Ignite Creation Date:
2025-12-24 @ 6:27 PM
Ignite Modification Date:
2026-03-18 @ 6:00 AM
Study NCT ID:
NCT02801968
Status:
UNKNOWN
Last Update Posted:
2016-06-16
First Post:
2016-05-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Tap Block and Cesarean Delivery: Efficacy and Consumption of Postoperative Drugs
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 62}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-05', 'completionDateStruct': {'date': '2016-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-06-12', 'studyFirstSubmitDate': '2016-05-28', 'studyFirstSubmitQcDate': '2016-06-12', 'lastUpdatePostDateStruct': {'date': '2016-06-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-06-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain evaluation with Numerical Rating Scale (NRS)', 'timeFrame': 'Pain evaluation with NRS at 2,6,12,24 hours after cesarean delivery in TAP block group and in the control group.', 'description': "We don't want to measure the change between each assessment within a single group, instead we want considering the difference in the measurements between two separate groups (TAP block group and control group) for each time point."}], 'secondaryOutcomes': [{'measure': 'Evaluation of NSAIDs (nonsteroidal anti-inflammatory drugs) consumption as rescue dose during the first 24 hours after cesarean delivery', 'timeFrame': 'Doses of NSAIDs (nonsteroidal anti-inflammatory drugs) administered at 2, 6, 12 ,24 hours after cesarean delivery TAP block group and in the control group.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Cesarean Delivery']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the efficacy of Tap block after cesarean delivery as a component of multimodal analgesia and evaluation of postoperative drugs consumption.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* age \\> 18 years\n* written consent\n* anesthesiologist's assent on preoperative evaluation\n\nExclusion Criteria:\n\n* age\\< 18 years\n* uncooperative patients\n* written consent not obtained\n* local anesthetic allergy\n* BMI \\> 35"}, 'identificationModule': {'nctId': 'NCT02801968', 'acronym': 'TAPFANS', 'briefTitle': 'Tap Block and Cesarean Delivery: Efficacy and Consumption of Postoperative Drugs', 'organization': {'class': 'OTHER', 'fullName': 'S. Anna Hospital'}, 'orgStudyIdInfo': {'id': 'CEIIAV1574'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Tap block', 'description': 'Tap block with ropivacaine 2 mg/kg at the end of cesarean delivery. Postoperative analgesia with acetaminophen and tramadol plus NSAIDs (nonsteroidal anti-inflammatory drugs) as rescue dose.', 'interventionNames': ['Procedure: Tap block', 'Other: intravenous analgesia']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'control group', 'description': 'Postoperative analgesia after cesarean delivery with acetaminophen and tramadol plus NSAIDs (nonsteroidal anti-inflammatory drugs) as rescue dose.', 'interventionNames': ['Other: intravenous analgesia']}], 'interventions': [{'name': 'Tap block', 'type': 'PROCEDURE', 'armGroupLabels': ['Tap block']}, {'name': 'intravenous analgesia', 'type': 'OTHER', 'armGroupLabels': ['Tap block', 'control group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ravenna', 'state': 'Ravenna', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Riccardo Ragazzi', 'role': 'CONTACT', 'email': 'rgc@unife.it', 'phone': '+390532236306'}, {'name': 'Ilaria Farinelli', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Osepdale Santa Maria delle Croci', 'geoPoint': {'lat': 44.41344, 'lon': 12.20121}}], 'centralContacts': [{'name': 'Ilaria Farinelli', 'role': 'CONTACT', 'email': 'ilaria.farinelli@unife.it', 'phone': '+393332082120'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'S. Anna Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Doctor', 'investigatorFullName': 'Ilaria Farinelli', 'investigatorAffiliation': 'S. Anna Hospital'}}}}