Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-31 @ 4:43 AM
Study NCT ID:
NCT07423650
Status:
RECRUITING
Last Update Posted:
2026-03-24
First Post:
2026-02-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Continous Infusion of Nefopam for Patients Undergoing Pancreatoduodenectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000377', 'term': 'Agnosia'}], 'ancestors': [{'id': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009340', 'term': 'Nefopam'}, {'id': 'D000082', 'term': 'Acetaminophen'}, {'id': 'D009020', 'term': 'Morphine'}], 'ancestors': [{'id': 'D010079', 'term': 'Oxazocines'}, {'id': 'D001392', 'term': 'Azocines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D000083', 'term': 'Acetanilides'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009022', 'term': 'Morphine Derivatives'}, {'id': 'D009019', 'term': 'Morphinans'}, {'id': 'D053610', 'term': 'Opiate Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006572', 'term': 'Heterocyclic Compounds, Bridged-Ring'}, {'id': 'D006576', 'term': 'Heterocyclic Compounds, 4 or More Rings'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D010616', 'term': 'Phenanthrenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 93}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2026-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-19', 'studyFirstSubmitDate': '2026-02-04', 'studyFirstSubmitQcDate': '2026-02-14', 'lastUpdatePostDateStruct': {'date': '2026-03-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Opioid consumption', 'timeFrame': 'From enrollment to 48 hours after the surgery', 'description': 'Perioperative opioid consumption, expressed in morphine milligram equivalents, during the intraoperative period and within the first 6, 18, 24, and 48 hours postoperatively.'}, {'measure': 'Pain levels after surgery', 'timeFrame': 'From enrollment to 48 hours after the surgery', 'description': 'Numeric Rating Scale (NRS) pain scores at rest and during straining (coughing), assessed at 30 minutes, 6 hours, 18 hours, 24 hours, and 48 hours postoperatively.'}], 'secondaryOutcomes': [{'measure': 'Quality of Recovery (QoR-15)', 'timeFrame': 'From enrollment to 48 hours after the surgery', 'description': 'Quality of Recovery (QoR-15) scores, assessed preoperatively and at 24 and 48 hours after surgery.'}, {'measure': 'Adverse events', 'timeFrame': 'From enrollment to 48 hours postoperative', 'description': 'Incidence of adverse events: pruritus, tachycardia, bradycardia, arrhythmia, lidocaine toxicity signs (metallic taste in the mouth, oral numbness, tinnitus, blurred vision), nausea, vomiting, rescue antiemetic etc.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Nefopam', 'Pancreatoduodenectomy', 'Opioids', 'Multimodal analgesia'], 'conditions': ['Pancreatoduodenectomy', 'Pain Management', 'Opioid Analgesia', 'Multimodal Analgesia']}, 'referencesModule': {'references': [{'pmid': '14690106', 'type': 'RESULT', 'citation': 'Tramoni G, Viale JP, Cazals C, Bhageerutty K. Morphine-sparing effect of nefopam by continuous intravenous injection after abdominal surgery by laparotomy. Eur J Anaesthesiol. 2003 Dec;20(12):990-2. doi: 10.1017/s0265021503251590. No abstract available.'}, {'pmid': '28192892', 'type': 'RESULT', 'citation': "Cuvillon P, Zoric L, Demattei C, Alonso S, Casano F, L'hermite J, Ripart J, Lefrant JY, Muller L. Opioid-sparing effect of nefopam in combination with paracetamol after major abdominal surgery: a randomized double-blind study. Minerva Anestesiol. 2017 Sep;83(9):914-920. doi: 10.23736/S0375-9393.17.11508-7. Epub 2017 Feb 13."}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': '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'}, 'identificationModule': {'nctId': 'NCT07423650', 'briefTitle': 'Continous Infusion of Nefopam for Patients Undergoing Pancreatoduodenectomy', 'organization': {'class': 'OTHER', 'fullName': 'Iuliu Hatieganu University of Medicine and Pharmacy'}, 'officialTitle': 'Continous Infusion of Nefopam for Patients Undergoing Pancreatoduodenectomy: A Randomized Controlled Double-Blind Trial', 'orgStudyIdInfo': {'id': '11348/25.09.2025'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Peridural', 'description': 'Patients will receive standard multimodal analgesic medications plus epidural analgesia during the postoperative period.', 'interventionNames': ['Drug: Peridural', 'Drug: Multimodal IV analgesia']}, {'type': 'EXPERIMENTAL', 'label': 'Nefopam', 'description': 'Patients will receive standard multimodal analgesic medications plus continuous nefopam infusion from the intraoperative through the postoperative period.', 'interventionNames': ['Drug: Nefopam 120mg/day infusion', 'Drug: Multimodal IV analgesia']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Lidocaine', 'description': 'Patients will receive standard multimodal analgesic medications plus continuous lidocaine infusion from the intraoperative through the postoperative period.', 'interventionNames': ['Drug: Lidocaine Infusion', 'Drug: Multimodal IV analgesia']}], 'interventions': [{'name': 'Nefopam 120mg/day infusion', 'type': 'DRUG', 'description': 'Nefopam administration will start in the intraoperative period and continue for 48 hours in the postoperative period', 'armGroupLabels': ['Nefopam']}, {'name': 'Lidocaine Infusion', 'type': 'DRUG', 'description': 'Lidocaine infusion will begin in the intraoperative period and continue in the postoperative period for 48 hours', 'armGroupLabels': ['Lidocaine']}, {'name': 'Peridural', 'type': 'DRUG', 'description': 'This group will receive the stardad practice in our hospital, peridural analgesia alongside a multimodal analgesic approach involving paracetamol 4g/day', 'armGroupLabels': ['Peridural']}, {'name': 'Multimodal IV analgesia', 'type': 'DRUG', 'otherNames': ['Ketoprofene', 'Paracetamol', 'Morphine'], 'description': 'Standard postoperative multimodal pain management regimen', 'armGroupLabels': ['Lidocaine', 'Nefopam', 'Peridural']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cluj-Napoca', 'state': 'Cluj', 'status': 'RECRUITING', 'country': 'Romania', 'contacts': [{'name': 'Andrei O Mitre', 'role': 'CONTACT', 'email': 'andrei.mitre97@gmail.com', 'phone': '+40724275556'}], 'facility': 'Prof. O. Fodor Regional Institute of Gastroenterology and Hepatology', 'geoPoint': {'lat': 46.76667, 'lon': 23.6}}], 'centralContacts': [{'name': 'Andrei O Mitre', 'role': 'CONTACT', 'email': 'andrei.otto.mitre@elearn.umfcluj.ro', 'phone': '+40724275556'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Iuliu Hatieganu University of Medicine and Pharmacy', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Andrei Mitre', 'investigatorAffiliation': 'Iuliu Hatieganu University of Medicine and Pharmacy'}}}}