Ignite Creation Date:
2025-12-24 @ 7:15 PM
Ignite Modification Date:
2026-04-22 @ 8:19 AM
Study NCT ID:
NCT03051503
Status:
UNKNOWN
Last Update Posted:
2017-02-24
First Post:
2017-02-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Transdermal Fentanyl Patches in Relief of Acute Postoperative Pain After Mastectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D016058', 'term': 'Analgesia, Patient-Controlled'}, {'id': 'D010323', 'term': 'Passive Cutaneous Anaphylaxis'}], 'ancestors': [{'id': 'D000698', 'term': 'Analgesia'}, {'id': 'D000760', 'term': 'Anesthesia and Analgesia'}, {'id': 'D012882', 'term': 'Skin Tests'}, {'id': 'D007159', 'term': 'Immunologic Tests'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D007158', 'term': 'Immunologic Techniques'}, {'id': 'D000937', 'term': 'Antigen-Antibody Reactions'}, {'id': 'D055633', 'term': 'Immune System Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-02-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'completionDateStruct': {'date': '2017-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-02-22', 'studyFirstSubmitDate': '2017-02-03', 'studyFirstSubmitQcDate': '2017-02-08', 'lastUpdatePostDateStruct': {'date': '2017-02-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-02-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total dose of morphine consumption in the first 48 hours postoperative', 'timeFrame': '48 hours', 'description': 'Total dose of I.V. PCA morphine consumption in the first 48 hours postoperative'}, {'measure': 'Visual Analogue Scale', 'timeFrame': '48 hours', 'description': 'Pain measurement scale'}], 'secondaryOutcomes': [{'measure': 'Level of stress hormones', 'timeFrame': '48 hours', 'description': 'Cortisol levels'}, {'measure': 'Side effects related to the opioids', 'timeFrame': '48 hours', 'description': 'Nausea and vomiting; Itching; Respiratory depression.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Breast Cancer Female']}, 'descriptionModule': {'briefSummary': 'to determine the safety, efficacy and tolerability of transdermal fentanyl in patients undergoing mastectomy, as well as the postoperative consumption of analgesic.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ASA I - II patients\n* aged 30-60 years\n* body weight ranged between 65-10kg\n\nExclusion Criteria:\n\n* Patients with history of allergy to morphine\n* chronic intake of analgesics or non-steroidal anti-inflammatory drug 24 h prior to surgery,\n* there was a history of a psychiatric disorder patients weight was less then 50kg.\n* impaired kidney function.'}, 'identificationModule': {'nctId': 'NCT03051503', 'briefTitle': 'Efficacy of Transdermal Fentanyl Patches in Relief of Acute Postoperative Pain After Mastectomy', 'organization': {'class': 'OTHER', 'fullName': 'South Egypt Cancer Institute'}, 'officialTitle': 'Efficacy of Transdermal Fentanyl Patches in Relief of Acute Postoperative Pain After Mastectomy', 'orgStudyIdInfo': {'id': '228'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'The Transdermal Therapeutic System-Fentanyl (TTS-F) group', 'description': '(TTS-F) group (n=30) 50ug/h patch, placed 12 hs preoperatively.', 'interventionNames': ['Drug: The Transdermal Therapeutic System-Fentanyl (TTS-F)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Intravenous patient-controlled analgesia (PCA) morphine', 'description': 'IV (PCA) morphine for pain in the postoperative period.', 'interventionNames': ['Device: Intravenous patient-controlled analgesia (PCA) morphine']}], 'interventions': [{'name': 'The Transdermal Therapeutic System-Fentanyl (TTS-F)', 'type': 'DRUG', 'otherNames': ['Fentanyl patch'], 'description': '(TTS-F) group (n=30) 50ug/h patch, placed 12 hours preoperatively', 'armGroupLabels': ['The Transdermal Therapeutic System-Fentanyl (TTS-F) group']}, {'name': 'Intravenous patient-controlled analgesia (PCA) morphine', 'type': 'DEVICE', 'otherNames': ['IV PCA morphine'], 'description': 'IV PCA morphine for pain in the postoperative period.', 'armGroupLabels': ['Intravenous patient-controlled analgesia (PCA) morphine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '171516', 'city': 'Asyut', 'status': 'RECRUITING', 'country': 'Egypt', 'facility': 'South Egypt Cancer Institute, Assiut University, Assiut, Egypt.', 'geoPoint': {'lat': 27.18096, 'lon': 31.18368}}], 'centralContacts': [{'name': 'mohamad F mohamad, MD', 'role': 'CONTACT', 'email': 'mfaroukma@gmail.com', 'phone': '+201093942354'}], 'overallOfficials': [{'name': 'Ahmed H Othman, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Cancer Institute, Anesthesia, Intensive Care, and Pain Management, South Egypt Cancer Institute, Assiut University, Assiut, Egypt'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'South Egypt Cancer Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'lecturer of anesthesia and pain relief', 'investigatorFullName': 'Dr.mohamad farouk mohamad', 'investigatorAffiliation': 'South Egypt Cancer Institute'}}}}