[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100607351":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":32,"centralContacts":33,"locations":43,"responsibleParty":60,"collaborators":32,"id":64,"slug":65,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":32,"eligibilityCriteria":70,"healthyVolunteers":66,"sex":71,"minAge":72,"maxAge":32,"enrollmentInfo":73,"targetDuration":32,"studyType":76,"phases":77,"briefSummary":79,"conditions":80,"keywords":93,"overallStatus":96,"whyStopped":32,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":106},{"fullName":5,"class":6},"St. Justine's Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Spinal","ACTIVE_COMPARATOR","Intrathecal fentanyl This group will receive intrathecal Bupivacaïne 0.25% 1ml + Fentanyl 15mcg And epidural Nacl 0.9%",[13],"Procedure: Spinal analgesia",{"label":15,"type":10,"description":16,"interventionNames":17},"Epidural","Epidural fentanyl This group will receive intrathecal Bupivacaïne 0.25% 1ml + NaCl 0,9% And epidural fentanyl 100mcg",[18],"Procedure: Epidural Analgesia",[20,27],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"PROCEDURE","Spinal analgesia","All procedures performed will be standardized. When neuraxial analgesia is required, an non-implicated anesthesiologist will performe the technique (not blind) The procedure will involve two steps. The first will involve an intraspinal injection of the solution using a 25-gauge Whitacre needle, while the second will be administered through the epidural catheter.\n\nSTEP 1: Intraspinal SPINAL Group: Bupivacaine 0.25% Isobaric 1 ml + Fentanyl 15 mcg, (0,3ml)\n\nSTEP 2: Epidural SPINAL group: 0.9% NaCl 2 ml.",[9],[9,26],"fentanyl",{"type":21,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"Epidural Analgesia","All procedures performed will be standardized. When neuraxial analgesia is required, an non-implicated anesthesiologist will performe the technique (not blind) The procedure will involve two steps. The first will involve an intraspinal injection of the solution using a 25-gauge Whitacre needle, while the second will be administered through the epidural catheter.\n\nSTEP 1: Intraspinal EPI Group: Bupivacaine 0.25% Isobaric 1 ml + NaCl 0.9% 0.3 ml\n\nSTEP 2: Epidural EPI group: Fentanyl 100 mcg, (2 ml of a concentration of 50 mcg\u002Fml)",[15],[15,26],null,[34,39],{"name":35,"role":36,"phone":37,"phoneExt":32,"email":38},"Valerie Zaphiratos, MD, MSc, FRCPC, Anesthesiology","CONTACT","5146684778","valerie@zaphiratos.ca",{"name":40,"role":36,"phone":41,"phoneExt":32,"email":42},"Aymen Messadaa, MD, Anesthesiology","514-603-5177","aymen.messadaa@umontreal.ca",[44],{"facility":45,"status":32,"city":46,"state":47,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"Centre Hospitalier Universitaire de Sainte Justine","Montreal","Quebec","H3T 1C5","Canada","CA",{"type":52,"coordinates":53},"Point",[54,55],-73.58781,45.50884,{"lat":55,"lon":54},[58],{"name":59,"role":36,"phone":32,"phoneExt":32,"email":32},"Valérie Zaphiratos, MD, MSc, FRCPC Anesthesiology",{"type":61,"investigatorFullName":62,"investigatorTitle":63,"investigatorAffiliation":5,"oldNameTitle":32,"oldOrganization":32},"PRINCIPAL_INVESTIGATOR","Valerie Zaphiratos","Associate Professor of Anesthesiology","100607351","incidence-of-pruritus-using-intrathecal-fentanyl-versus-epidural-fentanyl-to-initiate-labour-analgesia-100607351",false,"NCT07187427","Incidence of Pruritus Using Intrathecal Fentanyl Versus Epidural Fentanyl to Initiate Labour Analgesia.","Randomized Trial Comparing the Injection of Intrathecal Fentanyl Versus Epidural Fentanyl for the Initiation of Labour Analgesia on the Incidence of Pruritis.","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Vaginal delivery\n* Gestational age ≥ 37 weeks\n* Requesting neuraxial analgesia\n* French or English language\n\nExclusion Criteria:\n\n* ASA score \\> 3\n* Allergy or contraindication to receiving opioids\u002Flocal anesthesia (morphine or fentanyl)\n* BMI \\> 40 kg\u002Fm²\n* Hepatic or renal failure,\n* Severe preeclampsia and signs of severity according to the criteria of the American College of Obstetricians and Gynecologists\n* Maternal hemorrhage (placental abruption, hepatic subcapsular hematoma,...)\n* Severe scoliosis\n* Biliary cholestasis or polymorphic eruption of pregnancy\n* Inability to provide informed consent, either secondary to mental or physical disability or a significant language barrier (inability to understand English or French)\n* Prior administration of an opioid or opioid misuse","FEMALE","18 Years",{"count":74,"type":75},80,"ESTIMATED","INTERVENTIONAL",[78],"NA","The purpose of this study is to investigate the effect of neuraxial analgesia initiation on the incidence of pruritus in laboring women. Specifically, this study aim to compare intrathecal fentanyl with epidural fentanyl in order to determine whether the epidural route is associated with a lower occurrence and severity of pruritus. By clarifying these differences, the research seek to optimize analgesic strategies during labor while minimizing opioid-related side effects",[81,82,83,84,85,86,87,88,89,90,91,92],"Pruritis","Hypotension Drug-Induced","Urinary Retention","Fetal Bradycardia During Labor","Nausea and Vomitting","Satisfaction, Patient","Labor Analgesia","Neuraxial Opioid","Opioid Analgesic Adverse Reaction","Term Labour","Fentanyl Analgesia","Fentanyl Adverse Reaction",[94,95],"neuraxial opioid induced pruritus during labor","Intrathecal fentanyl versus Epidural fentanyl","NOT_YET_RECRUITING","2025-11-20",{"date":99,"type":100},"2025-11-26","ACTUAL",{"date":102,"type":75},"2026-01",{"date":104,"type":75},"2027-05",{"name":5,"class":6},1]