Ignite Creation Date:
2025-12-25 @ 12:04 AM
Ignite Modification Date:
2026-02-23 @ 12:54 AM
Study NCT ID:
NCT02778958
Status:
COMPLETED
Last Update Posted:
2018-03-14
First Post:
2016-05-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparisons of iv Ibuprofen and iv Paracetamol During Bariatric Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009767', 'term': 'Obesity, Morbid'}], 'ancestors': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'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': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-03', 'completionDateStruct': {'date': '2017-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-03-12', 'studyFirstSubmitDate': '2016-05-17', 'studyFirstSubmitQcDate': '2016-05-19', 'lastUpdatePostDateStruct': {'date': '2018-03-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-05-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Side effects', 'timeFrame': 'First 24 hours during postoperative period', 'description': 'Side effects of study drugs and opioids'}], 'primaryOutcomes': [{'measure': 'Opioid (morphine) consumption', 'timeFrame': 'First 24 hours during postoperative period', 'description': 'iv morphine patient controlled analgesia for multimodal analgesia'}], 'secondaryOutcomes': [{'measure': 'Postoperative pain level', 'timeFrame': 'First 24 hours during postoperative period', 'description': 'Visual analog scale for evaluation of postoperative pain levels'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['bariatric surgery', 'morbid obesity', 'nonopioid analgesics'], 'conditions': ['Bariatric Surgery Candidate', 'Obesity, Morbid']}, 'referencesModule': {'references': [{'pmid': '20642488', 'type': 'RESULT', 'citation': 'Kroll PB, Meadows L, Rock A, Pavliv L. A multicenter, randomized, double-blind, placebo-controlled trial of intravenous ibuprofen (i.v.-ibuprofen) in the management of postoperative pain following abdominal hysterectomy. Pain Pract. 2011 Jan-Feb;11(1):23-32. doi: 10.1111/j.1533-2500.2010.00402.x.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to evaluate and to compare the effectiveness of iv ibuprofen and iv paracetamol during bariatric surgery.', 'detailedDescription': 'Evaluation of effectiveness of iv ibuprofen and iv paracetamol on postoperative pain, opioid consumption, and side effects in morbidly obese patients undergoing bariatric laparoscopic surgery'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients undergoing laparoscopic sleeve gastrectomy and gastric by-pass surgery\n\nExclusion Criteria:\n\n* Hepatic disfunction,\n* Renal failure (creatinine \\> 3 mg/dL,creatinin clearance \\< 60 mL/dk or urine out-put \\< 500 mL/day ) or a history of dialysis 28 days before surgery,\n* A history of gastrointestinal bleeding or bleeding diathesis 6 weeks before surgery, therapeutic dose of anticoagulation therapy (except subcutaneous heparin prophylactic dose),\n* Angiotensin converting enzymes inhibitor or antihypertensive combination with furosemide,\n* A history of opioid addiction or opioid tolerance\n* Allergy to study drugs,\n* Noncooperative patients for pain assessments'}, 'identificationModule': {'nctId': 'NCT02778958', 'briefTitle': 'Comparisons of iv Ibuprofen and iv Paracetamol During Bariatric Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Inonu University'}, 'officialTitle': 'Comparisons of iv Ibuprofen and iv Paracetamol for Postoperative Pain Levels and Opioid Consumption During Bariatric Surgery', 'orgStudyIdInfo': {'id': 'Inonu Medicine Faculty'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ibuprofen and morphine', 'description': 'iv ibuprofen 800 mg infusion at 30 min before skin incision closed and per 6 hours during postoperative period; iv morphine with patient controlled analgesia (1 mg demand bolus dose, 20 min lockout time)', 'interventionNames': ['Drug: ibuprofen']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'paracetamol and morphine', 'description': 'iv paracetamol 1 gram infusion at 30 min before skin incision closed and per 6 hours during postoperative period; iv morphine with patient controlled analgesia (1 mg demand bolus dose, 20 min lockout time)', 'interventionNames': ['Drug: paracetamol']}], 'interventions': [{'name': 'paracetamol', 'type': 'DRUG', 'otherNames': ['Acetaminophen'], 'description': 'iv paracetamol flakon, 1 gram infusion at 30 min;\n\niv morphine with patient controlled analgesia (1 mg demand bolus dose, 20 min lockout time)', 'armGroupLabels': ['paracetamol and morphine']}, {'name': 'ibuprofen', 'type': 'DRUG', 'otherNames': ['İntrafen'], 'description': 'iv ibuprofen flakon, 800 mg;\n\niv morphine with patient controlled analgesia (1 mg demand bolus dose, 20 min lockout time)', 'armGroupLabels': ['ibuprofen and morphine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44315', 'city': 'Malatya', 'country': 'Turkey (Türkiye)', 'facility': 'Inonu University Faculty of Medicine Department of Anesthesiology and Reanimation', 'geoPoint': {'lat': 38.35018, 'lon': 38.31667}}], 'overallOfficials': [{'name': 'Gulay Erdogan Kayhan, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Associated Professor Doctor Gulay ERDOGAN KAYHAN'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Inonu University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of the study', 'investigatorFullName': 'Gulay ERDOGAN KAYHAN', 'investigatorAffiliation': 'Inonu University'}}}}