Ignite Creation Date:
2025-12-24 @ 10:56 PM
Ignite Modification Date:
2026-01-02 @ 10:46 AM
Study NCT ID:
NCT03805269
Status:
RECRUITING
Last Update Posted:
2024-01-16
First Post:
2019-01-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Transversus Abdominis Plane(TAP) Block Versus Local Anesthetic Infiltration
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': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 94}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-03-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-01-11', 'studyFirstSubmitDate': '2019-01-12', 'studyFirstSubmitQcDate': '2019-01-14', 'lastUpdatePostDateStruct': {'date': '2024-01-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-01-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-28', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'post operative pain score', 'timeFrame': '4 hours after end of surgery', 'description': '100 mm scale of visual analogue scale'}], 'secondaryOutcomes': [{'measure': 'post operative opioid consumption', 'timeFrame': '4 hours after end of surgery', 'description': 'total amount of opioid'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pain, Postoperative']}, 'descriptionModule': {'briefSummary': 'There have been some studies to compared trans abdominis plane(TAP) block with wound infiltration of local anesthetics in multiport laparoscopic surgery, but there have been no studies in single incision laparoscopic gastrectomy.\n\nThe purpose of this study was to compare the effect of ultrasonography-guided transverse nerve block and localized anesthesia infiltration in patients with single incision laparoscopic gastrectomy.', 'detailedDescription': 'Patients were randomly divided into group N(ultrasonography-guided TAP) block and group W( before surgery local anesthetic infiltration at the incision site). We compared the opioid usage, postoperative 6, 24, and 48 hours pain, presence of vomiting, and duration of hospitalization during the operation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ASA class I-II\n* Age: \\>18\n\nExclusion Criteria:\n\n* patients of severe kidney \\& liver dysfunction\n* allergy of local anesthetics'}, 'identificationModule': {'nctId': 'NCT03805269', 'briefTitle': 'Transversus Abdominis Plane(TAP) Block Versus Local Anesthetic Infiltration', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Bundang Hospital'}, 'officialTitle': 'Analgesic Efficacy of Ultrasound Guided Transversus Abdominis Plane(TAP) Block Versus Local Anesthetic Infiltration in Adult Patients Undergoing Single Incision Laparoscopic Gastrectomy: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'SNUBHTAP'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TAP block', 'description': 'USG guided TAP block', 'interventionNames': ['Drug: TAP block']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'wound infiltration', 'description': 'local anesthetics infiltration at surgical incision site', 'interventionNames': ['Drug: wound infiltration']}], 'interventions': [{'name': 'TAP block', 'type': 'DRUG', 'otherNames': ['TAP'], 'description': 'TAP block: local anesthetics infiltration at trans abdominis plane', 'armGroupLabels': ['TAP block']}, {'name': 'wound infiltration', 'type': 'DRUG', 'otherNames': ['Wound'], 'description': 'wound infiltration: local anesthetics infiltration at surgical incision', 'armGroupLabels': ['wound infiltration']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seongnam-si', 'state': 'Gyonggido', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Bon-Wook Koo, MD', 'role': 'CONTACT', 'email': 'tendong2@gmail.com', 'phone': '+82-10-7227-1379'}], 'facility': 'Seoul National Universuty, Bundang Hospital', 'geoPoint': {'lat': 37.43861, 'lon': 127.13778}}], 'centralContacts': [{'name': 'Bon-Wook Koo, Dr.', 'role': 'CONTACT', 'email': 'tendong2@gmail.com', 'phone': '+82-10-7227-1379'}], 'overallOfficials': [{'name': 'Jung-hi Ryu, Dr.', 'role': 'STUDY_CHAIR', 'affiliation': 'Seoul National University Bundang Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Bundang Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'asociative professor', 'investigatorFullName': 'BON WOOK KOO', 'investigatorAffiliation': 'Seoul National University Bundang Hospital'}}}}