Ignite Creation Date:
2025-12-24 @ 2:44 PM
Ignite Modification Date:
2026-02-23 @ 12:22 PM
Study NCT ID:
NCT04590859
Status:
UNKNOWN
Last Update Posted:
2021-09-30
First Post:
2020-09-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Penile Blood Flow Characteristics Following Caudal or Penile Block
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2024-01-26', 'releaseDate': '2023-05-16'}, {'resetDate': '2024-09-19', 'releaseDate': '2024-05-20'}, {'resetDate': '2025-04-15', 'releaseDate': '2025-03-31'}, {'resetDate': '2025-04-30', 'releaseDate': '2025-04-15'}, {'resetDate': '2025-08-06', 'releaseDate': '2025-07-22'}], 'estimatedResultsFirstSubmitDate': '2023-05-16'}}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 25}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-09-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2021-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-09-29', 'studyFirstSubmitDate': '2020-09-10', 'studyFirstSubmitQcDate': '2020-10-15', 'lastUpdatePostDateStruct': {'date': '2021-09-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-10-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'penile blood flow', 'timeFrame': '20 minutes', 'description': 'assessment of changes using ultrasound to blood flow based on block performed'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['The Aim of This Study is to Measure Blood Flow Before and After a Block']}, 'descriptionModule': {'briefSummary': 'Pediatric urologic surgery is generally accompanied by use of a caudal or penile block for analgesia. A caudal block is performed by injecting local anesthetic in the low epidural space while a penile block is performed by injecting local anesthetic above the pubic symphysis. Local anesthetic in the epidural space is known to caudal vasodilation interiorly. It is unknown as to whether this vasodilation results in alteration in flow to the penile tissue and potentially changes tissue characteristics. The aim of this study is to measure blood ultrasound velocity in the dorsal penile artery and vein before and after a block.', 'detailedDescription': 'Pediatric urologic surgery is generally accompanied by use of a caudal or penile block for analgesia. A caudal block is performed by injecting local anesthetic in the low epidural space while a penile block is performed by injecting local anesthetic above the pubic symphysis. Local anesthetic in the epidural space is known to caudal vasodilation interiorly. It is unknown as to whether this vasodilation results in alteration in flow to the penile tissue and potentially changes tissue characteristics. The aim of this study is to measure blood ultrasound velocity in the dorsal penile artery and vein before and after a block.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['CHILD'], 'maximumAge': '7 Years', 'minimumAge': '2 Years', 'genderBased': True, 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'males undergoing circumcision using penile or caudal', 'genderDescription': 'penile study only applicable to males', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children ages \\<7 years undergoing circumcision at TCH Penile or Caudal block to be performed at discretion of anesthesiology/Urology providers\n* ASA classification1,2\n* use of laryngeal mask airway\n\nExclusion Criteria:\n\n* Previous cardiac surgery\n* Antihypertensive medication\n* requirement for intravenous anesthetic\n* ASA classification non 1,2\n* parental refusal of participation parental refusal of block\n* patients requiring intubation'}, 'identificationModule': {'nctId': 'NCT04590859', 'briefTitle': 'Penile Blood Flow Characteristics Following Caudal or Penile Block', 'organization': {'class': 'OTHER', 'fullName': 'Baylor College of Medicine'}, 'officialTitle': 'Penile Blood Flow Characteristics Following Caudal or Penile Block', 'orgStudyIdInfo': {'id': 'H-48138'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Penile block', 'description': 'Patients undergoing procedure with penile block', 'interventionNames': ['Procedure: Block performed', 'Device: LMA placement']}, {'label': 'caudal block', 'description': 'Patients undergoing procedure with caudal block', 'interventionNames': ['Procedure: Block performed', 'Device: LMA placement']}], 'interventions': [{'name': 'Block performed', 'type': 'PROCEDURE', 'description': 'Comparing block performed with penile blood flow', 'armGroupLabels': ['Penile block', 'caudal block']}, {'name': 'LMA placement', 'type': 'DEVICE', 'description': 'Placement of LMA for airway securement', 'armGroupLabels': ['Penile block', 'caudal block']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Adam Adler, MD', 'role': 'CONTACT', 'email': 'axadler@texaschildrens.org', 'phone': '832-824-5800'}], 'facility': 'Texas childrens Hospital', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'centralContacts': [{'name': 'adam c adler, MD', 'role': 'CONTACT', 'email': 'adam.adler@gmail.com', 'phone': '7864177529'}, {'name': 'paul austin, md', 'role': 'CONTACT', 'phone': '832-824-5800'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Baylor College of Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Adam Adler MD, MS, FAAP', 'investigatorAffiliation': 'Baylor College of Medicine'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2023-05-16', 'type': 'RELEASE'}, {'date': '2024-01-26', 'type': 'RESET'}, {'date': '2024-05-20', 'type': 'RELEASE'}, {'date': '2024-09-19', 'type': 'RESET'}, {'date': '2025-03-31', 'type': 'RELEASE'}, {'date': '2025-04-15', 'type': 'RESET'}, {'date': '2025-04-15', 'type': 'RELEASE'}, {'date': '2025-04-30', 'type': 'RESET'}, {'date': '2025-07-22', 'type': 'RELEASE'}, {'date': '2025-08-06', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Adam Adler MD, MS, FAAP, Assistant Professor, Baylor College of Medicine'}}}}