Ignite Creation Date:
2025-12-24 @ 4:59 PM
Ignite Modification Date:
2026-02-21 @ 5:53 AM
Study NCT ID:
NCT03721250
Status:
COMPLETED
Last Update Posted:
2020-02-28
First Post:
2018-10-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Thoracic Epidural Analgesia and Intercostal Blockade in Patients Undergoing Thoracotomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000377', 'term': 'Agnosia'}], 'ancestors': [{'id': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007268', 'term': 'Injections, Epidural'}], 'ancestors': [{'id': 'D007278', 'term': 'Injections, Spinal'}, {'id': 'D007267', 'term': 'Injections'}, {'id': 'D004333', 'term': 'Drug Administration Routes'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-12-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2019-04-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-02-27', 'studyFirstSubmitDate': '2018-10-23', 'studyFirstSubmitQcDate': '2018-10-24', 'lastUpdatePostDateStruct': {'date': '2020-02-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-10-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-03-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'verbal analog score', 'timeFrame': 'postoperative 24 hour'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Analgesia, Postoperative']}, 'descriptionModule': {'briefSummary': 'Postoperative pain is an important issue after thoracotomy operations. Thoracic epidural analgesia is most popular analgesic method, but sometimes it is not sufficient for pain. This study is designed to compare intercostal block with thoracic epidural analgesia in patients undergoing thoracotomy'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'patients undergoing thoracotomy', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nlung cancer\n\nExclusion Criteria:\n\npatient refusal bleeding diathesisi emergency cases\n\n\\-'}, 'identificationModule': {'nctId': 'NCT03721250', 'briefTitle': 'Comparison of Thoracic Epidural Analgesia and Intercostal Blockade in Patients Undergoing Thoracotomy', 'organization': {'class': 'OTHER', 'fullName': 'Ankara University'}, 'officialTitle': 'Comparison of Thoracic Epidural Analgesia and Intercostal Blockade in Patients Undergoing Thoracotomy', 'orgStudyIdInfo': {'id': 'Ank230918'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'thoracic epidural', 'description': 'patients receiving thoracic epidural', 'interventionNames': ['Other: epidural']}], 'interventions': [{'name': 'epidural', 'type': 'OTHER', 'description': 'thoracic epidural analgesia', 'armGroupLabels': ['thoracic epidural']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06550', 'city': 'Ankara', 'country': 'Turkey (Türkiye)', 'facility': 'Ankara University', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ankara University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associated professor', 'investigatorFullName': 'CIGDEM YILDIRIM GUCLU', 'investigatorAffiliation': 'Ankara University'}}}}