Ignite Creation Date:
2025-12-25 @ 3:00 AM
Ignite Modification Date:
2026-03-13 @ 11:33 AM
Study NCT ID:
NCT01868633
Status:
COMPLETED
Last Update Posted:
2017-09-19
First Post:
2013-05-30
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Dexamethasone for Post Cesarean Delivery Analgesia
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}, {'id': 'D000377', 'term': 'Agnosia'}, {'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'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': 'D003907', 'term': 'Dexamethasone'}, {'id': 'D002123', 'term': 'Calcium Dobesilate'}, {'id': 'D000077330', 'term': 'Saline Solution'}], 'ancestors': [{'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013259', 'term': 'Steroids, Fluorinated'}, {'id': 'D001557', 'term': 'Benzenesulfonates'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001190', 'term': 'Arylsulfonates'}, {'id': 'D017739', 'term': 'Arylsulfonic Acids'}, {'id': 'D013451', 'term': 'Sulfonic Acids'}, {'id': 'D013456', 'term': 'Sulfur Acids'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'unyime-ituk@uiowa.edu', 'phone': '3193562633', 'title': 'Dr. Unyime Ituk', 'organization': 'University of Iowa'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'A safety analysis of adverse events was done by a clinician investigator not involved in study after enrollment of every 20 patients and at the 6th-week postnatal outpatient visit( That is 6 weeks after exposure to the intervention). Adverse event data collected included surgical wound examination findings (signs of infection, poor healing, wound breakdown), postpartum blood loss and vital signs ( blood pressure, heart rate and temperature)', 'eventGroups': [{'id': 'EG000', 'title': 'Dexamethasone & Spinal Morphine', 'description': 'intrathecal morphine administered at time of spinal anesthesia. After cesarean delivery 8mg (2ml) of Dexamethasone given intraoperatively\n\nDexamethasone', 'otherNumAtRisk': 26, 'otherNumAffected': 0, 'seriousNumAtRisk': 26, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo Injection and Spinal Morphine', 'description': 'intrathecal morphine administered at time of spinal anesthesia. After cesarean delivery 2ml of placebo (Normal saline) drawn to mimic active drug given intraoperatively\n\nPlacebo', 'otherNumAtRisk': 26, 'otherNumAffected': 0, 'seriousNumAtRisk': 26, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Postoperative Analgesia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dexamethasone & Spinal Morphine', 'description': 'intrathecal morphine administered at time of spinal anesthesia. After cesarean delivery 8mg (2ml) of Dexamethasone given intraoperatively\n\nDexamethasone'}, {'id': 'OG001', 'title': 'Placebo Injection and Spinal Morphine', 'description': 'intrathecal morphine administered at time of spinal anesthesia. After cesarean delivery 2ml of placebo (Normal saline) drawn to mimic active drug given intraoperatively\n\nPlacebo'}], 'classes': [{'categories': [{'measurements': [{'value': '11.8', 'groupId': 'OG000', 'lowerLimit': '5', 'upperLimit': '20'}, {'value': '15', 'groupId': 'OG001', 'lowerLimit': '5', 'upperLimit': '22.5'}]}]}], 'analyses': [{'pValue': '0.32', 'groupIds': ['OG000'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': '24 hours', 'description': 'Comparison of postoperative opioid analgesia use between the 2 groups', 'unitOfMeasure': 'milligrams of morphine', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Postoperative Pain at Rest and With Movement 24 Hours After Cesarean Delivery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dexamethasone & Spinal Morphine', 'description': 'intrathecal morphine administered at time of spinal anesthesia. After cesarean delivery 8mg (2ml) of Dexamethasone given intraoperatively\n\nDexamethasone'}, {'id': 'OG001', 'title': 'Placebo Injection and Spinal Morphine', 'description': 'intrathecal morphine administered at time of spinal anesthesia. After cesarean delivery 2ml of placebo (Normal saline) drawn to mimic active drug given intraoperatively\n\nPlacebo'}], 'classes': [{'title': 'Pain at rest @ 0-6hr', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '2'}, {'value': '1', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '3'}]}]}, {'title': 'Pain with movement @ 0-6hr', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '5'}, {'value': '4.5', 'groupId': 'OG001', 'lowerLimit': '3', 'upperLimit': '5'}]}]}, {'title': 'Pain at rest @ 6-12hr', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '1'}, {'value': '2', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '3'}]}]}, {'title': 'Pain with movement @ 6-12hr', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '4'}, {'value': '4', 'groupId': 'OG001', 'lowerLimit': '4', 'upperLimit': '5'}]}]}, {'title': 'Pain at rest @ 12-24hr', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '2'}, {'value': '1', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '3'}]}]}, {'title': 'Pain with movement @ 12-24hr', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000', 'lowerLimit': '3', 'upperLimit': '5'}, {'value': '4', 'groupId': 'OG001', 'lowerLimit': '3', 'upperLimit': '5'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '24 hours', 'description': 'Pain scores were assessed at 6, 12 and 24 hours after surgery using a numerical rating scale (10 cm line marked at 1 cm intervals anchored on the left with "no pain" = 0 and "the worst possible pain = 10). Pain was assessed at rest and with movement', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Quality of Recovery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dexamethasone & Spinal Morphine', 'description': 'intrathecal morphine administered at time of spinal anesthesia. After cesarean delivery 8mg (2ml) of Dexamethasone given intraoperatively\n\nDexamethasone'}, {'id': 'OG001', 'title': 'Placebo Injection and Spinal Morphine', 'description': 'intrathecal morphine administered at time of spinal anesthesia. After cesarean delivery 2ml of placebo (Normal saline) drawn to mimic active drug given intraoperatively\n\nPlacebo'}], 'classes': [{'categories': [{'measurements': [{'value': '180', 'spread': '10', 'groupId': 'OG000'}, {'value': '177', 'spread': '10', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '48 hours', 'description': 'Comparison of the quality of Recovery between the 2 groups using a Quality of recovery questionnaire (QoR-40). It incorporates five dimensions of health: patient support, comfort, emotions, physical independence, and pain; each item is graded on a five-point Likert scale. QoR-40 scores range from 40 (extremely poor quality of recovery) to 200 (excellent quality of recovery). The scores on all 40 items are summed and the mean scores and standard deviation calculated for each study group', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Two patients in the dexamethasone group and 8 patients in the placebo did not complete the quality of recovery questionnaire.'}, {'type': 'SECONDARY', 'title': 'Incidence and Severity of Nausea and Pruritus', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dexamethasone & Spinal Morphine', 'description': 'intrathecal morphine administered at time of spinal anesthesia. After cesarean delivery 8mg (2ml) of Dexamethasone given intraoperatively\n\nDexamethasone'}, {'id': 'OG001', 'title': 'Placebo Injection and Spinal Morphine', 'description': 'intrathecal morphine administered at time of spinal anesthesia. After cesarean delivery 2ml of placebo (Normal saline) drawn to mimic active drug given intraoperatively\n\nPlacebo'}], 'classes': [{'title': 'Nausea @ 0-6hr', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '10'}, {'value': '2.5', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '7'}]}]}, {'title': 'Pruritus@ 0-6hr', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '8'}, {'value': '3', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '6'}]}]}, {'title': 'Nausea @ 6-12hr', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '3'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '2'}]}]}, {'title': 'Pruritus @ 6-12hr', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '7'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '2'}]}]}, {'title': 'Nausea @12-24hr', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '0'}]}]}, {'title': 'Pruritus @ 12-24hr', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '4'}, {'value': '1', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '3'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '24 hours', 'description': 'Patients were asked to rate the severity of postoperative nausea using an 11-point numerical rating scale (NRS) from 0 to 10, (0: no nausea, 10: worst nausea possible). The number of vomiting episodes, if any during the 24-hour study period, was documented. Pruritus was also assessed using an 11-point NRS (0 no pruritus,10 worst pruritus possible)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Participants With Chronic Pain After Cesarean Delivery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dexamethasone & Spinal Morphine', 'description': 'intrathecal morphine administered at time of spinal anesthesia. After cesarean delivery 8mg (2ml) of Dexamethasone given intraoperatively\n\nDexamethasone'}, {'id': 'OG001', 'title': 'Placebo Injection and Spinal Morphine', 'description': 'intrathecal morphine administered at time of spinal anesthesia. After cesarean delivery 2ml of placebo (Normal saline) drawn to mimic active drug given intraoperatively\n\nPlacebo'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 months', 'description': 'Comparison of incidence of chronic pain associated with cesarean delivery between the 2 groups', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Study participants had a telephone call follow-up 6 months after cesarean delivery by a research nurse. They were asked questions about current pain symptoms and if it is related to their cesarean delivery. Seven patients in the dexamethasone group and eight patients in the placebo did not respond when contacted'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Dexamethasone & Spinal Morphine', 'description': 'intrathecal morphine administered at time of spinal anesthesia. After cesarean delivery 8mg (2ml) of Dexamethasone given intraoperatively\n\nDexamethasone'}, {'id': 'FG001', 'title': 'Placebo Injection and Spinal Morphine', 'description': 'intrathecal morphine administered at time of spinal anesthesia. After cesarean delivery 2ml of placebo (Normal saline) drawn to mimic active drug given intraoperatively\n\nPlacebo'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '26'}, {'groupId': 'FG001', 'numSubjects': '26'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '26'}, {'groupId': 'FG001', 'numSubjects': '26'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Dexamethasone & Spinal Morphine', 'description': 'intrathecal morphine administered at time of spinal anesthesia. After cesarean delivery 8mg (2ml) of Dexamethasone given intraoperatively\n\nDexamethasone'}, {'id': 'BG001', 'title': 'Placebo Injection and Spinal Morphine', 'description': 'intrathecal morphine administered at time of spinal anesthesia. After cesarean delivery 2ml of placebo (Normal saline) drawn to mimic active drug given intraoperatively\n\nPlacebo'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '31.69', 'spread': '4.02', 'groupId': 'BG000'}, {'value': '31.65', 'spread': '5.83', 'groupId': 'BG001'}, {'value': '31.67', 'spread': '4.95', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '48', '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': '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': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '48', '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 52}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-08', 'completionDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-08-24', 'studyFirstSubmitDate': '2013-05-30', 'resultsFirstSubmitDate': '2016-10-26', 'studyFirstSubmitQcDate': '2013-06-03', 'lastUpdatePostDateStruct': {'date': '2017-09-19', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-04-27', 'studyFirstPostDateStruct': {'date': '2013-06-04', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-06-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Number of Participants With Chronic Pain After Cesarean Delivery', 'timeFrame': '6 months', 'description': 'Comparison of incidence of chronic pain associated with cesarean delivery between the 2 groups'}], 'primaryOutcomes': [{'measure': 'Postoperative Analgesia', 'timeFrame': '24 hours', 'description': 'Comparison of postoperative opioid analgesia use between the 2 groups'}], 'secondaryOutcomes': [{'measure': 'Postoperative Pain at Rest and With Movement 24 Hours After Cesarean Delivery', 'timeFrame': '24 hours', 'description': 'Pain scores were assessed at 6, 12 and 24 hours after surgery using a numerical rating scale (10 cm line marked at 1 cm intervals anchored on the left with "no pain" = 0 and "the worst possible pain = 10). Pain was assessed at rest and with movement'}, {'measure': 'Quality of Recovery', 'timeFrame': '48 hours', 'description': 'Comparison of the quality of Recovery between the 2 groups using a Quality of recovery questionnaire (QoR-40). It incorporates five dimensions of health: patient support, comfort, emotions, physical independence, and pain; each item is graded on a five-point Likert scale. QoR-40 scores range from 40 (extremely poor quality of recovery) to 200 (excellent quality of recovery). The scores on all 40 items are summed and the mean scores and standard deviation calculated for each study group'}, {'measure': 'Incidence and Severity of Nausea and Pruritus', 'timeFrame': '24 hours', 'description': 'Patients were asked to rate the severity of postoperative nausea using an 11-point numerical rating scale (NRS) from 0 to 10, (0: no nausea, 10: worst nausea possible). The number of vomiting episodes, if any during the 24-hour study period, was documented. Pruritus was also assessed using an 11-point NRS (0 no pruritus,10 worst pruritus possible)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Cesarean delivery', 'Analgesia', 'Pain', 'Dexamethasone', 'intrathecal morphine', 'spinal anesthesia'], 'conditions': ['Postoperative Pain']}, 'referencesModule': {'references': [{'pmid': '17900579', 'type': 'BACKGROUND', 'citation': 'Fujii Y, Nakayama M. Dexamethasone for reduction of nausea, vomiting and analgesic use after gynecological laparoscopic surgery. Int J Gynaecol Obstet. 2008 Jan;100(1):27-30. doi: 10.1016/j.ijgo.2007.07.017. Epub 2007 Sep 27.', 'retractions': [{'pmid': '23599954', 'source': 'Int J Gynaecol Obstet. 2013 Apr;121(1):97'}]}, {'pmid': '21297442', 'type': 'BACKGROUND', 'citation': 'Murphy GS, Szokol JW, Greenberg SB, Avram MJ, Vender JS, Nisman M, Vaughn J. Preoperative dexamethasone enhances quality of recovery after laparoscopic cholecystectomy: effect on in-hospital and postdischarge recovery outcomes. Anesthesiology. 2011 Apr;114(4):882-90. doi: 10.1097/ALN.0b013e3181ec642e.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the effectiveness intravenous (IV) dexamethasone when used as part of a multimodal regimen to manage post cesarean delivery pain.\n\nWe hypothesize that a single dose of IV dexamethasone administered, as part of a multimodal analgesia after spinal anesthesia will significantly reduce post cesarean delivery opioid consumption and pain', 'detailedDescription': 'After the subjects consent to participate in the study they will be transferred to the operating room for their scheduled cesarean delivery. They will have their routine spinal anesthesia with the dosages of drugs used standardized, and a standardized regimen to manage hypotension. After delivery of the baby the subjects will be administered either the study drug or placebo depending on the randomization. The subjects will then be prescribed a standard post-operative analgesia regimen. The subjects will then be interviewed at 12,24 and 48 hours post cesarean delivery. During the interview the subjects will be asked to rate their pain, nausea and vomiting and pruritus. They will also be asked to rate their quality of recovery from the surgery using Quality of Recovery-40 questionnaire. The subjects will be contacted 6 months after the study to rate their pain using a Short-Form McGill Pain Questionnaire'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* English Speaking\n* Non-laboring women\n* Scheduled Elective Cesarean section under spinal anesthesia\n* American Society of Anesthesiologists I-II physical status\n\nExclusion Criteria:\n\n* Contraindications to spinal anesthesia\n* allergy to study medication\n* patients with allergy to morphine\n* patients with uncontrolled hypertension\n* history of peptic ulcer disease\n* liver cirrhosis\n* diabetes mellitus\n* glaucoma\n* known IV drug abusers\n* patients with chronic pain or on long term opioids\n* patients administered steroids in the past week\n* women with fetuses having known congenital abnormalities\n* psychiatric illness such that they are unable to comprehend or participate in study questions\n* patients on antiviral medications or live virus vaccines would also be excluded.'}, 'identificationModule': {'nctId': 'NCT01868633', 'briefTitle': 'Dexamethasone for Post Cesarean Delivery Analgesia', 'organization': {'class': 'OTHER', 'fullName': 'University of Iowa'}, 'officialTitle': 'The Effect of a Single Intraoperative Dose of Dexamethasone in Combination With Intrathecal Morphine for Post Cesarean Delivery Analgesia', 'orgStudyIdInfo': {'id': '201210765'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Dexamethasone & spinal morphine', 'description': 'intrathecal morphine administered at time of spinal anesthesia. After cesarean delivery 8mg (2ml) of Dexamethasone given intraoperatively', 'interventionNames': ['Drug: Dexamethasone']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo injection and spinal morphine', 'description': 'intrathecal morphine administered at time of spinal anesthesia. After cesarean delivery 2ml of placebo (Normal saline) drawn to mimic active drug given intraoperatively', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Dexamethasone', 'type': 'DRUG', 'otherNames': ['Decadron'], 'armGroupLabels': ['Dexamethasone & spinal morphine']}, {'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['Normal saline'], 'armGroupLabels': ['Placebo injection and spinal morphine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '52242', 'city': 'Iowa City', 'state': 'Iowa', 'country': 'United States', 'facility': 'University of Iowa Hospitals and Clinics', 'geoPoint': {'lat': 41.66113, 'lon': -91.53017}}], 'overallOfficials': [{'name': 'Unyime Ituk, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Iowa'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Iowa', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Unyime Ituk', 'investigatorAffiliation': 'University of Iowa'}}}}