[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100454728":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":33,"centralContacts":38,"locations":39,"responsibleParty":52,"collaborators":38,"id":56,"slug":57,"hasResults":58,"nctId":59,"briefTitle":60,"officialTitle":61,"acronym":62,"eligibilityCriteria":63,"healthyVolunteers":64,"sex":65,"minAge":66,"maxAge":38,"enrollmentInfo":67,"targetDuration":38,"studyType":70,"phases":71,"briefSummary":73,"conditions":74,"keywords":78,"overallStatus":82,"whyStopped":38,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":91},{"fullName":5,"class":6},"Azienda Sanitaria-Universitaria Integrata di Udine","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"lidocaine spray","EXPERIMENTAL","nebulization 3 puffs of 10 mL Lidocaine hydrochloride 10% spray at a distance of 4-5 cm",[13],"Drug: Lidocaine Hydrochloride",{"label":15,"type":16,"description":17,"interventionNames":18},"mepivacaine infiltration","ACTIVE_COMPARATOR","subcutaneous \u002F submucosal infiltration depending on the type of perineal tear of 10 ml of 1% mepivacaine hydrochloride",[19],"Drug: Mepivacaine Injection",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Lidocaine Hydrochloride","nebulization of 3 puffs of 10 mL Lidocaine hydrochloride 10% spray at a distance of 4-5 cm",[9],[27],"ECOCAIN",{"type":22,"name":29,"description":17,"armGroupLabels":30,"otherNames":31},"Mepivacaine Injection",[15],[32],"MEPIVACAINA CLORIDRATO",[34],{"name":35,"affiliation":36,"role":37},"Lorenza Driul, professor","DAME","STUDY_CHAIR",null,[40],{"facility":41,"status":38,"city":42,"state":38,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":38},"ASUFC","Udine","33100","Italy","IT",{"type":47,"coordinates":48},"Point",[49,50],13.23715,46.0693,{"lat":50,"lon":49},{"type":53,"investigatorFullName":54,"investigatorTitle":55,"investigatorAffiliation":5,"oldNameTitle":38,"oldOrganization":38},"PRINCIPAL_INVESTIGATOR","Stefano Restaino","Principal Investigator","100454728","phase-3-efficacy-and-safety-of-the-application-of-local-anaesthetic-in-spray-to-repair-of-1st--2nd-perineal-lacerations-100454728",false,"NCT05201313","Efficacy and Safety of the Application of Local Anaesthetic in Spray to Repair of 1st- 2nd Perineal Lacerations","Randomised Controlled Trial to Evaluate the Efficacy of Local Anaesthetic Application in Spray for the Repair of 1st- 2nd Perineal Lacerations Following Vaginal Delivery","LISPRAY","Inclusion Criteria:\n\n* have a 1st or 2nd degree postpartum perineal laceration requiring suturing;\n* have reached 37 gestational weeks;\n* are over 18 years of age;\n* had a top birth;\n* are able to understand the Italian language;\n* have a consent to participate in the study;\n\nExclusion Criteria:\n\n\\- have received epidural anesthesia within 2 hours prior to delivery;\n\n* had an operative birth;\n* have a psychiatric pathology;\n* have had a twin birth;\n* have experienced adverse reactions to any local anesthetic in the past;\n* hypersensitivity to the active substance or to any of the excipients\n* Severe disturbances of the cardiac conduction system\n* Acute non compensated heart failure\n* Severe arteriopathies\n* Severe uncontrolled hypertension\n* Intravascular injections\n* Septicemia Dysfunction\n* Infection at the injection site\n* Kidney failure. Providing for the exclusion of patients with severe renal impairment (estimated GFR \\\u003C30 mL \u002F min \u002F 1.73 m2 at the time of screening).\n* Advanced liver dysfunction\n* Hyperthyroidism\n* Acute angle glaucoma\n* Participation in a clinical trial in which an investigational drug was administered within 30 days of screening or 5 half-lives of the study drug\n* Any clinical condition that in the investigator's judgment would render the patient unsuitable for the study including, but not limited to, infectious, inflammatory, psychiatric, neurological, cardiological, renal, hepatic, respiratory, diabetes) conditions or laboratory value at clinically meaningful screening that, an investigator's opinion, may present a safety risk, interface with study compliance and follow-up;\n* have had in pregnancy liver disease including pre-eclampsia.",true,"FEMALE","18 Years",{"count":68,"type":69},136,"ACTUAL","INTERVENTIONAL",[72],"PHASE3","Randomized controlled trial aimed at evaluating the efficacy and safety of the use of a local anesthetic spray, commonly used in clinical practice as off-label, during the suturing of perineal lacerations in post-partum, comparing it with the standard technique that involves the infiltration of lacerated tissues, by administering a NRS card at the end of the procedure.",[75,76,77],"Vaginal Discharge","Perineum; Rupture","Analgesia",[79,80,81],"perineal laceration","suturing","anesthetic","COMPLETED","2023-09-16",{"date":85,"type":69},"2023-09-21",{"date":87,"type":69},"2022-01-20",{"date":89,"type":69},"2022-08-08",{"name":5,"class":6},1]