[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100625516":3},{"organization":4,"armGroups":7,"interventions":26,"overallOfficials":32,"centralContacts":48,"locations":54,"responsibleParty":71,"collaborators":32,"id":75,"slug":76,"hasResults":77,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":32,"eligibilityCriteria":81,"healthyVolunteers":77,"sex":82,"minAge":83,"maxAge":84,"enrollmentInfo":85,"targetDuration":32,"studyType":88,"phases":89,"briefSummary":91,"conditions":92,"keywords":97,"overallStatus":57,"whyStopped":32,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":109},{"fullName":5,"class":6},"Iuliu Hatieganu University of Medicine and Pharmacy","OTHER",[8,15,21],{"label":9,"type":10,"description":11,"interventionNames":12},"Peridural","ACTIVE_COMPARATOR","Patients will receive standard multimodal analgesic medications plus epidural analgesia during the postoperative period.",[13,14],"Drug: Peridural","Drug: Multimodal IV analgesia",{"label":16,"type":17,"description":18,"interventionNames":19},"Nefopam","EXPERIMENTAL","Patients will receive standard multimodal analgesic medications plus continuous nefopam infusion from the intraoperative through the postoperative period.",[20,14],"Drug: Nefopam 120mg\u002Fday infusion",{"label":22,"type":10,"description":23,"interventionNames":24},"Lidocaine","Patients will receive standard multimodal analgesic medications plus continuous lidocaine infusion from the intraoperative through the postoperative period.",[25,14],"Drug: Lidocaine Infusion",[27,33,37,40],{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"DRUG","Nefopam 120mg\u002Fday infusion","Nefopam administration will start in the intraoperative period and continue for 48 hours in the postoperative period",[16],null,{"type":28,"name":34,"description":35,"armGroupLabels":36,"otherNames":32},"Lidocaine Infusion","Lidocaine infusion will begin in the intraoperative period and continue in the postoperative period for 48 hours",[22],{"type":28,"name":9,"description":38,"armGroupLabels":39,"otherNames":32},"This group will receive the stardad practice in our hospital, peridural analgesia alongside a multimodal analgesic approach involving paracetamol 4g\u002Fday",[9],{"type":28,"name":41,"description":42,"armGroupLabels":43,"otherNames":44},"Multimodal IV analgesia","Standard postoperative multimodal pain management regimen",[22,16,9],[45,46,47],"Ketoprofene","Paracetamol","Morphine",[49],{"name":50,"role":51,"phone":52,"phoneExt":32,"email":53},"Andrei O Mitre","CONTACT","+40724275556","andrei.otto.mitre@elearn.umfcluj.ro",[55],{"facility":56,"status":57,"city":58,"state":59,"zip":32,"country":60,"countryCode":61,"cosmosGeoPoint":62,"geoPoint":67,"contacts":68},"Prof. O. Fodor Regional Institute of Gastroenterology and Hepatology","RECRUITING","Cluj-Napoca","Cluj","Romania","RO",{"type":63,"coordinates":64},"Point",[65,66],23.6,46.76667,{"lat":66,"lon":65},[69],{"name":50,"role":51,"phone":52,"phoneExt":32,"email":70},"andrei.mitre97@gmail.com",{"type":72,"investigatorFullName":73,"investigatorTitle":74,"investigatorAffiliation":5,"oldNameTitle":32,"oldOrganization":32},"PRINCIPAL_INVESTIGATOR","Andrei Mitre","MD","100625516","phase-4-continous-infusion-of-nefopam-for-patients-undergoing-pancreatoduodenectomy-100625516",false,"NCT07423650","Continous Infusion of Nefopam for Patients Undergoing Pancreatoduodenectomy","Continous Infusion of Nefopam for Patients Undergoing Pancreatoduodenectomy: A Randomized Controlled Double-Blind Trial","Inclusion Criteria:\n\n1. Patients scheduled for elective pancreatoduodenectomy surgery\n2. Agreed to participate in the study\n\nExclusion Criteria:\n\n1. Refusal to participate\n2. Emergency surgery\n3. Patients with neurological disorders or other muscular or psychiatric disorders that impede communication\n4. Known allergic reactions to the used medication\n5. Known hyperalgesia\n6. Chronic opioid consumption\n7. Patients that require reintervention in the first 48h postoperatively\n8. Patients with pancreaticogastrostomy","ALL","18 Years","80 Years",{"count":86,"type":87},93,"ESTIMATED","INTERVENTIONAL",[90],"PHASE4","The goal of this clinical trial is to determine whether continuous nefopam administration, as part of a multimodal analgesia strategy, reduces opioid consumption and improves patient satisfaction after pancreatoduodenectomy.\n\nThe main questions are:\n\nDoes nefopam administration reduce opioid consumption after pancreatoduodenectomy?\n\nDoes nefopam administration reduce postoperative pain levels after pancreatoduodenectomy?\n\nResearchers will compare two other analgesic strategies, namely continuous lidocaine infusion and epidural analgesia, to assess whether they lead to better outcomes.\n\nParticipants will complete the QoR-15 questionnaire and report their pain levels at predefined time points before and after surgery.",[93,94,95,96],"Pancreatoduodenectomy","Pain Management","Opioid Analgesia","Multimodal Analgesia",[16,93,98,99],"Opioids","Multimodal analgesia","2026-03-19",{"date":102,"type":103},"2026-03-24","ACTUAL",{"date":105,"type":87},"2026-03",{"date":107,"type":87},"2026-10",{"name":5,"class":6},1]