Ignite Creation Date:
2025-12-24 @ 3:51 PM
Ignite Modification Date:
2026-01-25 @ 1:10 AM
Study NCT ID:
NCT02741492
Status:
COMPLETED
Last Update Posted:
2018-07-18
First Post:
2016-04-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Transversus Abdominus Plane Catheters for Open Inguinal Hernia Repair
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2018-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-07-16', 'studyFirstSubmitDate': '2016-04-12', 'studyFirstSubmitQcDate': '2016-04-13', 'lastUpdatePostDateStruct': {'date': '2018-07-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-04-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Opioid Consumption (Intravenous Morphine Equivalents)', 'timeFrame': '48 Hours', 'description': 'Total Opioid Consumption'}], 'secondaryOutcomes': [{'measure': 'Pain (Numeric Rating)', 'timeFrame': '30 Days', 'description': 'NRS Pain Scale'}, {'measure': 'Activity Assessment Score', 'timeFrame': '30 Days', 'description': 'Composite Score'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Post-Operative Pain']}, 'referencesModule': {'references': [{'pmid': '31670776', 'type': 'DERIVED', 'citation': 'Flaherty JM, Auyong DB, Yuan SC, Lin SE, Meier AW, Biehl TR, Helton WS, Slee A, Hanson NA. Continuous Transversus Abdominis Plane Block for Primary Open Inguinal Hernia Repair: A Randomized, Double-Blind, Placebo-Controlled Trial. Pain Med. 2020 Feb 1;21(2):e201-e207. doi: 10.1093/pm/pnz275.'}]}, 'descriptionModule': {'briefSummary': 'This study is designed to evaluate pain control of continuous transversus abdominis plane (TAP) blocks placed for open inguinal hernia repair. The investigators hypothesize that there will be improved pain control when compared with sham blocks.', 'detailedDescription': 'This study is a randomized, controlled trial designed to determine whether continuous transversus abdominis plane (TAP) block versus sham block has a substantial impact on pain following open inguinal hernia repair. Our primary outcome is to determine whether there will be a difference in opioid consumption within the first two days following surgery. Secondary outcomes will include: pain scores and activity assessment score.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Unilateral open inguinal hernia repair\n* ASA physical status I-III\n* \\>18 years old\n* Consent to participate in the study\n\nExclusion Criteria:\n\n* Refusal to participate in the study\n* \\<18 years old\n* Chronic opioid use\n* Localized infection\n* Pregnancy or lactating\n* Pre-existing coagulopathy or active anticoagulant use\n* Allergy to ultrasound gel or local anesthetics'}, 'identificationModule': {'nctId': 'NCT02741492', 'briefTitle': 'Transversus Abdominus Plane Catheters for Open Inguinal Hernia Repair', 'organization': {'class': 'OTHER', 'fullName': 'Benaroya Research Institute'}, 'officialTitle': 'Continuous Transversus Abdominus Plane Block for Open Inguinal Hernia Repair', 'orgStudyIdInfo': {'id': 'Benaroya Research Institute'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Block Group', 'description': 'Continuous Transversus Abdominis Plane Catheter', 'interventionNames': ['Procedure: Transversus Abdominis Plane Block']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham Group', 'description': 'Continuous Sham Catheter', 'interventionNames': ['Procedure: Sham Block']}], 'interventions': [{'name': 'Transversus Abdominis Plane Block', 'type': 'PROCEDURE', 'description': 'Continuous Nerve Block', 'armGroupLabels': ['Block Group']}, {'name': 'Sham Block', 'type': 'PROCEDURE', 'description': 'Continuous Sham Catheter', 'armGroupLabels': ['Sham Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '98101', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Virginia Mason Medical Center', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'Neil A Hanson, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Virginia Mason Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Benaroya Research Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Staff Anesthesiologist', 'investigatorFullName': 'Neil Hanson', 'investigatorAffiliation': 'Benaroya Research Institute'}}}}