraCT Number:2018-004672-35
    Sponsor's Protocol Code Number:PACS2019
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2019-09-27
    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 number2018-004672-35
    A.3Full title of the trial
    Open heart surgery – does it have to hurt that much? PACS – Parasternal After Cardiac Surgery. A prospective randomised study to assess the analgesic effect of a continuous bilateral parasternal block with lidocaine after sternotomy.
    Öppen hjärtkirurgi - måste det göra så ont? En prospektiv randomiserad studie för att utvärdera den smärtlindrande effekten av en bilateral parasternal blockad med lidokain efter sternotomi.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Open heart surgery – does it have to hurt that much? Does a continuous infusion of local anaesthetic on either side of the chest wound result in better pain relief and recovery after open heart surgery compared to current treatment?
    Öppen hjärtkirurgi - måste det göra så ont? Ger en kontinuerlig infusion av lokalbedövningsmedel på vardera sida om operationssåret bättre smärtlindring och återhämtning efter öppen hjärtkirurgi än dagens behandling?
    A.3.2Name or abbreviated title of the trial where available
    PACS
    A.4.1Sponsor's protocol code numberPACS2019
    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 supportKarolinska University Hospital
    B.4.2CountrySweden
    B.4.1Name of organisation providing supportKarolinska Institute
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationKarolinska University Hospital, Dep of Cardiothoracic Anesthesia and Intensive Care
    B.5.2Functional name of contact pointMark Larsson
    B.5.3 Address:
    B.5.3.1Street AddressPMI, C7:26 Thoraxanestesi och -intensivvård
    B.5.3.2Town/ cityStockholm
    B.5.3.3Post code171 76
    B.5.3.4CountrySweden
    B.5.4Telephone number46851770914
    B.5.6E-mailmark.larsson@sll.se
    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 Xylocain
    D.2.1.1.2Name of the Marketing Authorisation holderAspen Pharma Trading Limited
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboInfusion
    D.8.4Route of administration of the placeboOther use (Noncurrent)
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    The analgesic effect of continuous bilateral parasternal infusion of local anaesthetic after open cardiac surgery.
    Den analgetiska effekten av en kontinuerlig bilateral parasternal infusion av lokalbedövningsmedel efter öppen hjärtkirurgi.
    E.1.1.1Medical condition in easily understood language
    Pain treatment with local anaesthetic that is being infused on both sides of the sternal wound after open heart surgery.
    Smärtbehandling genom kontinuerlig infusion av lokalbedövningsmedel på bägge sidor om såret i bröstet efter öppen hjärtkirurgi.
    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
    The study will test the hypothesis that a continuous bilateral parasternal block with lidocaine will decrease postoperative pain after sternotomy for open cardiac surgery.
    Studien kommer att pröva hypotesen att en kontinuerlig bilateral parasternal blockad med lidocaine kommer att minska den postoperativa smärtan efter sternotomi för öppen hjärtkirurgi.
    E.2.2Secondary objectives of the trial
    The study will evaluate whether improved analgesia by a continuous parasternal block will increase postoperative recovery.
    Studien kommer att utvärdera om förbättrad smärtlindring genom kontinuerlig parasternal blockad kommer att förbättra den postoperativa återhämtningen.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Age 20 to 80 years
    • ASA 2-3 (American Society of Anesthesiologists) Physcial Status Class 2-3
    • Informed consent
    • Ålder 20 till 80 år
    • ASA (American Society of Anesthesiologists) Physcial Status Class 2-3
    Informerat samtycke
    E.4Principal exclusion criteria
    • Emergency surgery
    • Redo sternotomy
    • Preoperative severe left heart failure
    • Preoperative respiratory insufficiency
    • Preoperative advanced kidney failure
    • Pronounced hepatic disease
    • Allergy to local anaesthetic
    • 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
    • Failure to be extubated within 4 hours after surgery
    • Deep hypothermia during surgery
    • Akut kirurgi
    • Reoperation sternotomi
    • Preoperativ grav vänstersidig hjärtsvikt
    • Preoperativ respiratorisk svikt
    • Preoperativ uttalad njursvikt
    • Uttalad leversjukdom
    • Allergi mot lokalbedövningsmedel
    • Psykisk sjukdom eller psykoaktiv medicinering
    • Nedsatt kognitiv förmåga och/eller oförmåga att förstå skrivna och/eller muntliga instruktioner
    • Långvarig smärta eller pågående behandling med läkemedel mot långvarig smärta
    • Ej möjlig att extubera inom 4 timmar efter kirurgi
    • Djup hypotermi under kirurgi
    E.5 End points
    E.5.1Primary end point(s)
    Cumulated intravenous PCA (Patient Controlled Analgesia) morphine consumption at 72 hours
    Totala intravenösa morfindosen som administrerats via PCA (Patient Controlled Analgesia) pump under 72 timmar
    E.5.1.1Timepoint(s) of evaluation of this end point
    After 72 hours
    Efter 72 timmar
    E.5.2Secondary end point(s)
    • Cumulated NRS (Numeric Rating Scale) score for pain every 8 hours at 72 hours
    • QoR-15 (Quality of Recovery questionnaire) score at 24,48 and 72 hours as well as 2, 4, 8 and 12 weeks after surgery
    • NRS at rest at all time points during initial 72 hours
    • NRS score at rest and in movement at 2, 4, 8 and 12 weeks after surgery
    • Morphine consumption at 24, 48 and 72 hours
    • Oxycodon requirement at 2, 4, 8 and 12 weeks after surgery
    • Cumulated NRS after two deep breaths three times daily, during 72 hours
    • NRS after two deep breaths three times daily, during 72 hours
    • NRS at rest and after two deep breaths at 2, 4, 8 and 12 weeks after surgery
    • Incidence of nausea and/or vomiting at any time during initial 72 hours
    • Incidence of sedation at any time during initial 72 hours
    • Incidence of arrhythmia, more than single or solitary coupled supraventricular and ventricular extra beats at any time during initial 72 hours
    • Spirometry preoperatively, and then postoperatively at the morning after surgery and in the evening from day after surgery until postoperative day 3
    • Plasma levels of stress markers and lidocaine 1, 24, 48 and 72 hours postoperatively compared to preoperative values
    • Day of discharge and discharge time
    • Sammanräknade NRS (Numeric Rating Scale) värde för smärta för alla 8-timmars värden efter 72 timmar
    • QoR-15 (Quality of Recovery – Grad av återhämtning enkät) poäng vid 24, 48 och 72 timmar samt 2, 4, 8 och 12 veckor efter operation
    • NRS värde i vila vid alla tidpunkter under initiala 72 timmar
    • NRS värde i vila och vid rörelse vid 2, 4, 8 och 12 veckor efter operation
    • Morfinbehov vid 24, 48 och 72 timmar
    • Oxycodon behov vid 2, 4, 8 och 12 veckor efter operation
    • Sammanräknad NRS score för två djupa andetag tre gånger per dag efter 72 timmar
    • NRS score efter två djupa andetag tre gånger per dag, under 72 timmar
    • NRS score i vila och efter två djupa andetag 2, 4, 8 och 12 veckor efter operation
    • Förekomst av illamående och/eller kräkning under studiens första 72 timmar
    • Förekomst av sedering under studiens första 72 timmar
    • Förekomst av arytmier, mer än enstaka eller enstaka kopplade supraventrikulära och ventrikulära extraslag under studiens första 72 timmar
    • Spirometri före operation, samt morgon och kväll tre dagar efter operation
    • Plasma koncentrationer av stress markörer och lidocaine 1, 24, 48 och 72 timmar efter operation jämfört med preoperativt värde
    • Tid för utskrivning
    E.5.2.1Timepoint(s) of evaluation of this end point
    Please see E.5.2
    Var god se E.5.2
    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 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
    Twelve weeks after LVLS in follow-up through mobile application.
    Tolv veckor efter LVLS genom uppföljning via mobil applikation.
    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: 20
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 40
    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 Decision2019-11-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-01-10
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2022-07-16
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