Ignite Creation Date:
2025-12-25 @ 2:40 AM
Ignite Modification Date:
2026-02-20 @ 6:45 PM
Study NCT ID:
NCT02936934
Status:
UNKNOWN
Last Update Posted:
2016-10-18
First Post:
2016-10-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Adverse Drug Reactions Associated for Oxycodone and Morphine in Postoperative Pain After Abdominal Hysterectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}, {'id': 'D064420', 'term': 'Drug-Related Side Effects and Adverse Reactions'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009020', 'term': 'Morphine'}, {'id': 'D010098', 'term': 'Oxycodone'}], 'ancestors': [{'id': 'D009022', 'term': 'Morphine Derivatives'}, {'id': 'D009019', 'term': 'Morphinans'}, {'id': 'D053610', 'term': 'Opiate Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'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'}, {'id': 'D003061', 'term': 'Codeine'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 64}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2016-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'completionDateStruct': {'date': '2017-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-10-14', 'studyFirstSubmitDate': '2016-10-14', 'studyFirstSubmitQcDate': '2016-10-14', 'lastUpdatePostDateStruct': {'date': '2016-10-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-10-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adverse drug reactions (questionnaire)', 'timeFrame': '24 hours', 'description': 'Nausea, vomiting, respiratory depression, dizziness, headache, sedation, pruritus and anaphylaxis'}], 'secondaryOutcomes': [{'measure': 'Postoperative pain (Numeric Pain Rating Scale)', 'timeFrame': '24 hours'}, {'measure': 'systemic blood pressure (mmHg) (physiological parameter)', 'timeFrame': '24 hours', 'description': 'Monitor Nihon Kohden BSM-2301K'}, {'measure': 'Heart rate (physiological parameter)', 'timeFrame': '24 hours', 'description': 'Monitor Nihon Kohden BSM-2301K'}, {'measure': 'Oxygen saturation (physiological parameter)', 'timeFrame': '24 hours', 'description': 'Monitor Nihon Kohden BSM-2301K'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Adverse Drug Reaction', 'Morphine', 'Oxycodone', 'Abdominal hysterectomy'], 'conditions': ['Pain, Postoperative']}, 'descriptionModule': {'briefSummary': 'The objective of this study is compare adverse reactions associated with oxycodone and morphine for the treatment of postoperative pain after abdominal hysterectomy', 'detailedDescription': 'A randomized single-blind study, was performed to compare the adverse reactions associated with oxycodone and morphine in patients undergoing abdominal hysterectomy.\n\nprocess:\n\n1. A clinical history of patients candidates to participate in the study will be developed.\n2. If you meet the selection criteria will be held the invitation to participate in the study, reading the letter under information\n\nPatients who agree to participate in the study will be managet during the surgical procedure:\n\n15 mg mixed blockade with bupivacaine 0.5% + 25 micrograms of fentanyl 10mg / kg intravenously during surgery metamizol 3) After the surgical procedure (immediate postoperative)\n\n• the patient to group A or B (randomization) is assigned, masking infusions and allocation will be conducted by an outside person who will test an additional record the names of the patients and the drug administered.\n\nA bolus of oxycodone or morphine 10% calculated dose for intravenous infusion 0.075mg intravenous palonosetron prophylaxis of emesis Detection and assessment of severity of adverse drug reactions will be conducted by an interview that will be at 0,1,2,6,12 and 24 hours after the onset of analgesia. Instrument designed for the detection of RAM will be used and classify its severity according to common terminology criteria for adverse events (CTCAE). Futhermore, measuring systemic blood pressure, heart rate, oxygen saturation will be performed through the use of Nihon Kohden monitor (model BSN-2301K). Pain assessment will be made by the numerical scale (NRS). The researcher responsible for the detection and assessment of adverse reactions to opioids and others determinations, remain mowed.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '30 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients scheduled for abdominal hysterectomy\n* Signing for informed consent\n\nExclusion Criteria:\n\n* Patients used with MAO inhibitor drugs (\\<14 days before surgery)\n* History of substance abuse\n* Hypersensitivity to opioids and others drugs of multimodal analgesia (metamizol and lidocaine)\n* Pretreatment of any opioid (\\<7/2 lives of the drug in question)\n* Chronic pain of any etiology (\\> 6 months)\n* Diagnosis of bowel obstruction\n* Renal or hepatic insufficiency\n* Asthma, chronic obstructive pulmonary disease (COPD), and/ or hypothyroidism.\n* Patients requiring general anesthesia for surgical complications'}, 'identificationModule': {'nctId': 'NCT02936934', 'briefTitle': 'Comparison of Adverse Drug Reactions Associated for Oxycodone and Morphine in Postoperative Pain After Abdominal Hysterectomy', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Civil de Guadalajara'}, 'orgStudyIdInfo': {'id': 'HospitalCG'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Morphine', 'description': 'Multimodal analgesia to morphine', 'interventionNames': ['Drug: Morphine']}, {'type': 'EXPERIMENTAL', 'label': 'Oxycodone', 'description': 'Multimodal analgesia to oxycodone', 'interventionNames': ['Drug: Oxycodone']}], 'interventions': [{'name': 'Morphine', 'type': 'DRUG', 'description': 'Interventions pre-specified to be administered to participants:\n\nAbdominal hysterectomy Block Anesthesia: bupivacaine 0.5% + 25 micrograms of fentanyl 10mg / kg metamizol sodium intravenously during surgery\n\nIntravenous infusion:\n\n200μg / kg of morphine + 3g metamizole sodium + 3mg / kg 2% lidocaine + 500mL saline solution. Time administration:24hours', 'armGroupLabels': ['Morphine']}, {'name': 'Oxycodone', 'type': 'DRUG', 'description': 'Interventions pre-specified to be administered to participants:\n\nAbdominal hysterectomy Block Anesthesia: bupivacaine 0.5% + 25 micrograms of fentanyl 10mg / kg metamizol sodium intravenously during surgery\n\nIntravenous infusion:\n\n150μg / kg of oxycodone + 3g metamizole sodium + 3mg / kg 2% lidocaine + 500mL saline solution. Time administration: 24hours.', 'armGroupLabels': ['Oxycodone']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'VIRGINIA A SANCHEZ, MD', 'role': 'CONTACT', 'email': 'aleyda_sanmis7@hotmail.com', 'phone': '3319837964'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital Civil de Guadalajara', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD Pharmacology', 'investigatorFullName': 'VIRGINIA ALEYDA SANCHEZ LOPEZ', 'investigatorAffiliation': 'Hospital Civil de Guadalajara'}}}}