Ignite Creation Date:
2025-12-25 @ 1:19 AM
Ignite Modification Date:
2025-12-29 @ 3:29 AM
Study NCT ID:
NCT01062893
Status:
TERMINATED
Last Update Posted:
2018-10-16
First Post:
2010-02-01
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Combined Spinal/Epidural (CSE) Saline Duration/Spread
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D048949', 'term': 'Labor Pain'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ppan@wakehealth.edu', 'phone': '336-718-8278', 'title': 'Peter H. Pan, MD', 'organization': 'Wake Forest University School of Medicine'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': '0 Mls Saline Injected', 'description': 'NO SALINE INJECTED\n\nSterile normal saline 0 mls: at time of epidural needle placement there will not be any saline injected into the epidural space prior to placement of the spinal needle to administer the CSE dose of standard analgesic medications. Instead a pause will be done as by the investigator to maintain blind for the assessor.', 'otherNumAtRisk': 27, 'deathsNumAtRisk': 27, 'otherNumAffected': 0, 'seriousNumAtRisk': 27, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': '15 Mls Saline', 'description': '15ML SALINE ADMINISTERED EPIDURALLY\n\n15 mls sterile normal saline: After the epidural needle is placed, 15 mls of sterile normal saline will be injected into the epidural space, then the spinal needle will be placed to administer the CSE dose of standard analgesic medications.', 'otherNumAtRisk': 28, 'deathsNumAtRisk': 28, 'otherNumAffected': 0, 'seriousNumAtRisk': 28, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Highest Sensory Blockade Level to Pinprick and to Cold', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '0 Mls Saline Injected', 'description': 'NO SALINE INJECTED\n\nSterile normal saline 0 mls: at time of epidural needle placement there will not be any saline injected into the epidural space prior to placement of the spinal needle to administer the CSE dose of standard analgesic medications. Instead a pause will be done as by the investigator to maintain blind for the assessor.'}, {'id': 'OG001', 'title': '15 Mls Saline', 'description': '15ML SALINE ADMINISTERED EPIDURALLY\n\n15 mls sterile normal saline: After the epidural needle is placed, 15 mls of sterile normal saline will be injected into the epidural space, then the spinal needle will be placed to administer the CSE dose of standard analgesic medications.'}], 'classes': [{'categories': [{'measurements': [{'value': '10.1', 'spread': '2.9', 'groupId': 'OG000'}, {'value': '11.6', 'spread': '1.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'up to 20 minutes', 'description': 'Onset of analgesia to recession of analgesia. Highest spread of analgesia (highest sensory level) to cold temp and pinprick, with level defined from T1 to L5, where T1 is highest =level 17 and L5 is lowest =Level 1)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Duration of Analgesia (Time to Request Additional Analgesia)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '0 Mls Saline Injected', 'description': 'NO SALINE INJECTED\n\nSterile normal saline 0 mls: at time of epidural needle placement there will not be any saline injected into the epidural space prior to placement of the spinal needle to administer the CSE dose of standard analgesic medications. Instead a pause will be done as by the investigator to maintain blind for the assessor.'}, {'id': 'OG001', 'title': '15 Mls Saline', 'description': '15ML SALINE ADMINISTERED EPIDURALLY\n\n15 mls sterile normal saline: After the epidural needle is placed, 15 mls of sterile normal saline will be injected into the epidural space, then the spinal needle will be placed to administer the CSE dose of standard analgesic medications.'}], 'classes': [{'categories': [{'measurements': [{'value': '57.2', 'spread': '33.9', 'groupId': 'OG000'}, {'value': '77.3', 'spread': '30.0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'up 120 minutes', 'description': 'time of CSE to time request of additional supplement analgesia in minutes', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Onset of Analgesia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '0 Mls Saline Injected', 'description': 'NO SALINE INJECTED\n\nSterile normal saline 0 mls: at time of epidural needle placement there will not be any saline injected into the epidural space prior to placement of the spinal needle to administer the CSE dose of standard analgesic medications. Instead a pause will be done as by the investigator to maintain blind for the assessor.'}, {'id': 'OG001', 'title': '15 Mls Saline', 'description': '15ML SALINE ADMINISTERED EPIDURALLY\n\n15 mls sterile normal saline: After the epidural needle is placed, 15 mls of sterile normal saline will be injected into the epidural space, then the spinal needle will be placed to administer the CSE dose of standard analgesic medications.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.96', 'spread': '5.24', 'groupId': 'OG000'}, {'value': '6.07', 'spread': '3.15', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'up to 20 minutes', 'description': 'time to VAS\\</=3 on a 0-10 scale with 0=no pain up to 10= worst pain imaginable', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Time to Highest Sensory Block', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '0 Mls Saline Injected', 'description': 'NO SALINE INJECTED\n\nSterile normal saline 0 mls: at time of epidural needle placement there will not be any saline injected into the epidural space prior to placement of the spinal needle to administer the CSE dose of standard analgesic medications. Instead a pause will be done as by the investigator to maintain blind for the assessor.'}, {'id': 'OG001', 'title': '15 Mls Saline', 'description': '15ML SALINE ADMINISTERED EPIDURALLY\n\n15 mls sterile normal saline: After the epidural needle is placed, 15 mls of sterile normal saline will be injected into the epidural space, then the spinal needle will be placed to administer the CSE dose of standard analgesic medications.'}], 'classes': [{'categories': [{'measurements': [{'value': '12.96', 'spread': '8.69', 'groupId': 'OG000'}, {'value': '13.57', 'spread': '6.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'up to 20 minutes', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Had Occurrence of Fetal Bradycardia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '0 Mls Saline Injected', 'description': 'NO SALINE INJECTED\n\nSterile normal saline 0 mls: at time of epidural needle placement there will not be any saline injected into the epidural space prior to placement of the spinal needle to administer the CSE dose of standard analgesic medications. Instead a pause will be done as by the investigator to maintain blind for the assessor.'}, {'id': 'OG001', 'title': '15 Mls Saline', 'description': '15ML SALINE ADMINISTERED EPIDURALLY\n\n15 mls sterile normal saline: After the epidural needle is placed, 15 mls of sterile normal saline will be injected into the epidural space, then the spinal needle will be placed to administer the CSE dose of standard analgesic medications.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'length of labor, up to 24 hours', 'description': 'occurrence of common side effects of spinal/epidural administration', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Had Occurrence of Maternal Hypotension', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '0 Mls Saline Injected', 'description': 'NO SALINE INJECTED\n\nSterile normal saline 0 mls: at time of epidural needle placement there will not be any saline injected into the epidural space prior to placement of the spinal needle to administer the CSE dose of standard analgesic medications. Instead a pause will be done as by the investigator to maintain blind for the assessor.'}, {'id': 'OG001', 'title': '15 Mls Saline', 'description': '15ML SALINE ADMINISTERED EPIDURALLY\n\n15 mls sterile normal saline: After the epidural needle is placed, 15 mls of sterile normal saline will be injected into the epidural space, then the spinal needle will be placed to administer the CSE dose of standard analgesic medications.'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'length of labor, up to 24 hours', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Occurrence of Use of Vasopressors', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '0 Mls Saline Injected', 'description': 'NO SALINE INJECTED\n\nSterile normal saline 0 mls: at time of epidural needle placement there will not be any saline injected into the epidural space prior to placement of the spinal needle to administer the CSE dose of standard analgesic medications. Instead a pause will be done as by the investigator to maintain blind for the assessor.'}, {'id': 'OG001', 'title': '15 Mls Saline', 'description': '15ML SALINE ADMINISTERED EPIDURALLY\n\n15 mls sterile normal saline: After the epidural needle is placed, 15 mls of sterile normal saline will be injected into the epidural space, then the spinal needle will be placed to administer the CSE dose of standard analgesic medications.'}], 'classes': [{'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'length of labor, up to 24 hours', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Had Occurrence of Itching', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '0 Mls Saline Injected', 'description': 'NO SALINE INJECTED\n\nSterile normal saline 0 mls: at time of epidural needle placement there will not be any saline injected into the epidural space prior to placement of the spinal needle to administer the CSE dose of standard analgesic medications. Instead a pause will be done as by the investigator to maintain blind for the assessor.'}, {'id': 'OG001', 'title': '15 Mls Saline', 'description': '15ML SALINE ADMINISTERED EPIDURALLY\n\n15 mls sterile normal saline: After the epidural needle is placed, 15 mls of sterile normal saline will be injected into the epidural space, then the spinal needle will be placed to administer the CSE dose of standard analgesic medications.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'length of labor, up to 24 hours', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Had Occurrence of Post Dural Puncture Headache', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '0 Mls Saline Injected', 'description': 'NO SALINE INJECTED\n\nSterile normal saline 0 mls: at time of epidural needle placement there will not be any saline injected into the epidural space prior to placement of the spinal needle to administer the CSE dose of standard analgesic medications. Instead a pause will be done as by the investigator to maintain blind for the assessor.'}, {'id': 'OG001', 'title': '15 Mls Saline', 'description': '15ML SALINE ADMINISTERED EPIDURALLY\n\n15 mls sterile normal saline: After the epidural needle is placed, 15 mls of sterile normal saline will be injected into the epidural space, then the spinal needle will be placed to administer the CSE dose of standard analgesic medications.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'length of labor, up to 24 hours', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Time for 2 Dermatome Level Regression of Sensory Block', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '0 Mls Saline Injected', 'description': 'NO SALINE INJECTED\n\nSterile normal saline 0 mls: at time of epidural needle placement there will not be any saline injected into the epidural space prior to placement of the spinal needle to administer the CSE dose of standard analgesic medications. Instead a pause will be done as by the investigator to maintain blind for the assessor.'}, {'id': 'OG001', 'title': '15 Mls Saline', 'description': '15ML SALINE ADMINISTERED EPIDURALLY\n\n15 mls sterile normal saline: After the epidural needle is placed, 15 mls of sterile normal saline will be injected into the epidural space, then the spinal needle will be placed to administer the CSE dose of standard analgesic medications.'}], 'timeFrame': 'up to 20 minutes', 'reportingStatus': 'POSTED', 'populationDescription': 'No data collected'}, {'type': 'SECONDARY', 'title': 'Time for Regression of Motor Blockade', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '0 Mls Saline Injected', 'description': 'NO SALINE INJECTED\n\nSterile normal saline 0 mls: at time of epidural needle placement there will not be any saline injected into the epidural space prior to placement of the spinal needle to administer the CSE dose of standard analgesic medications. Instead a pause will be done as by the investigator to maintain blind for the assessor.'}, {'id': 'OG001', 'title': '15 Mls Saline', 'description': '15ML SALINE ADMINISTERED EPIDURALLY\n\n15 mls sterile normal saline: After the epidural needle is placed, 15 mls of sterile normal saline will be injected into the epidural space, then the spinal needle will be placed to administer the CSE dose of standard analgesic medications.'}], 'timeFrame': 'up to 20 minutes', 'reportingStatus': 'POSTED', 'populationDescription': 'No data collected'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '0 Mls Saline Injected', 'description': 'NO SALINE INJECTED\n\nSterile normal saline 0 mls: at time of epidural needle placement there will not be any saline injected into the epidural space prior to placement of the spinal needle to administer the CSE dose of standard analgesic medications. Instead a pause will be done as by the investigator to maintain blind for the assessor.'}, {'id': 'FG001', 'title': '15 Mls Saline', 'description': '15ML SALINE ADMINISTERED EPIDURALLY\n\n15 mls sterile normal saline: After the epidural needle is placed, 15 mls of sterile normal saline will be injected into the epidural space, then the spinal needle will be placed to administer the CSE dose of standard analgesic medications.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '41'}, {'groupId': 'FG001', 'numSubjects': '41'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '27'}, {'groupId': 'FG001', 'numSubjects': '28'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '13'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '55', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': '0 Mls Saline Injected', 'description': 'NO SALINE INJECTED\n\nSterile normal saline 0 mls: at time of epidural needle placement there will not be any saline injected into the epidural space prior to placement of the spinal needle to administer the CSE dose of standard analgesic medications. Instead a pause will be done as by the investigator to maintain blind for the assessor.'}, {'id': 'BG001', 'title': '15 Mls Saline', 'description': '15ML SALINE ADMINISTERED EPIDURALLY\n\n15 mls sterile normal saline: After the epidural needle is placed, 15 mls of sterile normal saline will be injected into the epidural space, then the spinal needle will be placed to administer the CSE dose of standard analgesic medications.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '55', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '55', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '55', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2011-01-25', 'size': 399416, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2018-09-05T11:06', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 82}}, 'statusModule': {'whyStopped': 'lack of subjects and manpower issues', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2009-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-10-12', 'studyFirstSubmitDate': '2010-02-01', 'resultsFirstSubmitDate': '2018-09-10', 'studyFirstSubmitQcDate': '2010-02-03', 'lastUpdatePostDateStruct': {'date': '2018-10-16', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-10-12', 'studyFirstPostDateStruct': {'date': '2010-02-04', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-10-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Highest Sensory Blockade Level to Pinprick and to Cold', 'timeFrame': 'up to 20 minutes', 'description': 'Onset of analgesia to recession of analgesia. Highest spread of analgesia (highest sensory level) to cold temp and pinprick, with level defined from T1 to L5, where T1 is highest =level 17 and L5 is lowest =Level 1)'}], 'secondaryOutcomes': [{'measure': 'Duration of Analgesia (Time to Request Additional Analgesia)', 'timeFrame': 'up 120 minutes', 'description': 'time of CSE to time request of additional supplement analgesia in minutes'}, {'measure': 'Onset of Analgesia', 'timeFrame': 'up to 20 minutes', 'description': 'time to VAS\\</=3 on a 0-10 scale with 0=no pain up to 10= worst pain imaginable'}, {'measure': 'Time to Highest Sensory Block', 'timeFrame': 'up to 20 minutes'}, {'measure': 'Number of Participants Who Had Occurrence of Fetal Bradycardia', 'timeFrame': 'length of labor, up to 24 hours', 'description': 'occurrence of common side effects of spinal/epidural administration'}, {'measure': 'Number of Participants Who Had Occurrence of Maternal Hypotension', 'timeFrame': 'length of labor, up to 24 hours'}, {'measure': 'Occurrence of Use of Vasopressors', 'timeFrame': 'length of labor, up to 24 hours'}, {'measure': 'Number of Participants Who Had Occurrence of Itching', 'timeFrame': 'length of labor, up to 24 hours'}, {'measure': 'Number of Participants Who Had Occurrence of Post Dural Puncture Headache', 'timeFrame': 'length of labor, up to 24 hours'}, {'measure': 'Time for 2 Dermatome Level Regression of Sensory Block', 'timeFrame': 'up to 20 minutes'}, {'measure': 'Time for Regression of Motor Blockade', 'timeFrame': 'up to 20 minutes'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['labor pain treatment', 'duration analgesia', 'Analgesic duration with normal saline injection.', 'Analgesic duration without normal saline injection'], 'conditions': ['Labor Pain']}, 'descriptionModule': {'briefSummary': 'An attempt is being made to see if by injecting a set volume of sterile saline into the epidural space during the treatment of labor pain with a combined spinal/epidural (CSE) increases the amount of pain relief obtained and makes the labor analgesia lasts longer. Subjects are in the study from the time their CSE is placed until they request additional pain medication from the spinal dose of numbing medicine wearing off.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age greater than 12 years of age\n* ASA status 1 or 2\n* cervical dilation \\< 6cm\n\nExclusion Criteria:\n\n* ASA assigned 3 or 4\n* advanced labor (\\> 6cm cervical dilated)\n* distorted epidural anatomy'}, 'identificationModule': {'nctId': 'NCT01062893', 'briefTitle': 'Combined Spinal/Epidural (CSE) Saline Duration/Spread', 'organization': {'class': 'OTHER', 'fullName': 'Wake Forest University Health Sciences'}, 'officialTitle': 'Effect of Epidural Saline on Duration and Spread of Subsequent Spinal Analgesia/Anesthesia Using a CSE Technique', 'orgStudyIdInfo': {'id': 'IRB00009631'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': '0 mls saline injected', 'description': 'NO SALINE INJECTED', 'interventionNames': ['Other: Sterile normal saline 0 mls']}, {'type': 'ACTIVE_COMPARATOR', 'label': '15 mls saline', 'description': '15ML SALINE ADMINISTERED EPIDURALLY', 'interventionNames': ['Other: 15 mls sterile normal saline']}], 'interventions': [{'name': 'Sterile normal saline 0 mls', 'type': 'OTHER', 'description': 'at time of epidural needle placement there will not be any saline injected into the epidural space prior to placement of the spinal needle to administer the CSE dose of standard analgesic medications. Instead a pause will be done as by the investigator to maintain blind for the assessor.', 'armGroupLabels': ['0 mls saline injected']}, {'name': '15 mls sterile normal saline', 'type': 'OTHER', 'description': 'After the epidural needle is placed, 15 mls of sterile normal saline will be injected into the epidural space, then the spinal needle will be placed to administer the CSE dose of standard analgesic medications.', 'armGroupLabels': ['15 mls saline']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27103', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': "Forsyth Medical Center-Sara Lee Center for Women's Health", 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}], 'overallOfficials': [{'name': 'Peter H Pan, MD, MSEE', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Wake Forest University Health Sciences'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wake Forest University Health Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}