Ignite Creation Date:
2025-12-24 @ 9:40 PM
Ignite Modification Date:
2025-12-25 @ 7:22 PM
Study NCT ID:
NCT06301932
Status:
COMPLETED
Last Update Posted:
2024-03-12
First Post:
2024-03-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effectiveness and Outcomes of Epidural Analgesia in Patients Undergoing Open Hepatectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 654}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2023-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-03-07', 'studyFirstSubmitDate': '2024-03-04', 'studyFirstSubmitQcDate': '2024-03-04', 'lastUpdatePostDateStruct': {'date': '2024-03-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Post-operative opioid consumption', 'timeFrame': 'Within 72 hours', 'description': 'Post-operative opioid consumption at 24,48,72 hour'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Liver resection', 'Propensity score matching'], 'conditions': ['Epidural Analgesia', 'Patient Controlled Analgesia']}, 'referencesModule': {'references': [{'pmid': '39223470', 'type': 'DERIVED', 'citation': 'Pianngarn I, Lapisatepun W, Kulpanun M, Chotirosniramit A, Junrungsee S, Lapisatepun W. The effectiveness and outcomes of epidural analgesia in patients undergoing open liver resection: a propensity score matching analysis. BMC Anesthesiol. 2024 Sep 2;24(1):305. doi: 10.1186/s12871-024-02697-1.'}]}, 'descriptionModule': {'briefSummary': 'This observational study is to compare the effectiveness and outcomes of epidural analgesia in patients undergoing open hepatectomy: A propensity score matching analysis.\n\nThe main question is: What is the superior method of pain control in open hepatectomy: epidural analgesia or intravenous PCA?', 'detailedDescription': 'After approval of the study protocol from the institutional review board of Chiangmai University (Approval number: ANE-2562-06771), the investigators performed a retrospective review of all patients who underwent an elective open liver resection in the specialized hepato-biliary center from January 2007 through December 2018. This retrospective inquiry comprised 612 patients. The data was systematically retrieved from electronic medical records. Baseline characteristics including age, gender, body mass index (BMI), co-morbidity, American Society of Anesthesiologists (ASA) classification, diagnosis, hepatitis profile, Child-Pugh classification, cirrhosis, the largest tumor size, previous liver resection, and pre-operative laboratory investigations were collected. The following intra-operative data were collected: type of liver resection, hilar resection, vascular reconstruction, intra-operative opioid consumption and type of fluid administration, estimated blood loss, packed red cell and blood product transfusion, and operation time. Post-operative pain score and opioid consumption also be collected.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients more than 18 years old, who underwent an open hepatectomy between January 2007 - December 2018 at Maharay Nakhon Chiangmai Hospital', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All gender age above 18 years old\n* Undergoing open liver resection surgery\n\nExclusion Criteria:\n\n* No documentation of the numerical rating scale (NRS)\n* Epidural failure'}, 'identificationModule': {'nctId': 'NCT06301932', 'briefTitle': 'The Effectiveness and Outcomes of Epidural Analgesia in Patients Undergoing Open Hepatectomy', 'organization': {'class': 'OTHER', 'fullName': 'Chiang Mai University'}, 'officialTitle': 'The Effectiveness and Outcomes of Epidural Analgesia in Patients Undergoing Open Hepatectomy: A Propensity Score Matching Analysis', 'orgStudyIdInfo': {'id': 'ANE-2562-06771'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Epidural analgesia', 'description': 'Group of the patients received epidural analgesia', 'interventionNames': ['Procedure: Open liver resection']}, {'label': 'Non epidural analgesia', 'description': 'Group of the patients who did not received epidural analgesia', 'interventionNames': ['Procedure: Open liver resection']}], 'interventions': [{'name': 'Open liver resection', 'type': 'PROCEDURE', 'description': 'The definitions of liver resection and the type of hepatectomy were aligned with the anatomic classification of the Brisbane 2000 Terminology', 'armGroupLabels': ['Epidural analgesia', 'Non epidural analgesia']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chiang Mai University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Isarapong Pianngarn', 'investigatorAffiliation': 'Chiang Mai University'}}}}