Ignite Creation Date:
2025-12-25 @ 2:36 AM
Ignite Modification Date:
2026-02-24 @ 1:16 AM
Study NCT ID:
NCT04889534
Status:
COMPLETED
Last Update Posted:
2021-05-17
First Post:
2018-08-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Predictive Factors for Postoperative Pain, Nausea and Vomiting in Oncological Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009325', 'term': 'Nausea'}, {'id': 'D014839', 'term': 'Vomiting'}, {'id': 'D010149', 'term': 'Pain, Postoperative'}, {'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000698', 'term': 'Analgesia'}], 'ancestors': [{'id': 'D000760', 'term': 'Anesthesia and Analgesia'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-02', 'completionDateStruct': {'date': '2017-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-05-14', 'studyFirstSubmitDate': '2018-08-09', 'studyFirstSubmitQcDate': '2021-05-14', 'lastUpdatePostDateStruct': {'date': '2021-05-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-05-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Intensity of postoperative pain', 'timeFrame': '24 hours', 'description': 'pain intensity was measured using descriptive and verbal number scale'}], 'secondaryOutcomes': [{'measure': 'side effects from analgesia', 'timeFrame': '24 hours', 'description': 'nausea, vomiting, pruritus and hypotension were measured during first 24 postoperative hours'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['nausea', 'vomiting', 'pain'], 'conditions': ['Nausea', 'Vomiting', 'Pain, Postoperative']}, 'referencesModule': {'references': [{'pmid': '25249302', 'type': 'BACKGROUND', 'citation': 'Lee SY, Hung CJ, Chen CC, Wu CC. Survival analysis of postoperative nausea and vomiting in patients receiving patient-controlled epidural analgesia. J Chin Med Assoc. 2014 Nov;77(11):589-93. doi: 10.1016/j.jcma.2014.08.008. Epub 2014 Sep 22.'}, {'pmid': '19542791', 'type': 'BACKGROUND', 'citation': 'Gramke HF, de Rijke JM, van Kleef M, Kessels AG, Peters ML, Sommer M, Marcus MA. Predictive factors of postoperative pain after day-case surgery. Clin J Pain. 2009 Jul-Aug;25(6):455-60. doi: 10.1097/AJP.0b013e31819a6e34.'}]}, 'descriptionModule': {'briefSummary': '1809 patients were evaluated in postoperative period. They were asked about nausea, vomiting, retching and pain in the first postoperative 24 hours', 'detailedDescription': 'Patients were prospectively evaluated , and nausea, vomiting and pain were recorded.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients submitted to oncological surgeries in a specialized Hospital', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients submitted to oncological surgeries\n\nExclusion Criteria:\n\n* refusal to sign the agreement term\n* lack of information in the records'}, 'identificationModule': {'nctId': 'NCT04889534', 'acronym': 'PONV', 'briefTitle': 'Predictive Factors for Postoperative Pain, Nausea and Vomiting in Oncological Patients', 'organization': {'class': 'OTHER', 'fullName': 'Instituto do Cancer do Estado de São Paulo'}, 'officialTitle': 'Evaluation of Predictive Factors for Nausea, Vomiting and Postoperative Acute Pain in Oncological Patients', 'orgStudyIdInfo': {'id': 'NP380/2013'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Analgesia', 'type': 'PROCEDURE', 'description': 'Patients will be observed during postoperative period,'}]}, 'contactsLocationsModule': {'locations': [{'zip': '01403010', 'city': 'São Paulo', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Angela Maria Sousa', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}], 'overallOfficials': [{'name': 'Hazem A Ashmawi, phD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Sao Paulo'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Instituto do Cancer do Estado de São Paulo', 'class': 'OTHER'}, 'collaborators': [{'name': 'Sponsor GmbH', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}