Ignite Creation Date:
2025-12-24 @ 4:56 PM
Ignite Modification Date:
2026-01-22 @ 12:56 PM
Study NCT ID:
NCT03016650
Status:
UNKNOWN
Last Update Posted:
2017-01-18
First Post:
2017-01-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Opioid-sparing Effect of Intravenous Ibuprofen
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': 'D000082', 'term': 'Acetaminophen'}, {'id': 'D007052', 'term': 'Ibuprofen'}], 'ancestors': [{'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': 'D010666', 'term': 'Phenylpropionates'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}]}}, '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': 80}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2017-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2017-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-01-17', 'studyFirstSubmitDate': '2017-01-09', 'studyFirstSubmitQcDate': '2017-01-09', 'lastUpdatePostDateStruct': {'date': '2017-01-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2017-01-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Morphine Consumption', 'timeFrame': 'postoperatively 24 hours'}], 'secondaryOutcomes': [{'measure': 'Visual Analog Scale', 'timeFrame': 'postoperatively 30 minute, 2, 4, 6,12 and 24 hours'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Acetaminophen', 'Ibuprofen'], 'conditions': ['Analgesia', 'Percutaneous Nephrolithotomy']}, 'referencesModule': {'references': [{'pmid': '23952097', 'type': 'RESULT', 'citation': 'Maghsoudi R, Tabatabai M, Radfar MH, Movasagi G, Etemadian M, Shati M, Amjadi M. Opioid-sparing effect of intravenous paracetamol after percutaneous nephrolithotomy: a double-blind randomized controlled trial. J Endourol. 2014 Jan;28(1):23-7. doi: 10.1089/end.2013.0267. Epub 2013 Oct 17.'}]}, 'descriptionModule': {'briefSummary': 'The investigators aimed to evaluate tramadol-sparing effect of intravenous (IV) ibuprofen in patients undergoing percutaneous nephrolithotomy (PCNL).', 'detailedDescription': 'Eighty patients who will undergoing PCNL are randomized to intravenous paracetamol (n=40) and intravenous ibuprofen (n=40) groups. Patients will receive 100 mL of physiologic saline with 1 g IV paracetamol or 800 mg IV ibuprofen 30 minutes before the end of the operation and postoperatively 6, 12 and 18 hours after PCNL in the paracetamol and ibuprofen groups, respectively. Patients in both groups will receive intravenous tramadol with patient controlled analgesia device (PCA).\n\nThe visual analog scale (VAS) will used to evaluate pain intensity scores in the postoperative period.\n\nTotal tramadol consumption, mean VAS score in the 1, 8 and 24 hours, demographic variables, operative variables, and side effects will record.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Study include 80 patients of American Society of Anesthesiologists (ASA) physical status I-II aged between 18-70 years who scheduled for percutaneous nephrolithotomy operation.\n\nExclusion Criteria:\n\n* chronic pain,\n* psychiatric disease,\n* renal dysfunction,\n* allergy to nonsteroidal anti-inflammatory drugs,\n* history of drug addiction,\n* pregnancy,\n* inability to use a patient controlled analgesia (PCA) device.'}, 'identificationModule': {'nctId': 'NCT03016650', 'briefTitle': 'Opioid-sparing Effect of Intravenous Ibuprofen', 'organization': {'class': 'OTHER', 'fullName': 'Inonu University'}, 'orgStudyIdInfo': {'id': 'muharrem-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Paracetamol', 'description': 'Patients will receive 100 mL of physiologic saline with 1 g IV acetaminophen (paracetamol) 30 minutes before the end of the operation and postoperatively 6, 12 and 18 hours after percutaneous nephrolithotomy, respectively.', 'interventionNames': ['Drug: Acetaminophen']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'ibuprofen', 'description': 'Patients will receive 100 mL of physiologic saline with 800 mg IV ibuprofen 30 minutes before the end of the operation and postoperatively 6, 12 and 18 hours after percutaneous nephrolithotomy, respectively.', 'interventionNames': ['Drug: Ibuprofen']}], 'interventions': [{'name': 'Acetaminophen', 'type': 'DRUG', 'otherNames': ['Perfalgan'], 'description': 'Patients receive 100 mL of physiologic saline with 1 g IV paracetamol 30 minutes before the end of the operation and postoperatively 6, 12 and 18 hours after PCNL', 'armGroupLabels': ['Paracetamol']}, {'name': 'Ibuprofen', 'type': 'DRUG', 'otherNames': ['Intrafen'], 'description': 'Patients receive 100 mL of physiologic saline with 800 mg IV ibuprofen 30 minutes before the end of the operation and postoperatively 6, 12 and 18 hours after PCNL', 'armGroupLabels': ['ibuprofen']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Muharrem Ucar, Asst.Prof.', 'role': 'CONTACT', 'email': 'umuharrem@hotmail.com', 'phone': '+90 422 341 06 60', 'phoneExt': '3136'}, {'name': 'Mehmet ALi ERDOGAN, Ass.Prof.', 'role': 'CONTACT', 'email': 'drmalierdogan@gmail.com', 'phone': '+90 422 341 06 60', 'phoneExt': '6419'}], 'overallOfficials': [{'name': 'Muharrem Ucar', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'İnonu University Faculty of Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Muharrem Ucar', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Muharrem Ucar', 'investigatorAffiliation': 'Inonu University'}}}}