Ignite Creation Date:
2025-12-24 @ 9:11 PM
Ignite Modification Date:
2026-01-01 @ 3:44 PM
Study NCT ID:
NCT02043704
Status:
COMPLETED
Last Update Posted:
2018-08-16
First Post:
2014-01-21
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
RCT (Randomized Controlled Trial) of IV Acetaminophen for Post Operative Vaginal Reconstruction Pain
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': 'D000082', 'term': 'Acetaminophen'}], 'ancestors': [{'id': 'D000083', 'term': 'Acetanilides'}, {'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': 'ganga_devaiah@trihealth.com', 'phone': '513-862-2341', 'title': 'Clinical Research Specialist', 'organization': 'TriHealth'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'IV Acetaminophen', 'description': 'Subjects will receive a 1000mg dose of IV acetaminophen in 100mL solution every 6 hours for 24 hours. The first dose will be administered prior to anesthesia induction, approximately 30 minutes before skin incision. A total of 4 doses will be given.\n\nIV Acetaminophen: Details covered in arm description.', 'otherNumAtRisk': 50, 'otherNumAffected': 0, 'seriousNumAtRisk': 50, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Saline', 'description': 'Subjects will receive a 100mL dose of IV saline every 6 hours for 24 hours. The first dose will be administered prior to anesthesia induction, approximately 30 minutes before skin incision. A total of 4 doses will be given.\n\nIV Acetaminophen: Details covered in arm description.', 'otherNumAtRisk': 50, 'otherNumAffected': 0, 'seriousNumAtRisk': 50, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Pain While Active - 18 hr', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IV Acetaminophen', 'description': 'Subjects will receive a 1000mg dose of IV acetaminophen in 100mL solution every 6 hours for 24 hours. The first dose will be administered prior to anesthesia induction, approximately 30 minutes before skin incision. A total of 4 doses will be given.\n\nIV Acetaminophen: Details covered in arm description.'}, {'id': 'OG001', 'title': 'Saline', 'description': 'Subjects will receive a 100mL dose of IV saline every 6 hours for 24 hours. The first dose will be administered prior to anesthesia induction, approximately 30 minutes before skin incision. A total of 4 doses will be given.\n\nIV Acetaminophen: Details covered in arm description.'}], 'classes': [{'categories': [{'measurements': [{'value': '42.0', 'groupId': 'OG000', 'lowerLimit': '27.5', 'upperLimit': '61'}, {'value': '50.0', 'groupId': 'OG001', 'lowerLimit': '28.5', 'upperLimit': '71.5'}]}]}], 'analyses': [{'pValue': '0.328', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'The p-value was not adjusted for multiple comparisons.', 'groupDescription': 'The comparison was analyzed using the Mann-Whitney U test.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'EQUIVALENCE', 'statisticalComment': 'There were no adjustments.', 'nonInferiorityComment': 'The null hypothesis is that there is no difference in the pain scores between the groups.'}], 'paramType': 'MEDIAN', 'timeFrame': '18 hours', 'description': 'Post operative pain will be assessed 18 hours after surgery. Pain will be self reported by patients using a 0-100 mm visual analog scale (VAS) with 0 indicating no pain and 100 indicating the worst pain imaginable. A pain score will be collected for pain while active.', 'unitOfMeasure': 'mm', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Total Amount of Narcotic Consumption in the First 24 Hours Post Surgery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IV Acetaminophen', 'description': 'Subjects will receive a 1000mg dose of IV acetaminophen in 100mL solution every 6 hours for 24 hours. The first dose will be administered prior to anesthesia induction, approximately 30 minutes before skin incision. A total of 4 doses will be given.\n\nIV Acetaminophen: Details covered in arm description.'}, {'id': 'OG001', 'title': 'Saline', 'description': 'Subjects will receive a 100mL dose of IV saline every 6 hours for 24 hours. The first dose will be administered prior to anesthesia induction, approximately 30 minutes before skin incision. A total of 4 doses will be given.\n\nIV Acetaminophen: Details covered in arm description.'}], 'classes': [{'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000', 'lowerLimit': '6.67', 'upperLimit': '26.68'}, {'value': '15', 'groupId': 'OG001', 'lowerLimit': '5', 'upperLimit': '26.67'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '24 hours', 'description': 'Hydromorphone will be administered for breakthrough pain. The total amount consumed in the first 24 hours post surgery will be recorded.', 'unitOfMeasure': 'mgs', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Narcotic Associated Side Effects', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IV Acetaminophen', 'description': 'Subjects will receive a 1000mg dose of IV acetaminophen in 100mL solution every 6 hours for 24 hours. The first dose will be administered prior to anesthesia induction, approximately 30 minutes before skin incision. A total of 4 doses will be given.\n\nIV Acetaminophen: Details covered in arm description.'}, {'id': 'OG001', 'title': 'Saline', 'description': 'Subjects will receive a 100mL dose of IV saline every 6 hours for 24 hours. The first dose will be administered prior to anesthesia induction, approximately 30 minutes before skin incision. A total of 4 doses will be given.\n\nIV Acetaminophen: Details covered in arm description.'}], 'classes': [{'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '24 hours', 'description': 'The incidence of known narcotic associated side effects will be recorded for nausea/vomiting.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Count reported for nausea/vomiting.'}, {'type': 'SECONDARY', 'title': 'Time to First Rescue Narcotic', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IV Acetaminophen', 'description': 'Subjects will receive a 1000mg dose of IV acetaminophen in 100mL solution every 6 hours for 24 hours. The first dose will be administered prior to anesthesia induction, approximately 30 minutes before skin incision. A total of 4 doses will be given.\n\nIV Acetaminophen: Details covered in arm description.'}, {'id': 'OG001', 'title': 'Saline', 'description': 'Subjects will receive a 100mL dose of IV saline every 6 hours for 24 hours. The first dose will be administered prior to anesthesia induction, approximately 30 minutes before skin incision. A total of 4 doses will be given.\n\nIV Acetaminophen: Details covered in arm description.'}], 'classes': [{'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000', 'lowerLimit': '18', 'upperLimit': '64'}, {'value': '41', 'groupId': 'OG001', 'lowerLimit': '22', 'upperLimit': '67'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '24 hours', 'description': 'The time from the end of surgery to the time any IV narcotic is given.', 'unitOfMeasure': 'minutes', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Narcotic Associated Side Effects', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IV Acetaminophen', 'description': 'Subjects will receive a 1000mg dose of IV acetaminophen in 100mL solution every 6 hours for 24 hours. The first dose will be administered prior to anesthesia induction, approximately 30 minutes before skin incision. A total of 4 doses will be given.\n\nIV Acetaminophen: Details covered in arm description.'}, {'id': 'OG001', 'title': 'Saline', 'description': 'Subjects will receive a 100mL dose of IV saline every 6 hours for 24 hours. The first dose will be administered prior to anesthesia induction, approximately 30 minutes before skin incision. A total of 4 doses will be given.\n\nIV Acetaminophen: Details covered in arm description.'}], 'classes': [{'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '24 hours', 'description': 'The incidence of known narcotic associated side effects will be recorded for itching.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Narcotic Associated Side Effects', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IV Acetaminophen', 'description': 'Subjects will receive a 1000mg dose of IV acetaminophen in 100mL solution every 6 hours for 24 hours. The first dose will be administered prior to anesthesia induction, approximately 30 minutes before skin incision. A total of 4 doses will be given.\n\nIV Acetaminophen: Details covered in arm description.'}, {'id': 'OG001', 'title': 'Saline', 'description': 'Subjects will receive a 100mL dose of IV saline every 6 hours for 24 hours. The first dose will be administered prior to anesthesia induction, approximately 30 minutes before skin incision. A total of 4 doses will be given.\n\nIV Acetaminophen: Details covered in arm description.'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '24 hours', 'description': 'The incidence of known narcotic associated side effects will be recorded for headache.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Narcotic Associated Side Effects', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IV Acetaminophen', 'description': 'Subjects will receive a 1000mg dose of IV acetaminophen in 100mL solution every 6 hours for 24 hours. The first dose will be administered prior to anesthesia induction, approximately 30 minutes before skin incision. A total of 4 doses will be given.\n\nIV Acetaminophen: Details covered in arm description.'}, {'id': 'OG001', 'title': 'Saline', 'description': 'Subjects will receive a 100mL dose of IV saline every 6 hours for 24 hours. The first dose will be administered prior to anesthesia induction, approximately 30 minutes before skin incision. A total of 4 doses will be given.\n\nIV Acetaminophen: Details covered in arm description.'}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '24 hours', 'description': 'The incidence of known narcotic associated side effects will be recorded for insomnia.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Narcotic Associated Side Effects', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IV Acetaminophen', 'description': 'Subjects will receive a 1000mg dose of IV acetaminophen in 100mL solution every 6 hours for 24 hours. The first dose will be administered prior to anesthesia induction, approximately 30 minutes before skin incision. A total of 4 doses will be given.\n\nIV Acetaminophen: Details covered in arm description.'}, {'id': 'OG001', 'title': 'Saline', 'description': 'Subjects will receive a 100mL dose of IV saline every 6 hours for 24 hours. The first dose will be administered prior to anesthesia induction, approximately 30 minutes before skin incision. A total of 4 doses will be given.\n\nIV Acetaminophen: Details covered in arm description.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '24 hours', 'description': 'The incidence of known narcotic associated side effects will be recorded for rash/hives.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Narcotic Associated Side Effects', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IV Acetaminophen', 'description': 'Subjects will receive a 1000mg dose of IV acetaminophen in 100mL solution every 6 hours for 24 hours. The first dose will be administered prior to anesthesia induction, approximately 30 minutes before skin incision. A total of 4 doses will be given.\n\nIV Acetaminophen: Details covered in arm description.'}, {'id': 'OG001', 'title': 'Saline', 'description': 'Subjects will receive a 100mL dose of IV saline every 6 hours for 24 hours. The first dose will be administered prior to anesthesia induction, approximately 30 minutes before skin incision. A total of 4 doses will be given.\n\nIV Acetaminophen: Details covered in arm description.'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '24 hours', 'description': 'The incidence of known narcotic associated side effects will be recorded for shortness of breath.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Narcotic Associated Side Effects', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IV Acetaminophen', 'description': 'Subjects will receive a 1000mg dose of IV acetaminophen in 100mL solution every 6 hours for 24 hours. The first dose will be administered prior to anesthesia induction, approximately 30 minutes before skin incision. A total of 4 doses will be given.\n\nIV Acetaminophen: Details covered in arm description.'}, {'id': 'OG001', 'title': 'Saline', 'description': 'Subjects will receive a 100mL dose of IV saline every 6 hours for 24 hours. The first dose will be administered prior to anesthesia induction, approximately 30 minutes before skin incision. A total of 4 doses will be given.\n\nIV Acetaminophen: Details covered in arm description.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '24 hours', 'description': 'The incidence of known narcotic associated side effects will be recorded for respiratory depression.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Narcotic Associated Side Effects', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IV Acetaminophen', 'description': 'Subjects will receive a 1000mg dose of IV acetaminophen in 100mL solution every 6 hours for 24 hours. The first dose will be administered prior to anesthesia induction, approximately 30 minutes before skin incision. A total of 4 doses will be given.\n\nIV Acetaminophen: Details covered in arm description.'}, {'id': 'OG001', 'title': 'Saline', 'description': 'Subjects will receive a 100mL dose of IV saline every 6 hours for 24 hours. The first dose will be administered prior to anesthesia induction, approximately 30 minutes before skin incision. A total of 4 doses will be given.\n\nIV Acetaminophen: Details covered in arm description.'}], 'classes': [{'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '24 hours', 'description': 'The incidence of known narcotic associated side effects will be recorded for urinary retention.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Time to Ambulation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IV Acetaminophen', 'description': 'Subjects will receive a 1000mg dose of IV acetaminophen in 100mL solution every 6 hours for 24 hours. The first dose will be administered prior to anesthesia induction, approximately 30 minutes before skin incision. A total of 4 doses will be given.\n\nIV Acetaminophen: Details covered in arm description.'}, {'id': 'OG001', 'title': 'Saline', 'description': 'Subjects will receive a 100mL dose of IV saline every 6 hours for 24 hours. The first dose will be administered prior to anesthesia induction, approximately 30 minutes before skin incision. A total of 4 doses will be given.\n\nIV Acetaminophen: Details covered in arm description.'}], 'classes': [{'categories': [{'measurements': [{'value': '1295', 'groupId': 'OG000', 'lowerLimit': '1108', 'upperLimit': '1462'}, {'value': '1252', 'groupId': 'OG001', 'lowerLimit': '778', 'upperLimit': '1459'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '1800 minutes', 'description': 'Length of time from the end of surgery to the time of ambulation.', 'unitOfMeasure': 'minutes', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Time to First Flatus/Bowel Movement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IV Acetaminophen', 'description': 'Subjects will receive a 1000mg dose of IV acetaminophen in 100mL solution every 6 hours for 24 hours. The first dose will be administered prior to anesthesia induction, approximately 30 minutes before skin incision. A total of 4 doses will be given.\n\nIV Acetaminophen: Details covered in arm description.'}, {'id': 'OG001', 'title': 'Saline', 'description': 'Subjects will receive a 100mL dose of IV saline every 6 hours for 24 hours. The first dose will be administered prior to anesthesia induction, approximately 30 minutes before skin incision. A total of 4 doses will be given.\n\nIV Acetaminophen: Details covered in arm description.'}], 'classes': [{'categories': [{'measurements': [{'value': '3977', 'groupId': 'OG000', 'lowerLimit': '1437', 'upperLimit': '5564'}, {'value': '1899', 'groupId': 'OG001', 'lowerLimit': '1275', 'upperLimit': '4580'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '9000 minutes', 'description': 'Length of time from the end of surgery to the time of first flatus or bowel movement.', 'unitOfMeasure': 'minutes', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'IV Acetaminophen', 'description': 'Subjects will receive a 1000mg dose of IV acetaminophen in 100mL solution every 6 hours for 24 hours. The first dose will be administered prior to anesthesia induction, approximately 30 minutes before skin incision. A total of 4 doses will be given.\n\nIV Acetaminophen: Details covered in arm description.'}, {'id': 'FG001', 'title': 'Saline', 'description': 'Subjects will receive a 100mL dose of IV saline every 6 hours for 24 hours. The first dose will be administered prior to anesthesia induction, approximately 30 minutes before skin incision. A total of 4 doses will be given.\n\nIV Acetaminophen: Details covered in arm description.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '50'}, {'groupId': 'FG001', 'numSubjects': '50'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '47'}, {'groupId': 'FG001', 'numSubjects': '43'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '7'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '90', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'IV Acetaminophen', 'description': 'Subjects will receive a 1000mg dose of IV acetaminophen in 100mL solution every 6 hours for 24 hours. The first dose will be administered prior to anesthesia induction, approximately 30 minutes before skin incision. A total of 4 doses will be given.\n\nIV Acetaminophen: Details covered in arm description.'}, {'id': 'BG001', 'title': 'Saline', 'description': 'Subjects will receive a 100mL dose of IV saline every 6 hours for 24 hours. The first dose will be administered prior to anesthesia induction, approximately 30 minutes before skin incision. A total of 4 doses will be given.\n\nIV Acetaminophen: Details covered in arm description.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '57.3', 'spread': '12.8', 'groupId': 'BG000'}, {'value': '59.4', 'spread': '11.4', 'groupId': 'BG001'}, {'value': '58.3', 'spread': '12.12', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '47', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '90', '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': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', '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': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '47', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '90', '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': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '47', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '90', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-02', 'completionDateStruct': {'date': '2016-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-07-19', 'studyFirstSubmitDate': '2014-01-21', 'resultsFirstSubmitDate': '2017-10-11', 'studyFirstSubmitQcDate': '2014-01-21', 'lastUpdatePostDateStruct': {'date': '2018-08-16', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-02-16', 'studyFirstPostDateStruct': {'date': '2014-01-23', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-03-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Time to First Flatus/Bowel Movement', 'timeFrame': '9000 minutes', 'description': 'Length of time from the end of surgery to the time of first flatus or bowel movement.'}], 'primaryOutcomes': [{'measure': 'Pain While Active - 18 hr', 'timeFrame': '18 hours', 'description': 'Post operative pain will be assessed 18 hours after surgery. Pain will be self reported by patients using a 0-100 mm visual analog scale (VAS) with 0 indicating no pain and 100 indicating the worst pain imaginable. A pain score will be collected for pain while active.'}, {'measure': 'Total Amount of Narcotic Consumption in the First 24 Hours Post Surgery', 'timeFrame': '24 hours', 'description': 'Hydromorphone will be administered for breakthrough pain. The total amount consumed in the first 24 hours post surgery will be recorded.'}], 'secondaryOutcomes': [{'measure': 'Narcotic Associated Side Effects', 'timeFrame': '24 hours', 'description': 'The incidence of known narcotic associated side effects will be recorded for nausea/vomiting.'}, {'measure': 'Time to First Rescue Narcotic', 'timeFrame': '24 hours', 'description': 'The time from the end of surgery to the time any IV narcotic is given.'}, {'measure': 'Narcotic Associated Side Effects', 'timeFrame': '24 hours', 'description': 'The incidence of known narcotic associated side effects will be recorded for itching.'}, {'measure': 'Narcotic Associated Side Effects', 'timeFrame': '24 hours', 'description': 'The incidence of known narcotic associated side effects will be recorded for headache.'}, {'measure': 'Narcotic Associated Side Effects', 'timeFrame': '24 hours', 'description': 'The incidence of known narcotic associated side effects will be recorded for insomnia.'}, {'measure': 'Narcotic Associated Side Effects', 'timeFrame': '24 hours', 'description': 'The incidence of known narcotic associated side effects will be recorded for rash/hives.'}, {'measure': 'Narcotic Associated Side Effects', 'timeFrame': '24 hours', 'description': 'The incidence of known narcotic associated side effects will be recorded for shortness of breath.'}, {'measure': 'Narcotic Associated Side Effects', 'timeFrame': '24 hours', 'description': 'The incidence of known narcotic associated side effects will be recorded for respiratory depression.'}, {'measure': 'Narcotic Associated Side Effects', 'timeFrame': '24 hours', 'description': 'The incidence of known narcotic associated side effects will be recorded for urinary retention.'}, {'measure': 'Time to Ambulation', 'timeFrame': '1800 minutes', 'description': 'Length of time from the end of surgery to the time of ambulation.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['IV Acetaminophen', 'Vaginal Reconstruction', 'Pain, Postoperative'], 'conditions': ['Post Operative Pain']}, 'referencesModule': {'references': [{'pmid': '28230615', 'type': 'DERIVED', 'citation': 'Crisp CC, Khan M, Lambers DL, Westermann LB, Mazloomdoost DM, Yeung JJ, Kleeman SD, Pauls RN. The Effect of Intravenous Acetaminophen on Postoperative Pain and Narcotic Consumption After Vaginal Reconstructive Surgery: A Double-Blind Randomized Placebo-Controlled Trial. Female Pelvic Med Reconstr Surg. 2017 Mar/Apr;23(2):80-85. doi: 10.1097/SPV.0000000000000347.'}]}, 'descriptionModule': {'briefSummary': 'This randomized controlled trial will evaluate the effects of perioperative intravenous (IV) acetaminophen on postoperative narcotic consumption and pain scores in subjects undergoing vaginal reconstructive surgery. One hundred subjects will be randomly assigned to receive either IV acetaminophen or IV placebo. Those in the IV acetaminophen group will receive 1000mg IV every 6 hours for 24 hours beginning prior to anesthesia induction. The control group will receive placebo saline infusions at the same time intervals. All subjects will receive as needed (prn) IV narcotic for additional pain relief. Visual analog scales (VAS) regarding pain will be evaluated at 18 and 24 hours postoperative and immediately prior to discharge. We will also collect total IV narcotic consumption. We hypothesize that subjects receiving IV acetaminophen will have lower VAS scores and decreased total narcotic consumption in comparison to the control group.', 'detailedDescription': 'see brief summary'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women between the ages of 18 and 70 years\n* Patients of the Division of Urogynecology at Good Samaritan and Bethesda North Hospitals in Cincinnati, Ohio\n* Scheduled to undergo major vaginal reconstruction\n* Must undergo total vaginal hysterectomy, anterior repair, posterior repair, enterocele repair, and intraperitoneal vault suspension. The addition of suburethral sling is not a cause for exclusion.\n\nExclusion Criteria:\n\n* Allergy to acetaminophen\n* Liver disease (chronic or active)\n* Chronic alcohol use (\\>1 drink/day)\n* Bleeding diathesis\n* Renal disease\n* Opiate dependent or daily use\n* History of chronic pain\n* Mental or cognitive disorder preventing patient to accurately verbalize pain levels\n* Undergoing abdominal or laparoscopic procedures at the time of surgery\n* Allergy to hydromorphone\n* Surgery is not performed under general anesthesia'}, 'identificationModule': {'nctId': 'NCT02043704', 'briefTitle': 'RCT (Randomized Controlled Trial) of IV Acetaminophen for Post Operative Vaginal Reconstruction Pain', 'organization': {'class': 'OTHER', 'fullName': 'TriHealth Inc.'}, 'officialTitle': 'The Effect of Intravenous Acetaminophen on Post-operative Pain and Narcotic Consumption in Vaginal Reconstructive Surgery Patients: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '13072'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'IV Acetaminophen', 'description': 'Subjects will receive a 1000mg dose of IV acetaminophen in 100mL solution every 6 hours for 24 hours. The first dose will be administered prior to anesthesia induction, approximately 30 minutes before skin incision. A total of 4 doses will be given.', 'interventionNames': ['Drug: IV Acetaminophen']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Saline', 'description': 'Subjects will receive a 100mL dose of IV saline every 6 hours for 24 hours. The first dose will be administered prior to anesthesia induction, approximately 30 minutes before skin incision. A total of 4 doses will be given.', 'interventionNames': ['Drug: IV Acetaminophen']}], 'interventions': [{'name': 'IV Acetaminophen', 'type': 'DRUG', 'otherNames': ['Ofirmev'], 'description': 'Details covered in arm description.', 'armGroupLabels': ['IV Acetaminophen', 'Saline']}]}, 'contactsLocationsModule': {'locations': [{'zip': '45220', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'TriHealth - Good Samaritan and Bethesda North Hospitals', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}], 'overallOfficials': [{'name': 'Catrina Crisp, MD, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'TriHealth Inc.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'TriHealth Inc.', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}