Ignite Creation Date:
2025-12-25 @ 2:30 AM
Ignite Modification Date:
2026-02-21 @ 10:11 PM
Study NCT ID:
NCT03835234
Status:
COMPLETED
Last Update Posted:
2024-08-27
First Post:
2018-09-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Incidence and Factors Associated With PONV in Regional Anaesthesia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020250', 'term': 'Postoperative Nausea and Vomiting'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009325', 'term': 'Nausea'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D014839', 'term': 'Vomiting'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-01-31', 'size': 266186, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-08-16T06:04', 'hasProtocol': True}, {'date': '2019-01-31', 'size': 274740, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-08-16T06:05', 'hasProtocol': False}, {'date': '2018-08-01', 'size': 98388, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_002.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2024-08-16T06:06', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 364}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2019-01-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-24', 'studyFirstSubmitDate': '2018-09-11', 'studyFirstSubmitQcDate': '2019-02-07', 'lastUpdatePostDateStruct': {'date': '2024-08-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-02-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-01-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'incidence of post operative nausea and vomiting following surgery under regional anaesthesia at Mulago hospital', 'timeFrame': '24 hours', 'description': 'Any retching, nausea or vomiting within 24 hours following surgery under regional anaesthesia in Mulago hospital'}, {'measure': 'factors associated with post operative nausea and vomiting following surgery under anaesthesia at Mulago hospital using the Apfel score.', 'timeFrame': '24 hours', 'description': 'to determine factors associated with post operative nausea and vomiting following surgery under regional anaesthesia at Mulago hospital using the Apfel score.\n\nThe Apfel score is a verified risk score for predicting post operative nausea and vomiting.It describes four risk factors that when present are scored 1 point each and 0 points when absent. These four risk factors are: use of post operative opioids, female gender, non-smoking status and history of post operative nausea and vomiting or motion sickness. The highest possible score is 4 and lowest possible score is 0.'}], 'secondaryOutcomes': [{'measure': 'Proportion of patients that received prophylaxis against post operative nausea and vomiting during surgery under regional anaesthesia at Mulago hospital', 'timeFrame': '24 hours', 'description': 'Proportion of patients who received prophylaxis against post operative nausea and vomiting during surgery under regional anaesthesia at Mulago hospital'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['PONV', 'Regional anaesthesia', 'LMIC'], 'conditions': ['PONV', 'Regional Anaesthesia']}, 'descriptionModule': {'briefSummary': 'Post-operative nausea and vomiting (PONV) is one of the complications associated with surgery and anaesthesia. The main aim of the study is to determine the incidence of post-operative nausea and vomiting among surgical patients undergoing regional anaesthesia and the factors associated with it. Patients above the age of 18 who have consented and are undergoing surgery under regional anaesthesia will be enrolled into the study over 6months. They will then be observed for up to 24 hours post operatively to determine the incidence of PONV and factors associated with it.', 'detailedDescription': 'Post-operative nausea and vomiting (PONV) is one of the complications associated with surgery and anaesthesia. Due to advanced techniques in the field of anaesthesia and surgery, patients are commonly operated on under regional anaesthesia (RA) rather than general anaesthesia (GA). Post-operative nausea and vomiting (PONV) still occurs with regional anaesthesia, but the incidence and associated factors in our setting remain unknown. An optimal management of PONV is important because they can lead to increased morbidity.\n\nThe main aim of the study is to determine the incidence of post-operative nausea and vomiting among surgical patients undergoing regional anaesthesia and the factors associated with it.\n\nThis will be a prospective cohort study. Patients aged 18 years and above in whom surgery under regional anaesthesia is planned at Mulago hospital will be consented and enrolled into the study over 6months. Data will be collected using semi structured and pre-tested questionnaires. Patients will be observed for up to 24 hours post operatively to determine the incidence of and factors associated with PONV in regional anaesthesia at Mulago hospital. After recruitment, patients will be followed up once at 24 hours post-operatively.\n\nResults from this study will determine the incidence of post-operative nausea and vomiting in surgical patients undergoing regional anaesthesia and the associated factors, data which we do not have in our setting. This will help to guide practice on the prevention and management of post-operative nausea and vomiting.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The target populations are all patients 18 years of age and above scheduled for an elective or emergency surgical procedure under regional anaesthesia at Mulago hospital.\n\nThe accessible population includes all patients attending Mulago hospital for elective and emergency surgery under regional anaesthesia during the study period.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients undergoing regional anaesthesia for emergency or elective surgery.\n* Patients aged 18 years and above.\n* ASA class 1, 2, 3 and 4 patients\n\nExclusion Criteria:\n\n* Patients who are switched to general anaesthesia after planned regional anaesthesia.\n* Patients with pre-existing nausea and vomiting from co-morbidities.'}, 'identificationModule': {'nctId': 'NCT03835234', 'briefTitle': 'Incidence and Factors Associated With PONV in Regional Anaesthesia', 'organization': {'class': 'OTHER', 'fullName': 'Makerere University'}, 'officialTitle': 'Incidence of and Factors Associated With Post-operative Nausea and Vomiting Following Surgery Under Regional Anaesthesia', 'orgStudyIdInfo': {'id': 'PONVRA'}}, 'contactsLocationsModule': {'locations': [{'zip': '256', 'city': 'Kampala', 'country': 'Uganda', 'facility': 'Mulago hospital', 'geoPoint': {'lat': 0.31628, 'lon': 32.58219}}], 'overallOfficials': [{'name': 'Dorothy Turitwenka', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Makerere University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Makerere University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}