Ignite Creation Date:
2025-12-25 @ 12:04 AM
Ignite Modification Date:
2026-02-25 @ 8:15 PM
Study NCT ID:
NCT02970058
Status:
UNKNOWN
Last Update Posted:
2020-03-16
First Post:
2016-11-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Platelet-rich Plasma Use as Prophylactic of Low Back Pain Post-spinal Following Gynecological Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-03-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'completionDateStruct': {'date': '2020-07-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-03-13', 'studyFirstSubmitDate': '2016-11-17', 'studyFirstSubmitQcDate': '2016-11-17', 'lastUpdatePostDateStruct': {'date': '2020-03-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-11-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual Analogue Scale', 'timeFrame': '7 days'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Platelet-rich Plasma in Low Back Pain']}, 'descriptionModule': {'briefSummary': 'Platelet-rich Plasma Use as Prophylactic of Post-operative Low Back Pain Following gynecological surgery.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Elective gynecological surgery.\n\nExclusion Criteria:\n\n* Spinal Pathology'}, 'identificationModule': {'nctId': 'NCT02970058', 'briefTitle': 'Platelet-rich Plasma Use as Prophylactic of Low Back Pain Post-spinal Following Gynecological Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Platelet-rich Plasma Use as Prophylactic of Low Back Pain Post-spinal Following Gynecological Surgery', 'orgStudyIdInfo': {'id': '01003060392'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Platelet-rich Plasma', 'description': '30 patients will receive platelet-rich plasma post-spinal anesthesia', 'interventionNames': ['Other: Platelet-rich Plasma']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control', 'description': '30 patients will receive sterile saline post-spinal anesthesia', 'interventionNames': ['Other: Control']}], 'interventions': [{'name': 'Platelet-rich Plasma', 'type': 'OTHER', 'description': 'The active group will receive Platelet-rich Plasma following spinal injection', 'armGroupLabels': ['Platelet-rich Plasma']}, {'name': 'Control', 'type': 'OTHER', 'description': 'The control group will receive saline as a placebo', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '71515', 'city': 'Asyut', 'status': 'RECRUITING', 'country': 'Egypt', 'facility': 'Assiut University Hospital', 'geoPoint': {'lat': 27.18096, 'lon': 31.18368}}], 'centralContacts': [{'name': 'mohmed Bakri, prof', 'role': 'CONTACT', 'email': 'mhbakri@gmail.com', 'phone': '+20882413201'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer of anesthesia', 'investigatorFullName': 'Eman A. Ismail', 'investigatorAffiliation': 'Assiut University'}}}}