Ignite Creation Date:
2025-12-24 @ 6:55 PM
Ignite Modification Date:
2026-01-03 @ 6:17 AM
Study NCT ID:
NCT03199157
Status:
COMPLETED
Last Update Posted:
2017-06-26
First Post:
2017-06-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Fentanyl 12 Mcg Transdermal Patch For Postoperative Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2020-08-21', 'releaseDate': '2020-08-10'}], 'estimatedResultsFirstSubmitDate': '2020-08-10'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 78}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-06', 'completionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-06-23', 'studyFirstSubmitDate': '2017-06-23', 'studyFirstSubmitQcDate': '2017-06-23', 'lastUpdatePostDateStruct': {'date': '2017-06-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-06-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Numeric rating score for pain (NRS)', 'timeFrame': 'Postoperative 24 hours'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Postoperative Pain']}, 'descriptionModule': {'briefSummary': 'The investigators designed a prospective randomized study to investigate the effect of fentanyl 12 mcg transdermal patch on postoperative pain following unilateral, single-level laminectomy/discectomy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients between the ages of 20-70 years\n* ASA physical status 1-2 patients undergoing single-level laminectomy/discectomy\n\nExclusion Criteria:\n\n* A history of allergy to any study drugs\n* History of opioid use, obstructive sleep apnea\n* Any psychological disorders\n* hepatic or renal failure'}, 'identificationModule': {'nctId': 'NCT03199157', 'briefTitle': 'Fentanyl 12 Mcg Transdermal Patch For Postoperative Pain', 'organization': {'class': 'OTHER', 'fullName': 'Baskent University'}, 'officialTitle': 'The Effect Of Fentanyl 12 Mcg Transdermal Patch On Postoperative Pain Following Unilateral, Single-Level Laminectomy/Discectomy: A Randomized, Controlled, Double-Blind Study', 'orgStudyIdInfo': {'id': 'KA14-66'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Fentanyl Group', 'description': 'Patients received the fentanyl 12 mcg transdermal patch (FG, n=38) 8 hours preoperatively and until 24 hours after the surgery', 'interventionNames': ['Drug: Fentanyl transdermal patch']}, {'type': 'NO_INTERVENTION', 'label': 'Control group'}], 'interventions': [{'name': 'Fentanyl transdermal patch', 'type': 'DRUG', 'description': 'Patients received fentanyl 12 mcg transdermal patch group 8 hours preoperatively and until 24 hours after the surgery', 'armGroupLabels': ['Fentanyl Group']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Baskent University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Medical Doctor', 'investigatorFullName': 'Oya Yalcin Cok', 'investigatorAffiliation': 'Baskent University'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2020-08-10', 'type': 'RELEASE'}, {'date': '2020-08-21', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Oya Yalcin Cok, Medical Doctor, Baskent University'}}}}