Ignite Creation Date:
2025-12-24 @ 6:37 PM
Ignite Modification Date:
2026-02-21 @ 10:12 PM
Study NCT ID:
NCT02052557
Status:
COMPLETED
Last Update Posted:
2021-01-08
First Post:
2014-01-24
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
The Effect of Exparel on Post Operative Pain and Narcotic Use After Colon Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}, {'id': 'D003110', 'term': 'Colonic Neoplasms'}, {'id': 'D004238', 'term': 'Diverticulitis'}], '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'}, {'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D000076385', 'term': 'Diverticular Diseases'}, {'id': 'D005759', 'term': 'Gastroenteritis'}]}, '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': 'mlyon@dmu.edu', 'phone': '5152711657', 'title': 'Grants and Contracts Manager', 'organization': 'Des Moines University'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'The study personnel have left the institution or are unreachable. efforts were made to contact the PI/study team members but were unsuccessful. Efforts were also made to get data from Mercy IRB and patient records staff. These staff did not have the information to find such data. Available data from the publication has been entered, but no other data is available and all efforts to locate the data have been exhausted.', 'description': 'The study personnel have left the institution or are unreachable. efforts were made to contact the PI/study team members but were unsuccessful. Efforts were also made to get data from Mercy IRB and patient records staff. These staff did not have the information to find such data. Available data from the publication has been entered, but no other data is available and all efforts to locate the data have been exhausted.', 'eventGroups': [{'id': 'EG000', 'title': 'Bupivacaine', 'description': '30 milliliters (ml) of 0.5% marcaine with epinephrine\n\nBupivacaine: 30ml of bupivacaine were injecting into the subcutaneous tissue at the incision sites after surgery in the OR', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Bupivacaine Liposome Suspension', 'description': 'exparel 20ml, diluted with 10ml sterile saline for total of 30ml\n\nBupivacaine liposome suspension: 30ml of Bupivacaine liposome injectable suspension were injecting into the subcutaneous tissue at the incision sites after surgery in the OR', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'PCA (Patient Controlled Analgesia) Usage', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Bupivacaine', 'description': '30 milliliters (ml) of 0.5% marcaine with epinephrine\n\nBupivacaine: 30ml of bupivacaine were injecting into the subcutaneous tissue at the incision sites after surgery in the OR'}, {'id': 'OG001', 'title': 'Bupivacaine Liposome Suspension', 'description': 'exparel 20ml, diluted with 10ml sterile saline for total of 30ml\n\nBupivacaine liposome suspension: 30ml of Bupivacaine liposome injectable suspension were injecting into the subcutaneous tissue at the incision sites after surgery in the OR'}], 'timeFrame': '48 hours post operatively', 'description': 'Will measure the amount of PCA use for the first 48 hours after surgery.', 'reportingStatus': 'POSTED', 'populationDescription': 'The study personnel have left the institution or are unreachable. efforts were made to contact the PI/study team members but were unsuccessful. Efforts were also made to get data from Mercy IRB and patient records staff. These staff did not have the information to find such data. Available data from the publication has been entered, but no other data is available and all efforts to locate the data have been exhausted.'}, {'type': 'SECONDARY', 'title': 'Oral Pain Medications', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Bupivacaine', 'description': '30 milliliters (ml) of 0.5% marcaine with epinephrine\n\nBupivacaine: 30ml of bupivacaine were injecting into the subcutaneous tissue at the incision sites after surgery in the OR'}, {'id': 'OG001', 'title': 'Bupivacaine Liposome Suspension', 'description': 'exparel 20ml, diluted with 10ml sterile saline for total of 30ml\n\nBupivacaine liposome suspension: 30ml of Bupivacaine liposome injectable suspension were injecting into the subcutaneous tissue at the incision sites after surgery in the OR'}], 'timeFrame': '48 hours postoperatively', 'description': 'the amount of post operative oral narcotic is measured post op', 'reportingStatus': 'POSTED', 'populationDescription': 'The study personnel have left the institution or are unreachable. efforts were made to contact the PI/study team members but were unsuccessful. Efforts were also made to get data from Mercy IRB and patient records staff. These staff did not have the information to find such data. Available data from the publication has been entered, but no other data is available and all efforts to locate the data have been exhausted.'}, {'type': 'SECONDARY', 'title': 'Total IV (Intravenous) Narcotic Used', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Bupivacaine', 'description': '30 milliliters (ml) of 0.5% marcaine with epinephrine\n\nBupivacaine: 30ml of bupivacaine were injecting into the subcutaneous tissue at the incision sites after surgery in the OR'}, {'id': 'OG001', 'title': 'Bupivacaine Liposome Suspension', 'description': 'exparel 20ml, diluted with 10ml sterile saline for total of 30ml\n\nBupivacaine liposome suspension: 30ml of Bupivacaine liposome injectable suspension were injecting into the subcutaneous tissue at the incision sites after surgery in the OR'}], 'timeFrame': 'participants will be followed for the duration of hospital stay, an expected average of 3 days', 'description': 'the total amount of IV narcotic is measured that is given during post op period prior to discharge', 'reportingStatus': 'POSTED', 'populationDescription': 'The study personnel have left the institution or are unreachable. efforts were made to contact the PI/study team members but were unsuccessful. Efforts were also made to get data from Mercy IRB and patient records staff. These staff did not have the information to find such data. Available data from the publication has been entered, but no other data is available and all efforts to locate the data have been exhausted.'}, {'type': 'SECONDARY', 'title': 'Total Oral Narcotic Used', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Bupivacaine', 'description': '30 milliliters (ml) of 0.5% marcaine with epinephrine\n\nBupivacaine: 30ml of bupivacaine were injecting into the subcutaneous tissue at the incision sites after surgery in the OR'}, {'id': 'OG001', 'title': 'Bupivacaine Liposome Suspension', 'description': 'exparel 20ml, diluted with 10ml sterile saline for total of 30ml\n\nBupivacaine liposome suspension: 30ml of Bupivacaine liposome injectable suspension were injecting into the subcutaneous tissue at the incision sites after surgery in the OR'}], 'timeFrame': 'participants will be followed for the duration of hospital stay, an expected average of 3 days', 'reportingStatus': 'POSTED', 'populationDescription': 'The study personnel have left the institution or are unreachable. efforts were made to contact the PI/study team members but were unsuccessful. Efforts were also made to get data from Mercy IRB and patient records staff. These staff did not have the information to find such data. Available data from the publication has been entered, but no other data is available and all efforts to locate the data have been exhausted.'}, {'type': 'SECONDARY', 'title': 'Length of Stay', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Bupivacaine', 'description': '30 milliliters (ml) of 0.5% marcaine with epinephrine\n\nBupivacaine: 30ml of bupivacaine were injecting into the subcutaneous tissue at the incision sites after surgery in the OR'}, {'id': 'OG001', 'title': 'Bupivacaine Liposome Suspension', 'description': 'exparel 20ml, diluted with 10ml sterile saline for total of 30ml\n\nBupivacaine liposome suspension: 30ml of Bupivacaine liposome injectable suspension were injecting into the subcutaneous tissue at the incision sites after surgery in the OR'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'participants will be followed for the duration of hospital stay, an expected average of 3 days', 'unitOfMeasure': 'days', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Return of Bowel Function', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Bupivacaine', 'description': '30 milliliters (ml) of 0.5% marcaine with epinephrine\n\nBupivacaine: 30ml of bupivacaine were injecting into the subcutaneous tissue at the incision sites after surgery in the OR'}, {'id': 'OG001', 'title': 'Bupivacaine Liposome Suspension', 'description': 'exparel 20ml, diluted with 10ml sterile saline for total of 30ml\n\nBupivacaine liposome suspension: 30ml of Bupivacaine liposome injectable suspension were injecting into the subcutaneous tissue at the incision sites after surgery in the OR'}], 'timeFrame': 'participants will be followed for the duration of hospital stay, an expected average of 3 days, and the timing of return of bowel function returning will be recorded', 'reportingStatus': 'POSTED', 'populationDescription': 'The study personnel have left the institution or are unreachable. efforts were made to contact the PI/study team members but were unsuccessful. Efforts were also made to get data from Mercy IRB and patient records staff. These staff did not have the information to find such data. Available data from the publication has been entered, but no other data is available and all efforts to locate the data have been exhausted.'}, {'type': 'SECONDARY', 'title': 'Readmission', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Bupivacaine', 'description': '30 milliliters (ml) of 0.5% marcaine with epinephrine\n\nBupivacaine: 30ml of bupivacaine were injecting into the subcutaneous tissue at the incision sites after surgery in the OR'}, {'id': 'OG001', 'title': 'Bupivacaine Liposome Suspension', 'description': 'exparel 20ml, diluted with 10ml sterile saline for total of 30ml\n\nBupivacaine liposome suspension: 30ml of Bupivacaine liposome injectable suspension were injecting into the subcutaneous tissue at the incision sites after surgery in the OR'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '30 days post operative readmission', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'No one readmitted.'}, {'type': 'SECONDARY', 'title': 'Toradol Use', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Bupivacaine Liposome Suspension', 'description': 'exparel 20ml, diluted with 10ml sterile saline for total of 30ml\n\nBupivacaine liposome suspension: 30ml of Bupivacaine liposome injectable suspension were injecting into the subcutaneous tissue at the incision sites after surgery in the OR'}, {'id': 'OG001', 'title': 'Bupivacaine', 'description': '30 milliliters (ml) of 0.5% marcaine with epinephrine\n\nBupivacaine: 30ml of bupivacaine were injecting into the subcutaneous tissue at the incision sites after surgery in the OR'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'participants will be followed for the duration of hospital stay, an expected average of 3 days', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Ofirmev', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Bupivacaine', 'description': '30 milliliters (ml) of 0.5% marcaine with epinephrine\n\nBupivacaine: 30ml of bupivacaine were injecting into the subcutaneous tissue at the incision sites after surgery in the OR'}, {'id': 'OG001', 'title': 'Bupivacaine Liposome Suspension', 'description': 'exparel 20ml, diluted with 10ml sterile saline for total of 30ml\n\nBupivacaine liposome suspension: 30ml of Bupivacaine liposome injectable suspension were injecting into the subcutaneous tissue at the incision sites after surgery in the OR'}], 'timeFrame': 'participants will be followed for the duration of hospital stay, an expected average of 3 days, and the amount of ofirmev used during admission will be recorded', 'reportingStatus': 'POSTED', 'populationDescription': 'The study personnel have left the institution or are unreachable. efforts were made to contact the PI/study team members but were unsuccessful. Efforts were also made to get data from Mercy IRB and patient records staff. These staff did not have the information to find such data. Available data from the publication has been entered, but no other data is available and all efforts to locate the data have been exhausted.'}, {'type': 'SECONDARY', 'title': 'Nausea Medication', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Bupivacaine', 'description': '30 milliliters (ml) of 0.5% marcaine with epinephrine\n\nBupivacaine: 30ml of bupivacaine were injecting into the subcutaneous tissue at the incision sites after surgery in the OR'}, {'id': 'OG001', 'title': 'Bupivacaine Liposome Suspension', 'description': 'exparel 20ml, diluted with 10ml sterile saline for total of 30ml\n\nBupivacaine liposome suspension: 30ml of Bupivacaine liposome injectable suspension were injecting into the subcutaneous tissue at the incision sites after surgery in the OR'}], 'timeFrame': 'The amount of nausea medicine used 48 hours post op was recorded', 'reportingStatus': 'POSTED', 'populationDescription': 'The study personnel have left the institution or are unreachable. efforts were made to contact the PI/study team members but were unsuccessful. Efforts were also made to get data from Mercy IRB and patient records staff. These staff did not have the information to find such data. Available data from the publication has been entered, but no other data is available and all efforts to locate the data have been exhausted.'}, {'type': 'SECONDARY', 'title': 'Foley Catheter Removal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Bupivacaine', 'description': '30 milliliters (ml) of 0.5% marcaine with epinephrine\n\nBupivacaine: 30ml of bupivacaine were injecting into the subcutaneous tissue at the incision sites after surgery in the OR'}, {'id': 'OG001', 'title': 'Bupivacaine Liposome Suspension', 'description': 'exparel 20ml, diluted with 10ml sterile saline for total of 30ml\n\nBupivacaine liposome suspension: 30ml of Bupivacaine liposome injectable suspension were injecting into the subcutaneous tissue at the incision sites after surgery in the OR'}], 'timeFrame': 'participants will be followed for the duration of hospital stay, an expected average of 3 days, the timing of foley catheter removal will be recorded', 'reportingStatus': 'POSTED', 'populationDescription': 'The study personnel have left the institution or are unreachable. efforts were made to contact the PI/study team members but were unsuccessful. Efforts were also made to get data from Mercy IRB and patient records staff. These staff did not have the information to find such data. Available data from the publication has been entered, but no other data is available and all efforts to locate the data have been exhausted.'}, {'type': 'SECONDARY', 'title': 'Postoperative Pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Bupivacaine', 'description': '30 milliliters (ml) of 0.5% marcaine with epinephrine\n\nBupivacaine: 30ml of bupivacaine were injecting into the subcutaneous tissue at the incision sites after surgery in the OR'}, {'id': 'OG001', 'title': 'Bupivacaine Liposome Suspension', 'description': 'exparel 20ml, diluted with 10ml sterile saline for total of 30ml\n\nBupivacaine liposome suspension: 30ml of Bupivacaine liposome injectable suspension were injecting into the subcutaneous tissue at the incision sites after surgery in the OR'}], 'timeFrame': 'POD #3-5 and POD #13-15', 'description': 'The investigators will talk to the patient after surgery immediately post operatively Post Operative Day (POD) #3-5 and POD #13-15 and ask the patients to rate their pain on a scale of 1-10.', 'reportingStatus': 'POSTED', 'populationDescription': 'The study personnel have left the institution or are unreachable. efforts were made to contact the PI/study team members but were unsuccessful. Efforts were also made to get data from Mercy IRB and patient records staff. These staff did not have the information to find such data. Available data from the publication has been entered, but no other data is available and all efforts to locate the data have been exhausted.'}, {'type': 'SECONDARY', 'title': 'Post Operative Satisfaction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Bupivacaine', 'description': '30 milliliters (ml) of 0.5% marcaine with epinephrine\n\nBupivacaine: 30ml of bupivacaine were injecting into the subcutaneous tissue at the incision sites after surgery in the OR'}, {'id': 'OG001', 'title': 'Bupivacaine Liposome Suspension', 'description': 'exparel 20ml, diluted with 10ml sterile saline for total of 30ml\n\nBupivacaine liposome suspension: 30ml of Bupivacaine liposome injectable suspension were injecting into the subcutaneous tissue at the incision sites after surgery in the OR'}], 'timeFrame': 'POD #3-5 and POD #13-15', 'description': 'The investigators will ask the patient to rate their satisfaction with pain control.', 'reportingStatus': 'POSTED', 'populationDescription': 'The study personnel have left the institution or are unreachable. efforts were made to contact the PI/study team members but were unsuccessful. Efforts were also made to get data from Mercy IRB and patient records staff. These staff did not have the information to find such data. Available data from the publication has been entered, but no other data is available and all efforts to locate the data have been exhausted.'}, {'type': 'SECONDARY', 'title': 'Home Oral Narcotic Use', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Bupivacaine Liposome Suspension', 'description': 'exparel 20ml, diluted with 10ml sterile saline for total of 30ml\n\nBupivacaine liposome suspension: 30ml of Bupivacaine liposome injectable suspension were injecting into the subcutaneous tissue at the incision sites after surgery in the OR'}, {'id': 'OG001', 'title': 'Bupivacaine', 'description': '30 milliliters (ml) of 0.5% marcaine with epinephrine\n\nBupivacaine: 30ml of bupivacaine were injecting into the subcutaneous tissue at the incision sites after surgery in the OR'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'POD #13-15', 'description': 'The investigators will ask the patients how many of their narcotic pain pills they used after surgery up to the POD #13-15', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'NG (Nasogastric) Placement', 'timeFrame': 'POD #0 if NG was placed', 'description': 'We recorded if an NG was placed immediately post operatively', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Bupivacaine', 'description': '30 milliliters (ml) of 0.5% marcaine with epinephrine\n\nBupivacaine: 30ml of bupivacaine were injecting into the subcutaneous tissue at the incision sites after surgery in the OR'}, {'id': 'FG001', 'title': 'Bupivacaine Liposome Suspension', 'description': 'exparel 20ml, diluted with 10ml sterile saline for total of 30ml\n\nBupivacaine liposome suspension: 30ml of Bupivacaine liposome injectable suspension were injecting into the subcutaneous tissue at the incision sites after surgery in the OR'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '26'}, {'groupId': 'FG001', 'numSubjects': '25'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '26'}, {'groupId': 'FG001', 'numSubjects': '25'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Bupivacaine', 'description': '30 milliliters (ml) of 0.5% marcaine with epinephrine\n\nBupivacaine: 30ml of bupivacaine were injecting into the subcutaneous tissue at the incision sites after surgery in the OR'}, {'id': 'BG001', 'title': 'Bupivacaine Liposome Suspension', 'description': 'exparel 20ml, diluted with 10ml sterile saline for total of 30ml\n\nBupivacaine liposome suspension: 30ml of Bupivacaine liposome injectable suspension were injecting into the subcutaneous tissue at the incision sites after surgery in the OR'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], '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': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'The study personnel have left the institution or are unreachable. efforts were made to contact the PI/study team members but were unsuccessful. Efforts were also made to get data from Mercy IRB and patient records staff. These staff did not have the information to find such data. Available data from the publication has been entered, but no other data is available and all efforts to locate the data have been exhausted.'}, {'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '67', 'spread': '2', 'groupId': 'BG000'}, {'value': '67', 'spread': '2', 'groupId': 'BG001'}, {'value': '67', 'spread': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The study personnel have left the institution or are unreachable. efforts were made to contact the PI/study team members but were unsuccessful. Efforts were also made to get data from Mercy IRB and patient records staff. These staff did not have the information to find such data. Available data from the publication has been entered, but no other data is available and all efforts to locate the data have been exhausted.', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 51}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-12', 'completionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-12-14', 'studyFirstSubmitDate': '2014-01-24', 'resultsFirstSubmitDate': '2020-12-14', 'studyFirstSubmitQcDate': '2014-01-30', 'lastUpdatePostDateStruct': {'date': '2021-01-08', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-12-14', 'studyFirstPostDateStruct': {'date': '2014-02-03', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-01-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'NG (Nasogastric) Placement', 'timeFrame': 'POD #0 if NG was placed', 'description': 'We recorded if an NG was placed immediately post operatively'}], 'primaryOutcomes': [{'measure': 'PCA (Patient Controlled Analgesia) Usage', 'timeFrame': '48 hours post operatively', 'description': 'Will measure the amount of PCA use for the first 48 hours after surgery.'}], 'secondaryOutcomes': [{'measure': 'Oral Pain Medications', 'timeFrame': '48 hours postoperatively', 'description': 'the amount of post operative oral narcotic is measured post op'}, {'measure': 'Total IV (Intravenous) Narcotic Used', 'timeFrame': 'participants will be followed for the duration of hospital stay, an expected average of 3 days', 'description': 'the total amount of IV narcotic is measured that is given during post op period prior to discharge'}, {'measure': 'Total Oral Narcotic Used', 'timeFrame': 'participants will be followed for the duration of hospital stay, an expected average of 3 days'}, {'measure': 'Length of Stay', 'timeFrame': 'participants will be followed for the duration of hospital stay, an expected average of 3 days'}, {'measure': 'Return of Bowel Function', 'timeFrame': 'participants will be followed for the duration of hospital stay, an expected average of 3 days, and the timing of return of bowel function returning will be recorded'}, {'measure': 'Readmission', 'timeFrame': '30 days post operative readmission'}, {'measure': 'Toradol Use', 'timeFrame': 'participants will be followed for the duration of hospital stay, an expected average of 3 days'}, {'measure': 'Ofirmev', 'timeFrame': 'participants will be followed for the duration of hospital stay, an expected average of 3 days, and the amount of ofirmev used during admission will be recorded'}, {'measure': 'Nausea Medication', 'timeFrame': 'The amount of nausea medicine used 48 hours post op was recorded'}, {'measure': 'Foley Catheter Removal', 'timeFrame': 'participants will be followed for the duration of hospital stay, an expected average of 3 days, the timing of foley catheter removal will be recorded'}, {'measure': 'Postoperative Pain', 'timeFrame': 'POD #3-5 and POD #13-15', 'description': 'The investigators will talk to the patient after surgery immediately post operatively Post Operative Day (POD) #3-5 and POD #13-15 and ask the patients to rate their pain on a scale of 1-10.'}, {'measure': 'Post Operative Satisfaction', 'timeFrame': 'POD #3-5 and POD #13-15', 'description': 'The investigators will ask the patient to rate their satisfaction with pain control.'}, {'measure': 'Home Oral Narcotic Use', 'timeFrame': 'POD #13-15', 'description': 'The investigators will ask the patients how many of their narcotic pain pills they used after surgery up to the POD #13-15'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Exparel', 'liposomal bupivicaine', 'post operative pain control', 'local anesthetic after surgery', 'colorectal surgery', 'marcaine', 'long acting local anesthetic', 'pain medication use after surgery'], 'conditions': ['Post-operative Pain', 'Colon Cancer', 'Diverticulitis']}, 'referencesModule': {'references': [{'pmid': '27505115', 'type': 'DERIVED', '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.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to evaluate the effect of Exparel on pain control and patient outcome after colon resection. The investigators will evaluate the clinical course of the patients who receive exparel as compared to the patients who do not receive exparel. Exparel is a 72 hour bupivacaine which is slowly released from lysosomes over the course of three days. A long acting local anesthetic should provide better pain control than conventional bupivacaine which has a 3.5 hour half-life.', 'detailedDescription': 'Patients who are undergoing elective colon resection with Dr. Kraemer and Dr. Raman will be offered participation in the study. This will include robotic, laparoscopic and open procedures.\n\nIn the pre-operative area prior to surgery, the surgical resident will inform the patient of the opportunity to participate in the research study. The resident will consent the patient at that time, if the patient chooses to participate, they will be randomized to an exparel or non-exparel group. The randomization will be done by having the resident pick an envelope that will state whether or not the patient is randomized to the exparel or non-exparel group, this will randomize to 50% in each group. The patient will not be notified of the type of local anesthetic they receive. The attending surgeon will also be blind to the type of local the pt will receive; only the resident and Operating Room (OR) staff will know what type of local anesthetic was given. Unfortunately the opaque color of the exparel precludes the physician injecting the local anesthetic from being blinded to the type of anesthetic given.\n\nThe patient will be taken to the operating room as usual, and the surgery will proceed as it normally would. At the end of the surgery the patient will receive either exparel or bupivacaine depending upon which the patient was randomized to. The attending surgeon will not be in the operating suite while the local anesthetic is being injected. 30 milliliters (mL) of either exparel or bupivacaine will be injected into the subcutaneous tissues at the end of surgery.\n\nThe patient will be taken to the post operative care unit (PACU), the medications for post-operative pain will be standardized between the two groups, a standard starting dose on the patient controlled analgesia (PCA) will be used, and will be adjusted as needed. The postoperative care will attempt to be standardized in regard to diet, discharge (dc) of foley, not using nasogastric (NG) tubes, however this will be based on the individual patient was what is best for their care. This data will then be analyzed to determine if exparel has a beneficial effect on surgical care.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Elective colon resection for both benign and malignant disease\n* Laparoscopic, robotic and open techniques\n\nExclusion Criteria:\n\n* emergent colon cases\n* cases preformed by surgeons other than Dr. Raman or Dr. Kraemer\n* pregnant patients\n* patients currently breast feeding\n* patients under the age of 18\n* other patients unable to give informed consent\n* bupivacaine use within 96 hours\n* allergy to amide anesthetics\n* prisoners\n* caution will be used in patients with renal or hepatic failure.'}, 'identificationModule': {'nctId': 'NCT02052557', 'briefTitle': 'The Effect of Exparel on Post Operative Pain and Narcotic Use After Colon Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Des Moines University'}, 'officialTitle': 'The Effect of Exparel on Post Operative Pain and Narcotic Use After Colon Surgery', 'orgStudyIdInfo': {'id': 'MMC2013-09'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Bupivacaine', 'description': '30 milliliters (ml) of 0.5% marcaine with epinephrine', 'interventionNames': ['Drug: Bupivacaine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Bupivacaine liposome suspension', 'description': 'exparel 20ml, diluted with 10ml sterile saline for total of 30ml', 'interventionNames': ['Drug: Bupivacaine liposome suspension']}], 'interventions': [{'name': 'Bupivacaine', 'type': 'DRUG', 'otherNames': ['Marcaine'], 'description': '30ml of bupivacaine were injecting into the subcutaneous tissue at the incision sites after surgery in the OR', 'armGroupLabels': ['Bupivacaine']}, {'name': 'Bupivacaine liposome suspension', 'type': 'DRUG', 'otherNames': ['Exparel', '72 hour Bupivacaine', 'Long acting Bupivacaine'], 'description': '30ml of Bupivacaine liposome injectable suspension were injecting into the subcutaneous tissue at the incision sites after surgery in the OR', 'armGroupLabels': ['Bupivacaine liposome suspension']}]}, 'contactsLocationsModule': {'locations': [{'zip': '50314', 'city': 'Des Moines', 'state': 'Iowa', 'country': 'United States', 'facility': 'Mercy Medical Center', 'geoPoint': {'lat': 41.60054, 'lon': -93.60911}}], 'overallOfficials': [{'name': 'Rachel Knudson, DO', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mercy Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Des Moines University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Mercy Medical Center', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}