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    Summary
    EudraCT Number:2021-002257-28
    Sponsor's Protocol Code Number:2021-002257-28
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-10-22
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2021-002257-28
    A.3Full title of the trial
    Randomised controlled trial to evaluate the efficacy of local anaesthetic application in spray for the repair of 1st- 2nd perineal lacerations following vaginal delivery
    Trial controllato randomizzato per valutare l'efficacia dell’applicazione di anestetico locale in forma di spray per la riparazione di lacerazioni di I°-II° perineali a seguito di parto vaginale
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy and safety of the application of local anaesthetic in spray form for the repair of 1st- 2nd perineal lacerations following vaginal delivery
    Efficacia e sicurezza dell’applicazione di anestetico locale in forma di spray per la riparazione di lacerazioni di I°-II° perineali a seguito di parto vaginale
    A.3.2Name or abbreviated title of the trial where available
    Lispray
    Lispray
    A.4.1Sponsor's protocol code number2021-002257-28
    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 SponsorAZIENDA OSPEDALIERO-UNIVERSITARIA UDINE
    B.1.3.4CountryItaly
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAzienda Sanitaria Universitaria Friuli Centrale - Udine
    B.5.2Functional name of contact pointSOC Ginecologia ed Ostetricia
    B.5.3 Address:
    B.5.3.1Street AddressP.le Santa Maria della Misericordia
    B.5.3.2Town/ cityUdine
    B.5.3.3Post code33100
    B.5.3.4CountryItaly
    B.5.6E-mailstefano.restaino@asufc.sanita.fvg.it
    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 Ecocain
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 nameEcocain
    D.3.2Product code [027388091]
    D.3.4Pharmaceutical form
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPVaginal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLIDOCAINA CLORIDRATO
    D.3.9.2Current sponsor code61528
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number50
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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 mepivacaina cloridrato
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 namemepivacaina cloridrato
    D.3.2Product code [102614070]
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPVaginal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNMEPIVACAINA CLORIDRATO
    D.3.9.2Current sponsor code61528
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number20
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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
    Considering the high percentage of grade 1 and 2 perineal lacerations, it is evident that another route of administration of the anaesthetic could be of great help in further reducing the discomfort of the woman. In particular, the use of topical lidocaine spray administered by nebulisation onto the wound could ensure greater clinical efficacy on pain control, pain-free administration, and ease of use by operators.
    Considerando l’alta percentuale di lacerazioni perineali di grado 1 e 2 risulta evidente come potrebbe essere di grande ausilio l’utilizzo di un’altra via di somministrazione dell’anestetico al fine di ridurre ulteriormente il discomfort della donna. L’utilizzo della lidocaina spray per uso topico somministrata attraverso nebulizzazione sulla ferita potrebbe garantire una maggiore efficacia clinica sul controllo del dolore ed una maggiore facilità d’utilizzo da parte degli operatori.
    E.1.1.1Medical condition in easily understood language
    To evaluate the efficacy and safety of using a spray anaesthetic during suturing of perineal lacerations, comparing it with the standard technique.
    Valutare l’efficacia e la sicurezza dell’utilizzo di un anestetico spray durante la sutura di lacerazioni perineali, confrontandola con la tecnica standard.
    E.1.1.2Therapeutic area Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level SOC
    E.1.2Classification code 10021428
    E.1.2Term Immune system disorders
    E.1.2System Organ Class 10021428 - Immune system disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To compare the effectiveness of treating pain during suturing of postpartum perineal lacerations with lidocaine spray vs skin infiltration.
    Confrontare l’efficacia del trattamento del dolore durante la sutura delle lacerazioni perineali post-partum con nebulizzazione di lidocaina spray vs infiltrazione cutanea.
    E.2.2Secondary objectives of the trial
    /
    /
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Grade I or II post-partum perineal laceration requiring suturing;
    - full-term delivery (beyond 36 weeks and 6 days of gestation)
    - over 18 years of age
    - childbirth at the top;
    - understanding of the Italian language;
    - consent to participate in the study.
    • lacerazione perineale post-partum di I o II grado con necessità di sutura;
    • parto a termine (oltre le 36 settimane e 6 giorni di gestazione
    • età superiore a 18 anni;
    • parto di vertice;
    • comprensione della lingua italiana;
    • consenso a partecipare allo studio.
    E.4Principal exclusion criteria
    - epidural anaesthesia during the 2 hours preceding delivery;
    - operative delivery with the application of forceps or suction cups;
    - psychiatric pathology;
    - twin births;
    - known allergies to study instruments
    - previous adverse reactions to local anaesthetics
    • anestesia epidurale nelle 2 ore precedenti all’espletamento del parto;
    • parto operativo con applicazione di forcipe o ventosa;
    • patologia psichiatrica;
    • parto gemellare;
    • allergie note agli strumenti di studio;
    • precedenti reazioni avverse ad anestetici locali
    E.5 End points
    E.5.1Primary end point(s)
    To evaluate the efficacy and safety of using a local anaesthetic spray, commonly used in clinical practice as an off label, during suturing of perineal lacerations in the postpartum period, comparing it with the standard technique involving infiltration of the lacerated tissues.
    Valutare l’efficacia e la sicurezza dell’utilizzo di un anestetico locale spray, utilizzato comunemente nella pratica clinica come off label, durante la sutura di lacerazioni perineali nel post-partum, confrontandola con la tecnica standard che prevede l’infiltrazione dei tessuti lacerati.
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 months
    12 mesi
    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 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) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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) 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.8.4.1Number of sites anticipated in Member State concerned1
    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 Information not present in EudraCT
    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
    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 months12
    E.8.9.1In the Member State concerned days36
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months12
    E.8.9.2In all countries concerned by the trial days36
    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: 128
    F.1.3Elderly (>=65 years) No
    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 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 state128
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 128
    F.4.2.2In the whole clinical trial 128
    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)
    not foreseen
    non previsti
    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 Decision2021-10-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-11-09
    P. End of Trial
    P.End of Trial StatusOngoing
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