Viewing Study NCT07033104


Ignite Creation Date: 2025-12-24 @ 9:11 PM
Ignite Modification Date: 2026-01-02 @ 3:38 AM
Study NCT ID: NCT07033104
Status: RECRUITING
Last Update Posted: 2025-06-24
First Post: 2025-06-13
Is NOT Gene Therapy: True
Has Adverse Events: False

Brief Title: Adding Calcitonin to Bupivacaine in Transversalis Fascia Plane Block for Cesarean Section
Sponsor:
Organization:

Raw JSON

{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 70}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2025-09-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-23', 'studyFirstSubmitDate': '2025-06-13', 'studyFirstSubmitQcDate': '2025-06-23', 'lastUpdatePostDateStruct': {'date': '2025-06-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-06-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-08-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'time to first rescue analgesia', 'timeFrame': '24 hours'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Transversalis Fascia Plane Block']}, 'descriptionModule': {'briefSummary': 'Evaluate calcitonin as an adjuvant to bupivacaine in ultrasound guided tansversalis fascia plane block'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'genderBased': True, 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* female pt ASA2 scheduled for cs under spinal anesthesia\n\nExclusion Criteria:\n\n* patient refusal ASAmore than 3 patients with pregnancy related disease emergency cs history of coagulopathy'}, 'identificationModule': {'nctId': 'NCT07033104', 'briefTitle': 'Adding Calcitonin to Bupivacaine in Transversalis Fascia Plane Block for Cesarean Section', 'organization': {'class': 'OTHER', 'fullName': 'Tanta University'}, 'officialTitle': 'Analgesic Effect of Adding Calcitonin to Bupivacaine in Transversalis Fascia Plane Block for Cesarean Section, A Prospective Randomized Study', 'orgStudyIdInfo': {'id': '36264PR1160'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Transversalis fascia plane block with bupivacaine', 'description': 'us guided transversalis fascia plane block with bupivacaine', 'interventionNames': ['Other: us guided Transversalis fascia plane block']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Transversalis fascia plane block with calcitonin and bupivacaine', 'description': 'us guided transvesalis fascia plane block with calcitonin and bupivacaine', 'interventionNames': ['Other: us guided Transversalis fascia plane block']}], 'interventions': [{'name': 'us guided Transversalis fascia plane block', 'type': 'OTHER', 'description': 'addition of calcitonin to pubivacaine', 'armGroupLabels': ['Transversalis fascia plane block with bupivacaine', 'Transversalis fascia plane block with calcitonin and bupivacaine']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tanta', 'state': 'Gharbia Governorate', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'marwa ahmed Abogabal, PhD', 'role': 'CONTACT', 'email': 'dr_mora1985@med.tanta.edu.eg', 'phone': '+201004190210'}], 'facility': 'tanta University hospital', 'geoPoint': {'lat': 30.78847, 'lon': 31.00192}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tanta University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Marwa Abogabal', 'investigatorFullName': 'Marwa Ahmed Abogabal', 'investigatorAffiliation': 'Tanta University'}}}}