Ignite Creation Date:
2025-12-24 @ 7:40 PM
Ignite Modification Date:
2026-02-23 @ 8:57 PM
Study NCT ID:
NCT05322603
Status:
COMPLETED
Last Update Posted:
2023-08-22
First Post:
2022-03-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficiency and Safety a Fixed Combination of Orphenadrine and Diclofenac for Postoperative Analgesia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': 'D018712', 'term': 'Analgesics, Non-Narcotic'}, {'id': 'D004008', 'term': 'Diclofenac'}, {'id': 'D000700', 'term': 'Analgesics'}, {'id': 'D016058', 'term': 'Analgesia, Patient-Controlled'}], 'ancestors': [{'id': 'D018689', 'term': 'Sensory System Agents'}, {'id': 'D018373', 'term': 'Peripheral Nervous System Agents'}, {'id': 'D045505', 'term': 'Physiological Effects of Drugs'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D002491', 'term': 'Central Nervous System Agents'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}, {'id': 'D010648', 'term': 'Phenylacetates'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000698', 'term': 'Analgesia'}, {'id': 'D000760', 'term': 'Anesthesia and Analgesia'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-03-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2022-08-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-08-18', 'studyFirstSubmitDate': '2022-03-26', 'studyFirstSubmitQcDate': '2022-04-11', 'lastUpdatePostDateStruct': {'date': '2023-08-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-08-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'visual-analog scale', 'timeFrame': 'hospitalisation period, an average of 24 hours', 'description': 'dynamics of points 100 mm visual-analog scale'}], 'secondaryOutcomes': [{'measure': 'the minute inspiratory lung volume using a spirometer', 'timeFrame': 'hospitalisation period, an average of 24 hours', 'description': 'Comparison of minute inspiratory lung volume befor/after research using a spirometer'}, {'measure': 'opioid-sparing effect', 'timeFrame': 'hospitalisation period, an average of 24 hours', 'description': 'Comparison of the number of opioid analgesics'}, {'measure': 'adverse events', 'timeFrame': 'hospitalisation period, an average of 1 week', 'description': 'registration of adverse events'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['analgesia, non-opioid, patient-controlled analgesia'], 'conditions': ['Analgesia']}, 'descriptionModule': {'briefSummary': 'The study will include 60 patients after cardiac surgery. The first group will include 30 patients who will use the drug Neodolpasse manufactured by Fresenius Kabi, which is a fixed combination of 30 mg of orphenadrine and 75 mg of diclofenac; the second group will consist of 30 patients who will use patient-controlled morphine analgesia (РСА) in the form of monotherapy.', 'detailedDescription': 'The patient signs an informed consent to participate in the study after tracheal extubation.The application of one or another method of influence is carried out by the method of random sampling (the envelope method). The drug Neodolpasse is used according to the following plan: in the form of an intravenous infusion of 250 ml for 2 hours 1 or 2 times a day with intervals between infusions about 12 hours. The second injection will be prescribed at VAS \\> 40 mm no earlier than 12 hours after the first. The first injection will begin immediately after tracheal extubation. Morphine analgesia controlled by the patient will begin 2 hours after tracheal extubation (the concentration of the drug will be 1 mg /ml; the initial or loading dose is 3 mg; the bolus dose was 1 mg; the lockout interval is 6 minutes; the 4-hour maximum dose is 10 mg; the rate of constant infusion is 0.1 mg / hour).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. age from 18 years to 80 years inclusive\n2. surgical access - median sternotomy\n3. the first 2 hours after tracheal extubation\n4. clear consciousness and productive contact with the patient\n5. absence of erosive or ulcerative lesions of the mucous membrane of the esophagus, stomach and duodenum during preoperative esophago-gastro-duodenoscopy and clinical manifestations of gastrointestinal bleeding\n6. no signs of renal dysfunction (KDIGO 0)\n7. stable state of hemodynamics\n\nExclusion Criteria:\n\n1. a history of mental illness\n2. the presence of contraindications to the appointment of diclofenac and orphenadrine or individual intolerance to drugs of these groups\n3. renal and hepatic insufficiency\n4. perioperative brain lesions\n5. postoperative bleeding\\>1.4 ml/kg/hour\n6. severe cardiovascular (inotropic index\\>10) and/or respiratory (RaO2 /FiO2\\<200 mmHg) insufficiency'}, 'identificationModule': {'nctId': 'NCT05322603', 'briefTitle': 'Efficiency and Safety a Fixed Combination of Orphenadrine and Diclofenac for Postoperative Analgesia', 'organization': {'class': 'OTHER', 'fullName': 'Petrovsky National Research Centre of Surgery'}, 'officialTitle': 'Efficiency and Safety a Fixed Combination of Orphenadrine and Diclofenac for Postoperative Analgesia in Cardiac Surgery Patients', 'orgStudyIdInfo': {'id': '00191200'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'the first group: a fixed combination of Orphenadrine and Diclofenac', 'description': 'dynamics of points 100 mm visual-analog scale,minute inspiratory lung volume', 'interventionNames': ['Drug: Analgesics Non Opioid (Neodolpasse manufactured by Fresenius Kabi)']}, {'type': 'EXPERIMENTAL', 'label': 'the second group: patient-controlled analgesia (РСА) with Morphine', 'description': 'dynamics of points 100 mm visual-analog scale,minute inspiratory lung volume', 'interventionNames': ['Drug: Analgesics']}], 'interventions': [{'name': 'Analgesics Non Opioid (Neodolpasse manufactured by Fresenius Kabi)', 'type': 'DRUG', 'otherNames': ['Fixed combination of Orfenadrine and Diclofenac'], 'description': 'A decrease in the pain severity (VAS);opioid-sparing effect', 'armGroupLabels': ['the first group: a fixed combination of Orphenadrine and Diclofenac']}, {'name': 'Analgesics', 'type': 'DRUG', 'otherNames': ['Patient-controlled analgesia (with Morphine)'], 'description': 'A decrease in the pain severity (VAS)', 'armGroupLabels': ['the second group: patient-controlled analgesia (РСА) with Morphine']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Moscow', 'country': 'Russia', 'facility': 'Petrovsky Research National Centre of Surgery', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}], 'overallOfficials': [{'name': 'Alexander A. Eremenko, prof', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Head of the Intensive Care Unit'}, {'name': 'Lyubov S. Sorokina', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'anesthesiologist-resuscitator'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Petrovsky National Research Centre of Surgery', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor', 'investigatorFullName': 'Aleksandr Eremenko', 'investigatorAffiliation': 'Petrovsky National Research Centre of Surgery'}}}}