Ignite Creation Date:
2025-12-24 @ 5:38 PM
Ignite Modification Date:
2025-12-27 @ 7:55 AM
Study NCT ID:
NCT01516268
Status:
COMPLETED
Last Update Posted:
2013-03-27
First Post:
2012-01-19
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
The Effect of Adding Sufentanyl to Bupivacaine in Transversus Abdominis Plane Block to Reduce the Narcotic Dosage and Pain After Cesarean Delivery
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017409', 'term': 'Sufentanil'}], 'ancestors': [{'id': 'D005283', 'term': 'Fentanyl'}, {'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'leslamian@tums.ac.ir', 'phone': '0098218490', 'title': 'Dr. Laleh Eslamian', 'phoneExt': '2415', 'organization': 'Tehran University of Medical Sciences'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '24h', 'eventGroups': [{'id': 'EG000', 'title': 'Sufentanyl Group', 'description': 'IN case group we add 1cc sufentanyl to 20 cc bupivacain in TAP block', 'otherNumAtRisk': 25, 'otherNumAffected': 0, 'seriousNumAtRisk': 25, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Control Group', 'description': 'In control group we add 1cc salin to 20cc bupivacain in TAP block', 'otherNumAtRisk': 25, 'otherNumAffected': 1, 'seriousNumAtRisk': 25, 'seriousNumAffected': 3}], 'otherEvents': [{'term': 'itching', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'SNOMED CT'}], 'seriousEvents': [{'term': 'Nausea and vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'SNOMED CT'}, {'term': 'itching', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'SNOMED CT'}], 'frequencyThreshold': '3'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Narcotic Dosage', 'timeFrame': '24 h', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Pain', 'timeFrame': '24h', 'reportingStatus': 'NOT_POSTED'}, {'type': 'PRIMARY', 'title': 'Narcotic Dosage', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sufentanyl Group', 'description': 'IN case group we add 1cc sufentanyl to 20 cc bupivacain in TAP block'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'In control group we add 1cc salin to 20cc bupivacain in TAP block'}], 'classes': [{'categories': [{'measurements': [{'value': '37.2', 'spread': '16.15', 'groupId': 'OG000'}, {'value': '52.8', 'spread': '16.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'over 24 hours after surgery', 'description': 'The total dosage of morphin consumed by the patients in sufentanil or control group.', 'unitOfMeasure': 'mgm,.', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Sufentanyl Group', 'description': 'IN case group we add 1cc sufentanyl to 20 cc bupivacain in TAP block'}, {'id': 'FG001', 'title': 'Control Group', 'description': 'In control group we add 1cc salin to 20cc bupivacain in TAP block'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '25'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '25'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'recruitment period: Jan 2012- Dec 2013 Shariati hospital, a tertiary center', 'preAssignmentDetails': 'Exclusions were based on exclusion criteria previously mentioned.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Sufentanyl Group', 'description': 'IN case group we add 1cc sufentanyl to 20 cc bupivacain in TAP block'}, {'id': 'BG001', 'title': 'Control Group', 'description': 'In control group we add 1cc salin to 20cc bupivacain in TAP block'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '28.9', 'spread': '3.4', 'groupId': 'BG000'}, {'value': '29.9', 'spread': '5.6', 'groupId': 'BG001'}, {'value': '29.1', 'spread': '4.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Iran, Islamic Republic of', 'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': '25 \\& 25'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-02', 'completionDateStruct': {'date': '2013-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-02-19', 'studyFirstSubmitDate': '2012-01-19', 'resultsFirstSubmitDate': '2013-02-19', 'studyFirstSubmitQcDate': '2012-01-23', 'lastUpdatePostDateStruct': {'date': '2013-03-27', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-02-19', 'studyFirstPostDateStruct': {'date': '2012-01-24', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-03-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Narcotic Dosage', 'timeFrame': '24 h'}, {'measure': 'Narcotic Dosage', 'timeFrame': 'over 24 hours after surgery', 'description': 'The total dosage of morphin consumed by the patients in sufentanil or control group.'}], 'secondaryOutcomes': [{'measure': 'Pain', 'timeFrame': '24h'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Cesarean Delivery', 'TAP block', 'sufentanyl', 'Narcotic dosages'], 'conditions': ['Pain']}, 'descriptionModule': {'briefSummary': 'Adding sufentanyl to bupivacain in Transversus Abdominis Plane (TAP) block under ultrasound guide can reduce narcotic dosage, side effects and pain after cesarean delivery.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* female 18 to 40 Years\n* class ASA 1 and 2\n* candidates for elective cesarean section\n\nExclusion Criteria:\n\n* renal failure\n* liver failure\n* cardiac disorder\n* coagulopathy\n* hepatomegaly\n* splenomegaly\n* drug sensitivity and abuse\n* morbid obesity\n* smoking\n* history of post operative nausea and vomiting\n* motion sickness\n* local hypoesthesia'}, 'identificationModule': {'nctId': 'NCT01516268', 'acronym': 'TAP', 'briefTitle': 'The Effect of Adding Sufentanyl to Bupivacaine in Transversus Abdominis Plane Block to Reduce the Narcotic Dosage and Pain After Cesarean Delivery', 'organization': {'class': 'OTHER', 'fullName': 'Tehran University of Medical Sciences'}, 'officialTitle': 'the Effect of Adding Sufentanyl to Bupivacaine in Transversus Abdominis Plane (TAP) Block Under the Guide of Ultrasound to Reduce the Narcotic Dosage, Side Effects and Pain in the First 24 Hours After Cesarean Delivery', 'orgStudyIdInfo': {'id': '886'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Sufentanyl group', 'description': 'IN case group we add 1cc sufentanyl to 20 cc bupivacain in TAP block', 'interventionNames': ['Drug: Sufentanyl']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control group', 'description': 'In control group we add 1cc salin to 20cc bupivacain in TAP block', 'interventionNames': ['Drug: Sufentanyl']}], 'interventions': [{'name': 'Sufentanyl', 'type': 'DRUG', 'description': 'As intervention 1cc sufentanyl is added to bupivacain in case group for TAP block.\n\nAs comparator 1cc normal saline is added to bupivacain in control group for Tap block.', 'armGroupLabels': ['Control group', 'Sufentanyl group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14114', 'city': 'Tehran', 'country': 'Iran', 'facility': 'Shariati hospital, TUMS', 'geoPoint': {'lat': 35.69439, 'lon': 51.42151}}], 'overallOfficials': [{'name': 'Laleh Eslamian, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'TUMS, Tehran University of Medical Sciences'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tehran University of Medical Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associated Prof.MD', 'investigatorFullName': 'Laleh Eslamian', 'investigatorAffiliation': 'Tehran University of Medical Sciences'}}}}