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    Summary
    EudraCT Number:2020-004353-80
    Sponsor's Protocol Code Number:179/2020
    National Competent Authority:Finland - Fimea
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2020-12-07
    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 ConcernedFinland - Fimea
    A.2EudraCT number2020-004353-80
    A.3Full title of the trial
    Laparoscopically inserted transversus abdominis plane block versus local wound anesthesia in laparoscopic peritoneal endometriosis surgery: a prospective randomized controlled double-blinded LTAP-trial
    Laparoskopiaohjattu TAP-puudutus (LTAP) vs. paikallispuudutus tähystinkirurgisessa endometrioosileikkauksessa; randomoitu sokkoutettu prospektiivinen tutkimus
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Abdominal wall anesthetic versus local wound anesthetic in laparoscopic endometriosis surgery; a prospective randomized controlled double-blinded study
    Vatsanpeitteiden johtopuudutuksen ja leikkaushaavojen paikallispuudutuksen vertailu tähystinkirurgisen endometrioosileikkauksen jälkeen; satunnaistettu ja kaksoisokkoutettu tutkimus
    A.4.1Sponsor's protocol code number179/2020
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    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 Chirocaine 2,5mg/ml
    D.2.1.1.2Name of the Marketing Authorisation holderAbbVie Oy
    D.2.1.2Country which granted the Marketing AuthorisationFinland
    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 Injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPInfiltration
    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 Chirocaine 5mg/ml
    D.2.1.1.2Name of the Marketing Authorisation holderAbbVie Oy
    D.2.1.2Country which granted the Marketing AuthorisationFinland
    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 Injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPInfiltration
    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 placeboInfiltration
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    The study subjects are patients with endometriosis needing surgical treatment.
    Tutkimuspotilaat ovat endometrioosipotilaita, jotka tarvitsevat kirurgista hoitoa.
    E.1.1.1Medical condition in easily understood language
    The study subjects are patients with endometriosis needing surgical treatment.
    Tutkimuspotilaat ovat endometrioosipotilaita, jotka tarvitsevat kirurgista hoitoa.
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
    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 objective of this study is to compare the effect and safety of LTAP (Chirocaine 2,5 mg/ml 40 ml) to local wound analgesia (Chirocaine 5mg/ml 10 ml) treating post-laparoscopic pain measured by postoperative opioid consumption.
    Tutkimuksessa verrataan LTAP-puudutuksen (Chirocaine 2,5mg/ml 40 ml) tehoa ja turvallisuutta leikkaushaavojen paikallispuudutukseen (Chirocaine 5mg/ml 10 ml) mittaamalla PCA-pumpun opioidikulutusta leikkauksen jälkeisen kivun hoidossa.
    E.2.2Secondary objectives of the trial
    As for secondary outcome, postoperative pain will be measured using NRS scaled 1 to 10 at the recovery room, at the ward and at discharge every six hours. Facts related to postoperative recovery (nausea, vomiting, peroral intake, mobilization, complications and time of discharge) will serve as other outcomes and will be measured accordingly. Additionally, a 6-month postoperative follow-up will be conducted using NRS pain inquiry and EHP-30 questionnaire sent to participants.
    Postoperatiivista kipua mitataan NRS-skaalalla 1-10 kuuden tunnin välein heräämössä, osastolla ja kotiutumisen yhteydessä. Lisäksi tutkimme LTAP-puudutuksen vaikutusta potilaan postoperatiiviseen toipumiseen (pahoinvointi, oksentelu, suun kautta ravitsemus, mobilisaatio, komplikaatiot) ja kotiutumiseen. Potilaiden kokema leikkaustulos arvioidaan preoperatiivisesti ja 6 kk kuluttua leikkauksesta täytettyjen kipu- ja EHP-30- kyselyiden avulla.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Age 18-50 years.
    Diagnosed or suspected peritoneal endometriosis. Laparoscopic surgery indicated.
    ASA 1-3.
    The study subject is able to understand the study plan and to give informed consent.
    Ikä 18 – 50 v.
    Leikkaushoito indisoitu peritoneaalisen endometrioosin tai sen epäilyn takia.
    ASA-riskiluokka 1-3.
    Tutkittava ymmärtää tutkimuksen merkityksen ja kykenee antamaan vapaaehtoisen suostumuksen
    E.4Principal exclusion criteria
    Sleep-apnea.
    ASA > 3.
    Other risk factors related to opioid use.
    contraindications to opioids or non-steroidal anti-inflammatory drugs.
    continuous opioid intake preoperatively.
    Uniapnea.
    ASA-riskiluokka >3.
    Muu opioidin annosteluun liittyvä merkittävä riskitekijä.
    Vasta-aihe puuduteaineille tai tulehduskipulääkkeelle.
    Säännöllinen preoperatiivinen opioidin käyttö.
    E.5 End points
    E.5.1Primary end point(s)
    The primary end point of the study is the assumption that LTAP will decrease the postoperative opioid consumption measured by PCA-pump by 50% in comparison to local wound analgesia.
    Tutkimuksen päähypoteesin mukaan LTAP-ryhmässä PCA-pumpun avulla mitattu postoperatiivinen opioidin kulutus on 50% vähäisempää kuin paikallispuudutusryhmässä.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The total opioid consumption will be measured from the beginning of surgery until hospital discharge.
    Totaali opioidin kulutus mitataan leikkauksen alusta kotiutukseen asti.
    E.5.2Secondary end point(s)
    Secondary end points are postoperative pain and facts related to recovery; nausea, vomiting, peroral intake, mobilisation, complications, time to discharge. Additional end points are pain and general health six months after surgery evaluated by questionnaires (NRS, EHP-30).
    Sekundaariset vastemuuttujat ovat postoperatiivinen kipu ja leikkauksesta toipuminen; pahoinvointi, oksentelu, suun kautta ravitsemus, mobilisoituminen, komplikaatiot ja kotiutumis-aikataulu. Lisäksi tutkitaan 6 kuukauden leikkaustulokset kivun ja yleisterveyden suhteen kyselykaavakkein (NRS ja EHP-30).
    E.5.2.1Timepoint(s) of evaluation of this end point
    Secondary end points will be measured every six hours from the beginning of surgery until discharge. Questionnaires will be evaluated six months after surgery.
    Sekundaariset vastemuuttujat mitataan kuuden tunnin välein leikkauksesta aina kotiutumiseen asti. Kyselykaavakkeet evaluoidaan 6 kuukauden kuluttua leikkauksesta.
    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 Yes
    E.8.2.3.1Comparator description
    Tutkimuksessa verrataan kahta puudutemenetelmää; LTAP vs. paikallispuudutus
    We compare two methods of postoperative analgesia; LTAP and local wound analgesia
    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
    The trial with postoperative pain and recovery measurements will end at discharge. The follow-up section will end at six months after surgery. No additional visits are included in the study plan.
    Postoperatiiviseen kipuun ja toipumiseen liittyvät tutkimukset saadaan päätökseen potilaan kotiuessa leikkauksesta. Seurantatutkimus loppuu kuusi kuukautta leikkauksen jälkeen. Tutkimusprotokollaan ei kuulu leikkauksen jälkeisiä tutkimuskäyntejä.
    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: 44
    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 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 2020-12-07. 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 state44
    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.
    Ei.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2021-01-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-11-30
    P. End of Trial
    P.End of Trial StatusOngoing
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