[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100559757":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":24,"centralContacts":28,"locations":34,"responsibleParty":55,"collaborators":24,"id":59,"slug":60,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":24,"eligibilityCriteria":65,"healthyVolunteers":61,"sex":66,"minAge":67,"maxAge":68,"enrollmentInfo":69,"targetDuration":24,"studyType":72,"phases":73,"briefSummary":75,"conditions":76,"keywords":24,"overallStatus":36,"whyStopped":24,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":90},{"fullName":5,"class":6},"Ain Shams University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Lignocaine group","EXPERIMENTAL","A perineal infiltration of a 5-ml of the drug (100 mg of lignocaine) in the margins of the episiotomy. Careful aspiration before and during injection of the product should be performed to prevent intravascular injection. The entire contents will then be injected slowly at several points of infiltration. All planes will be infiltrated (vagina, muscle, and skin) before episiotomy repair.",[13],"Drug: Lignocaine",{"label":15,"type":10,"description":16,"interventionNames":17},"Bupivacaine group","A perineal infiltration of a 5-ml of the study drug (20 mg of Bupivacaine) in the margins of the episiotomy. Careful aspiration before and during injection of the product should be performed to prevent intravascular injection. The entire contents will then be injected slowly at several points of infiltration. All planes will be infiltrated (vagina, muscle, and skin) before episiotomy repair.",[18],"Drug: Bupivacaine",[20,25],{"type":21,"name":22,"description":11,"armGroupLabels":23,"otherNames":24},"DRUG","Lignocaine",[9],null,{"type":21,"name":26,"description":16,"armGroupLabels":27,"otherNames":24},"Bupivacaine",[15],[29],{"name":30,"role":31,"phone":32,"phoneExt":24,"email":33},"Mostafa M El Bukhari, MBBCH","CONTACT","00201002609476","mostafaserry15@gmail.com",[35],{"facility":5,"status":36,"city":37,"state":24,"zip":24,"country":38,"countryCode":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":46},"RECRUITING","Cairo","Egypt","EG",{"type":41,"coordinates":42},"Point",[43,44],31.24967,30.06263,{"lat":44,"lon":43},[47,48,51,53],{"name":30,"role":31,"phone":32,"phoneExt":24,"email":33},{"name":49,"role":50,"phone":24,"phoneExt":24,"email":24},"Mohamed T Mahmoud, MD","SUB_INVESTIGATOR",{"name":52,"role":50,"phone":24,"phoneExt":24,"email":24},"Ahmed M Mansour, MD",{"name":54,"role":50,"phone":24,"phoneExt":24,"email":24},"Ahmed M Hassan, MD",{"type":56,"investigatorFullName":57,"investigatorTitle":58,"investigatorAffiliation":5,"oldNameTitle":24,"oldOrganization":24},"PRINCIPAL_INVESTIGATOR","Mostafa Serry","Captain Doctor, Resident of Obstetrics and Gynecology-The Police academy hospitals","100559757","lignocaine-vs-bupivacaine-infiltration-for-postpartum-perineal-pain-after-vaginal-delivery-with-episiotomy-in-primigravidae-100559757",false,"NCT06568289","Lignocaine vs Bupivacaine Infiltration for Postpartum Perineal Pain After Vaginal Delivery With Episiotomy in Primigravidae","Lignocaine vs Bupivacaine Infiltration for Postpartum Perineal Pain After Vaginal Delivery With Episiotomy in Primigravidae: A Prospective Randomized, Double-Blind, Clinical Trial","Inclusion Criteria:\n\n* Primigravidae with the full term undergoing vaginal delivery with episiotomy.\n* Pregnancies and singleton vertex cephalic fetuses.\n* In the active phase of the first stage of labor.\n\nExclusion Criteria:\n\n* Patients with history of drug allergies to study drugs as this will increase the risk of complications.\n* Patients undergoing vaginal delivery under epidural or spinal anesthesia as they will affect post-operative pain and interfere with assessment of efficacy of local infiltration of the study drugs.\n* Evidence of local infection at site of injection as this will interfere with the action of the study drug and will increase the risk of complications.\n* Inability to cooperate as this will affect our assessment.\n* Patient's refusal.\n* Any intraoperative complications that will affect our outcome criteria (bleeding, organ injury) as they will affect patient's vital data and affect our assessment.\n* Neurological comorbidities (chronic pain disorder, chronic systemic disease, neurological disorder, neuropathic pain) as they will need more analgesia.\n* Drug abuse as they will be tolerant to the used analgesics.","FEMALE","18 Years","40 Years",{"count":70,"type":71},60,"ESTIMATED","INTERVENTIONAL",[74],"NA","In this study, we will compare the effect and safety of lignocaine versus bupivacaine infiltration for postpartum perineal pain after vaginal delivery with episiotomy in primigravidae.",[22,26,77,78,79,80],"Postpartum Perineal Pain","Vaginal Delivery","Episiotomy","Primigravidae","2024-08-22",{"date":83,"type":84},"2024-08-23","ACTUAL",{"date":86,"type":84},"2024-03-01",{"date":88,"type":71},"2024-09-01",{"name":5,"class":6},1]