Ignite Creation Date:
2025-12-26 @ 4:03 PM
Ignite Modification Date:
2025-12-30 @ 5:27 AM
Study NCT ID:
NCT02340806
Status:
COMPLETED
Last Update Posted:
2019-11-26
First Post:
2014-12-29
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Association Between Bolus Rate and the Adequacy of Labor Analgesia Using Timed-intermittent Boluses
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D048949', 'term': 'Labor Pain'}, {'id': 'D000377', 'term': 'Agnosia'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'elizabeth.lange@northwestern.edu', 'phone': '312-472-3585', 'title': 'Elizabeth Lange, MD', 'organization': 'Northwestern University'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Limiting our study subjects to nulliparous patients in early labor could have led to a cohort that was more prone to sysfunctional labor and these results could be different in multiparous women with shorter labors.'}}, 'adverseEventsModule': {'timeFrame': '24 hours after delivery of the baby', 'eventGroups': [{'id': 'EG000', 'title': 'High Rate Bolus (CADD-Solis Pump)', 'description': 'Labor analgesia will be maintained using timed-intermittent boluses of local anesthetic with PCEA using the CADD-Solis pump. The bolus rate will be 300 mL/h in the high-rate bolus group.\n\nCADD-Solis pump (Smiths Medical): The maintenance epidural solution for both groups will be bupivacaine 0.625 mg/mL with fentanyl 1.95 mcg/mL. The intermittent bolus volume will be 10 mL administered every 60 minutes. The first bolus will be given 30 minutes after intrathecal injection. In addition to the programmed boluses, patients will be able to administer patient-controlled epidural analgesia (PCEA) boluses of 5 mL every 10 minutes to a maximum of 15 mL (three PCEA boluses in a one hour period).', 'otherNumAtRisk': 102, 'deathsNumAtRisk': 102, 'otherNumAffected': 0, 'seriousNumAtRisk': 102, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Low Rate Bolus (CADD-Solis Pump)', 'description': 'Labor analgesia will be maintained using timed-intermittent boluses of local anesthetic with PCEA using the CADD-Solis pump. The bolus rate will be 100 mL/h in the low-rate bolus group.\n\nCADD-Solis pump (Smiths Medical): The maintenance epidural solution for both groups will be bupivacaine 0.625 mg/mL with fentanyl 1.95 mcg/mL. The intermittent bolus volume will be 10 mL administered every 60 minutes. The first bolus will be given 30 minutes after intrathecal injection. In addition to the programmed boluses, patients will be able to administer patient-controlled epidural analgesia (PCEA) boluses of 5 mL every 10 minutes to a maximum of 15 mL (three PCEA boluses in a one hour period).', 'otherNumAtRisk': 108, 'deathsNumAtRisk': 108, 'otherNumAffected': 0, 'seriousNumAtRisk': 108, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants Who Experienced Breakthrough Pain.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'OG000'}, {'value': '108', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'High Rate Bolus (CADD-Solis Pump)', 'description': 'Labor analgesia will be maintained using timed-intermittent boluses of local anesthetic with PCEA using the CADD-Solis pump. The bolus rate will be 300 mL/h in the high-rate bolus group.\n\nCADD-Solis pump (Smiths Medical): The maintenance epidural solution for both groups will be bupivacaine 0.625 mg/mL with fentanyl 1.95 mcg/mL. The intermittent bolus volume will be 10 mL administered every 60 minutes. The first bolus will be given 30 minutes after intrathecal injection. In addition to the programmed boluses, patients will be able to administer patient-controlled epidural analgesia (PCEA) boluses of 5 mL every 10 minutes to a maximum of 15 mL (three PCEA boluses in a one hour period).'}, {'id': 'OG001', 'title': 'Low Rate Bolus (CADD-Solis Pump)', 'description': 'Labor analgesia will be maintained using timed-intermittent boluses of local anesthetic with PCEA using the CADD-Solis pump. The bolus rate will be 100 mL/h in the low-rate bolus group.\n\nCADD-Solis pump (Smiths Medical): The maintenance epidural solution for both groups will be bupivacaine 0.625 mg/mL with fentanyl 1.95 mcg/mL. The intermittent bolus volume will be 10 mL administered every 60 minutes. The first bolus will be given 30 minutes after intrathecal injection. In addition to the programmed boluses, patients will be able to administer patient-controlled epidural analgesia (PCEA) boluses of 5 mL every 10 minutes to a maximum of 15 mL (three PCEA boluses in a one hour period).'}], 'classes': [{'categories': [{'measurements': [{'value': '37', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.67', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Chi-squared, Corrected', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'epidural placement to delivery, up to 36 hours.', 'description': 'Number of participants who experienced breakthrough pain requiring a provider administered bolus by the anesthesia providers.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Total Bupivacaine Consumption Per Hour of Labor Analgesia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'OG000'}, {'value': '108', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'High Rate Bolus (CADD-Solis Pump)', 'description': 'Labor analgesia will be maintained using timed-intermittent boluses of local anesthetic with PCEA using the CADD-Solis pump. The bolus rate will be 300 mL/h in the high-rate bolus group.\n\nCADD-Solis pump (Smiths Medical): The maintenance epidural solution for both groups will be bupivacaine 0.625 mg/mL with fentanyl 1.95 mcg/mL. The intermittent bolus volume will be 10 mL administered every 60 minutes. The first bolus will be given 30 minutes after intrathecal injection. In addition to the programmed boluses, patients will be able to administer patient-controlled epidural analgesia (PCEA) boluses of 5 mL every 10 minutes to a maximum of 15 mL (three PCEA boluses in a one hour period).'}, {'id': 'OG001', 'title': 'Low Rate Bolus (CADD-Solis Pump)', 'description': 'Labor analgesia will be maintained using timed-intermittent boluses of local anesthetic with PCEA using the CADD-Solis pump. The bolus rate will be 100 mL/h in the low-rate bolus group.\n\nCADD-Solis pump (Smiths Medical): The maintenance epidural solution for both groups will be bupivacaine 0.625 mg/mL with fentanyl 1.95 mcg/mL. The intermittent bolus volume will be 10 mL administered every 60 minutes. The first bolus will be given 30 minutes after intrathecal injection. In addition to the programmed boluses, patients will be able to administer patient-controlled epidural analgesia (PCEA) boluses of 5 mL every 10 minutes to a maximum of 15 mL (three PCEA boluses in a one hour period).'}], 'classes': [{'categories': [{'measurements': [{'value': '9.9', 'groupId': 'OG000', 'lowerLimit': '8.1', 'upperLimit': '11.4'}, {'value': '10.8', 'groupId': 'OG001', 'lowerLimit': '8.6', 'upperLimit': '11.4'}]}]}], 'analyses': [{'pValue': '.08', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'epidural placement to delivery, up to 36 hours.', 'description': 'Total bupivacaine amount (milligrams/hour mg/h) via pump and provider administered supplemental boluses', 'unitOfMeasure': 'milligrams per hour', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Total Number of Requested PCEA Boluses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'OG000'}, {'value': '108', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'High Rate Bolus (CADD-Solis Pump)', 'description': 'Labor analgesia will be maintained using timed-intermittent boluses of local anesthetic with PCEA using the CADD-Solis pump. The bolus rate will be 300 mL/h in the high-rate bolus group.\n\nCADD-Solis pump (Smiths Medical): The maintenance epidural solution for both groups will be bupivacaine 0.625 mg/mL with fentanyl 1.95 mcg/mL. The intermittent bolus volume will be 10 mL administered every 60 minutes. The first bolus will be given 30 minutes after intrathecal injection. In addition to the programmed boluses, patients will be able to administer patient-controlled epidural analgesia (PCEA) boluses of 5 mL every 10 minutes to a maximum of 15 mL (three PCEA boluses in a one hour period).'}, {'id': 'OG001', 'title': 'Low Rate Bolus (CADD-Solis Pump)', 'description': 'Labor analgesia will be maintained using timed-intermittent boluses of local anesthetic with PCEA using the CADD-Solis pump. The bolus rate will be 100 mL/h in the low-rate bolus group.\n\nCADD-Solis pump (Smiths Medical): The maintenance epidural solution for both groups will be bupivacaine 0.625 mg/mL with fentanyl 1.95 mcg/mL. The intermittent bolus volume will be 10 mL administered every 60 minutes. The first bolus will be given 30 minutes after intrathecal injection. In addition to the programmed boluses, patients will be able to administer patient-controlled epidural analgesia (PCEA) boluses of 5 mL every 10 minutes to a maximum of 15 mL (three PCEA boluses in a one hour period).'}], 'classes': [{'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000', 'lowerLimit': '6', 'upperLimit': '27'}, {'value': '17', 'groupId': 'OG001', 'lowerLimit': '10', 'upperLimit': '31'}]}]}], 'analyses': [{'pValue': '.21', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'epidural placement to delivery, up to 36 hours.', 'description': 'Number of PCEA (Patient Controlled Epidural Anesthesia) bolus doses delivered', 'unitOfMeasure': 'Doses', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Total Number of Delivered PCEA Boluses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'OG000'}, {'value': '108', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'High Rate Bolus (CADD-Solis Pump)', 'description': 'Labor analgesia will be maintained using timed-intermittent boluses of local anesthetic with PCEA using the CADD-Solis pump. The bolus rate will be 300 mL/h in the high-rate bolus group.\n\nCADD-Solis pump (Smiths Medical): The maintenance epidural solution for both groups will be bupivacaine 0.625 mg/mL with fentanyl 1.95 mcg/mL. The intermittent bolus volume will be 10 mL administered every 60 minutes. The first bolus will be given 30 minutes after intrathecal injection. In addition to the programmed boluses, patients will be able to administer patient-controlled epidural analgesia (PCEA) boluses of 5 mL every 10 minutes to a maximum of 15 mL (three PCEA boluses in a one hour period).'}, {'id': 'OG001', 'title': 'Low Rate Bolus (CADD-Solis Pump)', 'description': 'Labor analgesia will be maintained using timed-intermittent boluses of local anesthetic with PCEA using the CADD-Solis pump. The bolus rate will be 100 mL/h in the low-rate bolus group.\n\nCADD-Solis pump (Smiths Medical): The maintenance epidural solution for both groups will be bupivacaine 0.625 mg/mL with fentanyl 1.95 mcg/mL. The intermittent bolus volume will be 10 mL administered every 60 minutes. The first bolus will be given 30 minutes after intrathecal injection. In addition to the programmed boluses, patients will be able to administer patient-controlled epidural analgesia (PCEA) boluses of 5 mL every 10 minutes to a maximum of 15 mL (three PCEA boluses in a one hour period).'}], 'classes': [{'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000', 'lowerLimit': '5', 'upperLimit': '18'}, {'value': '10', 'groupId': 'OG001', 'lowerLimit': '7', 'upperLimit': '17'}]}]}], 'analyses': [{'pValue': '.14', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'epidural placement to delivery, up to 36 hours.', 'description': "Total number of PCEA (Patient Controlled Epidural Anesthesia) bolus's delivered.", 'unitOfMeasure': 'Doses', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Ratio of Total Number of PCEA Boluses Requested and Delivered', 'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'OG000'}, {'value': '108', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'High Rate Bolus (CADD-Solis Pump)', 'description': 'Labor analgesia will be maintained using timed-intermittent boluses of local anesthetic with PCEA using the CADD-Solis pump. The bolus rate will be 300 mL/h in the high-rate bolus group.\n\nCADD-Solis pump (Smiths Medical): The maintenance epidural solution for both groups will be bupivacaine 0.625 mg/mL with fentanyl 1.95 mcg/mL. The intermittent bolus volume will be 10 mL administered every 60 minutes. The first bolus will be given 30 minutes after intrathecal injection. In addition to the programmed boluses, patients will be able to administer patient-controlled epidural analgesia (PCEA) boluses of 5 mL every 10 minutes to a maximum of 15 mL (three PCEA boluses in a one hour period).'}, {'id': 'OG001', 'title': 'Low Rate Bolus (CADD-Solis Pump)', 'description': 'Labor analgesia will be maintained using timed-intermittent boluses of local anesthetic with PCEA using the CADD-Solis pump. The bolus rate will be 100 mL/h in the low-rate bolus group.\n\nCADD-Solis pump (Smiths Medical): The maintenance epidural solution for both groups will be bupivacaine 0.625 mg/mL with fentanyl 1.95 mcg/mL. The intermittent bolus volume will be 10 mL administered every 60 minutes. The first bolus will be given 30 minutes after intrathecal injection. In addition to the programmed boluses, patients will be able to administer patient-controlled epidural analgesia (PCEA) boluses of 5 mL every 10 minutes to a maximum of 15 mL (three PCEA boluses in a one hour period).'}], 'classes': [{'categories': [{'measurements': [{'value': '1.4', 'groupId': 'OG000', 'lowerLimit': '1.2', 'upperLimit': '2.1'}, {'value': '1.5', 'groupId': 'OG001', 'lowerLimit': '1.2', 'upperLimit': '2.1'}]}]}], 'analyses': [{'pValue': '.66', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'epidural placement to delivery, up to 36 hours.', 'description': "The ratio of the total number of PCEA (Patient Controlled Epidural Anesthesia) bolus's requested and PCEA doses delivered.", 'unitOfMeasure': 'Ratio', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Satisfaction Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'OG000'}, {'value': '108', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'High Rate Bolus (CADD-Solis Pump)', 'description': 'Labor analgesia will be maintained using timed-intermittent boluses of local anesthetic with PCEA using the CADD-Solis pump. The bolus rate will be 300 mL/h in the high-rate bolus group.\n\nCADD-Solis pump (Smiths Medical): The maintenance epidural solution for both groups will be bupivacaine 0.625 mg/mL with fentanyl 1.95 mcg/mL. The intermittent bolus volume will be 10 mL administered every 60 minutes. The first bolus will be given 30 minutes after intrathecal injection. In addition to the programmed boluses, patients will be able to administer patient-controlled epidural analgesia (PCEA) boluses of 5 mL every 10 minutes to a maximum of 15 mL (three PCEA boluses in a one hour period).'}, {'id': 'OG001', 'title': 'Low Rate Bolus (CADD-Solis Pump)', 'description': 'Labor analgesia will be maintained using timed-intermittent boluses of local anesthetic with PCEA using the CADD-Solis pump. The bolus rate will be 100 mL/h in the low-rate bolus group.\n\nCADD-Solis pump (Smiths Medical): The maintenance epidural solution for both groups will be bupivacaine 0.625 mg/mL with fentanyl 1.95 mcg/mL. The intermittent bolus volume will be 10 mL administered every 60 minutes. The first bolus will be given 30 minutes after intrathecal injection. In addition to the programmed boluses, patients will be able to administer patient-controlled epidural analgesia (PCEA) boluses of 5 mL every 10 minutes to a maximum of 15 mL (three PCEA boluses in a one hour period).'}], 'classes': [{'categories': [{'measurements': [{'value': '98', 'groupId': 'OG000', 'lowerLimit': '86', 'upperLimit': '100'}, {'value': '98', 'groupId': 'OG001', 'lowerLimit': '88', 'upperLimit': '100'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'up to 24 hours after delivery', 'description': 'Patients overall satisfaction with pain management. The scale 0= poor satisfaction and 100= good satisfaction with pain management.', 'unitOfMeasure': 'score on a scale (0 poor 100 good)', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Time to Provider Administered Supplemental Boluses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'OG000'}, {'value': '108', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'High Rate Bolus (CADD-Solis Pump)', 'description': 'Labor analgesia will be maintained using timed-intermittent boluses of local anesthetic with PCEA using the CADD-Solis pump. The bolus rate will be 300 mL/h in the high-rate bolus group.\n\nCADD-Solis pump (Smiths Medical): The maintenance epidural solution for both groups will be bupivacaine 0.625 mg/mL with fentanyl 1.95 mcg/mL. The intermittent bolus volume will be 10 mL administered every 60 minutes. The first bolus will be given 30 minutes after intrathecal injection. In addition to the programmed boluses, patients will be able to administer patient-controlled epidural analgesia (PCEA) boluses of 5 mL every 10 minutes to a maximum of 15 mL (three PCEA boluses in a one hour period).'}, {'id': 'OG001', 'title': 'Low Rate Bolus (CADD-Solis Pump)', 'description': 'Labor analgesia will be maintained using timed-intermittent boluses of local anesthetic with PCEA using the CADD-Solis pump. The bolus rate will be 100 mL/h in the low-rate bolus group.\n\nCADD-Solis pump (Smiths Medical): The maintenance epidural solution for both groups will be bupivacaine 0.625 mg/mL with fentanyl 1.95 mcg/mL. The intermittent bolus volume will be 10 mL administered every 60 minutes. The first bolus will be given 30 minutes after intrathecal injection. In addition to the programmed boluses, patients will be able to administer patient-controlled epidural analgesia (PCEA) boluses of 5 mL every 10 minutes to a maximum of 15 mL (three PCEA boluses in a one hour period).'}], 'classes': [{'categories': [{'measurements': [{'value': '357', 'groupId': 'OG000', 'lowerLimit': '215', 'upperLimit': '525'}, {'value': '302', 'groupId': 'OG001', 'lowerLimit': '148', 'upperLimit': '559'}]}]}], 'analyses': [{'pValue': '.92', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'epidural to first request of redose up to 10 hours', 'description': 'Time to provider administered supplemental boluses measured in minutes', 'unitOfMeasure': 'Minutes', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Mean Pain Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'OG000'}, {'value': '108', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'High Rate Bolus (CADD-Solis Pump)', 'description': 'Labor analgesia will be maintained using timed-intermittent boluses of local anesthetic with PCEA using the CADD-Solis pump. The bolus rate will be 300 mL/h in the high-rate bolus group.\n\nCADD-Solis pump (Smiths Medical): The maintenance epidural solution for both groups will be bupivacaine 0.625 mg/mL with fentanyl 1.95 mcg/mL. The intermittent bolus volume will be 10 mL administered every 60 minutes. The first bolus will be given 30 minutes after intrathecal injection. In addition to the programmed boluses, patients will be able to administer patient-controlled epidural analgesia (PCEA) boluses of 5 mL every 10 minutes to a maximum of 15 mL (three PCEA boluses in a one hour period).'}, {'id': 'OG001', 'title': 'Low Rate Bolus (CADD-Solis Pump)', 'description': 'Labor analgesia will be maintained using timed-intermittent boluses of local anesthetic with PCEA using the CADD-Solis pump. The bolus rate will be 100 mL/h in the low-rate bolus group.\n\nCADD-Solis pump (Smiths Medical): The maintenance epidural solution for both groups will be bupivacaine 0.625 mg/mL with fentanyl 1.95 mcg/mL. The intermittent bolus volume will be 10 mL administered every 60 minutes. The first bolus will be given 30 minutes after intrathecal injection. In addition to the programmed boluses, patients will be able to administer patient-controlled epidural analgesia (PCEA) boluses of 5 mL every 10 minutes to a maximum of 15 mL (three PCEA boluses in a one hour period).'}], 'classes': [{'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000', 'lowerLimit': '3.9', 'upperLimit': '17.2'}, {'value': '6.9', 'groupId': 'OG001', 'lowerLimit': '3.7', 'upperLimit': '15'}]}]}], 'analyses': [{'pValue': '.58', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'epidural placement to delivery, up to 36 hours.', 'description': 'Weighted mean pain score (measured by the area under the VAS (Visual Analog Scale)-time curve calculated using the trapezoidal integration divided by the duration of labor analgesia).Visual Analog Scale is a 100 millimeter scale where 0 is no pain and 100 is worst pain imaginable.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Stage of Labor at Re-dose Request', 'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'OG000'}, {'value': '108', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'High Rate Bolus (CADD-Solis Pump)', 'description': 'Labor analgesia will be maintained using timed-intermittent boluses of local anesthetic with PCEA using the CADD-Solis pump. The bolus rate will be 300 mL/h in the high-rate bolus group.\n\nCADD-Solis pump (Smiths Medical): The maintenance epidural solution for both groups will be bupivacaine 0.625 mg/mL with fentanyl 1.95 mcg/mL. The intermittent bolus volume will be 10 mL administered every 60 minutes. The first bolus will be given 30 minutes after intrathecal injection. In addition to the programmed boluses, patients will be able to administer patient-controlled epidural analgesia (PCEA) boluses of 5 mL every 10 minutes to a maximum of 15 mL (three PCEA boluses in a one hour period).'}, {'id': 'OG001', 'title': 'Low Rate Bolus (CADD-Solis Pump)', 'description': 'Labor analgesia will be maintained using timed-intermittent boluses of local anesthetic with PCEA using the CADD-Solis pump. The bolus rate will be 100 mL/h in the low-rate bolus group.\n\nCADD-Solis pump (Smiths Medical): The maintenance epidural solution for both groups will be bupivacaine 0.625 mg/mL with fentanyl 1.95 mcg/mL. The intermittent bolus volume will be 10 mL administered every 60 minutes. The first bolus will be given 30 minutes after intrathecal injection. In addition to the programmed boluses, patients will be able to administer patient-controlled epidural analgesia (PCEA) boluses of 5 mL every 10 minutes to a maximum of 15 mL (three PCEA boluses in a one hour period).'}], 'classes': [{'title': 'First stage of labor', 'categories': [{'measurements': [{'value': '34', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}]}, {'title': 'Second stage of labor', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.67', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Through 2 stages of labor up to 24 hours', 'description': 'The stage of labor ( first or second) at the time of re-dose request.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Participants With Epidural Re-doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'OG000'}, {'value': '108', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'High Rate Bolus (CADD-Solis Pump)', 'description': 'Labor analgesia will be maintained using timed-intermittent boluses of local anesthetic with PCEA using the CADD-Solis pump. The bolus rate will be 300 mL/h in the high-rate bolus group.\n\nCADD-Solis pump (Smiths Medical): The maintenance epidural solution for both groups will be bupivacaine 0.625 mg/mL with fentanyl 1.95 mcg/mL. The intermittent bolus volume will be 10 mL administered every 60 minutes. The first bolus will be given 30 minutes after intrathecal injection. In addition to the programmed boluses, patients will be able to administer patient-controlled epidural analgesia (PCEA) boluses of 5 mL every 10 minutes to a maximum of 15 mL (three PCEA boluses in a one hour period).'}, {'id': 'OG001', 'title': 'Low Rate Bolus (CADD-Solis Pump)', 'description': 'Labor analgesia will be maintained using timed-intermittent boluses of local anesthetic with PCEA using the CADD-Solis pump. The bolus rate will be 100 mL/h in the low-rate bolus group.\n\nCADD-Solis pump (Smiths Medical): The maintenance epidural solution for both groups will be bupivacaine 0.625 mg/mL with fentanyl 1.95 mcg/mL. The intermittent bolus volume will be 10 mL administered every 60 minutes. The first bolus will be given 30 minutes after intrathecal injection. In addition to the programmed boluses, patients will be able to administer patient-controlled epidural analgesia (PCEA) boluses of 5 mL every 10 minutes to a maximum of 15 mL (three PCEA boluses in a one hour period).'}], 'classes': [{'title': 'No- redoses', 'categories': [{'measurements': [{'value': '59', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}]}]}, {'title': '1 re-dose', 'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}]}, {'title': '2 re-doses', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': '3 re-doses', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.99', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'epidural placement to delivery, up to 36 hours.', 'description': 'Total number of patients requiring epidural re-doses given by the provider.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Patient Satisfaction of Labor Anesthesia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'OG000'}, {'value': '108', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'High Rate Bolus (CADD-Solis Pump)', 'description': 'Labor analgesia will be maintained using timed-intermittent boluses of local anesthetic with PCEA using the CADD-Solis pump. The bolus rate will be 300 mL/h in the high-rate bolus group.\n\nCADD-Solis pump (Smiths Medical): The maintenance epidural solution for both groups will be bupivacaine 0.625 mg/mL with fentanyl 1.95 mcg/mL. The intermittent bolus volume will be 10 mL administered every 60 minutes. The first bolus will be given 30 minutes after intrathecal injection. In addition to the programmed boluses, patients will be able to administer patient-controlled epidural analgesia (PCEA) boluses of 5 mL every 10 minutes to a maximum of 15 mL (three PCEA boluses in a one hour period).'}, {'id': 'OG001', 'title': 'Low Rate Bolus (CADD-Solis Pump)', 'description': 'Labor analgesia will be maintained using timed-intermittent boluses of local anesthetic with PCEA using the CADD-Solis pump. The bolus rate will be 100 mL/h in the low-rate bolus group.\n\nCADD-Solis pump (Smiths Medical): The maintenance epidural solution for both groups will be bupivacaine 0.625 mg/mL with fentanyl 1.95 mcg/mL. The intermittent bolus volume will be 10 mL administered every 60 minutes. The first bolus will be given 30 minutes after intrathecal injection. In addition to the programmed boluses, patients will be able to administer patient-controlled epidural analgesia (PCEA) boluses of 5 mL every 10 minutes to a maximum of 15 mL (three PCEA boluses in a one hour period).'}], 'classes': [{'categories': [{'measurements': [{'value': '98', 'groupId': 'OG000', 'lowerLimit': '86', 'upperLimit': '100'}, {'value': '98', 'groupId': 'OG001', 'lowerLimit': '88', 'upperLimit': '100'}]}]}], 'analyses': [{'pValue': '.37', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to 24 hours after delivery of baby', 'description': 'Patient satisfaction of labor anesthesia using a score of 0 low satisfaction to 100 high satisfaction on a 100 millimeter scale.', 'unitOfMeasure': 'score on a scale (0 poor 100 good)', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'High Rate Bolus (CADD-Solis Pump)', 'description': 'Labor analgesia will be maintained using timed-intermittent boluses of local anesthetic with PCEA using the CADD-Solis pump. The bolus rate will be 300 mL/h in the high-rate bolus group.\n\nCADD-Solis pump (Smiths Medical): The maintenance epidural solution for both groups will be bupivacaine 0.625 mg/mL with fentanyl 1.95 mcg/mL. The intermittent bolus volume will be 10 mL administered every 60 minutes. The first bolus will be given 30 minutes after intrathecal injection. In addition to the programmed boluses, patients will be able to administer patient-controlled epidural analgesia (PCEA) boluses of 5 mL every 10 minutes to a maximum of 15 mL (three PCEA boluses in a one hour period).'}, {'id': 'FG001', 'title': 'Low Rate Bolus (CADD-Solis Pump)', 'description': 'Labor analgesia will be maintained using timed-intermittent boluses of local anesthetic with PCEA using the CADD-Solis pump. The bolus rate will be 100 mL/h in the low-rate bolus group.\n\nCADD-Solis pump (Smiths Medical): The maintenance epidural solution for both groups will be bupivacaine 0.625 mg/mL with fentanyl 1.95 mcg/mL. The intermittent bolus volume will be 10 mL administered every 60 minutes. The first bolus will be given 30 minutes after intrathecal injection. In addition to the programmed boluses, patients will be able to administer patient-controlled epidural analgesia (PCEA) boluses of 5 mL every 10 minutes to a maximum of 15 mL (three PCEA boluses in a one hour period).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '108'}, {'groupId': 'FG001', 'numSubjects': '112'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '102'}, {'groupId': 'FG001', 'numSubjects': '108'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'epidural catheter replaced', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'history of chronic pain medication', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 're-dose < 90 min of CSE', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}]}]}], 'recruitmentDetails': '220 patients met inclusion criteria.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'BG000'}, {'value': '108', 'groupId': 'BG001'}, {'value': '210', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'High Rate Bolus (CADD-Solis Pump)', 'description': 'Labor analgesia will be maintained using timed-intermittent boluses of local anesthetic with PCEA using the CADD-Solis pump. The bolus rate will be 300 mL/h in the high-rate bolus group.\n\nCADD-Solis pump (Smiths Medical): The maintenance epidural solution for both groups will be bupivacaine 0.625 mg/mL with fentanyl 1.95 mcg/mL. The intermittent bolus volume will be 10 mL administered every 60 minutes. The first bolus will be given 30 minutes after intrathecal injection. In addition to the programmed boluses, patients will be able to administer patient-controlled epidural analgesia (PCEA) boluses of 5 mL every 10 minutes to a maximum of 15 mL (three PCEA boluses in a one hour period).'}, {'id': 'BG001', 'title': 'Low Rate Bolus (CADD-Solis Pump)', 'description': 'Labor analgesia will be maintained using timed-intermittent boluses of local anesthetic with PCEA using the CADD-Solis pump. The bolus rate will be 100 mL/h in the low-rate bolus group.\n\nCADD-Solis pump (Smiths Medical): The maintenance epidural solution for both groups will be bupivacaine 0.625 mg/mL with fentanyl 1.95 mcg/mL. The intermittent bolus volume will be 10 mL administered every 60 minutes. The first bolus will be given 30 minutes after intrathecal injection. In addition to the programmed boluses, patients will be able to administer patient-controlled epidural analgesia (PCEA) boluses of 5 mL every 10 minutes to a maximum of 15 mL (three PCEA boluses in a one hour period).'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'BG000'}, {'value': '108', 'groupId': 'BG001'}, {'value': '210', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '32', 'groupId': 'BG000', 'lowerLimit': '29', 'upperLimit': '33'}, {'value': '31', 'groupId': 'BG001', 'lowerLimit': '29', 'upperLimit': '33'}, {'value': '31', 'groupId': 'BG002', 'lowerLimit': '29', 'upperLimit': '33'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'BG000'}, {'value': '108', 'groupId': 'BG001'}, {'value': '210', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '102', 'groupId': 'BG000'}, {'value': '108', 'groupId': 'BG001'}, {'value': '210', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'BG000'}, {'value': '108', 'groupId': 'BG001'}, {'value': '210', 'groupId': 'BG002'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '14', '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': '5', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '86', 'groupId': 'BG000'}, {'value': '79', 'groupId': 'BG001'}, {'value': '165', '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': '6', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Gestational Age (weeks)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'BG000'}, {'value': '108', 'groupId': 'BG001'}, {'value': '210', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '40', 'groupId': 'BG000', 'lowerLimit': '39', 'upperLimit': '41'}, {'value': '40', 'groupId': 'BG001', 'lowerLimit': '39', 'upperLimit': '41'}, {'value': '40', 'groupId': 'BG002', 'lowerLimit': '39', 'upperLimit': '41'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'Weeks', 'dispersionType': 'FULL_RANGE'}, {'title': 'Body Mass Index (kg/m2)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'BG000'}, {'value': '108', 'groupId': 'BG001'}, {'value': '210', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '29', 'groupId': 'BG000', 'lowerLimit': '27', 'upperLimit': '33'}, {'value': '29', 'groupId': 'BG001', 'lowerLimit': '27', 'upperLimit': '31'}, {'value': '29', 'groupId': 'BG002', 'lowerLimit': '27', 'upperLimit': '33'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': '(kg/m2)', 'dispersionType': 'FULL_RANGE'}, {'title': 'Labor Type', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'BG000'}, {'value': '108', 'groupId': 'BG001'}, {'value': '210', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Spontaneous Labor', 'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '66', 'groupId': 'BG002'}]}, {'title': 'Induction of Labor', 'measurements': [{'value': '71', 'groupId': 'BG000'}, {'value': '73', 'groupId': 'BG001'}, {'value': '144', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Cervical dilation at request for epidural (cm)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'BG000'}, {'value': '108', 'groupId': 'BG001'}, {'value': '210', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000', 'lowerLimit': '2', 'upperLimit': '3.5'}, {'value': '2', 'groupId': 'BG001', 'lowerLimit': '2', 'upperLimit': '4'}, {'value': '2', 'groupId': 'BG002', 'lowerLimit': '2', 'upperLimit': '4'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'centimeters', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'VAS (visual analog scale)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'BG000'}, {'value': '108', 'groupId': 'BG001'}, {'value': '210', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '75', 'groupId': 'BG000', 'lowerLimit': '63', 'upperLimit': '87'}, {'value': '73', 'groupId': 'BG001', 'lowerLimit': '62', 'upperLimit': '84'}, {'value': '74', 'groupId': 'BG002', 'lowerLimit': '62', 'upperLimit': '86'}]}]}], 'paramType': 'MEDIAN', 'description': 'Visual Analog Scale is a scale used for pain where 0 equals no pain and 100 equals worse pain imaginable on a millimeter scale of 0-100.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Mode of delivery', 'classes': [{'title': 'Vaginal Delivery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'BG000'}, {'value': '108', 'groupId': 'BG001'}, {'value': '210', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '69', 'groupId': 'BG000'}, {'value': '71', 'groupId': 'BG001'}, {'value': '140', 'groupId': 'BG002'}]}]}, {'title': 'Assisted Vaginal Delivery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'BG000'}, {'value': '108', 'groupId': 'BG001'}, {'value': '210', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}]}, {'title': 'Cesarean Delivery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'BG000'}, {'value': '108', 'groupId': 'BG001'}, {'value': '210', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Mode of delivery of the baby (vaginal delivery, assisted vaginal delivery or Cesarean delivery)', 'unitOfMeasure': 'Participants'}, {'title': 'Indication for Cesarean delivery', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Arrest of dilation', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}, {'title': 'Arrest of descent', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}, {'title': 'Fetal Intolerance', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': '24 participants in each group underwent cesarean section. The below analyzes the reason for cesarean section in each group.'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-12-01', 'size': 401015, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-07-11T09:54', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 220}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-11', 'completionDateStruct': {'date': '2017-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-11-14', 'studyFirstSubmitDate': '2014-12-29', 'resultsFirstSubmitDate': '2019-06-19', 'studyFirstSubmitQcDate': '2015-01-13', 'lastUpdatePostDateStruct': {'date': '2019-11-26', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-09-09', 'studyFirstPostDateStruct': {'date': '2015-01-19', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-10-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Time to Provider Administered Supplemental Boluses', 'timeFrame': 'epidural to first request of redose up to 10 hours', 'description': 'Time to provider administered supplemental boluses measured in minutes'}, {'measure': 'Mean Pain Score', 'timeFrame': 'epidural placement to delivery, up to 36 hours.', 'description': 'Weighted mean pain score (measured by the area under the VAS (Visual Analog Scale)-time curve calculated using the trapezoidal integration divided by the duration of labor analgesia).Visual Analog Scale is a 100 millimeter scale where 0 is no pain and 100 is worst pain imaginable.'}, {'measure': 'Stage of Labor at Re-dose Request', 'timeFrame': 'Through 2 stages of labor up to 24 hours', 'description': 'The stage of labor ( first or second) at the time of re-dose request.'}, {'measure': 'Number of Participants With Epidural Re-doses', 'timeFrame': 'epidural placement to delivery, up to 36 hours.', 'description': 'Total number of patients requiring epidural re-doses given by the provider.'}, {'measure': 'Patient Satisfaction of Labor Anesthesia', 'timeFrame': 'Up to 24 hours after delivery of baby', 'description': 'Patient satisfaction of labor anesthesia using a score of 0 low satisfaction to 100 high satisfaction on a 100 millimeter scale.'}], 'primaryOutcomes': [{'measure': 'Number of Participants Who Experienced Breakthrough Pain.', 'timeFrame': 'epidural placement to delivery, up to 36 hours.', 'description': 'Number of participants who experienced breakthrough pain requiring a provider administered bolus by the anesthesia providers.'}], 'secondaryOutcomes': [{'measure': 'Total Bupivacaine Consumption Per Hour of Labor Analgesia', 'timeFrame': 'epidural placement to delivery, up to 36 hours.', 'description': 'Total bupivacaine amount (milligrams/hour mg/h) via pump and provider administered supplemental boluses'}, {'measure': 'Total Number of Requested PCEA Boluses', 'timeFrame': 'epidural placement to delivery, up to 36 hours.', 'description': 'Number of PCEA (Patient Controlled Epidural Anesthesia) bolus doses delivered'}, {'measure': 'Total Number of Delivered PCEA Boluses', 'timeFrame': 'epidural placement to delivery, up to 36 hours.', 'description': "Total number of PCEA (Patient Controlled Epidural Anesthesia) bolus's delivered."}, {'measure': 'Ratio of Total Number of PCEA Boluses Requested and Delivered', 'timeFrame': 'epidural placement to delivery, up to 36 hours.', 'description': "The ratio of the total number of PCEA (Patient Controlled Epidural Anesthesia) bolus's requested and PCEA doses delivered."}, {'measure': 'Satisfaction Scores', 'timeFrame': 'up to 24 hours after delivery', 'description': 'Patients overall satisfaction with pain management. The scale 0= poor satisfaction and 100= good satisfaction with pain management.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['epidural bolus', 'pain management', 'labor analgesia'], 'conditions': ['Labor Pain', 'Obstetric Pain']}, 'referencesModule': {'references': [{'pmid': '16492849', 'type': 'BACKGROUND', 'citation': 'Wong CA, Ratliff JT, Sullivan JT, Scavone BM, Toledo P, McCarthy RJ. A randomized comparison of programmed intermittent epidural bolus with continuous epidural infusion for labor analgesia. Anesth Analg. 2006 Mar;102(3):904-9. doi: 10.1213/01.ane.0000197778.57615.1a.'}, {'pmid': '16154735', 'type': 'BACKGROUND', 'citation': 'Lim Y, Sia AT, Ocampo C. Automated regular boluses for epidural analgesia: a comparison with continuous infusion. Int J Obstet Anesth. 2005 Oct;14(4):305-9. doi: 10.1016/j.ijoa.2005.05.004.'}, {'pmid': '15197122', 'type': 'BACKGROUND', 'citation': 'Chua SM, Sia AT. Automated intermittent epidural boluses improve analgesia induced by intrathecal fentanyl during labour. Can J Anaesth. 2004 Jun-Jul;51(6):581-5. doi: 10.1007/BF03018402.'}, {'pmid': '21788309', 'type': 'BACKGROUND', 'citation': 'Capogna G, Camorcia M, Stirparo S, Farcomeni A. Programmed intermittent epidural bolus versus continuous epidural infusion for labor analgesia: the effects on maternal motor function and labor outcome. A randomized double-blind study in nulliparous women. Anesth Analg. 2011 Oct;113(4):826-31. doi: 10.1213/ANE.0b013e31822827b8. Epub 2011 Jul 25.'}, {'pmid': '10439786', 'type': 'BACKGROUND', 'citation': 'Kaynar AM, Shankar KB. Epidural infusion: continuous or bolus? Anesth Analg. 1999 Aug;89(2):534. doi: 10.1097/00000539-199908000-00063. No abstract available.'}, {'pmid': '11915061', 'type': 'BACKGROUND', 'citation': 'Hogan Q. Distribution of solution in the epidural space: examination by cryomicrotome section. Reg Anesth Pain Med. 2002 Mar-Apr;27(2):150-6. doi: 10.1053/rapm.2002.29748.'}, {'pmid': '21430035', 'type': 'BACKGROUND', 'citation': 'Wong CA, McCarthy RJ, Hewlett B. The effect of manipulation of the programmed intermittent bolus time interval and injection volume on total drug use for labor epidural analgesia: a randomized controlled trial. Anesth Analg. 2011 Apr;112(4):904-11. doi: 10.1213/ANE.0b013e31820e7c2f.'}]}, 'descriptionModule': {'briefSummary': 'Administration of anesthetic solution into the epidural space is usually accomplished by a combination of continuous infusion, provider-administered boluses and patient-administered boluses (patient controlled epidural analgesia \\[PCEA\\]). The optimal method for maintaining labor analgesia is unknown. Several studies have demonstrated that timed-intermittent boluses, in combination with patient-controlled epidural analgesia (PCEA), provide superior maintenance of labor analgesia than maintenance with a continuous infusion with PCEA. Epidural infusion pumps capable of delivering timed boluses of local anesthetic with PCEA recently became commercially available. Several infusion rates are available for delivering the timed bolus, and the optimal bolus rate is unknown.', 'detailedDescription': 'Cervical dilation will be confirmed by a member of the obstetric team prior to epidural catheter placement as is routinely done at our institution. A baseline pain visual analog scale (VAS) score will be obtained using a 100-mm unmarked line with the end points labeled "no pain" and "worst pain imaginable.\n\nLabor analgesia will be initiated using CSE analgesia with 25 mcg of intrathecal fentanyl. An epidural test dose will be performed as routine (1.5% lidocaine with epinephrine 1:200, 3 mL).\n\nLabor analgesia will be maintained using timed-intermittent boluses of local anesthetic with PCEA using the CADD-Solis pump (Smiths Medical). An unblinded anesthesia research nurse will program the epidural pump and initiate the maintenance of labor analgesia.\n\nFifteen minutes following the intrathecal dose, a VAS score and a sensory level of analgesia will be obtained. The following information will be obtained hourly until complete cervical dilation (10 cm): VAS pain score, sensory level, a modified Bromage score (0 - no motor paralysis; 1 - inability to raise extended leg, but able to move knee and foot; 2 - inability to raise extended leg and to move knee, but able to move foot; 3 - inability to raise extended leg or to move knee and foot).\n\nThe time to the first request for supplemental analgesia will be recorded on the study data sheet. The time, type and volume of local anesthetic used, and VAS scores before and 15 minutes after the redose will be recorded.\n\nAll other clinical management will be as per routine, and study participation will not interfere with anesthetic or obstetric care. Anesthesiologists will manage breakthrough pain in the usual manner (assessment of stage of labor and extend/density of neuraxial blockade, followed by the appropriate maneuver to reestablish adequate analgesia).\n\nFollowing delivery, the patient will be asked to give one final VAS score and her overall satisfaction with labor using a 100 mm unmarked line. Mode of delivery, as well as the duration of the 1st and 2nd stage of labor will be recorded by study personnel.\n\nPatient Controlled Epidural Analgesia (PCEA) pump utilization data will be downloaded from epidural pumps after delivery. This will include the time to first PCEA request, the number of PCEA demands, the number of times that PCEA boluses were delivered, the total amount of local anesthetic consumed.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\nTerm, nulliparous, English-speaking patients with singleton vertex pregnancies, who were 18 years or older, who presented to the Labor and Delivery Unit of Prentice Women's Hospital of Northwestern Memorial Hospital in spontaneous labor or for induction of labor were eligible to participate in the study\n\nExclusion Criteria:\n\nHistory of chronic opioid analgesic use, prior opioid administration during labor, refusal of a vaginal examination prior to initiation of combined spinal-epidural (CSE) analgesia, or the presence of contraindications to neuraxial analgesia, such as coagulopathy or sepsis. Patients with cervical dilation \\> 5cm at the request for an epidural analgesia and women that were dilated \\> 5cm upon presentation to the labor and delivery unit were not approached for inclusion in the study; patients were excluded from the study after randomization if request for provider-administered supplemental bolus, or delivery, occurred within 90 minutes of intrathecal injection, or if there was a need for epidural catheter replacement during labor."}, 'identificationModule': {'nctId': 'NCT02340806', 'briefTitle': 'Association Between Bolus Rate and the Adequacy of Labor Analgesia Using Timed-intermittent Boluses', 'organization': {'class': 'OTHER', 'fullName': 'Northwestern University'}, 'officialTitle': 'Effect of Epidural Infusion Bolus Delivery Rate on the Duration of Labor Analgesia', 'orgStudyIdInfo': {'id': 'STU00100819'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'High rate bolus (CADD-Solis pump)', 'description': 'Labor analgesia will be maintained using timed-intermittent boluses of local anesthetic with PCEA using the CADD-Solis pump. The bolus rate will be 300 mL/h in the high-rate bolus group.', 'interventionNames': ['Device: CADD-Solis pump (Smiths Medical)']}, {'type': 'EXPERIMENTAL', 'label': 'Low rate bolus (CADD-Solis pump)', 'description': 'Labor analgesia will be maintained using timed-intermittent boluses of local anesthetic with PCEA using the CADD-Solis pump. The bolus rate will be 100 mL/h in the low-rate bolus group.', 'interventionNames': ['Device: CADD-Solis pump (Smiths Medical)']}], 'interventions': [{'name': 'CADD-Solis pump (Smiths Medical)', 'type': 'DEVICE', 'description': 'The maintenance epidural solution for both groups will be bupivacaine 0.625 mg/mL with fentanyl 1.95 mcg/mL. The intermittent bolus volume will be 10 mL administered every 60 minutes. The first bolus will be given 30 minutes after intrathecal injection. In addition to the programmed boluses, patients will be able to administer patient-controlled epidural analgesia (PCEA) boluses of 5 mL every 10 minutes to a maximum of 15 mL (three PCEA boluses in a one hour period).', 'armGroupLabels': ['High rate bolus (CADD-Solis pump)', 'Low rate bolus (CADD-Solis pump)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Northwestern Memorial Hospital', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}], 'overallOfficials': [{'name': 'Elizabeth Lange, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Northwestern University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Northwestern University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Anesthesiology', 'investigatorFullName': 'Elizabeth Lange', 'investigatorAffiliation': 'Northwestern University'}}}}