Ignite Creation Date:
2025-12-24 @ 5:52 PM
Ignite Modification Date:
2025-12-29 @ 3:56 PM
Study NCT ID:
NCT01698268
Status:
COMPLETED
Last Update Posted:
2017-08-24
First Post:
2012-08-14
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study of Transverse Abdominis Plane (TAP) Block in Children Undergoing Hydrocelectomy and/or Hernia Repair Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006848', 'term': 'Testicular Hydrocele'}, {'id': 'D006552', 'term': 'Hernia, Inguinal'}], 'ancestors': [{'id': 'D013733', 'term': 'Testicular Diseases'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D046449', 'term': 'Hernia, Abdominal'}, {'id': 'D006547', 'term': 'Hernia'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000772', 'term': 'Anesthesia, Local'}], 'ancestors': [{'id': 'D000765', 'term': 'Anesthesia, Conduction'}, {'id': 'D000758', 'term': 'Anesthesia'}, {'id': 'D000760', 'term': 'Anesthesia and Analgesia'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'kaslani@beaumont.org', 'phone': '248-898-81905', 'title': 'Kaveh Aslani, MD', 'organization': 'Beaumont Health'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Of the 47 treated patients, the local infiltration was administered by 8 different surgeons while the TAP block was administered by 2 different anesthesiologists.'}}, 'adverseEventsModule': {'timeFrame': 'Adverse Events were collected from the time of consent through the time of a followup phone call 24 hours post discharge from the hospital.', 'eventGroups': [{'id': 'EG000', 'title': 'TAP Group', 'description': 'Enrolled subjects will receive a TAP block with 0.5cc/kg of 0.25% ropivacaine.\n\nTAP block: TAP Block will be performed under ultrasound guidance via Sonosite device with an in-plane technique by the anesthesiologist.', 'otherNumAtRisk': 23, 'deathsNumAtRisk': 23, 'otherNumAffected': 9, 'seriousNumAtRisk': 23, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Local Infiltration Group', 'description': 'Enrolled subjects will receive will receive local infiltration of 0.5 cc/kg of 0.25% ropivacaine.\n\nLocal Infiltration: Local infiltration of 0.5 cc/kg of 0.25% ropivacaine will be administered by the surgeon.', 'otherNumAtRisk': 24, 'deathsNumAtRisk': 24, 'otherNumAffected': 7, 'seriousNumAtRisk': 24, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Agitation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Abdominal swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Restlessness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Incisional pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Skin irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'skin inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Urinary urgency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'FLACC: Face, Legs, Activity, Cry, and Consolability Pain Assessment Scale (FLACC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TAP Group', 'description': 'Enrolled subjects will receive a TAP block with 0.5cc/kg of 0.25% ropivacaine.\n\nTAP block: TAP Block will be performed under ultrasound guidance via Sonosite device with an in-plane technique by the anesthesiologist.'}, {'id': 'OG001', 'title': 'Local Infiltration Group', 'description': 'Enrolled subjects will receive will receive local infiltration of 0.5 cc/kg of 0.25% ropivacaine.\n\nLocal Infiltration: Local infiltration of 0.5 cc/kg of 0.25% ropivacaine will be administered by the surgeon.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '3.5'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Admission into PACU', 'description': 'FLACC: Face, Legs, Activity, Cry, and Consolability Pain Assessment Scale (FLACC), a five-item, three point scale that measures pain behavior on a scale of 0 - 2 which are summed to result in a total score of 0 - 10. Clinical judgment is used to interpret pain. The higher the score on the FLACC correlates with a higher pain score (0= no behaviors indicative of pain and 10= five behaviors indicative of significant pain). This scale was evaluated by blinded post-operative anesthesia care unit (PACU) Registered Nurses (RNs) at admission to PACU.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'TAP Group', 'description': 'Enrolled subjects will receive a TAP block with 0.5cc/kg of 0.25% ropivacaine.\n\nTAP block: TAP Block will be performed under ultrasound guidance via Sonosite device with an in-plane technique by the anesthesiologist.'}, {'id': 'FG001', 'title': 'Local Infiltration Group', 'description': 'Enrolled subjects will receive will receive local infiltration of 0.5 cc/kg of 0.25% ropivacaine.\n\nLocal Infiltration: Local infiltration of 0.5 cc/kg of 0.25% ropivacaine will be administered by the surgeon.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '25'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '23'}, {'groupId': 'FG001', 'numSubjects': '24'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'This single-center, prospective, single blind, randomized study enrolled subjects who were scheduled for elective hydrocelectomy and/or hernia repair at Beaumont Hospital-Royal Oak. The first procedure was on 3/16/2012 and the last one was on 11/12/2014.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'TAP Group', 'description': 'Enrolled subjects will receive a TAP block with 0.5cc/kg of 0.25% ropivacaine.\n\nTAP block: TAP Block will be performed under ultrasound guidance via Sonosite device with an in-plane technique by the anesthesiologist.'}, {'id': 'BG001', 'title': 'Local Infiltration Group', 'description': 'Enrolled subjects will receive will receive local infiltration of 0.5 cc/kg of 0.25% ropivacaine.\n\nLocal Infiltration: Local infiltration of 0.5 cc/kg of 0.25% ropivacaine will be administered by the surgeon.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', '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': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Data not included for patients removed from study by physician'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-07', 'completionDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-07-24', 'studyFirstSubmitDate': '2012-08-14', 'resultsFirstSubmitDate': '2017-01-18', 'studyFirstSubmitQcDate': '2012-09-27', 'lastUpdatePostDateStruct': {'date': '2017-08-24', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-03-31', 'studyFirstPostDateStruct': {'date': '2012-10-02', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-06-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'FLACC: Face, Legs, Activity, Cry, and Consolability Pain Assessment Scale (FLACC)', 'timeFrame': 'Admission into PACU', 'description': 'FLACC: Face, Legs, Activity, Cry, and Consolability Pain Assessment Scale (FLACC), a five-item, three point scale that measures pain behavior on a scale of 0 - 2 which are summed to result in a total score of 0 - 10. Clinical judgment is used to interpret pain. The higher the score on the FLACC correlates with a higher pain score (0= no behaviors indicative of pain and 10= five behaviors indicative of significant pain). This scale was evaluated by blinded post-operative anesthesia care unit (PACU) Registered Nurses (RNs) at admission to PACU.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Hydrocele', 'Inguinal Hernia']}, 'descriptionModule': {'briefSummary': 'Study measures the difference in pain after hernia \\&/or hydrocele repair based on site of local anesthesia injection.', 'detailedDescription': 'This single-center, prospective, single blind, randomized study will enroll up to 50 subjects who are scheduled for elective hydrocelectomy and/or hernia repair. At Beaumont Health System, post-operative pain management in children is managed either via oral/parenteral opiates and opiate adjuncts, surgeon-administered field blocks (instillation of local anesthetics in the general area of incision), or via regional techniques (spinal, epidural, or peripheral nerve blocks). We have designed this study to determine if there is improved qualitative and quantitative post-operative pain control in patients receiving TAP block versus intraoperative peri-incisional, surgeon administered field block. Once informed consent has been given, each patient will be randomized (like flip of the coin) to either Transverse Abdominis Plane Block (TAP Block)or surgeon administered anesthesia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '8 Years', 'minimumAge': '2 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Children 2-8 years of age\n* Elective inguinal hernia repair, inguinal hernia repair with peritoneoscopy and/or hydrocelectomy to be performed in the Center for Children's Surgery, Beaumont Hospital, Royal Oak\n* American Society of Anesthesiologists physical status classification 1 and 2 (patients that have either no systemic illness, or mild systemic disease that is well controlled, eg. mild asthma)\n\nExclusion Criteria:\n\n* History of allergy to study medications\n* Enrollment in concurrent research study\n* Pregnant patients\\*\n* Students/trainees/staff\\*\n* Mentally disabled/cognitively impaired\\*"}, 'identificationModule': {'nctId': 'NCT01698268', 'acronym': 'TAP', 'briefTitle': 'Study of Transverse Abdominis Plane (TAP) Block in Children Undergoing Hydrocelectomy and/or Hernia Repair Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Corewell Health East'}, 'officialTitle': 'The Efficacy of Transverse Abdominis Plane (TAP) Block in Children Undergoing Hydrocelectomy and/or Hernia Repair', 'orgStudyIdInfo': {'id': '2011-213'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TAP Group', 'description': 'Enrolled subjects will receive a TAP block with 0.5cc/kg of 0.25% ropivacaine.', 'interventionNames': ['Procedure: TAP block']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Local Infiltration Group', 'description': 'Enrolled subjects will receive will receive local infiltration of 0.5 cc/kg of 0.25% ropivacaine.', 'interventionNames': ['Procedure: Local Infiltration']}], 'interventions': [{'name': 'TAP block', 'type': 'PROCEDURE', 'description': 'TAP Block will be performed under ultrasound guidance via Sonosite device with an in-plane technique by the anesthesiologist.', 'armGroupLabels': ['TAP Group']}, {'name': 'Local Infiltration', 'type': 'PROCEDURE', 'description': 'Local infiltration of 0.5 cc/kg of 0.25% ropivacaine will be administered by the surgeon.', 'armGroupLabels': ['Local Infiltration Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48073', 'city': 'Royal Oak', 'state': 'Michigan', 'country': 'United States', 'facility': 'Beaumont Health System', 'geoPoint': {'lat': 42.48948, 'lon': -83.14465}}], 'overallOfficials': [{'name': 'Kaveh Aslani, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Beaumont Health'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kaveh Aslani, MD', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Kaveh Aslani, MD', 'investigatorAffiliation': 'Corewell Health East'}}}}