Ignite Creation Date:
2025-12-25 @ 5:08 AM
Ignite Modification Date:
2026-03-06 @ 2:54 AM
Study NCT ID:
NCT02601027
Status:
COMPLETED
Last Update Posted:
2021-09-23
First Post:
2015-11-04
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Transversus Abdominis Plane Block in Microsurgical Breast Recon w/Abdominal Free Flap in Breast CA
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D003766', 'term': 'Dental Occlusion'}, {'id': 'D002045', 'term': 'Bupivacaine'}, {'id': 'D000082', 'term': 'Acetaminophen'}, {'id': 'D004091', 'term': 'Hydromorphone'}, {'id': 'D010098', 'term': 'Oxycodone'}, {'id': 'D017294', 'term': 'Ondansetron'}], 'ancestors': [{'id': 'D003813', 'term': 'Dentistry'}, {'id': 'D009063', 'term': 'Dental Physiological Phenomena'}, {'id': 'D055688', 'term': 'Digestive System and Oral Physiological Phenomena'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D000083', 'term': 'Acetanilides'}, {'id': 'D009022', 'term': 'Morphine Derivatives'}, {'id': 'D009019', 'term': 'Morphinans'}, {'id': 'D053610', 'term': 'Opiate Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006572', 'term': 'Heterocyclic Compounds, Bridged-Ring'}, {'id': 'D006576', 'term': 'Heterocyclic Compounds, 4 or More Rings'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D010616', 'term': 'Phenanthrenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D003061', 'term': 'Codeine'}, {'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D002227', 'term': 'Carbazoles'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D006575', 'term': 'Heterocyclic Compounds, 3-Ring'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'glee@stanford.edu', 'phone': '650-723-5824', 'title': 'Gordon Kwanlyp Lee, Professor of Surgery (Plastic and Reconstructive Surgery)', 'organization': 'Stanford University'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Through 7 days post-operative', 'eventGroups': [{'id': 'EG000', 'title': '0.125% Bupivacaine', 'description': '* 0.125% bupivacaine infusion through transversus abdominis plane (TAP) catheter\n* Transversus Abdominis Plane (TAP) block\n* Nimbus Infusion Pump IV Administration\n* Bupivacaine infusion\n* Acetominophen\n* Hydromorphone\n* Oxycodone\n* Ondansetron', 'otherNumAtRisk': 64, 'deathsNumAtRisk': 64, 'otherNumAffected': 21, 'seriousNumAtRisk': 64, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': '* Saline infusion (sham) for transversus abdominis plane (TAP) catheter.\n* Transversus Abdominis Plane (TAP) block\n* Nimbus Infusion Pump IV Administration\n* Bupivacaine infusion\n* Acetominophen\n* Hydromorphone\n* Oxycodone\n* Ondansetron', 'otherNumAtRisk': 56, 'deathsNumAtRisk': 56, 'otherNumAffected': 27, 'seriousNumAtRisk': 56, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 56, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 56, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Bullous dermatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 56, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Bruising', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 56, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Musculoskeletal and connective tissue disorder - Chest wall necrosis, specify', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Edema Limbs', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 56, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 56, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Localized Edema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Hematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 56, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 56, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Muscle cramp', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 56, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Otitis media', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 56, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Peripheral sensory neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 56, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 56, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Shingles', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Sinus tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 56, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Skin and subcutaneous tissue disorders - Other, specify', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 56, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Skin ulceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 56, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Thromboembolic event', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Upper respiratory infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 56, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Urine output decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 56, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Urinary Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Vasovagal reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 56, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 56, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Wound complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Post-operative Narcotic Usage', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '0.125% Bupivacaine', 'description': '* 0.125% bupivacaine infusion through transversus abdominis plane (TAP) catheter\n* Transversus Abdominis Plane (TAP) block\n* Nimbus Infusion Pump IV Administration\n* Bupivacaine infusion\n* Acetominophen\n* Hydromorphone\n* Oxycodone\n* Ondansetron'}, {'id': 'OG001', 'title': 'Placebo', 'description': '* Saline infusion (sham) for transversus abdominis plane (TAP) catheter.\n* Transversus Abdominis Plane (TAP) block\n* Nimbus Infusion Pump IV Administration\n* Bupivacaine infusion\n* Acetominophen\n* Hydromorphone\n* Oxycodone\n* Ondansetron'}], 'classes': [{'categories': [{'measurements': [{'value': '139.3', 'spread': '117.2', 'groupId': 'OG000'}, {'value': '169.2', 'spread': '136.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '48 hours', 'description': 'Narcotic usage was collected for first 48 hours post-operatively after breast reconstruction. The type and amount of each narcotic administered were each converted to the morphine equivalent amount that would be orally administered to achieve the same event. This term is known as the oral morphine equivalent (OME). Narcotic usage was assessed between the group receiving transversus abdominis plane (TAP) nerve block compared to the group receiving the placebo control. The outcome is reported as the observed OME for each group.', 'unitOfMeasure': 'milligrams (mg)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Post-operative Pain Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '0.125% Bupivacaine', 'description': '* 0.125% bupivacaine infusion through transversus abdominis plane (TAP) catheter\n* Transversus Abdominis Plane (TAP) block\n* Nimbus Infusion Pump IV Administration\n* Bupivacaine infusion\n* Acetominophen\n* Hydromorphone\n* Oxycodone\n* Ondansetron'}, {'id': 'OG001', 'title': 'Placebo', 'description': '* Saline infusion (sham) for transversus abdominis plane (TAP) catheter.\n* Transversus Abdominis Plane (TAP) block\n* Nimbus Infusion Pump IV Administration\n* Bupivacaine infusion\n* Acetominophen\n* Hydromorphone\n* Oxycodone\n* Ondansetron'}], 'classes': [{'categories': [{'measurements': [{'value': '3.76', 'spread': '1.72', 'groupId': 'OG000'}, {'value': '3.96', 'spread': '2.14', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 days', 'description': 'Post-operative Pain Score is defined using Visual Analog Scale (VAS), a patient-reported pain score based on viewing a graphic of a scale 0 to 10, and indicating pain level. Each participant was asked about 48 hours after breast reconstruction to indicate their their perceived pain according on the VAS scale. Higher scores represent greater pain. The outcome is reported as the mean VAS score at 48 hours, with standard deviation.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Post-operative Anti-emetic Usage', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '0.125% Bupivacaine', 'description': '* 0.125% bupivacaine infusion through transversus abdominis plane (TAP) catheter\n* Transversus Abdominis Plane (TAP) block\n* Nimbus Infusion Pump IV Administration\n* Bupivacaine infusion\n* Acetominophen\n* Hydromorphone\n* Oxycodone\n* Ondansetron'}, {'id': 'OG001', 'title': 'Placebo', 'description': '* Saline infusion (sham) for transversus abdominis plane (TAP) catheter.\n* Transversus Abdominis Plane (TAP) block\n* Nimbus Infusion Pump IV Administration\n* Bupivacaine infusion\n* Acetominophen\n* Hydromorphone\n* Oxycodone\n* Ondansetron'}], 'classes': [{'categories': [{'measurements': [{'value': '5.14', 'spread': '5.30', 'groupId': 'OG000'}, {'value': '9.93', 'spread': '13.74', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '48 hours', 'description': 'Odansetron by intravenous administration was used to control nausea (ie, an anti-emetic drug). Anti-emetic usage was collected for first 48 hours post-operatively after breast reconstruction for the group receiving transversus abdominis plane (TAP) nerve block compared to the group receiving the placebo control. The outcome is reported as the mean quantity of Odansetron in milligrams (mg) administered to each group, with standard deviation.', 'unitOfMeasure': 'milligrams (mg)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Time to Ambulation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '0.125% Bupivacaine', 'description': '* 0.125% bupivacaine infusion through transversus abdominis plane (TAP) catheter\n* Transversus Abdominis Plane (TAP) block\n* Nimbus Infusion Pump IV Administration\n* Bupivacaine infusion\n* Acetominophen\n* Hydromorphone\n* Oxycodone\n* Ondansetron'}, {'id': 'OG001', 'title': 'Placebo', 'description': '* Saline infusion (sham) for transversus abdominis plane (TAP) catheter.\n* Transversus Abdominis Plane (TAP) block\n* Nimbus Infusion Pump IV Administration\n* Bupivacaine infusion\n* Acetominophen\n* Hydromorphone\n* Oxycodone\n* Ondansetron'}], 'classes': [{'categories': [{'measurements': [{'value': '1.28', 'spread': '0.52', 'groupId': 'OG000'}, {'value': '1.45', 'spread': '0.62', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'up to 1 week', 'description': 'Time to ambulation is defined as the amount of time, from midnight on post-operative Day 1 (ie, first midnight following the surgery), to when the participant to be able to stand up and walk a few steps post-operatively. The assessment of whether or not the participant was able to walk was subjective on the part of the shift nurse (ie, no defined number of steps nor quantitative assessment of gait or stability), and was not explicitly defined in the protocol or elsewhere. The outcome is reported as the time to ambulation in days, with standard deviation, for the group receiving transversus abdominis plane (TAP) nerve block and the group receiving the placebo control.', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Time to First Bowel Movement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '0.125% Bupivacaine', 'description': '* 0.125% bupivacaine infusion through transversus abdominis plane (TAP) catheter\n* Transversus Abdominis Plane (TAP) block\n* Nimbus Infusion Pump IV Administration\n* Bupivacaine infusion\n* Acetominophen\n* Hydromorphone\n* Oxycodone\n* Ondansetron'}, {'id': 'OG001', 'title': 'Placebo', 'description': '* Saline infusion (sham) for transversus abdominis plane (TAP) catheter.\n* Transversus Abdominis Plane (TAP) block\n* Nimbus Infusion Pump IV Administration\n* Bupivacaine infusion\n* Acetominophen\n* Hydromorphone\n* Oxycodone\n* Ondansetron'}], 'classes': [{'categories': [{'measurements': [{'value': '1.67', 'spread': '1.08', 'groupId': 'OG000'}, {'value': '1.62', 'spread': '0.99', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'up to 1 week', 'description': 'Time to first bowel movement is defined as the amount of time, from midnight on post-operative Day 1 (ie, first midnight following the surgery), to when the participant was to be able to pass a stool post-operatively. The outcome is reported as the time in days, with standard deviation, for the group receiving transversus abdominis plane (TAP) nerve block and the group receiving the placebo control.', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Quality of Life Measurement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '0.125% Bupivacaine', 'description': '* 0.125% bupivacaine infusion through transversus abdominis plane (TAP) catheter\n* Transversus Abdominis Plane (TAP) block\n* Nimbus Infusion Pump IV Administration\n* Bupivacaine infusion\n* Acetominophen\n* Hydromorphone\n* Oxycodone\n* Ondansetron'}, {'id': 'OG001', 'title': 'Placebo', 'description': '* Saline infusion (sham) for transversus abdominis plane (TAP) catheter.\n* Transversus Abdominis Plane (TAP) block\n* Nimbus Infusion Pump IV Administration\n* Bupivacaine infusion\n* Acetominophen\n* Hydromorphone\n* Oxycodone\n* Ondansetron'}], 'classes': [{'title': 'Pre-operative baseline', 'categories': [{'measurements': [{'value': '97.30', 'spread': '17.61', 'groupId': 'OG000'}, {'value': '99.08', 'spread': '20.73', 'groupId': 'OG001'}]}]}, {'title': 'Post-operative (2 to 6 month)', 'categories': [{'measurements': [{'value': '342.11', 'spread': '26.42', 'groupId': 'OG000'}, {'value': '358.00', 'spread': '16.83', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-operative Baseline and Post-operative (2-6 months)', 'description': 'Quality of life for the study groups was assessed with the BREAST-Q questionnaire, a survey set of 6 pre-operative questionnaires comprised of 58 questions, and 15 post-operative questionnaires, collected 2 to 6 months after surgery, which is comprised of 109 questions. The results range for the pre-operative and post-operative questionnaire sets is 0 to 269 and 0 to 462, respectively. Because the baseline and post-operative domains are different, the BREAST-Q survey is not a measure of quality of life change over time. The Breast Q questionnaire was validated by Pusic, et al (citation provided). Higher scores for a domain represents better quality of life. The outcome is reported as the mean for each group and timepoint, with standard deviation.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Most participants were lost to follow-up, and did not return the case report form (CRF) for this patient-reported Quality of Life (QoL) data'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '0.125% Bupivacaine', 'description': '* 0.125% bupivacaine infusion through transversus abdominis plane (TAP) catheter\n* Transversus Abdominis Plane (TAP) block\n* Nimbus Infusion Pump IV Administration\n* Bupivacaine infusion\n* Acetominophen\n* Hydromorphone\n* Oxycodone\n* Ondansetron'}, {'id': 'FG001', 'title': 'Placebo', 'description': '* Saline infusion (sham) for transversus abdominis plane (TAP) catheter.\n* Transversus Abdominis Plane (TAP) block\n* Nimbus Infusion Pump IV Administration\n* Bupivacaine infusion\n* Acetominophen\n* Hydromorphone\n* Oxycodone\n* Ondansetron'}], 'periods': [{'title': 'Registration to Surgery', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '64'}, {'groupId': 'FG001', 'numSubjects': '56'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '44'}, {'groupId': 'FG001', 'numSubjects': '46'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '10'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '10'}]}]}, {'title': 'Surgery to Assessments', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '44'}, {'groupId': 'FG001', 'numSubjects': '46'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '44'}, {'groupId': 'FG001', 'numSubjects': '46'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'BG000'}, {'value': '56', 'groupId': 'BG001'}, {'value': '120', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': '0.125% Bupivacaine', 'description': '0.125% bupivacaine infusion via transversus abdominis plane (TAP) catheter\n\nTransversus Abdominis Plane (TAP) block\n\nNimbus Infusion Pump IV Administration\n\nBupivacaine infusion\n\nAcetominophen\n\nHydromorphone\n\nOxycodone\n\nOndansetron'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Saline infusion (sham) via transversus abdominis plane (TAP) catheter.\n\nTransversus Abdominis Plane (TAP) block\n\nNimbus Infusion Pump IV Administration\n\nAcetominophen\n\nHydromorphone\n\nOxycodone\n\nOndansetron'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '58', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '107', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '50.24', 'spread': '9.58', 'groupId': 'BG000'}, {'value': '52.11', 'spread': '10.50', 'groupId': 'BG001'}, {'value': '51.11', 'spread': '9.98', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '64', 'groupId': 'BG000'}, {'value': '56', 'groupId': 'BG001'}, {'value': '120', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '44', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '82', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '64', 'groupId': 'BG000'}, {'value': '56', 'groupId': 'BG001'}, {'value': '120', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-04-28', 'size': 701644, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-06-18T20:11', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2021-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-08-28', 'studyFirstSubmitDate': '2015-11-04', 'resultsFirstSubmitDate': '2021-06-28', 'studyFirstSubmitQcDate': '2015-11-06', 'lastUpdatePostDateStruct': {'date': '2021-09-23', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-08-28', 'studyFirstPostDateStruct': {'date': '2015-11-10', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-09-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-09-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Post-operative Narcotic Usage', 'timeFrame': '48 hours', 'description': 'Narcotic usage was collected for first 48 hours post-operatively after breast reconstruction. The type and amount of each narcotic administered were each converted to the morphine equivalent amount that would be orally administered to achieve the same event. This term is known as the oral morphine equivalent (OME). Narcotic usage was assessed between the group receiving transversus abdominis plane (TAP) nerve block compared to the group receiving the placebo control. The outcome is reported as the observed OME for each group.'}], 'secondaryOutcomes': [{'measure': 'Post-operative Pain Score', 'timeFrame': '2 days', 'description': 'Post-operative Pain Score is defined using Visual Analog Scale (VAS), a patient-reported pain score based on viewing a graphic of a scale 0 to 10, and indicating pain level. Each participant was asked about 48 hours after breast reconstruction to indicate their their perceived pain according on the VAS scale. Higher scores represent greater pain. The outcome is reported as the mean VAS score at 48 hours, with standard deviation.'}, {'measure': 'Post-operative Anti-emetic Usage', 'timeFrame': '48 hours', 'description': 'Odansetron by intravenous administration was used to control nausea (ie, an anti-emetic drug). Anti-emetic usage was collected for first 48 hours post-operatively after breast reconstruction for the group receiving transversus abdominis plane (TAP) nerve block compared to the group receiving the placebo control. The outcome is reported as the mean quantity of Odansetron in milligrams (mg) administered to each group, with standard deviation.'}, {'measure': 'Time to Ambulation', 'timeFrame': 'up to 1 week', 'description': 'Time to ambulation is defined as the amount of time, from midnight on post-operative Day 1 (ie, first midnight following the surgery), to when the participant to be able to stand up and walk a few steps post-operatively. The assessment of whether or not the participant was able to walk was subjective on the part of the shift nurse (ie, no defined number of steps nor quantitative assessment of gait or stability), and was not explicitly defined in the protocol or elsewhere. The outcome is reported as the time to ambulation in days, with standard deviation, for the group receiving transversus abdominis plane (TAP) nerve block and the group receiving the placebo control.'}, {'measure': 'Time to First Bowel Movement', 'timeFrame': 'up to 1 week', 'description': 'Time to first bowel movement is defined as the amount of time, from midnight on post-operative Day 1 (ie, first midnight following the surgery), to when the participant was to be able to pass a stool post-operatively. The outcome is reported as the time in days, with standard deviation, for the group receiving transversus abdominis plane (TAP) nerve block and the group receiving the placebo control.'}, {'measure': 'Quality of Life Measurement', 'timeFrame': 'Pre-operative Baseline and Post-operative (2-6 months)', 'description': 'Quality of life for the study groups was assessed with the BREAST-Q questionnaire, a survey set of 6 pre-operative questionnaires comprised of 58 questions, and 15 post-operative questionnaires, collected 2 to 6 months after surgery, which is comprised of 109 questions. The results range for the pre-operative and post-operative questionnaire sets is 0 to 269 and 0 to 462, respectively. Because the baseline and post-operative domains are different, the BREAST-Q survey is not a measure of quality of life change over time. The Breast Q questionnaire was validated by Pusic, et al (citation provided). Higher scores for a domain represents better quality of life. The outcome is reported as the mean for each group and timepoint, with standard deviation.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Breast - Female']}, 'referencesModule': {'references': [{'pmid': '28445351', 'type': 'BACKGROUND', 'citation': 'Mundy LR, Homa K, Klassen AF, Pusic AL, Kerrigan CL. Breast Cancer and Reconstruction: Normative Data for Interpreting the BREAST-Q. Plast Reconstr Surg. 2017 May;139(5):1046e-1055e. doi: 10.1097/PRS.0000000000003241.'}, {'pmid': '19644246', 'type': 'BACKGROUND', 'citation': 'Pusic AL, Klassen AF, Scott AM, Klok JA, Cordeiro PG, Cano SJ. Development of a new patient-reported outcome measure for breast surgery: the BREAST-Q. Plast Reconstr Surg. 2009 Aug;124(2):345-353. doi: 10.1097/PRS.0b013e3181aee807.'}, {'pmid': '31577663', 'type': 'BACKGROUND', 'citation': 'Voineskos SH, Klassen AF, Cano SJ, Pusic AL, Gibbons CJ. Giving Meaning to Differences in BREAST-Q Scores: Minimal Important Difference for Breast Reconstruction Patients. Plast Reconstr Surg. 2020 Jan;145(1):11e-20e. doi: 10.1097/PRS.0000000000006317.'}, {'type': 'RESULT', 'citation': 'Kwong JW, Tijerina JD, Choi S, Shakir A, Nguyen DH, Nazerali RS, Lee GK. Randomized Double-Blinded, Placebo-Controlled Trial: Transversus Abdominis Plane (TAP) Blocks in Breast Cancer Patients Undergoing Reconstruction with Abdominal Free Flap. Annual Meeting of the California Society of Plastic Surgeons. San Diego, California. May 19, 2018.'}]}, 'descriptionModule': {'briefSummary': 'The primary objective is to determine if pre-operative transversus abdominis plane (TAP) nerve blocks by continued infusion of local anesthetic post-operatively affects post-operative narcotic usage, as compared to a placebo TAP block, after breast reconstruction surgery.', 'detailedDescription': 'Primary Objective: The primary objective is to determine if pre-operative transversus abdominis plane (TAP) blocks with continued infusion of local anesthetic post-operatively affect post-operative narcotic usage as compared to a placebo TAP block.\n\nSecondary Objectives:\n\n* Determine if pre-operative TAP blocks with continued infusion of local anesthetic post-operatively affect post-operative pain scores as compared to a placebo TAP block.\n* Determine if pre-operative TAP blocks with continued infusion of local anesthetic post-operatively affect anti-emetic usage as compared to a placebo TAP block.\n* Determine if pre-operative TAP blocks with continued infusion of local anesthetic post-operatively affect time to ambulation post-operatively as compared to a placebo TAP block.\n* Determine if pre-operative TAP blocks with continued infusion of local anesthetic post-operatively affect time to first bowel movement as compared to a placebo TAP block.\n* Determine if pre-operative TAP blocks with continued infusion of local anesthetic post-operatively affect patient-reported quality of life as compared to a placebo TAP block.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Female', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\n* Prior diagnosis or presumed diagnosis of breast cancer or undergoing prophylactic treatment.\n* Greater than 18 years old.\n* Female.\n* Undergoing microsurgical breast reconstruction with abdominal free flap.\n* Ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria\n\n* True allergy to local anesthetics or opioids.\n* History of addiction to narcotics within the last 24 months\n* History of chronic pain on opioids within the last 24 months.\n* Specific mental health issues such as schizophrenia or bipolar disorder.\n* Patients who are pregnant.'}, 'identificationModule': {'nctId': 'NCT02601027', 'briefTitle': 'Transversus Abdominis Plane Block in Microsurgical Breast Recon w/Abdominal Free Flap in Breast CA', 'organization': {'class': 'OTHER', 'fullName': 'Stanford University'}, 'officialTitle': 'A Phase III Study of Pre-operative Transversus Abdominis Plane Blocks Using the Nimbus Ambulatory Infusion System in Patients Undergoing Abdominal Free Flap-based Breast Reconstruction', 'orgStudyIdInfo': {'id': 'IRB-34315'}, 'secondaryIdInfos': [{'id': 'BRS0058', 'type': 'OTHER', 'domain': 'OnCore'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '0.125% Bupivacaine', 'description': '0.125% bupivacaine infusion via transversus abdominis plane (TAP) catheter', 'interventionNames': ['Procedure: Transversus Abdominis Plane (TAP) block', 'Device: Nimbus Infusion Pump IV Administration', 'Drug: Bupivacaine infusion', 'Drug: Acetominophen', 'Drug: Hydromorphone', 'Drug: Oxycodone', 'Drug: Ondansetron']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Saline infusion (sham) via transversus abdominis plane (TAP) catheter.', 'interventionNames': ['Procedure: Transversus Abdominis Plane (TAP) block', 'Device: Nimbus Infusion Pump IV Administration', 'Drug: Acetominophen', 'Drug: Hydromorphone', 'Drug: Oxycodone', 'Drug: Ondansetron']}], 'interventions': [{'name': 'Transversus Abdominis Plane (TAP) block', 'type': 'PROCEDURE', 'armGroupLabels': ['0.125% Bupivacaine', 'Placebo']}, {'name': 'Nimbus Infusion Pump IV Administration', 'type': 'DEVICE', 'armGroupLabels': ['0.125% Bupivacaine', 'Placebo']}, {'name': 'Bupivacaine infusion', 'type': 'DRUG', 'otherNames': ['Exparel', 'Marcaine', 'Marcaine Spinal', 'Sensorcaine', 'Sensorcaine-MPF', 'Sensorcaine-MPF Spinal', 'ReadySharp bupivacaine', 'P-Care M'], 'armGroupLabels': ['0.125% Bupivacaine']}, {'name': 'Acetominophen', 'type': 'DRUG', 'otherNames': ['Tylenol'], 'armGroupLabels': ['0.125% Bupivacaine', 'Placebo']}, {'name': 'Hydromorphone', 'type': 'DRUG', 'otherNames': ['Dilaudid', 'Dilaudid-HP', 'Exalgo'], 'armGroupLabels': ['0.125% Bupivacaine', 'Placebo']}, {'name': 'Oxycodone', 'type': 'DRUG', 'otherNames': ['Oxycontin', 'Xtampza ER', 'Oxaydo', 'Roxicodone'], 'armGroupLabels': ['0.125% Bupivacaine', 'Placebo']}, {'name': 'Ondansetron', 'type': 'DRUG', 'otherNames': ['Zofran', 'Zofran ODT', 'Zuplenz'], 'armGroupLabels': ['0.125% Bupivacaine', 'Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94305', 'city': 'Stanford', 'state': 'California', 'country': 'United States', 'facility': 'Stanford University Medical Center', 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}], 'overallOfficials': [{'name': 'Gordon K Lee, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Stanford University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stanford University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Surgery (Plastic and Reconstructive Surgery)', 'investigatorFullName': 'Gordon Kwanlyp Lee', 'investigatorAffiliation': 'Stanford University'}}}}