[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100559915":3},{"organization":4,"outcomesModule":7,"designInfo":89,"detailedDescription":88,"studyPopulation":88,"armGroups":99,"interventions":112,"overallOfficials":88,"centralContacts":120,"locations":88,"responsibleParty":126,"collaborators":88,"id":130,"slug":88,"hasResults":131,"nctId":132,"briefTitle":133,"officialTitle":134,"acronym":88,"eligibilityCriteria":135,"healthyVolunteers":136,"sex":137,"minAge":138,"maxAge":139,"enrollmentInfo":140,"targetDuration":88,"studyType":143,"phases":144,"briefSummary":146,"conditions":147,"keywords":88,"overallStatus":149,"whyStopped":88,"lastUpdateSubmitDate":150,"lastUpdatePostDateStruct":151,"startDateStruct":154,"completionDateStruct":156,"leadSponsor":158,"locationsCount":88},{"fullName":5,"class":6},"Seoul National University Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":88},[9],{"measure":10,"description":11,"timeFrame":12},"Incidence of intraoperative pain","Incidence of intraoperative pain of NRS (numeric rating scale) score of 4 or higher","From first skin incision to end of surgery",[14,17,19,22,25,27,29,33,35,39,42,45,47,50,52,54,58,61,64,68,72,76,80,83,85],{"measure":15,"description":16,"timeFrame":12},"Time of occurence of intraoperative pain","Time of occurence of intraoperative pain of NRS (numeric rating scale) score of 4 or higher",{"measure":18,"description":18,"timeFrame":12},"Incidence of intraoperative rescue analgesic administration",{"measure":20,"description":21,"timeFrame":12},"Total amount of intraoperative opioid rescue analgesic administration","Total amount of intraoperative opioid rescue analgesic administration (morphine mg equivalent)",{"measure":23,"description":24,"timeFrame":12},"Total amount of intraoperative non-opioid rescue analgesic administration","Total amount of intraoperative non-opioid rescue analgesic administration (mg)",{"measure":26,"description":26,"timeFrame":12},"Intraoperative pain characteristics",{"measure":28,"description":28,"timeFrame":12},"Conversion to general anesthesia",{"measure":30,"description":31,"timeFrame":32},"Preoperative anxiety","Preoperative anxiety (APAIS, Amsterdam Preoperative Anxiety and Information Score)","On the day before surgery",{"measure":30,"description":31,"timeFrame":34},"On the day of surgery",{"measure":36,"description":37,"timeFrame":38},"Total amount of postoperative opioid analgesic administered","Total amount of postoperative opioid analgesic administered (morphine mg equivalent)","From end of surgery to 24 hours after end of surgery",{"measure":40,"description":40,"timeFrame":41},"Incidence of intraoperative nausea\u002Fvomiting","From induction to end of surgery",{"measure":43,"description":43,"timeFrame":44},"Incidence of postoperative nausea\u002Fvomiting","From end of surgery to 24h post-surgery",{"measure":46,"description":46,"timeFrame":41},"Incidence of intraoperative shivering",{"measure":48,"description":49,"timeFrame":41},"Incidence of intraoperative hypotension","Incidence of intraoperative hypotension (MBP\\\u003C65 mmHg)",{"measure":51,"description":51,"timeFrame":41},"Incidence of intraoperative pruritus",{"measure":53,"description":53,"timeFrame":44},"Incidence of postoperative pruritus",{"measure":55,"description":56,"timeFrame":57},"Immediate post-operative patient satisfaction","Immediate post-operative patient satisfaction on intraoperative analgesia","At the end of surgery",{"measure":59,"description":59,"timeFrame":60},"Obstetric Quality of Recovery-11K score","At 24 hours post-surgery",{"measure":62,"description":62,"timeFrame":63},"Time of first postoperative pain","From end of surgery to 24 hours post-surgery",{"measure":65,"description":66,"timeFrame":67},"Pain score at 8 hours post-surgery","Pain score at 8 hours post-surgery (NRS, numeric rating scale pain score, 0: no pain; 10: worst imaginable pain)","at 8 hours post-surgery",{"measure":69,"description":70,"timeFrame":71},"Pain score at 16 hours post-surgery","Pain score at 16 hours post-surgery (NRS, numeric rating scale pain score, 0: no pain; 10: worst imaginable pain)","at 16 hours post-surgery",{"measure":73,"description":74,"timeFrame":75},"Pain score at 24 hours post-surgery","Pain score at 24 hours post-surgery (NRS, numeric rating scale pain score, 0: no pain; 10: worst imaginable pain)","at 24 hours post-surgery",{"measure":77,"description":78,"timeFrame":79},"Pain score at 2 hours post-surgery","Pain score at 2 hours post-surgery (NRS, numeric rating scale pain score, 0: no pain; 10: worst imaginable pain)","at 2 hours post-surgery",{"measure":81,"description":82,"timeFrame":63},"Incidence of postoperative hypotension","Incidence of postoperative hypotension (MBP\\<65 mmHg)",{"measure":84,"description":84,"timeFrame":63},"Incidence of postoperative shivering",{"measure":86,"description":87,"timeFrame":75},"24-hour post-operative patient satisfaction","24-hour post-operative patient satisfaction on postoperative analgesia",null,{"allocation":90,"interventionModel":91,"interventionModelDescription":88,"primaryPurpose":92,"observationalModel":88,"timePerspective":88,"maskingInfo":93},"RANDOMIZED","PARALLEL","PREVENTION",{"masking":94,"maskingDescription":88,"whoMasked":95},"TRIPLE",[96,97,98],"PARTICIPANT","CARE_PROVIDER","OUTCOMES_ASSESSOR",[100,106],{"label":101,"type":102,"description":103,"interventionNames":104},"Fentanyl-Morphine","EXPERIMENTAL","Spinal anesthesia with heavy bupivacaine, fentanyl and morphine",[105],"Drug: Fentanyl-Morphine",{"label":107,"type":108,"description":109,"interventionNames":110},"Morphine","ACTIVE_COMPARATOR","Spinal anesthesia with heavy bupivacaine and morphine",[111],"Drug: Morphine",[113,117],{"type":114,"name":101,"description":115,"armGroupLabels":116,"otherNames":88},"DRUG","Intrathecal injection of bupivacaine, fentanyl and morphine",[101],{"type":114,"name":107,"description":118,"armGroupLabels":119,"otherNames":88},"Intrathecal injection of bupivacaine and morphine",[107],[121],{"name":122,"role":123,"phone":124,"phoneExt":88,"email":125},"Jin-Tae Kim, M.D., Ph.D","CONTACT","+82-2-2072-2467","jintae73@gmail.com",{"type":127,"investigatorFullName":128,"investigatorTitle":129,"investigatorAffiliation":5,"oldNameTitle":88,"oldOrganization":88},"PRINCIPAL_INVESTIGATOR","Jin-Tae Kim","Professor","100559915",false,"NCT06570343","Analgesic Efficacy of Intrathecal Fentanyl-Morphine Combination Versus Morphine Alone for Intraoperative Pain During Elective Cesarean Delivery","Analgesic Efficacy of Intrathecal Fentanyl-Morphine Combination Versus Morphine Alone for Intraoperative Pain During Elective Cesarean Delivery: a Randomized Clinical Trial","Inclusion Criteria:\n\n* Parturients of gestational age \\> 37 weeks, scheduled for cesarean section under spinal anesthesia\n\nExclusion Criteria:\n\n* Contraindication to spinal anesthesia\n* Any sign of onset of labor\n* Emergency cesarean section\n* Body weight \\\u003C 40 kg or \\> 120 kg\n* Height \\\u003C 140 cm or \\> 190 cm\n* Severe underlying cardiovascular disease\n* Known fetal anomaly\n* Preeclampsia\n* History of hypersensitivity to fentanyl or morphine\n* Chronic opioid use",true,"FEMALE","19 Years","99 Years",{"count":141,"type":142},186,"ESTIMATED","INTERVENTIONAL",[145],"PHASE4","Pregnant women scheduled for elective cesarean sections under spinal anesthesia are randomly assigned to two groups: 1) the Fentanyl-Morphine (FM) group, and 2) the Morphine (M) group. In addition to 11.5 mg of bupivacaine, the FM group receives 15 μg of fentanyl and 50 μg of morphine intrathecally, while the M group receives 50 μg of morphine intrathecally. The incidence of intraoperative pain with a Numerical Rating Scale (NRS) score of 4 or higher is compared between the two groups to evaluate the analgesic effects of combined intrathecal fentanyl-morphine therapy versus morphine alone.",[148],"Intraoperative Pain","NOT_YET_RECRUITING","2024-09-29",{"date":152,"type":153},"2024-10-01","ACTUAL",{"date":155,"type":142},"2024-09-20",{"date":157,"type":142},"2025-12-25",{"name":5,"class":6}]