Ignite Creation Date:
2025-12-24 @ 6:31 PM
Ignite Modification Date:
2026-01-26 @ 7:10 PM
Study NCT ID:
NCT01812057
Status:
COMPLETED
Last Update Posted:
2017-07-25
First Post:
2013-03-13
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Dexamethasone for Post-cesarean Delivery Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}, {'id': 'D020250', 'term': 'Postoperative Nausea and Vomiting'}], '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': 'D009325', 'term': 'Nausea'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D014839', 'term': 'Vomiting'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003907', 'term': 'Dexamethasone'}, {'id': 'D012965', 'term': 'Sodium Chloride'}], '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': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'terrence.allen@duke.edu', 'phone': '9196682024', 'title': 'Dr Terrence K Allen', 'organization': 'Duke University Medical Center'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'The study was ended prior to completion of total planned enrollment of 104 subjects due to a change in clinical practice regarding post-operative pain medications that would have confounded the results of the study.'}}, 'adverseEventsModule': {'timeFrame': 'Adverse Events were collected from the time PACU admission until 48 hours from PACU admission.', 'description': 'Adverse Event reporting for this study were limited to surgical site infections and wound dehiscence assessed by the obstetricians daily', 'eventGroups': [{'id': 'EG000', 'title': 'Dexamethasone', 'description': 'Dexamethasone 8 mg IV given intraoperatively as a one-time dose.\n\nDexamethasone: Dexamethasone 8 mg IV (as a one time dose)', 'otherNumAtRisk': 23, 'otherNumAffected': 0, 'seriousNumAtRisk': 23, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Sodium chloride 0.9% (5 ml) given IV intraoperatively as a one time dose.\n\nPlacebo: Sodium Chloride 0.9% -5 ml', 'otherNumAtRisk': 24, 'otherNumAffected': 0, 'seriousNumAtRisk': 24, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Morphine Consumption at 24 Hours Post-op', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dexamethasone', 'description': 'Dexamethasone 8 mg IV given intraoperatively as a one-time dose.\n\nDexamethasone: Dexamethasone 8 mg IV (as a one time dose)'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Sodium chloride 0.9% (5 ml) given IV intraoperatively as a one time dose.\n\nPlacebo: Sodium Chloride 0.9% -5 ml'}], 'classes': [{'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000', 'lowerLimit': '7.5', 'upperLimit': '20.0'}, {'value': '13.75', 'groupId': 'OG001', 'lowerLimit': '2.5', 'upperLimit': '31.25'}]}]}], 'analyses': [{'pValue': '0.740', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': '24 hours from admission to Postanesthesia care unit (PACU)', 'description': 'The primary outcome will be the cumulative morphine consumption at 24 h in the two study groups. All postoperative opioids were converted to IV morphine equivalents using the following conversion factors: 100 micrograms IV = 10 mg IV morphine, 20 mg oxycodone po = 10 mg IV Morphine', 'unitOfMeasure': 'milligram', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Pain Scores Between the Groups at 2 Hours.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dexamethasone', 'description': 'Dexamethasone 8 mg IV given intraoperatively as a one-time dose.\n\nDexamethasone: Dexamethasone 8 mg IV (as a one time dose)'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Sodium chloride 0.9% (5 ml) given IV intraoperatively as a one time dose.\n\nPlacebo: Sodium Chloride 0.9% -5 ml'}], 'classes': [{'title': 'Pain Score at rest', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '4.0'}, {'value': '3.5', 'groupId': 'OG001', 'lowerLimit': '1.5', 'upperLimit': '5.0'}]}]}, {'title': 'Pain Score with movement', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000', 'lowerLimit': '2.0', 'upperLimit': '7.0'}, {'value': '5', 'groupId': 'OG001', 'lowerLimit': '4.0', 'upperLimit': '7.0'}]}]}], 'analyses': [{'pValue': '0.171', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Pain Score at rest at 2 hours'}, {'pValue': '0.204', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Pain Score with movement at 2 hours'}], 'paramType': 'MEDIAN', 'timeFrame': '2 hours from admission to postanesthesia care unit (PACU)', 'description': 'Pain scores were measured using a numeric rating scale with a range from 0 to 10, with 0 meaning no pain and 10 indicating the most severe pain.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Time to Administration of First Rescue Analgesic Request Between the Groups.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dexamethasone', 'description': 'Dexamethasone 8 mg IV given intraoperatively as a one-time dose.\n\nDexamethasone: Dexamethasone 8 mg IV (as a one time dose)'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Sodium chloride 0.9% (5 ml) given IV intraoperatively as a one time dose.\n\nPlacebo: Sodium Chloride 0.9% -5 ml'}], 'classes': [{'categories': [{'measurements': [{'value': '52.5', 'groupId': 'OG000', 'lowerLimit': '22.5', 'upperLimit': '88.5'}, {'value': '70', 'groupId': 'OG001', 'lowerLimit': '30', 'upperLimit': '112'}]}]}], 'analyses': [{'pValue': '0.1965', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'PACU admission to discharge from PACU an average of 2 hours', 'description': 'Time in minutes from admission to PACU to the first request by the patient for oral oxycodone (analgesia) administration for pain', 'unitOfMeasure': 'minutes', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was based on all 47 patients who completed the study.'}, {'type': 'SECONDARY', 'title': 'Cumulative Opioid Consumption at 48 Hours Between the Groups', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dexamethasone', 'description': 'Dexamethasone 8 mg IV given intraoperatively as a one-time dose.\n\nDexamethasone: Dexamethasone 8 mg IV (as a one time dose)'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Sodium chloride 0.9% (5 ml) given IV intraoperatively as a one time dose.\n\nPlacebo: Sodium Chloride 0.9% -5 ml'}], 'classes': [{'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000', 'lowerLimit': '10.0', 'upperLimit': '40.0'}, {'value': '22.5', 'groupId': 'OG001', 'lowerLimit': '3.75', 'upperLimit': '48.75'}]}]}], 'analyses': [{'pValue': '0.709', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Admission to PACU through 48 hours', 'description': 'The secondary outcome was the cumulative morphine consumption at 48 h in the two study groups. All postoperative opioids were converted to IV morphine equivalents using the following conversion factors: 100 micrograms IV = 10 mg IV morphine, 20 mg oxycodone po = 10 mg IV Morphine', 'unitOfMeasure': 'milligrams', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Pain Scores Between the Groups at 24 Hours.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dexamethasone', 'description': 'Dexamethasone 8 mg IV given intraoperatively as a one-time dose.\n\nDexamethasone: Dexamethasone 8 mg IV (as a one time dose)'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Sodium chloride 0.9% (5 ml) given IV intraoperatively as a one time dose.\n\nPlacebo: Sodium Chloride 0.9% -5 ml'}], 'classes': [{'title': 'Pain Score at rest', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '3.0'}, {'value': '2.5', 'groupId': 'OG001', 'lowerLimit': '1.0', 'upperLimit': '4.25'}]}]}, {'title': 'Pain Score with movement', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000', 'lowerLimit': '3.0', 'upperLimit': '7.0'}, {'value': '5', 'groupId': 'OG001', 'lowerLimit': '4.0', 'upperLimit': '6.75'}]}]}], 'analyses': [{'pValue': '0.267', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Pain Score at rest at 24 hours'}, {'pValue': '0.518', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Pain Score with movement at 24 hours'}], 'paramType': 'MEDIAN', 'timeFrame': '24 hours from PACU admission', 'description': 'Pain scores were measured using a numeric rating scale with a range from 0 to 10, with 0 meaning no pain and 10 indicating the most severe pain.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Pain Scores Between the Groups at 48 Hours.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dexamethasone', 'description': 'Dexamethasone 8 mg IV given intraoperatively as a one-time dose.\n\nDexamethasone: Dexamethasone 8 mg IV (as a one time dose)'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Sodium chloride 0.9% (5 ml) given IV intraoperatively as a one time dose.\n\nPlacebo: Sodium Chloride 0.9% -5 ml'}], 'classes': [{'title': 'Pain Score at rest', 'categories': [{'measurements': [{'value': '2.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '3.0'}, {'value': '2.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '4.0'}]}]}, {'title': 'Pain Score with movement', 'categories': [{'measurements': [{'value': '4.0', 'groupId': 'OG000', 'lowerLimit': '3.0', 'upperLimit': '6.0'}, {'value': '5.0', 'groupId': 'OG001', 'lowerLimit': '3.0', 'upperLimit': '7.0'}]}]}], 'analyses': [{'pValue': '0.491', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Pain Score at rest at 48 hours'}, {'pValue': '0.525', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Pain Scores with movement at 48 hours'}], 'paramType': 'MEAN', 'timeFrame': '48 hours from PACU Admission', 'description': 'Pain scores were measured using a numeric rating scale with a range from 0 to 10, with 0 meaning no pain and 10 indicating the most severe pain.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Cumulative Opioid Consumption at 24 Hours Between MTS Groups', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Positive MTS Score', 'description': 'Positive MTS score is defined as change of \\>1 in MTS score between 1st tap and 11th tap of 180 gram von Frey filament.'}, {'id': 'OG001', 'title': 'Negative MTS Score', 'description': 'Negative MTS score is defines as change of less than or equal to 1 in MTS scores between 1st tap and 11th tap.'}], 'classes': [{'categories': [{'measurements': [{'value': '17.5', 'groupId': 'OG000', 'lowerLimit': '7.5', 'upperLimit': '32.5'}, {'value': '15', 'groupId': 'OG001', 'lowerLimit': '2.5', 'upperLimit': '25'}]}]}], 'analyses': [{'pValue': '0.355', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Total opioid consumption at 24 hours', 'otherAnalysisDescription': 'We also performed a multivariable regression analysis to determine factors associated with 24h opioid consumption accounting for MTS category, demographic factors, study group allocation (dexamethasone vs placebo) and a preoperative questions to assess patients anxiety, anticipated pain scores after surgery and anticipated analgesic need after surgery. At each step of backward variable selection, we eliminate the factor with the largest p-value over 0.05.In the final model MTS was not associated with 24h opioid consumption parameter estimate (standard error) = 9.15 (5.27), p=0.09.'}], 'paramType': 'MEDIAN', 'timeFrame': '24 hours from admission to Postanesthesia care unit (PACU)', 'description': 'Mechanical temporal summation (MTS) was assessed using A 180 g Von Frey Filament was applied to the volar aspect of the dominant forearm, and subjects were asked to rate pain scores (NRS 0-100, 0 = no pain and 100= worst pain possible) after the 1st and 11th tap. A difference \\< 1 was recorded as MTS negative, and a difference \\> or = 1 was recorded as MTS positive.', 'unitOfMeasure': 'milligrams', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was based on all 47 patients who completed the study.'}, {'type': 'SECONDARY', 'title': 'Incidence of Chronic Persistent Pain at 8 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dexamethasone', 'description': 'Dexamethasone 8 mg IV given intraoperatively as a one-time dose. ...'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Sodium chloride 0.9% (5 ml) given IV intraoperatively as a one time dose. ...'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.420', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Chronic pain at 8 weeks'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '8 weeks from the day of surgery', 'description': 'Patients answered a questionnaire at 8 weeks to determine whether they still had persistent surgical site pain 8 weeks following surgery', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was based on available data from both arms including 26 patients. Data was missing for 13 patients in dexamethasone group and 8 patients in placebo group.'}, {'type': 'SECONDARY', 'title': 'Incidence of Chronic Persistent Pain at 6 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dexamethasone', 'description': 'Dexamethasone 8 mg IV given intraoperatively as a one-time dose. ...'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Sodium chloride 0.9% (5 ml) given IV intraoperatively as a one time dose. ...'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.322', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 months from the day of surgery', 'description': 'Patients answered a questionnaire at 6 months to determine whether they still had persistent surgical site pain 6 months following surgery', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was based on available data from both arms including 25 patients. Data was missing for 11 patients in dexamethasone group and 11 patients in placebo group.'}, {'type': 'SECONDARY', 'title': 'Pain Scores Between MTS Groups', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Positive MTS Score', 'description': 'Positive MTS score is defined as change of \\>1 in MTS score between 1st tap and 11th tap of 180 gram von Frey filament.'}, {'id': 'OG001', 'title': 'Negative MTS Score', 'description': 'Negative MTS score is defines as change of less than or equal to 1 in MTS scores between 1st tap and 11th tap.'}], 'classes': [{'title': 'Pain scores at rest at 24 hours', 'categories': [{'measurements': [{'value': '2.0', 'groupId': 'OG000', 'lowerLimit': '1.0', 'upperLimit': '4.0'}, {'value': '2.0', 'groupId': 'OG001', 'lowerLimit': '2.0', 'upperLimit': '4.0'}]}]}, {'title': 'Pains scores on movement at 24 hours', 'categories': [{'measurements': [{'value': '5.0', 'groupId': 'OG000', 'lowerLimit': '3.0', 'upperLimit': '7.0'}, {'value': '4.0', 'groupId': 'OG001', 'lowerLimit': '4.0', 'upperLimit': '6.0'}]}]}], 'analyses': [{'pValue': '0.805', 'groupIds': ['OG000', 'OG001'], 'groupDescription': '24 hour pain scores at rest between MTS groups', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY', 'otherAnalysisDescription': 'We also performed a multivariable regression analysis to determine factors associated with Pain scores at rest at 24 hours accounting for MTS category, demographic factors, study group allocation (dexamethasone vs placebo) and a preoperative questions to assess patients anxiety, anticipated pain scores after surgery and anticipated analgesic need after surgery. At each step of backward variable selection, we eliminate the factors with the largest p-value over 0.05. MTS category was not included in the final model for 24 h pain scores at rest.'}, {'pValue': '1.000', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Pain scores on movement at 24h', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY', 'otherAnalysisDescription': 'We also performed a multivariable regression analysis to determine factors associated with Pain scores at rest at 24 hours accounting for MTS category, demographic factors, study group allocation (dexamethasone vs placebo) and a preoperative questions to assess patients anxiety, anticipated pain scores after surgery and anticipated analgesic need after surgery. At each step of backward variable selection, we eliminated the factors with the largest p-value over 0.05. MTS category was not included in the final model for 24 h pain scores on movement.'}], 'paramType': 'MEDIAN', 'timeFrame': '24 hours after PACU admission', 'description': 'Mechanical temporal summation (MTS) was assessed using A 180 g Von Frey Filament was applied to the volar aspect of the dominant forearm, and subjects were asked to rate pain scores (NRS 0-100, 0=no pain and 100=worst pain possible) after the 1st and 11th tap. A difference \\< 1 was recorded as MTS negative, and a difference \\> or = 1 was recorded as MTS positive.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Incidence of Intraoperative Nausea and Vomiting (IONV) and Need for Rescue Antiemetics.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dexamethasone', 'description': 'Dexamethasone 8 mg IV given intraoperatively as a one-time dose. ...'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Sodium chloride 0.9% (5 ml) given IV intraoperatively as a one time dose. ...'}], 'classes': [{'title': 'Incidence of intraoperative nausea', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Intraoperative need for rescue antiemetic', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': 'Incidence of intraoperative vomiting', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.245', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Intraoperative nausea and vomiting'}, {'pValue': '0.676', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Need for intraoperative antiemetics'}, {'pValue': '1.000', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From spinal anesthesia placement to end of surgery, approximately 70 minutes', 'description': 'Incidence of intraoperative nausea and vomiting and need for rescue antiemetics were recorded during surgery. Patient who reported a nausea score on a 11 point NRS where 0=no nausea and 10 = the worse nausea possible. Patients who retched or vomited were reported to have vomited. Patients receiving any antiemetic during surgery were recorded as those requesting ( needing) rescue antiemetic.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Incidence of Intraoperative Pruritus', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dexamethasone', 'description': 'Dexamethasone 8 mg IV given intraoperatively as a one-time dose. ...'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Sodium chloride 0.9% (5 ml) given IV intraoperatively as a one time dose. ...'}], 'timeFrame': 'From spinal anesthesia placement to end of surgery, approximately 70 minutes', 'description': 'pruritus was defined as patients reporting a pruritus score of greater than o on a numerical rating scale with o=no pruritus and 10= worst pruritus', 'reportingStatus': 'POSTED', 'populationDescription': 'No data was collected on intraoperative pruritus on any participants.'}, {'type': 'SECONDARY', 'title': 'Incidence of Postoperative Pruritus', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dexamethasone', 'description': 'Dexamethasone 8 mg IV given intraoperatively as a one-time dose. ...'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Sodium chloride 0.9% (5 ml) given IV intraoperatively as a one time dose. ...'}], 'classes': [{'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.924', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Incidence of postoperative pruritus'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '48 hours from admission to PACU', 'description': 'Incidence of postoperative pruritus was calculated based on their postoperative pruritus scores measured at 2 hours, 24 hours and 48 hours. Median of the scores recorded at three time points was calculated.\n\nIf median score \\>0 then patient experienced postoperative pruritus.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Need for Intraoperative Analgesic Supplementation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dexamethasone', 'description': 'Dexamethasone 8 mg IV given intraoperatively as a one-time dose. ...'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Sodium chloride 0.9% (5 ml) given IV intraoperatively as a one time dose. ...'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.700', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From spinal anesthesia placement to end of surgery, approximately 70 minutes', 'description': 'Need for intraoperative analgesic supplementation was determined by patients who required intraoperative analgesics for pain', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Incidence of Post-operative Nausea and Vomiting (PONV) and Need for Rescue Antiemetics', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dexamethasone', 'description': 'Dexamethasone 8 mg IV given intraoperatively as a one-time dose. ...'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Sodium chloride 0.9% (5 ml) given IV intraoperatively as a one time dose. ...'}], 'classes': [{'title': 'Incidence of PONV at 24 hours', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}, {'title': 'Postoperative need for rescue antiemetics', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}]}, {'title': 'Incidence of PONV at 48 hours', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Incidence of PONV at 2 h', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.302', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Incidence of PONV at 24 h'}, {'pValue': '0.028', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Postoperative need for rescue antiemetic'}, {'pValue': '1.000', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.188', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '2, 24 and 48 hours from PACU admission', 'description': 'Patients who had experienced Postoperative nausea either reported postoperative nausea scores at 2, 24 and 48 hours from \\>0, reported an episode of vomiting or received an antiemetic were recorded as experiencing PONV.\n\nPatients who received at least one rescue antiemetic postoperatively were recorded as requiring a rescue antiemetic', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Incidence of Wound Complications', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dexamethasone', 'description': 'Dexamethasone 8 mg IV given intraoperatively as a one-time dose. ...'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Sodium chloride 0.9% (5 ml) given IV intraoperatively as a one time dose. ...'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '24 hours from PACU admission', 'description': 'Patients were assessed for signs of surgical wound inspection by the obstetric team following surgery', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Blood Pressure Measurements Obtained by the Standard of Care Non-invasive Blood Pressure Monitor Compared With the Continuous Noninvasive Arterial Pressure (CNAP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dexamethasone', 'description': 'Dexamethasone 8 mg IV given intraoperatively as a one-time dose.\n\nDexamethasone: Dexamethasone 8 mg IV (as a one time dose)'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Sodium chloride 0.9% (5 ml) given IV intraoperatively as a one time dose.\n\nPlacebo: Sodium Chloride 0.9% -5 ml'}], 'timeFrame': 'Intraoperatively', 'reportingStatus': 'POSTED', 'populationDescription': 'No data was collected intraoperatively using CNAP on any participants.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Dexamethasone', 'description': 'Dexamethasone 8 mg IV given intraoperatively as a one-time dose.\n\nDexamethasone: Dexamethasone 8 mg IV (as a one time dose)'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Sodium chloride 0.9% (5 ml) given IV intraoperatively as a one time dose.\n\nPlacebo: Sodium Chloride 0.9% -5 ml'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '24'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '23'}, {'groupId': 'FG001', 'numSubjects': '24'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'Of the 52 subjects that were enrolled, 3 subjects were not randomized due to later being deemed ineligible for the study; therefore, 49 subjects started on study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Dexamethasone', 'description': 'Dexamethasone 8 mg IV given intraoperatively as a one-time dose.\n\nDexamethasone: Dexamethasone 8 mg IV (as a one time dose)'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Sodium chloride 0.9% (5 ml) given IV intraoperatively as a one time dose.\n\nPlacebo: Sodium Chloride 0.9% -5 ml'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '32.2', 'spread': '4.7', 'groupId': 'BG000'}, {'value': '30.63', 'spread': '5.71', 'groupId': 'BG001'}, {'value': '31.40', 'spread': '5.23', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '47', '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/Ethnicity, Customized', 'classes': [{'title': 'Race/Ethnicity', 'categories': [{'title': 'Caucasian', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}, {'title': 'Black/African American', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}, {'title': 'Asian/Indian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Hispanic', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 53}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-06', 'completionDateStruct': {'date': '2016-09-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-06-26', 'studyFirstSubmitDate': '2013-03-13', 'resultsFirstSubmitDate': '2017-05-25', 'studyFirstSubmitQcDate': '2013-03-13', 'lastUpdatePostDateStruct': {'date': '2017-07-25', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-06-26', 'studyFirstPostDateStruct': {'date': '2013-03-15', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-07-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-05-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Morphine Consumption at 24 Hours Post-op', 'timeFrame': '24 hours from admission to Postanesthesia care unit (PACU)', 'description': 'The primary outcome will be the cumulative morphine consumption at 24 h in the two study groups. All postoperative opioids were converted to IV morphine equivalents using the following conversion factors: 100 micrograms IV = 10 mg IV morphine, 20 mg oxycodone po = 10 mg IV Morphine'}], 'secondaryOutcomes': [{'measure': 'Pain Scores Between the Groups at 2 Hours.', 'timeFrame': '2 hours from admission to postanesthesia care unit (PACU)', 'description': 'Pain scores were measured using a numeric rating scale with a range from 0 to 10, with 0 meaning no pain and 10 indicating the most severe pain.'}, {'measure': 'Time to Administration of First Rescue Analgesic Request Between the Groups.', 'timeFrame': 'PACU admission to discharge from PACU an average of 2 hours', 'description': 'Time in minutes from admission to PACU to the first request by the patient for oral oxycodone (analgesia) administration for pain'}, {'measure': 'Cumulative Opioid Consumption at 48 Hours Between the Groups', 'timeFrame': 'Admission to PACU through 48 hours', 'description': 'The secondary outcome was the cumulative morphine consumption at 48 h in the two study groups. All postoperative opioids were converted to IV morphine equivalents using the following conversion factors: 100 micrograms IV = 10 mg IV morphine, 20 mg oxycodone po = 10 mg IV Morphine'}, {'measure': 'Pain Scores Between the Groups at 24 Hours.', 'timeFrame': '24 hours from PACU admission', 'description': 'Pain scores were measured using a numeric rating scale with a range from 0 to 10, with 0 meaning no pain and 10 indicating the most severe pain.'}, {'measure': 'Pain Scores Between the Groups at 48 Hours.', 'timeFrame': '48 hours from PACU Admission', 'description': 'Pain scores were measured using a numeric rating scale with a range from 0 to 10, with 0 meaning no pain and 10 indicating the most severe pain.'}, {'measure': 'Cumulative Opioid Consumption at 24 Hours Between MTS Groups', 'timeFrame': '24 hours from admission to Postanesthesia care unit (PACU)', 'description': 'Mechanical temporal summation (MTS) was assessed using A 180 g Von Frey Filament was applied to the volar aspect of the dominant forearm, and subjects were asked to rate pain scores (NRS 0-100, 0 = no pain and 100= worst pain possible) after the 1st and 11th tap. A difference \\< 1 was recorded as MTS negative, and a difference \\> or = 1 was recorded as MTS positive.'}, {'measure': 'Incidence of Chronic Persistent Pain at 8 Weeks', 'timeFrame': '8 weeks from the day of surgery', 'description': 'Patients answered a questionnaire at 8 weeks to determine whether they still had persistent surgical site pain 8 weeks following surgery'}, {'measure': 'Incidence of Chronic Persistent Pain at 6 Months', 'timeFrame': '6 months from the day of surgery', 'description': 'Patients answered a questionnaire at 6 months to determine whether they still had persistent surgical site pain 6 months following surgery'}, {'measure': 'Pain Scores Between MTS Groups', 'timeFrame': '24 hours after PACU admission', 'description': 'Mechanical temporal summation (MTS) was assessed using A 180 g Von Frey Filament was applied to the volar aspect of the dominant forearm, and subjects were asked to rate pain scores (NRS 0-100, 0=no pain and 100=worst pain possible) after the 1st and 11th tap. A difference \\< 1 was recorded as MTS negative, and a difference \\> or = 1 was recorded as MTS positive.'}, {'measure': 'Incidence of Intraoperative Nausea and Vomiting (IONV) and Need for Rescue Antiemetics.', 'timeFrame': 'From spinal anesthesia placement to end of surgery, approximately 70 minutes', 'description': 'Incidence of intraoperative nausea and vomiting and need for rescue antiemetics were recorded during surgery. Patient who reported a nausea score on a 11 point NRS where 0=no nausea and 10 = the worse nausea possible. Patients who retched or vomited were reported to have vomited. Patients receiving any antiemetic during surgery were recorded as those requesting ( needing) rescue antiemetic.'}, {'measure': 'Incidence of Intraoperative Pruritus', 'timeFrame': 'From spinal anesthesia placement to end of surgery, approximately 70 minutes', 'description': 'pruritus was defined as patients reporting a pruritus score of greater than o on a numerical rating scale with o=no pruritus and 10= worst pruritus'}, {'measure': 'Incidence of Postoperative Pruritus', 'timeFrame': '48 hours from admission to PACU', 'description': 'Incidence of postoperative pruritus was calculated based on their postoperative pruritus scores measured at 2 hours, 24 hours and 48 hours. Median of the scores recorded at three time points was calculated.\n\nIf median score \\>0 then patient experienced postoperative pruritus.'}, {'measure': 'Need for Intraoperative Analgesic Supplementation', 'timeFrame': 'From spinal anesthesia placement to end of surgery, approximately 70 minutes', 'description': 'Need for intraoperative analgesic supplementation was determined by patients who required intraoperative analgesics for pain'}, {'measure': 'Incidence of Post-operative Nausea and Vomiting (PONV) and Need for Rescue Antiemetics', 'timeFrame': '2, 24 and 48 hours from PACU admission', 'description': 'Patients who had experienced Postoperative nausea either reported postoperative nausea scores at 2, 24 and 48 hours from \\>0, reported an episode of vomiting or received an antiemetic were recorded as experiencing PONV.\n\nPatients who received at least one rescue antiemetic postoperatively were recorded as requiring a rescue antiemetic'}, {'measure': 'Incidence of Wound Complications', 'timeFrame': '24 hours from PACU admission', 'description': 'Patients were assessed for signs of surgical wound inspection by the obstetric team following surgery'}, {'measure': 'Blood Pressure Measurements Obtained by the Standard of Care Non-invasive Blood Pressure Monitor Compared With the Continuous Noninvasive Arterial Pressure (CNAP)', 'timeFrame': 'Intraoperatively'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Anesthesia', 'Cesarean Section', 'Pain, Postoperative', 'Postoperative Nausea and Vomiting', 'Dexamethasone', 'Injections, Spinal', 'morphine'], 'conditions': ['Pain, Postoperative', 'Postoperative Nausea and Vomiting']}, 'referencesModule': {'references': [{'pmid': '34002866', 'type': 'DERIVED', 'citation': 'Griffiths JD, Gyte GM, Popham PA, Williams K, Paranjothy S, Broughton HK, Brown HC, Thomas J. Interventions for preventing nausea and vomiting in women undergoing regional anaesthesia for caesarean section. Cochrane Database Syst Rev. 2021 May 18;5(5):CD007579. doi: 10.1002/14651858.CD007579.pub3.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare post-cesarean section consumption of pain medication between two groups of patients undergoing scheduled cesarean section at term gestation who receive a single-dose of intraoperative steroid (dexamethasone 8 milligrams) versus placebo at 24 hours after surgery. The hypothesis is that a single perioperative dose of dexamethasone 8 mg will significantly reduce postoperative opioid consumption at 24 h in women having cesarean delivery under spinal anesthesia.', 'detailedDescription': 'Steroids have been used to reduce inflammation and tissue damage in a variety of conditions, have potent immunomodulatory effects, and are a mainstay in the treatment of acute allograft rejection. Dexamethasone has been shown to be a safe and effective anti-emetic therapy for patients undergoing cesarean section surgery with spinal anesthesia containing morphine.\n\nHowever, recent evidence suggests that dexamethasone may also play a role in reducing post-operative pain and opioid consumption. Early studies in patients undergoing dental procedures showed that glucocorticoids were effective in reducing postoperative pain and edema. Multiple recent studies have also investigated the potential analgesic benefit of a single perioperative dose of dexamethasone, but the results have been inconsistent. The effect of single-dose, intraoperative, intravenous dexamethasone therapy on post-operative pain and opioid consumption has not yet been studied in patients undergoing cesarean section.\n\nPain is a significant source of morbidity for many women following cesarean section, and has serious consequences beyond the immediate post-operative period. Patients with poorly-controlled pain may have difficulty with ambulation that can lead to atelectasis, pneumonia, and venous thromboembolism.\n\nPoor maternal pain control may also affect the infant by interfering with bonding and breastfeeding. Reduction of post-operative opioid consumption is desirable because it may also reduce the incidence of opioid-induced side effects such as sedation, constipation, nausea, vomiting and pruritus. Some evidence suggests that the severity of post-operative pain following cesarean section may predict progression to chronic pain, and postpartum depression.\n\nAlthough 10 to 18% of women who undergo cesarean section will experience chronic pain following surgery, it is difficult to predict those patients who will experience this complication. Recent investigations have shown that patient responses to standardized painful stimuli prior to surgery help predict severity of post-operative pain and possibly progression to chronic pain. This type of information could potentially help to tailor the clinical management of patients at risk for severe and/or chronic post-operative pain to improve outcomes for these patients. Landau and colleagues have described a simple and minimally-invasive method of assessing response to noxious stimuli using a von-Frey filament to obtain a mechanical temporal summation score.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* American Society of Anesthesiology (ASA) class 1, 2 and 3\n* Gestational age \\> 37 weeks\n* scheduled for elective cesarean delivery\n* spinal or combined spinal epidural anesthesia\n* 18 years or older\n* speak English\n\nExclusion Criteria:\n\n* BMI \\> 45 kg/m2\n* Diabetes Mellitus (Type 1, 2 and gestational)\n* mild or severe preeclampsia\n* history of intravenous drug or opioid abuse\n* previous history of chronic pain syndrome\n* history of opioid use in the past week\n* receipt of an antiemetic within 24 h prior to surgery\n* Non-English speaking'}, 'identificationModule': {'nctId': 'NCT01812057', 'briefTitle': 'Dexamethasone for Post-cesarean Delivery Pain', 'organization': {'class': 'OTHER', 'fullName': 'Duke University'}, 'officialTitle': 'Dexamethasone as an Analgesic Adjunct for Post-cesarean Delivery Pain Relief', 'orgStudyIdInfo': {'id': 'Pro00041334'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dexamethasone', 'description': 'Dexamethasone 8 mg IV given intraoperatively as a one-time dose.', 'interventionNames': ['Drug: Dexamethasone']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Sodium chloride 0.9% (5 ml) given IV intraoperatively as a one time dose.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Dexamethasone', 'type': 'DRUG', 'description': 'Dexamethasone 8 mg IV (as a one time dose)', 'armGroupLabels': ['Dexamethasone']}, {'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['Sodium Chloride 0.9%'], 'description': 'Sodium Chloride 0.9% -5 ml', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27705', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University Medical Center', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}], 'overallOfficials': [{'name': 'Terrence Allen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Duke University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Duke University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}