Ignite Creation Date:
2025-12-24 @ 7:39 PM
Ignite Modification Date:
2026-02-24 @ 11:00 AM
Study NCT ID:
NCT02487303
Status:
COMPLETED
Last Update Posted:
2018-12-05
First Post:
2015-06-25
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Intravenous Versus Oral Acetaminophen for Postoperative Pain Control After Cesarean Delivery
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}, {'id': 'D000377', 'term': 'Agnosia'}], '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': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, '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': 'wilsosh@musc.edu', 'phone': '8437921414', 'title': 'Sylvia Wilson', 'organization': 'Medical University of South Carolina'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'The timeframe for adverse event data was collected up to 48 hours.', 'eventGroups': [{'id': 'EG000', 'title': 'Acetaminophen Intravenous', 'description': '(group 1) 1 gram IV acetaminophen every 8 hours for three doses\n\nAcetaminophen Intravenous: IV 1 gram f3 doses over 24 hours', 'otherNumAtRisk': 47, 'deathsNumAtRisk': 47, 'otherNumAffected': 0, 'seriousNumAtRisk': 47, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Acetaminophen Oral', 'description': '(group 2) 1 gram oral acetaminophen every 8 hours for three doses\n\nAcetaminophen Oral: Oral 1 gram 3 doses over 24 hours', 'otherNumAtRisk': 47, 'deathsNumAtRisk': 47, 'otherNumAffected': 0, 'seriousNumAtRisk': 47, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'No Acetaminophen', 'description': '(group 3) no acetaminophen', 'otherNumAtRisk': 47, 'deathsNumAtRisk': 47, 'otherNumAffected': 0, 'seriousNumAtRisk': 47, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Cumulative Postoperative Opiate Consumption', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Acetaminophen Intravenous', 'description': '(group 1) 1 gram IV acetaminophen every 8 hours for three doses\n\nAcetaminophen Intravenous: IV 1 gram f3 doses over 24 hours'}, {'id': 'OG001', 'title': 'Acetaminophen Oral', 'description': '(group 2) 1 gram oral acetaminophen every 8 hours for three doses\n\nAcetaminophen Oral: Oral 1 gram 3 doses over 24 hours'}, {'id': 'OG002', 'title': 'No Acetaminophen', 'description': '(group 3) no acetaminophen'}], 'classes': [{'categories': [{'measurements': [{'value': '2.9', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '28'}, {'value': '3.8', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '17.5'}, {'value': '5.7', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '33'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24 hours', 'description': 'Cumulative opiate consumption (IV morphine equivalents)', 'unitOfMeasure': 'mg', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Time to First Opiate Rescue', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Acetaminophen Intravenous', 'description': '1 gram IV acetaminophen every 8 hours for three doses'}, {'id': 'OG001', 'title': 'Acetaminophen Oral', 'description': '1 gram oral acetaminophen every 8 hours for three doses'}, {'id': 'OG002', 'title': 'No Acetaminophen', 'description': 'No acetaminophen'}], 'classes': [{'categories': [{'measurements': [{'value': '25.3', 'spread': '8.5', 'groupId': 'OG000'}, {'value': '24.0', 'spread': '26.3', 'groupId': 'OG001'}, {'value': '21.3', 'spread': '23.9', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '48 hours', 'description': 'Time to first opiate pain medicine requested by patient', 'unitOfMeasure': 'hours', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'VAS (Visual Analog Scale)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Acetaminophen Intravenous', 'description': '1 gram IV acetaminophen every 8 hours for three doses'}, {'id': 'OG001', 'title': 'Acetaminophen Oral', 'description': '1 gram oral acetaminophen every 8 hours for three doses'}, {'id': 'OG002', 'title': 'No Acetaminophen', 'description': 'No acetaminophen'}], 'classes': [{'categories': [{'measurements': [{'value': '37.8', 'spread': '3.23', 'groupId': 'OG000'}, {'value': '44.3', 'spread': '3.28', 'groupId': 'OG001'}, {'value': '50.8', 'spread': '3.31', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24 hours', 'description': 'Visual Analog Scale (VAS) pain assessment with ambulation. The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain." For pain intensity, the scale is most commonly anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 100 \\[100-mm scale\\]) .', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Time Discharge', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Acetaminophen Intravenous', 'description': '(group 1) 1 gram IV acetaminophen every 8 hours for three doses\n\nAcetaminophen Intravenous: IV 1 gram f3 doses over 24 hours'}, {'id': 'OG001', 'title': 'Acetaminophen Oral', 'description': '(group 2) 1 gram oral acetaminophen every 8 hours for three doses\n\nAcetaminophen Oral: Oral 1 gram 3 doses over 24 hours'}, {'id': 'OG002', 'title': 'No Acetaminophen', 'description': '(group 3) no acetaminophen'}], 'classes': [{'categories': [{'measurements': [{'value': '48.4', 'spread': '13.7', 'groupId': 'OG000'}, {'value': '48.6', 'spread': '11.3', 'groupId': 'OG001'}, {'value': '50.5', 'spread': '15.7', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24 hours postoperative', 'description': 'Time patient meets discharge criteria will be recorded', 'unitOfMeasure': 'hours', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Acetaminophen Intravenous', 'description': '(group 1) 1 gram IV acetaminophen every 8 hours for three doses\n\nAcetaminophen Intravenous: IV 1 gram f3 doses over 24 hours'}, {'id': 'FG001', 'title': 'Acetaminophen Oral', 'description': '(group 2) 1 gram oral acetaminophen every 8 hours for three doses\n\nAcetaminophen Oral: Oral 1 gram 3 doses over 24 hours'}, {'id': 'FG002', 'title': 'No Acetaminophen', 'description': '(group 3) no acetaminophen'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '49'}, {'groupId': 'FG001', 'numSubjects': '51'}, {'groupId': 'FG002', 'numSubjects': '48'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '47'}, {'groupId': 'FG001', 'numSubjects': '47'}, {'groupId': 'FG002', 'numSubjects': '47'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}, {'value': '141', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Acetaminophen Intravenous', 'description': '(group 1) 1 gram IV acetaminophen every 8 hours for three doses\n\nAcetaminophen Intravenous: IV 1 gram f3 doses over 24 hours'}, {'id': 'BG001', 'title': 'Acetaminophen Oral', 'description': '(group 2) 1 gram oral acetaminophen every 8 hours for three doses\n\nAcetaminophen Oral: Oral 1 gram 3 doses over 24 hours'}, {'id': 'BG002', 'title': 'No Acetaminophen', 'description': '(group 3) no acetaminophen'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '47', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}, {'value': '141', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '28.7', 'groupId': 'BG000', 'lowerLimit': '19', 'upperLimit': '44'}, {'value': '30.5', 'groupId': 'BG001', 'lowerLimit': '21', 'upperLimit': '43'}, {'value': '31.2', 'groupId': 'BG002', 'lowerLimit': '18', 'upperLimit': '49'}, {'value': '30.1', 'groupId': 'BG003', 'lowerLimit': '18', 'upperLimit': '49'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '47', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}, {'value': '141', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], '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'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}, {'value': '57', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}, {'value': '82', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '47', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}, {'value': '141', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2015-08-31', 'size': 235448, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2018-11-05T10:29', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 148}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-03-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-11', 'completionDateStruct': {'date': '2017-07-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-11-05', 'studyFirstSubmitDate': '2015-06-25', 'resultsFirstSubmitDate': '2018-07-30', 'studyFirstSubmitQcDate': '2015-06-26', 'lastUpdatePostDateStruct': {'date': '2018-12-05', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-11-05', 'studyFirstPostDateStruct': {'date': '2015-07-01', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-12-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-07-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cumulative Postoperative Opiate Consumption', 'timeFrame': '24 hours', 'description': 'Cumulative opiate consumption (IV morphine equivalents)'}], 'secondaryOutcomes': [{'measure': 'Time to First Opiate Rescue', 'timeFrame': '48 hours', 'description': 'Time to first opiate pain medicine requested by patient'}, {'measure': 'VAS (Visual Analog Scale)', 'timeFrame': '24 hours', 'description': 'Visual Analog Scale (VAS) pain assessment with ambulation. The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain." For pain intensity, the scale is most commonly anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 100 \\[100-mm scale\\]) .'}, {'measure': 'Time Discharge', 'timeFrame': '24 hours postoperative', 'description': 'Time patient meets discharge criteria will be recorded'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Acetaminophen', 'Pain, Postoperative', 'Analgesia, Obstetrical', 'Cesarean Section'], 'conditions': ['Pain, Postoperative']}, 'referencesModule': {'references': [{'pmid': '21114616', 'type': 'RESULT', 'citation': 'Macario A, Royal MA. A literature review of randomized clinical trials of intravenous acetaminophen (paracetamol) for acute postoperative pain. Pain Pract. 2011 May-Jun;11(3):290-6. doi: 10.1111/j.1533-2500.2010.00426.x. Epub 2010 Nov 28.'}, {'pmid': '21627768', 'type': 'RESULT', 'citation': 'Smith HS. Perioperative intravenous acetaminophen and NSAIDs. Pain Med. 2011 Jun;12(6):961-81. doi: 10.1111/j.1526-4637.2011.01141.x. Epub 2011 May 31.'}, {'pmid': '21353105', 'type': 'RESULT', 'citation': 'Wininger SJ, Miller H, Minkowitz HS, Royal MA, Ang RY, Breitmeyer JB, Singla NK. A randomized, double-blind, placebo-controlled, multicenter, repeat-dose study of two intravenous acetaminophen dosing regimens for the treatment of pain after abdominal laparoscopic surgery. Clin Ther. 2010 Dec;32(14):2348-69. doi: 10.1016/j.clinthera.2010.12.011.'}, {'pmid': '22524979', 'type': 'RESULT', 'citation': 'Singla NK, Parulan C, Samson R, Hutchinson J, Bushnell R, Beja EG, Ang R, Royal MA. Plasma and cerebrospinal fluid pharmacokinetic parameters after single-dose administration of intravenous, oral, or rectal acetaminophen. Pain Pract. 2012 Sep;12(7):523-32. doi: 10.1111/j.1533-2500.2012.00556.x. Epub 2012 Apr 24.'}, {'pmid': '23220855', 'type': 'RESULT', 'citation': 'Fenlon S, Collyer J, Giles J, Bidd H, Lees M, Nicholson J, Dulai R, Hankins M, Edelman N. Oral vs intravenous paracetamol for lower third molar extractions under general anaesthesia: is oral administration inferior? Br J Anaesth. 2013 Mar;110(3):432-7. doi: 10.1093/bja/aes387. Epub 2012 Dec 6.'}, {'pmid': '17142654', 'type': 'RESULT', 'citation': 'Alhashemi JA, Alotaibi QA, Mashaat MS, Kaid TM, Mujallid RH, Kaki AM. Intravenous acetaminophen vs oral ibuprofen in combination with morphine PCIA after Cesarean delivery. Can J Anaesth. 2006 Dec;53(12):1200-6. doi: 10.1007/BF03021581.'}, {'pmid': '23159009', 'type': 'RESULT', 'citation': 'Wong JY, Carvalho B, Riley ET. Intrathecal morphine 100 and 200 mug for post-cesarean delivery analgesia: a trade-off between analgesic efficacy and side effects. Int J Obstet Anesth. 2013 Jan;22(1):36-41. doi: 10.1016/j.ijoa.2012.09.006. Epub 2012 Nov 15.'}, {'pmid': '23921652', 'type': 'RESULT', 'citation': 'Singh SI, Rehou S, Marmai KL, Jones APM. The efficacy of 2 doses of epidural morphine for postcesarean delivery analgesia: a randomized noninferiority trial. Anesth Analg. 2013 Sep;117(3):677-685. doi: 10.1213/ANE.0b013e31829cfd21. Epub 2013 Aug 6.'}, {'pmid': '23965210', 'type': 'RESULT', 'citation': 'Beatty NC, Arendt KW, Niesen AD, Wittwer ED, Jacob AK. Analgesia after Cesarean delivery: a retrospective comparison of intrathecal hydromorphone and morphine. J Clin Anesth. 2013 Aug;25(5):379-383. doi: 10.1016/j.jclinane.2013.01.014. Epub 2013 Aug 17.'}, {'pmid': '30561704', 'type': 'DERIVED', 'citation': 'Wilson SH, Wolf BJ, Robinson SM, Nelson C, Hebbar L. Intravenous vs Oral Acetaminophen for Analgesia After Cesarean Delivery: A Randomized Trial. Pain Med. 2019 Aug 1;20(8):1584-1591. doi: 10.1093/pm/pny253.'}]}, 'descriptionModule': {'briefSummary': 'This study will compare IV (intravenous) versus oral (PO) acetaminophen for postoperative pain after scheduled, elective Cesarean delivery. All patients will receive a standardized spinal anesthetic for operative anesthesia and will be randomized into one of three groups: (group 1) 1 gram IV acetaminophen every 8 hours for three doses, (group 2) 1 gram oral acetaminophen every 8 hours for three doses, or (group 3) no acetaminophen. This will be a randomized, open label study.', 'detailedDescription': 'This study will compare IV versus PO acetaminophen for postoperative pain in parturients after scheduled, elective Cesarean delivery. It is designed as a randomized, open label, controlled trial. All patients will receive a standardized spinal anesthetic for operative anesthesia and will be randomized into one of three groups: (group 1) 1 gram IV acetaminophen every 8 hours for three by a computer generated list.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Parturients 18 years\n* Elective Cesarean delivery\n* Spinal anesthesia\n* Able to consent to the study and participate in the follow-up.\n\nExclusion Criteria:\n\n* Weight under 50 kgs\n* Allergy to acetaminophen\n* General anesthesia\n* Urgent or emergent cases\n* Bleeding diathesis or other coagulopathy\n* G6PD deficiency\n* Liver disease\n* Substance abuse or dependence\n* HELLP syndrome\n* Thrombocytopenia or platelet dysfunction\n* History or active gastrointestinal bleeding\n* Acute kidney injury or chronic renal insufficiency\n* Contraindication/refusal to spinal anesthesia\n* Chronic pain\n* Chronic narcotic use\n* Illicit drug use\n* Allergy to any study related medications.'}, 'identificationModule': {'nctId': 'NCT02487303', 'briefTitle': 'Intravenous Versus Oral Acetaminophen for Postoperative Pain Control After Cesarean Delivery', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of South Carolina'}, 'officialTitle': 'Intravenous Versus Oral Acetaminophen for Postoperative Pain Control After Cesarean Delivery', 'orgStudyIdInfo': {'id': 'Pro00041193'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Acetaminophen Intravenous', 'description': '(group 1) 1 gram IV acetaminophen every 8 hours for three doses', 'interventionNames': ['Drug: Acetaminophen Intravenous']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Acetaminophen Oral', 'description': '(group 2) 1 gram oral acetaminophen every 8 hours for three doses', 'interventionNames': ['Drug: Acetaminophen Oral']}, {'type': 'NO_INTERVENTION', 'label': 'No acetaminophen', 'description': '(group 3) no acetaminophen'}], 'interventions': [{'name': 'Acetaminophen Intravenous', 'type': 'DRUG', 'otherNames': ['Tylenol'], 'description': 'IV 1 gram f3 doses over 24 hours', 'armGroupLabels': ['Acetaminophen Intravenous']}, {'name': 'Acetaminophen Oral', 'type': 'DRUG', 'otherNames': ['Tylenol'], 'description': 'Oral 1 gram 3 doses over 24 hours', 'armGroupLabels': ['Acetaminophen Oral']}]}, 'contactsLocationsModule': {'locations': [{'zip': '29425', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Medical University of South Carolina', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}], 'overallOfficials': [{'name': 'Sylvia Wilson, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical University of South Carolina'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of South Carolina', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}