Ignite Creation Date:
2025-12-25 @ 5:00 AM
Ignite Modification Date:
2025-12-26 @ 4:00 AM
Study NCT ID:
NCT03760718
Status:
COMPLETED
Last Update Posted:
2024-09-19
First Post:
2018-11-09
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Chloroprocaine Lavage to Improve Outcomes Related to Operative Cesarean Delivery
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C004616', 'term': 'chloroprocaine'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'togioka@ohsu.edu', 'phone': '503-494-4572', 'title': 'Brandon Togioka, MD', 'organization': 'Oregon Health & Science University'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '1 day', 'eventGroups': [{'id': 'EG000', 'title': 'Preservative Free Chloroprocaine Group 1', 'description': '40 ml of preservative-free 1% chloroprocaine\n\nPreservative free 1% Chloroprocaine: 40 ml of preservative-free 1% chloroprocaine is planned for administration into the peritoneal cavity after delivery of the baby.', 'otherNumAtRisk': 5, 'deathsNumAtRisk': 5, 'otherNumAffected': 1, 'seriousNumAtRisk': 5, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Preservative Free Chloroprocaine Group 2', 'description': '40 ml of preservative-free 2% chloroprocaine\n\nPreservative free 2% Chloroprocaine: 40 ml of preservative-free 2% chloroprocaine is planned for administration into the peritoneal cavity after delivery of the baby.', 'otherNumAtRisk': 5, 'deathsNumAtRisk': 5, 'otherNumAffected': 2, 'seriousNumAtRisk': 5, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Preservative Free Chloroprocaine Group 3', 'description': '40 ml of preservative-free 3% chloroprocaine\n\nPreservative free 3% Chloroprocaine: 40 ml of preservative-free 3% chloroprocaine is planned for administration into the peritoneal cavity after delivery of the baby.', 'otherNumAtRisk': 5, 'deathsNumAtRisk': 5, 'otherNumAffected': 1, 'seriousNumAtRisk': 5, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'metallic taste', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Chloroprocaine Plasma Concentration at 1 Minute', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Preservative Free Chloroprocaine Group 1', 'description': '40 ml of preservative-free 1% chloroprocaine\n\nPreservative free 1% Chloroprocaine: 40 ml of preservative-free 1% chloroprocaine is planned for administration into the peritoneal cavity after delivery of the baby.'}, {'id': 'OG001', 'title': 'Preservative Free Chloroprocaine Group 2', 'description': '40 ml of preservative-free 2% chloroprocaine\n\nPreservative free 2% Chloroprocaine: 40 ml of preservative-free 2% chloroprocaine is planned for administration into the peritoneal cavity after delivery of the baby.'}, {'id': 'OG002', 'title': 'Preservative Free Chloroprocaine Group 3', 'description': '40 ml of preservative-free 3% chloroprocaine\n\nPreservative free 3% Chloroprocaine: 40 ml of preservative-free 3% chloroprocaine is planned for administration into the peritoneal cavity after delivery of the baby.'}], 'classes': [{'categories': [{'measurements': [{'value': '14.3', 'groupId': 'OG000', 'lowerLimit': '0.4', 'upperLimit': '39.9'}, {'value': '7.5', 'groupId': 'OG001', 'lowerLimit': '1.0', 'upperLimit': '16.6'}, {'value': '3.5', 'groupId': 'OG002', 'lowerLimit': '1.1', 'upperLimit': '6.0'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 minute after intraperitoneal chloroprocaine administration', 'description': 'The chloroprocaine plasma concentration obtained from a venous sample 1 minute after intraperitoneal chloroprocaine administration.', 'unitOfMeasure': 'ng/ml', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Chloroprocaine Plasma Concentration at 5 Minutes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Preservative Free Chloroprocaine Group 1', 'description': '40 ml of preservative-free 1% chloroprocaine\n\nPreservative free 1% Chloroprocaine: 40 ml of preservative-free 1% chloroprocaine is planned for administration into the peritoneal cavity after delivery of the baby.'}, {'id': 'OG001', 'title': 'Preservative Free Chloroprocaine Group 2', 'description': '40 ml of preservative-free 2% chloroprocaine\n\nPreservative free 2% Chloroprocaine: 40 ml of preservative-free 2% chloroprocaine is planned for administration into the peritoneal cavity after delivery of the baby.'}, {'id': 'OG002', 'title': 'Preservative Free Chloroprocaine Group 3', 'description': '40 ml of preservative-free 3% chloroprocaine\n\nPreservative free 3% Chloroprocaine: 40 ml of preservative-free 3% chloroprocaine is planned for administration into the peritoneal cavity after delivery of the baby.'}], 'classes': [{'categories': [{'measurements': [{'value': '14.5', 'groupId': 'OG000', 'lowerLimit': '4.1', 'upperLimit': '24.7'}, {'value': '14.1', 'groupId': 'OG001', 'lowerLimit': '4.7', 'upperLimit': '24.0'}, {'value': '323.1', 'groupId': 'OG002', 'lowerLimit': '34.8', 'upperLimit': '611.4'}]}]}], 'paramType': 'MEAN', 'timeFrame': '5 minutes after intraperitoneal chloroprocaine administration', 'description': 'The chloroprocaine plasma concentration obtained from a venous sample 5 minutes after intraperitoneal chloroprocaine administration.', 'unitOfMeasure': 'ng/ml', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Chloroprocaine Plasma Concentration at 10 Minutes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Preservative Free Chloroprocaine Group 1', 'description': '40 ml of preservative-free 1% chloroprocaine\n\nPreservative free 1% Chloroprocaine: 40 ml of preservative-free 1% chloroprocaine is planned for administration into the peritoneal cavity after delivery of the baby.'}, {'id': 'OG001', 'title': 'Preservative Free Chloroprocaine Group 2', 'description': '40 ml of preservative-free 2% chloroprocaine\n\nPreservative free 2% Chloroprocaine: 40 ml of preservative-free 2% chloroprocaine is planned for administration into the peritoneal cavity after delivery of the baby.'}, {'id': 'OG002', 'title': 'Preservative Free Chloroprocaine Group 3', 'description': '40 ml of preservative-free 3% chloroprocaine\n\nPreservative free 3% Chloroprocaine: 40 ml of preservative-free 3% chloroprocaine is planned for administration into the peritoneal cavity after delivery of the baby.'}], 'classes': [{'categories': [{'measurements': [{'value': '10.4', 'groupId': 'OG000', 'lowerLimit': '5.8', 'upperLimit': '15.1'}, {'value': '6.0', 'groupId': 'OG001', 'lowerLimit': '1.1', 'upperLimit': '10.8'}, {'value': '217.9', 'groupId': 'OG002', 'lowerLimit': '11.0', 'upperLimit': '606.3'}]}]}], 'paramType': 'MEAN', 'timeFrame': '10 minutes after intraperitoneal chloroprocaine administration', 'description': 'The chloroprocaine plasma concentration obtained from a venous sample 10 minutes after intraperitoneal chloroprocaine administration.', 'unitOfMeasure': 'ng/ml', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Chloroprocaine Plasma Concentration at 20 Minutes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Preservative Free Chloroprocaine Group 1', 'description': '40 ml of preservative-free 1% chloroprocaine\n\nPreservative free 1% Chloroprocaine: 40 ml of preservative-free 1% chloroprocaine is planned for administration into the peritoneal cavity after delivery of the baby.'}, {'id': 'OG001', 'title': 'Preservative Free Chloroprocaine Group 2', 'description': '40 ml of preservative-free 2% chloroprocaine\n\nPreservative free 2% Chloroprocaine: 40 ml of preservative-free 2% chloroprocaine is planned for administration into the peritoneal cavity after delivery of the baby.'}, {'id': 'OG002', 'title': 'Preservative Free Chloroprocaine Group 3', 'description': '40 ml of preservative-free 3% chloroprocaine\n\nPreservative free 3% Chloroprocaine: 40 ml of preservative-free 3% chloroprocaine is planned for administration into the peritoneal cavity after delivery of the baby.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.2', 'groupId': 'OG000', 'lowerLimit': '0.5', 'upperLimit': '4.4'}, {'value': '1.7', 'groupId': 'OG001', 'lowerLimit': '1.0', 'upperLimit': '2.7'}, {'value': '3.4', 'groupId': 'OG002', 'lowerLimit': '0.7', 'upperLimit': '7.8'}]}]}], 'paramType': 'MEAN', 'timeFrame': '20 minutes after intraperitoneal chloroprocaine administration', 'description': 'The chloroprocaine plasma concentration obtained from a venous sample 20 minutes after intraperitoneal chloroprocaine administration.', 'unitOfMeasure': 'ng/ml', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Chloroprocaine Plasma Concentration at 30 Minutes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Preservative Free Chloroprocaine Group 1', 'description': '40 ml of preservative-free 1% chloroprocaine\n\nPreservative free 1% Chloroprocaine: 40 ml of preservative-free 1% chloroprocaine is planned for administration into the peritoneal cavity after delivery of the baby.'}, {'id': 'OG001', 'title': 'Preservative Free Chloroprocaine Group 2', 'description': '40 ml of preservative-free 2% chloroprocaine\n\nPreservative free 2% Chloroprocaine: 40 ml of preservative-free 2% chloroprocaine is planned for administration into the peritoneal cavity after delivery of the baby.'}, {'id': 'OG002', 'title': 'Preservative Free Chloroprocaine Group 3', 'description': '40 ml of preservative-free 3% chloroprocaine\n\nPreservative free 3% Chloroprocaine: 40 ml of preservative-free 3% chloroprocaine is planned for administration into the peritoneal cavity after delivery of the baby.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.4', 'groupId': 'OG000', 'lowerLimit': '0.2', 'upperLimit': '9.1'}, {'value': '1.2', 'groupId': 'OG001', 'lowerLimit': '0.5', 'upperLimit': '2.3'}, {'value': '3.1', 'groupId': 'OG002', 'lowerLimit': '0.6', 'upperLimit': '5.5'}]}]}], 'paramType': 'MEAN', 'timeFrame': '30 minutes after intraperitoneal chloroprocaine administration', 'description': 'The chloroprocaine plasma concentration obtained from a venous sample 30 minutes after intraperitoneal chloroprocaine administration.', 'unitOfMeasure': 'ng/ml', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Dizziness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Preservative Free Chloroprocaine Group 1', 'description': '40 ml of preservative-free 1% chloroprocaine\n\nPreservative free 1% Chloroprocaine: 40 ml of preservative-free 1% chloroprocaine is planned for administration into the peritoneal cavity after delivery of the baby.'}, {'id': 'OG001', 'title': 'Preservative Free Chloroprocaine Group 2', 'description': '40 ml of preservative-free 2% chloroprocaine\n\nPreservative free 2% Chloroprocaine: 40 ml of preservative-free 2% chloroprocaine is planned for administration into the peritoneal cavity after delivery of the baby.'}, {'id': 'OG002', 'title': 'Preservative Free Chloroprocaine Group 3', 'description': '40 ml of preservative-free 3% chloroprocaine\n\nPreservative free 3% Chloroprocaine: 40 ml of preservative-free 3% chloroprocaine is planned for administration into the peritoneal cavity after delivery of the baby.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Within 4 hours of intraperitoneal chloroprocaine administration', 'description': 'description of dizziness upon research coordinator query', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Metallic Taste', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Preservative Free Chloroprocaine Group 1', 'description': '40 ml of preservative-free 1% chloroprocaine administered into the peritoneal cavity after delivery of the baby'}, {'id': 'OG001', 'title': 'Preservative Free Chloroprocaine Group 2', 'description': '40 ml of preservative-free 2% chloroprocaine administered into the peritoneal cavity after delivery of the baby'}, {'id': 'OG002', 'title': 'Preservative Free Chloroprocaine Group 3', 'description': '40 ml of preservative-free 3% chloroprocaine administered into the peritoneal cavity after delivery of the baby'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'within 4 hours of study drug administration', 'description': 'description of metallic taste upon research coordinator query', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Nausea', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Preservative Free Chloroprocaine Group 1', 'description': '40 ml of preservative-free 1% chloroprocaine administered into the peritoneal cavity after delivery of the baby'}, {'id': 'OG001', 'title': 'Preservative Free Chloroprocaine Group 2', 'description': '40 ml of preservative-free 2% chloroprocaine administered into the peritoneal cavity after delivery of the baby'}, {'id': 'OG002', 'title': 'Preservative Free Chloroprocaine Group 3', 'description': '40 ml of preservative-free 3% chloroprocaine administered into the peritoneal cavity after delivery of the baby'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Within 4 hours of study drug administration', 'description': 'description of nausea upon research coordinator query', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Preservative Free Chloroprocaine Group 1', 'description': '40 ml of preservative-free 1% chloroprocaine administered into the peritoneal cavity after delivery of the baby'}, {'id': 'FG001', 'title': 'Preservative Free Chloroprocaine Group 2', 'description': '40 ml of preservative-free 2% chloroprocaine administered into the peritoneal cavity after delivery of the baby'}, {'id': 'FG002', 'title': 'Preservative Free Chloroprocaine Group 3', 'description': '40 ml of preservative-free 3% chloroprocaine administered into the peritoneal cavity after delivery of the baby'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '5'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '5'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '15', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Preservative Free Chloroprocaine Group 1', 'description': '40 ml of preservative-free 1% chloroprocaine\n\nPreservative free 1% Chloroprocaine: 40 ml of preservative-free 1% chloroprocaine is planned for administration into the peritoneal cavity after delivery of the baby.'}, {'id': 'BG001', 'title': 'Preservative Free Chloroprocaine Group 2', 'description': '40 ml of preservative-free 2% chloroprocaine\n\nPreservative free 2% Chloroprocaine: 40 ml of preservative-free 2% chloroprocaine is planned for administration into the peritoneal cavity after delivery of the baby.'}, {'id': 'BG002', 'title': 'Preservative Free Chloroprocaine Group 3', 'description': '40 ml of preservative-free 3% chloroprocaine\n\nPreservative free 3% Chloroprocaine: 40 ml of preservative-free 3% chloroprocaine is planned for administration into the peritoneal cavity after delivery of the baby.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '32.8', 'spread': '6.4', 'groupId': 'BG000'}, {'value': '34.8', 'spread': '3.8', 'groupId': 'BG001'}, {'value': '34', 'spread': '5.3', 'groupId': 'BG002'}, {'value': '33.9', 'spread': '5.0', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '15', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '15', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'American Society of Anesthesiologists Physical Status', 'classes': [{'categories': [{'title': 'American Society of Anesthesiologists Physical Status 2', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}]}, {'title': 'American Society of Anesthesiologists Physical Status 3', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'American Society of Anesthesiologist Physical Status 1 (healthiest/lowest risk patient): A normal healthy patient with no acute or chronic diseases.\n\nAmerican Society of Anesthesiologist Physical Status 2 (middle risk patient): A patient with mild systemic disease that does not cause functional limitations.\n\nAmerican Society of Anesthesiologist Physical Status 3 (least healthy/highest risk patient in the study): A patient with severe systemic disease that causes substantial functional limitations', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-11-30', 'size': 334825, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-10-05T17:07', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-09-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2021-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-20', 'studyFirstSubmitDate': '2018-11-09', 'resultsFirstSubmitDate': '2023-10-31', 'studyFirstSubmitQcDate': '2018-11-29', 'lastUpdatePostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-04-20', 'studyFirstPostDateStruct': {'date': '2018-11-30', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-09-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Dizziness', 'timeFrame': 'Within 4 hours of intraperitoneal chloroprocaine administration', 'description': 'description of dizziness upon research coordinator query'}, {'measure': 'Metallic Taste', 'timeFrame': 'within 4 hours of study drug administration', 'description': 'description of metallic taste upon research coordinator query'}, {'measure': 'Nausea', 'timeFrame': 'Within 4 hours of study drug administration', 'description': 'description of nausea upon research coordinator query'}], 'primaryOutcomes': [{'measure': 'Chloroprocaine Plasma Concentration at 1 Minute', 'timeFrame': '1 minute after intraperitoneal chloroprocaine administration', 'description': 'The chloroprocaine plasma concentration obtained from a venous sample 1 minute after intraperitoneal chloroprocaine administration.'}, {'measure': 'Chloroprocaine Plasma Concentration at 5 Minutes', 'timeFrame': '5 minutes after intraperitoneal chloroprocaine administration', 'description': 'The chloroprocaine plasma concentration obtained from a venous sample 5 minutes after intraperitoneal chloroprocaine administration.'}, {'measure': 'Chloroprocaine Plasma Concentration at 10 Minutes', 'timeFrame': '10 minutes after intraperitoneal chloroprocaine administration', 'description': 'The chloroprocaine plasma concentration obtained from a venous sample 10 minutes after intraperitoneal chloroprocaine administration.'}, {'measure': 'Chloroprocaine Plasma Concentration at 20 Minutes', 'timeFrame': '20 minutes after intraperitoneal chloroprocaine administration', 'description': 'The chloroprocaine plasma concentration obtained from a venous sample 20 minutes after intraperitoneal chloroprocaine administration.'}, {'measure': 'Chloroprocaine Plasma Concentration at 30 Minutes', 'timeFrame': '30 minutes after intraperitoneal chloroprocaine administration', 'description': 'The chloroprocaine plasma concentration obtained from a venous sample 30 minutes after intraperitoneal chloroprocaine administration.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['chloroprocaine', 'cesarean delivery', 'lavage'], 'conditions': ['Cesarean Section']}, 'referencesModule': {'references': [{'pmid': '1118089', 'type': 'BACKGROUND', 'citation': 'Ranney B, Stanage WF. Advantages of local anesthesia for cesarean section. Obstet Gynecol. 1975 Feb;45(2):163-7.'}, {'pmid': '35544759', 'type': 'DERIVED', 'citation': 'Togioka BM, Zarnegarnia Y, Bleyle LA, Koop D, Brookfield K, Yanez ND, Treggiari MM. Pharmacokinetics and Tolerability of Intraperitoneal Chloroprocaine After Fetal Extraction in Women Undergoing Cesarean Delivery. Anesth Analg. 2022 Oct 1;135(4):777-786. doi: 10.1213/ANE.0000000000006064. Epub 2022 May 11.'}]}, 'descriptionModule': {'briefSummary': "The long term objective is to show that intraperitoneal chloroprocaine can be used an alternative option to avoid general anesthesia during cesarean delivery, to alleviate mother's discomfort from surgical pain, reduce complications, and improve the birth experience. The objectives in this study are to determine the amount of chloroprocaine that is absorbed into the blood in order to create a plasma concentration time profile and to determine the incidence of side effects to help guide selection of an appropriate concentration for future study.", 'detailedDescription': 'Compared to general anesthesia, neuraxial anesthesia (spinals and epidurals) is associated with a lower risk for maternal aspiration and airway compromise, exposes the baby to less anesthetic, and allows for greater maternal involvement in the birth process. For these reasons, it has become the preferred method of anesthesia for cesarean delivery. Spinals that are placed to facilitate cesarean delivery have a duration of one to two hours. Currently, if that duration is exceeded patients must have general endotracheal anesthesia. In addition, suboptimal neuraxial anesthesia for cesarean delivery is not uncommon with an incidence of 2-9%, depending upon the urgency of surgery and the type of neuraxial block. Providing less than adequate anesthesia for cesarean delivery may increase the risk of legal liability. For this reason, some patients with suboptimal neuraxial anesthesia have intraoperative conversion to general endotracheal anesthesia.\n\nThe first known description of the use of intraperitoneal local anesthetic to provide anesthesia for cesarean delivery was published in 1975. In this article Ranney et al. described how to use up to 100 mL of 1% procaine to provide anesthesia for cesarean delivery under local field block alone. Some of this was injected into the skin and fascia, and the remainder was diluted to 0.5% and "spilled" into the peritoneum.\n\nMultiple publications have shown that intraperitoneal local anesthetic can be used to treat intraoperative and postoperative pain, prevent postoperative nausea, and shorten hospital length of stay. A recently published 40-month case series showed that chloroprocaine lavage can be used as part of a multimodal approach to treating intraoperative pain. In this case series, the technique of chloroprocaine lavage helped investigators to avoid general endotracheal anesthesia in 32 women having a cesarean delivery.\n\nIn this case series, no patients exhibited clinical signs of systemic local anesthetic toxicity. It is believed that chloroprocaine has a limited potential for toxicity because of its short plasma half-life, which is only 11-21 seconds. The purpose of this study is to determine the amount of chloroprocaine that is taken up into the blood stream after intraperitoneal administration to ensure that blood levels are low and do not raise a safety concern. Data obtained from this study will help to define a safe dose of chloroprocaine for intraperitoneal administration.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects ≥ 18 to 50 years of age having scheduled cesarean sections on 12C (Labor and Delivery) within Oregon Health \\& Science University (OHSU).\n* Only subjects having spinal anesthesia will be eligible.\n* Only subjects that can have a Pfannenstiel incision will be enrolled.\n\nExclusion Criteria:\n\n* Subjects with chronic narcotic usage\n* Subjects that are deemed to need a combined spinal epidural for any reason.\n* Subjects who are unable to successfully get a spinal block\n* Subjects with known atypical cholinesterase activity\n* American Society of Anesthesiologist physical status IV or higher\n* Subjects with contraindication to neuraxial anesthesia (coagulopathy, infection)\n* Subjects with stage 4 chronic kidney disease or worse (eGFR \\< 30 ml/min)\n* Subjects with significant hepatic dysfunction (AST or ALT \\> 2x the upper limit of normal)\n* Subjects with allergies to drugs required for this protocol.\n* Subjects with multifetal gestations\n* Subjects with a BMI \\> 40 kg/m2'}, 'identificationModule': {'nctId': 'NCT03760718', 'acronym': 'CLOR-PRO', 'briefTitle': 'Chloroprocaine Lavage to Improve Outcomes Related to Operative Cesarean Delivery', 'organization': {'class': 'OTHER', 'fullName': 'Oregon Health and Science University'}, 'officialTitle': 'Chloroprocaine Lavage to Improve Outcomes Related to Operative Cesarean Delivery', 'orgStudyIdInfo': {'id': '19021'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Preservative free Chloroprocaine Group 1', 'description': '40 ml of preservative-free 1% chloroprocaine', 'interventionNames': ['Drug: Preservative free 1% Chloroprocaine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Preservative free Chloroprocaine Group 2', 'description': '40 ml of preservative-free 2% chloroprocaine', 'interventionNames': ['Drug: Preservative free 2% Chloroprocaine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Preservative free Chloroprocaine Group 3', 'description': '40 ml of preservative-free 3% chloroprocaine', 'interventionNames': ['Drug: Preservative free 3% Chloroprocaine']}], 'interventions': [{'name': 'Preservative free 1% Chloroprocaine', 'type': 'DRUG', 'otherNames': ['Nesacaine'], 'description': '40 ml of preservative-free 1% chloroprocaine is planned for administration into the peritoneal cavity after delivery of the baby.', 'armGroupLabels': ['Preservative free Chloroprocaine Group 1']}, {'name': 'Preservative free 2% Chloroprocaine', 'type': 'DRUG', 'otherNames': ['Nesacaine'], 'description': '40 ml of preservative-free 2% chloroprocaine is planned for administration into the peritoneal cavity after delivery of the baby.', 'armGroupLabels': ['Preservative free Chloroprocaine Group 2']}, {'name': 'Preservative free 3% Chloroprocaine', 'type': 'DRUG', 'otherNames': ['Nesacaine'], 'description': '40 ml of preservative-free 3% chloroprocaine is planned for administration into the peritoneal cavity after delivery of the baby.', 'armGroupLabels': ['Preservative free Chloroprocaine Group 3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '97239', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'OHSU Labor and Delivery; Oregon Health and Science University Hospital', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}], 'overallOfficials': [{'name': 'Brandon M Togioka, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Oregon Health and Science University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oregon Health and Science University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Brandon M Togioka', 'investigatorAffiliation': 'Oregon Health and Science University'}}}}