Ignite Creation Date:
2025-12-24 @ 10:40 PM
Ignite Modification Date:
2026-02-25 @ 5:34 PM
Study NCT ID:
NCT03638635
Status:
TERMINATED
Last Update Posted:
2019-09-09
First Post:
2017-08-21
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Standard Bupivacaine vs Liposomal Bupivacaine in Colorectal Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': True, '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002045', 'term': 'Bupivacaine'}], 'ancestors': [{'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'erica.emery@inova.org', 'phone': '703-776-7615', 'title': 'Erica Emery', 'organization': 'Inova Health System'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Early termination due to lack of resources leading to incomplete data.'}}, 'adverseEventsModule': {'timeFrame': '30 days post-enrollment', 'eventGroups': [{'id': 'EG000', 'title': 'Standard Bupivacaine', 'description': 'Standard (0.25% bupivacaine) bupivacaine (133 mg in 10mL, diluted with 20 mL saline) will be injected into the fascial layer between the internal oblique and the transversus abdominis with ultrasound guidance, 30 mL per side for a total of 60 mL.\n\nBupivacaine: Abdominal injection of bupivacaine into fascial layer.', 'otherNumAtRisk': 39, 'deathsNumAtRisk': 39, 'otherNumAffected': 0, 'seriousNumAtRisk': 39, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Bupivacaine Liposome', 'description': 'Liposomal bupivacaine (133 mg in 10mL, diluted with 20 mL saline) will be injected into the fascial layer between the internal oblique and the transversus abdominis with ultrasound guidance, 30 mL per side for a total of 60 mL.\n\nBupivacaine liposome: Abdominal injection of bupivacaine liposome into fascial layer.', 'otherNumAtRisk': 24, 'deathsNumAtRisk': 24, 'otherNumAffected': 0, 'seriousNumAtRisk': 24, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'seriousEvents': [{'term': 'Hospitalization', 'notes': 'Return to the operating room', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'In-hospital Postoperative Opioid Consumption', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard Bupivacaine', 'description': 'Standard (0.25% bupivacaine) bupivacaine (133 mg in 10mL, diluted with 20 mL saline) will be injected into the fascial layer between the internal oblique and the transversus abdominis with ultrasound guidance, 30 mL per side for a total of 60 mL.\n\nBupivacaine: Abdominal injection of bupivacaine into fascial layer.'}, {'id': 'OG001', 'title': 'Bupivacaine Liposome', 'description': 'Liposomal bupivacaine (133 mg in 10mL, diluted with 20 mL saline) will be injected into the fascial layer between the internal oblique and the transversus abdominis with ultrasound guidance, 30 mL per side for a total of 60 mL.\n\nBupivacaine liposome: Abdominal injection of bupivacaine liposome into fascial layer.'}], 'timeFrame': 'up to postoperative day 3 at 1 pm', 'description': 'Daily overall opioid use recorded as morphine equivalents', 'reportingStatus': 'POSTED', 'populationDescription': 'The amount of in-hospital postoperative opioid consumption was going to be obtained from the charts, where it is recorded as standard of care. However, this study was terminated prematurely before data could be collected from the charts; therefore no data are available for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Pain Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard Bupivacaine', 'description': 'Standard (0.25% bupivacaine) bupivacaine (133 mg in 10mL, diluted with 20 mL saline) will be injected into the fascial layer between the internal oblique and the transversus abdominis with ultrasound guidance, 30 mL per side for a total of 60 mL.\n\nBupivacaine: Abdominal injection of bupivacaine into fascial layer.'}, {'id': 'OG001', 'title': 'Bupivacaine Liposome', 'description': 'Liposomal bupivacaine (133 mg in 10mL, diluted with 20 mL saline) will be injected into the fascial layer between the internal oblique and the transversus abdominis with ultrasound guidance, 30 mL per side for a total of 60 mL.\n\nBupivacaine liposome: Abdominal injection of bupivacaine liposome into fascial layer.'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '5'}, {'value': '3', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '6'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Approximately every 6 hours through postoperative day 3 by 1 pm', 'description': 'Recorded on a scale of 0 (No pain) to 10 (Worst possible pain)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Outcome data reported for patients with non-missing data. Pain scores presented are the first postoperative pain score per subject only due to missing data.'}, {'type': 'SECONDARY', 'title': 'Time to Patient Mobilization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard Bupivacaine', 'description': 'Standard (0.25% bupivacaine) bupivacaine (133 mg in 10mL, diluted with 20 mL saline) will be injected into the fascial layer between the internal oblique and the transversus abdominis with ultrasound guidance, 30 mL per side for a total of 60 mL.\n\nBupivacaine: Abdominal injection of bupivacaine into fascial layer.'}, {'id': 'OG001', 'title': 'Bupivacaine Liposome', 'description': 'Liposomal bupivacaine (133 mg in 10mL, diluted with 20 mL saline) will be injected into the fascial layer between the internal oblique and the transversus abdominis with ultrasound guidance, 30 mL per side for a total of 60 mL.\n\nBupivacaine liposome: Abdominal injection of bupivacaine liposome into fascial layer.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '1'}, {'value': '0.5', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '1'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From time of surgery until time of first patient ambulation post op. Assessed until date of discharge (usually up to 4 days after surgery).', 'description': 'Number of days from day of surgery until patient mobilization', 'unitOfMeasure': 'days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Outcome data reported for subjects with non-missing data.'}, {'type': 'SECONDARY', 'title': 'Time to Return of Bowel Function', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard Bupivacaine', 'description': 'Standard (0.25% bupivacaine) bupivacaine (133 mg in 10mL, diluted with 20 mL saline) will be injected into the fascial layer between the internal oblique and the transversus abdominis with ultrasound guidance, 30 mL per side for a total of 60 mL.\n\nBupivacaine: Abdominal injection of bupivacaine into fascial layer.'}, {'id': 'OG001', 'title': 'Bupivacaine Liposome', 'description': 'Liposomal bupivacaine (133 mg in 10mL, diluted with 20 mL saline) will be injected into the fascial layer between the internal oblique and the transversus abdominis with ultrasound guidance, 30 mL per side for a total of 60 mL.\n\nBupivacaine liposome: Abdominal injection of bupivacaine liposome into fascial layer.'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '2'}, {'value': '2', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '2'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From time of surgery until first time patient passes gas or stool per rectum or into ostomy bag. Assessed until date of discharge (usually up to 4 days after surgery).', 'description': 'Number of days from time of surgery until return of bowel function', 'unitOfMeasure': 'days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Outcome data reported for subjects with non-missing data.'}, {'type': 'SECONDARY', 'title': 'Time to Clear Liquid Diet', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard Bupivacaine', 'description': 'Standard (0.25% bupivacaine) bupivacaine (133 mg in 10mL, diluted with 20 mL saline) will be injected into the fascial layer between the internal oblique and the transversus abdominis with ultrasound guidance, 30 mL per side for a total of 60 mL.\n\nBupivacaine: Abdominal injection of bupivacaine into fascial layer.'}, {'id': 'OG001', 'title': 'Bupivacaine Liposome', 'description': 'Liposomal bupivacaine (133 mg in 10mL, diluted with 20 mL saline) will be injected into the fascial layer between the internal oblique and the transversus abdominis with ultrasound guidance, 30 mL per side for a total of 60 mL.\n\nBupivacaine liposome: Abdominal injection of bupivacaine liposome into fascial layer.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '1'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From time of surgery until first time patient tolerates clear liquids without nausea or vomiting. Assessed until date of discharge (usually up to 4 days after surgery).', 'description': 'Number of days from time of surgery until patient tolerates clear liquid diet', 'unitOfMeasure': 'days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Outcome data reported for subjects with non-missing data.'}, {'type': 'SECONDARY', 'title': 'Time to Low Fiber Diet', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard Bupivacaine', 'description': 'Standard (0.25% bupivacaine) bupivacaine (133 mg in 10mL, diluted with 20 mL saline) will be injected into the fascial layer between the internal oblique and the transversus abdominis with ultrasound guidance, 30 mL per side for a total of 60 mL.\n\nBupivacaine: Abdominal injection of bupivacaine into fascial layer.'}, {'id': 'OG001', 'title': 'Bupivacaine Liposome', 'description': 'Liposomal bupivacaine (133 mg in 10mL, diluted with 20 mL saline) will be injected into the fascial layer between the internal oblique and the transversus abdominis with ultrasound guidance, 30 mL per side for a total of 60 mL.\n\nBupivacaine liposome: Abdominal injection of bupivacaine liposome into fascial layer.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.5', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '2.25'}, {'value': '1', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '3'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From time of surgery until first time patient tolerates a low fiber diet without nausea or vomiting. Assessed until date of discharge (usually up to 4 days after surgery).', 'description': 'Number of days from day of surgery until patient tolerates low fiber diet', 'unitOfMeasure': 'days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Outcome data reported for subjects with non-missing data.'}, {'type': 'SECONDARY', 'title': 'Length of Stay', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard Bupivacaine', 'description': 'Standard (0.25% bupivacaine) bupivacaine (133 mg in 10mL, diluted with 20 mL saline) will be injected into the fascial layer between the internal oblique and the transversus abdominis with ultrasound guidance, 30 mL per side for a total of 60 mL.\n\nBupivacaine: Abdominal injection of bupivacaine into fascial layer.'}, {'id': 'OG001', 'title': 'Bupivacaine Liposome', 'description': 'Liposomal bupivacaine (133 mg in 10mL, diluted with 20 mL saline) will be injected into the fascial layer between the internal oblique and the transversus abdominis with ultrasound guidance, 30 mL per side for a total of 60 mL.\n\nBupivacaine liposome: Abdominal injection of bupivacaine liposome into fascial layer.'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000', 'lowerLimit': '3', 'upperLimit': '5'}, {'value': '3.5', 'groupId': 'OG001', 'lowerLimit': '3', 'upperLimit': '5.75'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Date of surgery to date of discharge (usually up to 4 days after surgery).', 'description': 'Total postoperative hospital stay in days', 'unitOfMeasure': 'days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Outcome data reported for subjects with non-missing data.'}, {'type': 'SECONDARY', 'title': 'In-hospital Antiemetic Use', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard Bupivacaine', 'description': 'Standard (0.25% bupivacaine) bupivacaine (133 mg in 10mL, diluted with 20 mL saline) will be injected into the fascial layer between the internal oblique and the transversus abdominis with ultrasound guidance, 30 mL per side for a total of 60 mL.\n\nBupivacaine: Abdominal injection of bupivacaine into fascial layer.'}, {'id': 'OG001', 'title': 'Bupivacaine Liposome', 'description': 'Liposomal bupivacaine (133 mg in 10mL, diluted with 20 mL saline) will be injected into the fascial layer between the internal oblique and the transversus abdominis with ultrasound guidance, 30 mL per side for a total of 60 mL.\n\nBupivacaine liposome: Abdominal injection of bupivacaine liposome into fascial layer.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.9', 'spread': '3.6', 'groupId': 'OG000'}, {'value': '5.6', 'spread': '12.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Time of transfer to post operative suite to time of discharge (usually up to 4 days after surgery).', 'description': 'Amount of ondansetron patient required postoperatively during hospital stay, in milligrams', 'unitOfMeasure': 'mg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Outcome data reported for subjects with non-missing data.'}, {'type': 'SECONDARY', 'title': 'Complications', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard Bupivacaine', 'description': 'Standard (0.25% bupivacaine) bupivacaine (133 mg in 10mL, diluted with 20 mL saline) will be injected into the fascial layer between the internal oblique and the transversus abdominis with ultrasound guidance, 30 mL per side for a total of 60 mL.\n\nBupivacaine: Abdominal injection of bupivacaine into fascial layer.'}, {'id': 'OG001', 'title': 'Bupivacaine Liposome', 'description': 'Liposomal bupivacaine (133 mg in 10mL, diluted with 20 mL saline) will be injected into the fascial layer between the internal oblique and the transversus abdominis with ultrasound guidance, 30 mL per side for a total of 60 mL.\n\nBupivacaine liposome: Abdominal injection of bupivacaine liposome into fascial layer.'}], 'timeFrame': 'Within 30 days of surgery', 'description': 'Patient suffered a complication (infection, small bowel obstruction, dehydration, deep vein thrombosis/pulmonary embolism, anastomotic leak, cardiac arrest, stroke, sepsis) after surgery', 'reportingStatus': 'POSTED', 'populationDescription': 'Complications data was going to be collected from chart review. However, the study was prematurely terminated before this data could be collected.'}, {'type': 'SECONDARY', 'title': 'Readmissions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard Bupivacaine', 'description': 'Standard (0.25% bupivacaine) bupivacaine (133 mg in 10mL, diluted with 20 mL saline) will be injected into the fascial layer between the internal oblique and the transversus abdominis with ultrasound guidance, 30 mL per side for a total of 60 mL.\n\nBupivacaine: Abdominal injection of bupivacaine into fascial layer.'}, {'id': 'OG001', 'title': 'Bupivacaine Liposome', 'description': 'Liposomal bupivacaine (133 mg in 10mL, diluted with 20 mL saline) will be injected into the fascial layer between the internal oblique and the transversus abdominis with ultrasound guidance, 30 mL per side for a total of 60 mL.\n\nBupivacaine liposome: Abdominal injection of bupivacaine liposome into fascial layer.'}], 'timeFrame': 'Within 30 days of hospital discharge', 'description': 'Patient readmitted to hospital after discharge', 'reportingStatus': 'POSTED', 'populationDescription': 'Readmissions data was going to be collected from chart review. However, the study was prematurely terminated before this data could be collected.'}, {'type': 'SECONDARY', 'title': 'Mortality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard Bupivacaine', 'description': 'Standard (0.25% bupivacaine) bupivacaine (133 mg in 10mL, diluted with 20 mL saline) will be injected into the fascial layer between the internal oblique and the transversus abdominis with ultrasound guidance, 30 mL per side for a total of 60 mL.\n\nBupivacaine: Abdominal injection of bupivacaine into fascial layer.'}, {'id': 'OG001', 'title': 'Bupivacaine Liposome', 'description': 'Liposomal bupivacaine (133 mg in 10mL, diluted with 20 mL saline) will be injected into the fascial layer between the internal oblique and the transversus abdominis with ultrasound guidance, 30 mL per side for a total of 60 mL.\n\nBupivacaine liposome: Abdominal injection of bupivacaine liposome into fascial layer.'}], 'timeFrame': 'Within 30 days of surgery', 'description': 'Patient death after surgery', 'reportingStatus': 'POSTED', 'populationDescription': 'Mortality data was going to be collected from chart review. However, the study was prematurely terminated before this data could be collected.'}, {'type': 'SECONDARY', 'title': 'Hospitalization Costs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard Bupivacaine', 'description': 'Standard (0.25% bupivacaine) bupivacaine (133 mg in 10mL, diluted with 20 mL saline) will be injected into the fascial layer between the internal oblique and the transversus abdominis with ultrasound guidance, 30 mL per side for a total of 60 mL.\n\nBupivacaine: Abdominal injection of bupivacaine into fascial layer.'}, {'id': 'OG001', 'title': 'Bupivacaine Liposome', 'description': 'Liposomal bupivacaine (133 mg in 10mL, diluted with 20 mL saline) will be injected into the fascial layer between the internal oblique and the transversus abdominis with ultrasound guidance, 30 mL per side for a total of 60 mL.\n\nBupivacaine liposome: Abdominal injection of bupivacaine liposome into fascial layer.'}], 'timeFrame': 'From date of this surgical admission to date of this surgical discharge (usually up to 4 days after surgery).', 'description': 'Total hospitalization costs per patient per this surgical encounter', 'reportingStatus': 'POSTED', 'populationDescription': 'Cost data was intended to be collected through the finance department at the end of the study. However, the study was terminated prematurely, so cost data is not able to be obtained.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Standard Bupivacaine', 'description': 'Standard (0.25% bupivacaine) bupivacaine (133 mg in 10mL, diluted with 20 mL saline) will be injected into the fascial layer between the internal oblique and the transversus abdominis with ultrasound guidance, 30 mL per side for a total of 60 mL.\n\nBupivacaine: Abdominal injection of bupivacaine into fascial layer.'}, {'id': 'FG001', 'title': 'Bupivacaine Liposome', 'description': 'Liposomal bupivacaine (133 mg in 10mL, diluted with 20 mL saline) will be injected into the fascial layer between the internal oblique and the transversus abdominis with ultrasound guidance, 30 mL per side for a total of 60 mL.\n\nBupivacaine liposome: Abdominal injection of bupivacaine liposome into fascial layer.'}], 'periods': [{'title': 'Initial Hospitalization', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '39'}, {'groupId': 'FG001', 'numSubjects': '24'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '39'}, {'groupId': 'FG001', 'numSubjects': '22'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Study terminated prematurely', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Withdrawal by study personnel', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}, {'title': 'Follow-Up (30 Days After Discharge)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '39'}, {'groupId': 'FG001', 'numSubjects': '22'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '39'}, {'groupId': 'FG001', 'numSubjects': '22'}]}], 'dropWithdraws': [{'type': 'Study terminated prematurely', 'reasons': [{'groupId': 'FG000', 'numSubjects': '39'}, {'groupId': 'FG001', 'numSubjects': '22'}]}]}], 'recruitmentDetails': 'Patients were approached for consent in the hospital postoperatively to request the use of their data for research purposes.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '63', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Standard Bupivacaine', 'description': 'Standard (0.25% bupivacaine) bupivacaine (133 mg in 10mL, diluted with 20 mL saline) will be injected into the fascial layer between the internal oblique and the transversus abdominis with ultrasound guidance, 30 mL per side for a total of 60 mL.\n\nBupivacaine: Abdominal injection of bupivacaine into fascial layer.'}, {'id': 'BG001', 'title': 'Bupivacaine Liposome', 'description': 'Liposomal bupivacaine (133 mg in 10mL, diluted with 20 mL saline) will be injected into the fascial layer between the internal oblique and the transversus abdominis with ultrasound guidance, 30 mL per side for a total of 60 mL.\n\nBupivacaine liposome: Abdominal injection of bupivacaine liposome into fascial layer.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '60.97', 'spread': '16.25', 'groupId': 'BG000'}, {'value': '60.04', 'spread': '17.36', 'groupId': 'BG001'}, {'value': '60.63', 'spread': '16.54', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '28', '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': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '50', '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': '3', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '63', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-09-26', 'size': 349001, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-04-17T12:01', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'The participant and the floor nursing staff recording pain scores will be blinded to the assigned intervention.'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants are randomized to receive either standard bupivacaine or liposomal bupivacaine.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 63}}, 'statusModule': {'whyStopped': 'Lack of personnel available to complete study.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2018-05-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2019-01-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-08-14', 'studyFirstSubmitDate': '2017-08-21', 'resultsFirstSubmitDate': '2019-04-22', 'studyFirstSubmitQcDate': '2018-08-17', 'lastUpdatePostDateStruct': {'date': '2019-09-09', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-08-14', 'studyFirstPostDateStruct': {'date': '2018-08-20', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2019-09-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-01-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'In-hospital Postoperative Opioid Consumption', 'timeFrame': 'up to postoperative day 3 at 1 pm', 'description': 'Daily overall opioid use recorded as morphine equivalents'}], 'secondaryOutcomes': [{'measure': 'Pain Score', 'timeFrame': 'Approximately every 6 hours through postoperative day 3 by 1 pm', 'description': 'Recorded on a scale of 0 (No pain) to 10 (Worst possible pain)'}, {'measure': 'Time to Patient Mobilization', 'timeFrame': 'From time of surgery until time of first patient ambulation post op. Assessed until date of discharge (usually up to 4 days after surgery).', 'description': 'Number of days from day of surgery until patient mobilization'}, {'measure': 'Time to Return of Bowel Function', 'timeFrame': 'From time of surgery until first time patient passes gas or stool per rectum or into ostomy bag. Assessed until date of discharge (usually up to 4 days after surgery).', 'description': 'Number of days from time of surgery until return of bowel function'}, {'measure': 'Time to Clear Liquid Diet', 'timeFrame': 'From time of surgery until first time patient tolerates clear liquids without nausea or vomiting. Assessed until date of discharge (usually up to 4 days after surgery).', 'description': 'Number of days from time of surgery until patient tolerates clear liquid diet'}, {'measure': 'Time to Low Fiber Diet', 'timeFrame': 'From time of surgery until first time patient tolerates a low fiber diet without nausea or vomiting. Assessed until date of discharge (usually up to 4 days after surgery).', 'description': 'Number of days from day of surgery until patient tolerates low fiber diet'}, {'measure': 'Length of Stay', 'timeFrame': 'Date of surgery to date of discharge (usually up to 4 days after surgery).', 'description': 'Total postoperative hospital stay in days'}, {'measure': 'In-hospital Antiemetic Use', 'timeFrame': 'Time of transfer to post operative suite to time of discharge (usually up to 4 days after surgery).', 'description': 'Amount of ondansetron patient required postoperatively during hospital stay, in milligrams'}, {'measure': 'Complications', 'timeFrame': 'Within 30 days of surgery', 'description': 'Patient suffered a complication (infection, small bowel obstruction, dehydration, deep vein thrombosis/pulmonary embolism, anastomotic leak, cardiac arrest, stroke, sepsis) after surgery'}, {'measure': 'Readmissions', 'timeFrame': 'Within 30 days of hospital discharge', 'description': 'Patient readmitted to hospital after discharge'}, {'measure': 'Mortality', 'timeFrame': 'Within 30 days of surgery', 'description': 'Patient death after surgery'}, {'measure': 'Hospitalization Costs', 'timeFrame': 'From date of this surgical admission to date of this surgical discharge (usually up to 4 days after surgery).', 'description': 'Total hospitalization costs per patient per this surgical encounter'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Bupivacaine', 'Exparel', 'TAP Block', 'Opioids', 'Narcotics', 'ERAS'], 'conditions': ['Opioid Use', 'Pain, Postoperative', 'Colectomy', 'Colorectal Surgery']}, 'referencesModule': {'references': [{'pmid': '11576144', 'type': 'BACKGROUND', 'citation': 'Rafi AN. Abdominal field block: a new approach via the lumbar triangle. Anaesthesia. 2001 Oct;56(10):1024-6. doi: 10.1046/j.1365-2044.2001.02279-40.x. No abstract available.'}, {'pmid': '22312327', 'type': 'BACKGROUND', 'citation': 'Young MJ, Gorlin AW, Modest VE, Quraishi SA. Clinical implications of the transversus abdominis plane block in adults. Anesthesiol Res Pract. 2012;2012:731645. doi: 10.1155/2012/731645. Epub 2012 Jan 19.'}, {'pmid': '27943522', 'type': 'BACKGROUND', 'citation': 'Rashid A, Gorissen KJ, Ris F, Gosselink MP, Shorthouse JR, Smith AD, Pandit JJ, Lindsey I, Crabtree NA. No benefit of ultrasound-guided transversus abdominis plane blocks over wound infiltration with local anaesthetic in elective laparoscopic colonic surgery: results of a double-blind randomized controlled trial. Colorectal Dis. 2017 Jul;19(7):681-689. doi: 10.1111/codi.13578.'}, {'pmid': '27129571', 'type': 'BACKGROUND', 'citation': 'Oh TK, Yim J, Kim J, Eom W, Lee SA, Park SC, Oh JH, Park JW, Park B, Kim DH. Effects of preoperative ultrasound-guided transversus abdominis plane block on pain after laparoscopic surgery for colorectal cancer: a double-blind randomized controlled trial. Surg Endosc. 2017 Jan;31(1):127-134. doi: 10.1007/s00464-016-4941-7. Epub 2016 Apr 29.'}, {'pmid': '23389068', 'type': 'BACKGROUND', 'citation': 'Walter CJ, Maxwell-Armstrong C, Pinkney TD, Conaghan PJ, Bedforth N, Gornall CB, Acheson AG. A randomised controlled trial of the efficacy of ultrasound-guided transversus abdominis plane (TAP) block in laparoscopic colorectal surgery. Surg Endosc. 2013 Jul;27(7):2366-72. doi: 10.1007/s00464-013-2791-0. Epub 2013 Feb 7.'}, {'pmid': '23810575', 'type': 'BACKGROUND', 'citation': 'Favuzza J, Delaney CP. Outcomes of discharge after elective laparoscopic colorectal surgery with transversus abdominis plane blocks and enhanced recovery pathway. J Am Coll Surg. 2013 Sep;217(3):503-6. doi: 10.1016/j.jamcollsurg.2013.03.030. Epub 2013 Jun 28.'}, {'pmid': '25350178', 'type': 'BACKGROUND', 'citation': 'Ris F, Findlay JM, Hompes R, Rashid A, Warwick J, Cunningham C, Jones O, Crabtree N, Lindsey I. Addition of transversus abdominis plane block to patient controlled analgesia for laparoscopic high anterior resection improves analgesia, reduces opioid requirement and expedites recovery of bowel function. Ann R Coll Surg Engl. 2014 Nov;96(8):579-85. doi: 10.1308/003588414X13946184900921.'}, {'pmid': '27856385', 'type': 'BACKGROUND', 'citation': 'Barron KI, Lamvu GM, Schmidt RC, Fisk M, Blanton E, Patanwala I. Wound Infiltration With Extended-Release Versus Short-Acting Bupivacaine Before Laparoscopic Hysterectomy: A Randomized Controlled Trial. J Minim Invasive Gynecol. 2017 Feb;24(2):286-292. doi: 10.1016/j.jmig.2016.11.002. Epub 2016 Nov 14.'}, {'pmid': '24214950', 'type': 'BACKGROUND', 'citation': 'Morales R Jr, Mentz H 3rd, Newall G, Patronella C, Masters O 3rd. Use of abdominal field block injections with liposomal bupivicaine to control postoperative pain after abdominoplasty. Aesthet Surg J. 2013 Nov 1;33(8):1148-53. doi: 10.1177/1090820X13510720. Epub 2013 Nov 8.'}, {'pmid': '22546131', 'type': 'BACKGROUND', 'citation': 'Haas E, Onel E, Miller H, Ragupathi M, White PF. A double-blind, randomized, active-controlled study for post-hemorrhoidectomy pain management with liposome bupivacaine, a novel local analgesic formulation. Am Surg. 2012 May;78(5):574-81. doi: 10.1177/000313481207800540.'}, {'pmid': '27505115', 'type': 'BACKGROUND', 'citation': 'Knudson RA, Dunlavy PW, Franko J, Raman SR, Kraemer SR. Effectiveness of Liposomal Bupivacaine in Colorectal Surgery: A Pragmatic Nonsponsored Prospective Randomized Double Blinded Trial in a Community Hospital. Dis Colon Rectum. 2016 Sep;59(9):862-9. doi: 10.1097/DCR.0000000000000648.'}, {'pmid': '27238859', 'type': 'BACKGROUND', 'citation': 'Hutchins JL, Kesha R, Blanco F, Dunn T, Hochhalter R. Ultrasound-guided subcostal transversus abdominis plane blocks with liposomal bupivacaine vs. non-liposomal bupivacaine for postoperative pain control after laparoscopic hand-assisted donor nephrectomy: a prospective randomised observer-blinded study. Anaesthesia. 2016 Aug;71(8):930-7. doi: 10.1111/anae.13502. Epub 2016 May 30.'}, {'pmid': '28059913', 'type': 'BACKGROUND', 'citation': 'Stokes AL, Adhikary SD, Quintili A, Puleo FJ, Choi CS, Hollenbeak CS, Messaris E. Liposomal Bupivacaine Use in Transversus Abdominis Plane Blocks Reduces Pain and Postoperative Intravenous Opioid Requirement After Colorectal Surgery. Dis Colon Rectum. 2017 Feb;60(2):170-177. doi: 10.1097/DCR.0000000000000747.'}]}, 'descriptionModule': {'briefSummary': 'The transversus abdominis plane (TAP) block can be used to reduce pain in patients who get abdominal surgery. TAP blocks are given with a local anesthetic. The purpose of this study is to compare pain medication usage after surgery between two different types of local anesthetic: liposomal bupivacaine and standard bupivacaine.', 'detailedDescription': "Pain control is a factor that is central to the surgical patient's postoperative experience. Opioid pain medications are a mainstay of postoperative pain management. However, these have several adverse effects.\n\nMultimodal pain regimens to minimize opioid use have become central to enhanced recovery after surgery (ERAS) protocols. The transversus abdominis plane (TAP) block is one intervention that contributes to this regimen. Traditionally, TAP blocks are performed with local anesthetics such as bupivacaine. More recently, these have also been performed with liposomal bupivacaine, whose duration of action is much greater than regular bupivacaine (96 hours versus 8-9 hours, respectively).\n\nIn this study, postoperative opioid usage will be compared between patients receiving regular bupivacaine and liposomal bupivacaine."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years of age or older\n* Undergoing elective colectomy by surgeons of Fairfax Colon and Rectal Surgery\n\nExclusion Criteria:\n\n* Allergic to local anesthetics\n* Unable to provide consent\n* Pregnant\n* On opioids at home chronically (Patients previously on a regular opioid regimen would need to be opioid-free for a period of 1 year for inclusion in the study)\n* Undergoing emergent operations\n* Undergoing loop ileostomy reversal\n* Undergoing abdominoperineal resection, pelvic exenteration, or perineal rectal prolapse repairs'}, 'identificationModule': {'nctId': 'NCT03638635', 'briefTitle': 'Standard Bupivacaine vs Liposomal Bupivacaine in Colorectal Patients', 'organization': {'class': 'OTHER', 'fullName': 'Inova Health Care Services'}, 'officialTitle': 'TAP Blocks Performed With Bupivacaine Versus Liposomal Bupivacaine in Colorectal Surgery Patients: A Prospective, Cluster Randomized Trial', 'orgStudyIdInfo': {'id': '17-2725'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Standard Bupivacaine', 'description': 'Standard (0.25% bupivacaine) bupivacaine (133 mg in 10mL, diluted with 20 mL saline) will be injected into the fascial layer between the internal oblique and the transversus abdominis with ultrasound guidance, 30 mL per side for a total of 60 mL.', 'interventionNames': ['Drug: Bupivacaine']}, {'type': 'EXPERIMENTAL', 'label': 'Bupivacaine Liposome', 'description': 'Liposomal bupivacaine (133 mg in 10mL, diluted with 20 mL saline) will be injected into the fascial layer between the internal oblique and the transversus abdominis with ultrasound guidance, 30 mL per side for a total of 60 mL.', 'interventionNames': ['Drug: Bupivacaine liposome']}], 'interventions': [{'name': 'Bupivacaine', 'type': 'DRUG', 'otherNames': ['Marcaine'], 'description': 'Abdominal injection of bupivacaine into fascial layer.', 'armGroupLabels': ['Standard Bupivacaine']}, {'name': 'Bupivacaine liposome', 'type': 'DRUG', 'otherNames': ['Exparel'], 'description': 'Abdominal injection of bupivacaine liposome into fascial layer.', 'armGroupLabels': ['Bupivacaine Liposome']}]}, 'contactsLocationsModule': {'locations': [{'zip': '22304', 'city': 'Alexandria', 'state': 'Virginia', 'country': 'United States', 'facility': 'Fairfax Colon & Rectal Surgery, Alexandria Office', 'geoPoint': {'lat': 38.80484, 'lon': -77.04692}}, {'zip': '22031', 'city': 'Fairfax', 'state': 'Virginia', 'country': 'United States', 'facility': 'Fairfax Colon & Rectal Surgery, Fairfax-Prosperity Office', 'geoPoint': {'lat': 38.84622, 'lon': -77.30637}}, {'zip': '22033', 'city': 'Fairfax', 'state': 'Virginia', 'country': 'United States', 'facility': 'Fairfax Colon & Rectal Surgery, Fair Oaks Office', 'geoPoint': {'lat': 38.84622, 'lon': -77.30637}}, {'zip': '22042', 'city': 'Falls Church', 'state': 'Virginia', 'country': 'United States', 'facility': 'Inova Fairfax Medical Campus', 'geoPoint': {'lat': 38.88233, 'lon': -77.17109}}, {'zip': '20176', 'city': 'Lansdowne Town Center', 'state': 'Virginia', 'country': 'United States', 'facility': 'Fairfax Colon & Rectal Surgery, Loudoun Office', 'geoPoint': {'lat': 39.08151, 'lon': -77.49569}}, {'zip': '20190', 'city': 'Reston', 'state': 'Virginia', 'country': 'United States', 'facility': 'Fairfax Colon & Rectal Surgery, Reston Office', 'geoPoint': {'lat': 38.96872, 'lon': -77.3411}}], 'overallOfficials': [{'name': 'Donald Colvin, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Inova Health Care System'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Inova Health Care Services', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}