Ignite Creation Date:
2025-12-25 @ 5:05 AM
Ignite Modification Date:
2026-03-03 @ 2:18 PM
Study NCT ID:
NCT03775018
Status:
UNKNOWN
Last Update Posted:
2018-12-13
First Post:
2018-12-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
TAP Blockade for Pain Control in One-Anastomosis Gastric Bypass
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': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'The analgesic treatment applied will be blinded to the treatment and to the epidemiology nurse who will assess the postoperative pain'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 140}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2018-12-13', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-12', 'completionDateStruct': {'date': '2019-04-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-12-12', 'studyFirstSubmitDate': '2018-12-12', 'studyFirstSubmitQcDate': '2018-12-12', 'lastUpdatePostDateStruct': {'date': '2018-12-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-12-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-04-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postoperative pain', 'timeFrame': '24 hours after surgery', 'description': 'Pain will be assessed 24 hours after surgery by a Visual Analogic Scale, ranging from 0 to 100mm'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pain, Postoperative']}, 'descriptionModule': {'briefSummary': 'Patients will be randomized into 2 groups:\n\n* TAP: Patients undergoing TAP blockade, associated with intravenous Acetaminophen analgesia\n* IV: Patients receiving only intravenous Acetaminophen analgesia\n\nPostoperative pain 24 hours after surgery will be evaluated.', 'detailedDescription': 'Patients will be randomized into 2 groups:\n\n* TAP: Patients undergoing TAP blockade, associated with intravenous Acetaminophen analgesia (1g/6h)\n* IV: Patients receiving only intravenous Acetaminophen analgesia (1g/6h)\n\nPostoperative pain 24 hours after surgery will be evaluated, by a Visual Analogic Scale (VAS), ranging from 0 to 100mm.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients undergoing One-anastomosis gastric bypass (OAGB) as primary bariatric procedure\n\nExclusion Criteria:\n\n* Patients undergoing OAGB as revisional procedure\n* Patients undergoing other bariatric procedures\n* Patients undergoing additional surgical procedures during the same surgical act (band removal, cholecystectomy, hernioplasty, or hiatal hernia treatment)\n* Patients with history of allegy to local anesthetic drugs'}, 'identificationModule': {'nctId': 'NCT03775018', 'briefTitle': 'TAP Blockade for Pain Control in One-Anastomosis Gastric Bypass', 'organization': {'class': 'OTHER', 'fullName': 'Hospital General Universitario Elche'}, 'officialTitle': 'Transversus Abdominis Plane (TAP) Blockade as Multimodal Analgesia for Pain Control in One-Anastomosis Gastric Bypass (OAGB)', 'orgStudyIdInfo': {'id': 'HRJC 18-14'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Transversus abdominis plain blockade', 'description': 'The patients will undergo Transversus abdominis plain blockade, associated with intravenous analgesia', 'interventionNames': ['Procedure: Transversus abdominis plane blockade', 'Drug: Intravenous analgesia']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Intravenous analgesia', 'description': 'The patients will receive intravenous analgesia with Acetaminophen (1g/6h)', 'interventionNames': ['Drug: Intravenous analgesia']}], 'interventions': [{'name': 'Transversus abdominis plane blockade', 'type': 'PROCEDURE', 'description': 'Patients will undergo Transversus abdominis plane blockade with Bupivacaine 0.25% 30ml, applied in the plane between the internal oblique muscle and the trasnversus abdominis. The injection will be performed laterally to the port-sites, bilaterally at the same levels.', 'armGroupLabels': ['Transversus abdominis plain blockade']}, {'name': 'Intravenous analgesia', 'type': 'DRUG', 'description': 'Acetaminophen 1g/6h iv will be administered', 'armGroupLabels': ['Intravenous analgesia', 'Transversus abdominis plain blockade']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Jaime Ruiz-Tovar, MD, PhD', 'role': 'CONTACT', 'email': 'jruiztovar@gmail.com', 'phone': '(0034)630534808'}, {'name': 'Manuel Duran, MD, PhD', 'role': 'CONTACT', 'email': 'manuel.duran@hrjc.es', 'phone': '(0034)682357456'}], 'overallOfficials': [{'name': 'Damian Garcia, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hospital Rey Juan Carlos'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital General Universitario Elche', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Department of Surgery', 'investigatorFullName': 'Jaime Ruiz-Tovar, MD, PhD', 'investigatorAffiliation': 'Hospital General Universitario Elche'}}}}