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    The EU Clinical Trials Register currently displays   44309   clinical trials with a EudraCT protocol, of which   7356   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2014-004236-19
    Sponsor's Protocol Code Number:PUB2014
    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:2014-12-03
    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 number2014-004236-19
    A.3Full title of the trial
    Pudendal block after posterior vaginal surgery. A randomized controlled trial on postoperative pain.
    Pudendusblockad efter bakre vaginal kirurgi. En randomiserad kontrollerad studie.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study on pain relief after vaginal surgery
    En studie om smärtlindring efter vaginal kirurgi.
    A.3.2Name or abbreviated title of the trial where available
    PUB2014
    A.4.1Sponsor's protocol code numberPUB2014
    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 SponsorLandstinget i Östergötland
    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 supportLandstinget i Östergötland
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationlandstinget i Östergötland
    B.5.2Functional name of contact pointKvinnokliniken
    B.5.3 Address:
    B.5.3.1Street AddressUniversitetssjukhuset
    B.5.3.2Town/ cityLinköping
    B.5.3.3Post code58185
    B.5.3.4CountrySweden
    B.5.4Telephone number0046101097897
    B.5.6E-maileva.uustal@lio.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 ropivacain hydrochloride
    D.2.1.1.2Name of the Marketing Authorisation holderFresenius Kabi
    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.3.1Product nameropivacain hydrochloride
    D.3.2Product code SUB22590
    D.3.4Pharmaceutical form Injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPPerineural use
    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 placeboInjection
    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
    postoperativ smärta
    E.1.1.1Medical condition in easily understood language
    pain after surgery
    smärta efter operation
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.1
    E.1.2Level LLT
    E.1.2Classification code 10036236
    E.1.2Term Postoperative pain relief
    E.1.2System Organ Class 100000004865
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To establish whether pudendal block with ropivacain after posterior vaginal surgery is better than placebo against postoperative pain.

    Att visa att pudendusblockad med ropivacain är bättre än placebo som smärtlindring efter bakre vaginal kirurgi
    E.2.2Secondary objectives of the trial
    To investigate whether the duration of and the experience of the hospital stay, need for additional pain relief, nausea, vomiting, micturition disturbances, and complications, recovery differ between the patients receiving ropivacain compared to receiving sodium chloride as pudendal blockade. To describe the levels of Hospital related anxiety and depression "HAD"and correlate these to experience of pain. Can staff identify patients with high levels of HAD?
    • Kan kvinnor som behandlas med pudendusblockad gå hem snabbare än kvinnor som får placebo
    • Behöver kvinnor som behandlas med pudendusblockad mindre opiatmedicinering än kvinnor som får placebo
    • Upplever kvinnor som behandlas med pudendusblockad vårdtillfället som mer positivt än kvinnor som får placebo
    • Har kvinnor som behandlas med pudendusblockad kortare tid till första miktion och mindre miktionsstörningar än kvinnor som får placebo
    • Mår kvinnor som behandlas med pudendusblockad mindre illa än kvinnor som får placebo
    • Har kvinnor som behandlas med pudendusblockad kortare tid till normal aktivitet i det postoperativa förloppet
    • Påverkar kvinnans preoperativa ångest- och depressionnivå mätt med HAD smärtupplevelsen
    • Kan personal som behandlar kvinnan vid operationen vid vanlig vårdkontakt identifiera kvinnor med hög ångestsnivå mätt med HAD
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Women between 18 and 70 years of age.
    The patient is scheduled for primary posterior vaginal reconstructive surgery because of posterios vaginal wall prolapse or suboptimally healed tear from previous delivery injury including suture between muscle tendons in local anesthesia and sedation.
    The woman can understand and express herself in Swedish.
    The woman agrees to participate in the study after written and verbal information through the signature of the form "informed consent".
    Kvinnan är mellan 18 och 70 år.
    Kvinnan ska genomgå primär bakre rekonstruktiv vaginalplastik på grund av bakväggsframfall eller tidigare förlossningsskada innefattande sutur i mellangårdens muskelfästen i lokalanestesi och sedering
    Kvinnan förstår och kan uttrycka sig på svenska.
    Kvinnan accepterar att delta i studien efter skriftlig och muntlig information genom signatur av formuläret ”Informerat samtycke”.
    E.4Principal exclusion criteria
    Additional surgery planned while at the hospital for the operation.
    Hypersensitivity to Ropivacaine, to other local anesthetics of the amide type, or to
    sodium chloride, hydrochloric acid (for pH adjustment), sodium hydroxide (for pH adjustment) and water for injections.
    Pregnancy
    Hypovolemia
    The woman is disabled and can’t be expected to be mobilized the day after surgery in the same way as non-disabled people.
    The woman is mentally incapacitated to such an extent that she can’t complete the relevant questionnaires, understand the implications of participating in the study, or the patient's participation it may be ethically questionable if
    The woman has severe mental illness or medication for severe mental illness. The responsible doctor considers it inappropriate that patient will be included in the study.
    Women with chronic pelvic pain
    Woman taking medication for severe pain with drugs other than paracetamol and NSAIDs, which can affect the outcome measure.
    Ytterligare kirurgiskt ingrepp planeras
    Kvinnan är överkänslig mot ropivacain eller i hjälpämnen i beredningen
    Graviditet
    Hypovolemi
    Kvinnan är rörelsehindrad och kan inte förväntas mobiliseras dagen efter operation på samma sätt som icke-rörelsehindrade.
    Kvinnan är förståndshandikappad i en sådan grad att hon inte kan fylla i de relevanta enkäterna mm. eller inte förstår innebörden av att delta i studien eller det kan vara etiskt tvivelaktigt om patientens deltagande i studien.
    Kvinnan har svår psykisk sjukdom eller medicinerar för svår psykisk sjukdom så ansvarig läkare anser det olämpligt att patienten inkluderas i studien.
    Kvinnan lider av kronisk bäckenbottensmärta
    Kvinnan medicinerar mot annan smärta med andra läkemedel än paracetamol och NSAID
    E.5 End points
    E.5.1Primary end point(s)
    Worst pain during the first 6 postoperative hours measured on a 10-point visual analog scale
    Maximal smärta skattad med VAS-skala de första 6 postoperativa timmarna efter operation
    E.5.1.1Timepoint(s) of evaluation of this end point
    With predefined intervals during the first postoperative 6 hours
    Med fördefinierade intervall under de första 6 postoperativa timmarna
    E.5.2Secondary end point(s)
    Length of hospital stay, given analgesics during the first 6 postoperative hours, VAS-assessed global experience of the care episode and nausea / vomiting, incidence of micturition disorders, time to breakthrough pain, number of days to recovery (normal ADL activity), incidence of reported complications, and the occurrence numbness or restricted movement in the legs
    HAD fylls i vid operationsplanering om kvinnan deltar i studien. Tiden mellan ifyllande och operation kan uppgå till 6 månader som mest. Normalt inom 2 månader
    .• Kan kvinnor som behandlas med pudendusblockad gå hem snabbare än kvinnor som får placebo
    • Behöver kvinnor som behandlas med pudendusblockad mindre opiatmedicinering än kvinnor som får placebo
    • Upplever kvinnor som behandlas med pudendusblockad vårdtillfället som mer positivt än kvinnor som får placebo
    • Har kvinnor som behandlas med pudendusblockad kortare tid till första miktion och mindre miktionsstörningar än kvinnor som får placebo
    • Mår kvinnor som behandlas med pudendusblockad mindre illa än kvinnor som får placebo
    • Har kvinnor som behandlas med pudendusblockad kortare tid till normal aktivitet i det postoperativa förloppet
    • Påverkar kvinnans preoperativa ångest- och depressionnivå mätt med HAD smärtupplevelsen
    Får kvinnor som får aktiv blockad färre komplikationer efter operationen
    E.5.2.1Timepoint(s) of evaluation of this end point
    HAD is completed after informed consent is given and the operation is planned. The interval between planning and surgery is up to 6 months, normally within 2 months.
    Pain, nausea, global impression of hospital stay and medication given is measured during the first postoperative 6 hours, if the patients wakes up during the night and the next day.
    Days to recovery and occurrence of complications perceived by the patient is measured in a questionnaire 8 weeks after surgery as part of routine quality registration for gynecological surgery.
    HAD vid operationsplanering. Perioperativa variabler mäts under det första postoperativa dygnet.
    Tid till ADL och förekomst av komplikationer mäts genom rutinuppföljning i kvalitetsregister för gynekologisk kirurgi
    " gynopregistret" med enkät efter 8 veckor.
    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 No
    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 Yes
    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
    Last patient last Contact.
    Sista patienten sista kontakt.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    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: 45
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 5
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    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 2014-12-03. Yes
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women Yes
    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 state50
    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)
    Complications after surgery are treated according to standard guidelines.
    Komplikationer efter operation behandlas utifrån klinisk rutin
    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 Decision2015-01-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-02-13
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-02-21
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