Ignite Creation Date:
2025-12-25 @ 12:27 AM
Ignite Modification Date:
2025-12-25 @ 10:32 PM
Study NCT ID:
NCT00779467
Status:
COMPLETED
Last Update Posted:
2018-09-11
First Post:
2008-10-22
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Epidural Neostigmine for Labor Pain
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009388', 'term': 'Neostigmine'}, {'id': 'D002045', 'term': 'Bupivacaine'}, {'id': 'D005283', 'term': 'Fentanyl'}], 'ancestors': [{'id': 'D050338', 'term': 'Phenylammonium Compounds'}, {'id': 'D000644', 'term': 'Quaternary Ammonium Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D009861', 'term': 'Onium Compounds'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ppan@wakehealth.edu', 'phone': '336-718-8278', 'title': 'Peter H. Pan, MD, MSEE', 'organization': 'Wake Forest School of Medicine'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Bupivacaine With Neostimgine 8 mcg/ml', 'description': 'STUDY DRUG INFUSION WITH NEOSTIGMINE 8 MCG/ML\n\nNeostigmine: utilizing 3 different dosages of neostigmine and comparing it to the standard of fentanyl. Infusion runs via PCA throughout labor analgesia.\n\nBupivacaine', 'otherNumAtRisk': 38, 'otherNumAffected': 0, 'seriousNumAtRisk': 38, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Bupivacaine and Neostigmine 4 mcg/ml', 'description': 'STUDY DRUG INFUSION CONC NEOSTIGMINE 4 MCG/ML\n\nNeostigmine: utilizing 3 different dosages of neostigmine and comparing it to the standard of fentanyl. Infusion runs via PCA throughout labor analgesia.\n\nBupivacaine', 'otherNumAtRisk': 40, 'otherNumAffected': 0, 'seriousNumAtRisk': 40, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Bupivacaine With Neostigmine 2 mcg/ml', 'description': 'STUDY DRUG INFUSION NEOSTIGMINE 2 MCG/ML\n\nNeostigmine: utilizing 3 different dosages of neostigmine and comparing it to the standard of fentanyl. Infusion runs via PCA throughout labor analgesia.\n\nBupivacaine', 'otherNumAtRisk': 38, 'otherNumAffected': 0, 'seriousNumAtRisk': 38, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'BUPIVACAINE WITH FENTANYL 2 MCG/ML', 'description': 'Bupivacaine with fentanyl 2 mcg/ml. STANDARD INFUSION\n\nBupivacaine\n\nfentanyl: fentanyl 2 mcg/ml', 'otherNumAtRisk': 35, 'otherNumAffected': 0, 'seriousNumAtRisk': 35, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Amount of Drug Consumed Per Hour in Each Group(Arm)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}, {'value': '35', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Bupivacaine With Neostimgine 8 mcg/ml', 'description': 'STUDY DRUG INFUSION WITH NEOSTIGMINE 8 MCG/ML\n\nNeostigmine: utilizing 3 different dosages of neostigmine and comparing it to the standard of fentanyl. Infusion runs via PCA throughout labor analgesia.\n\nBupivacaine'}, {'id': 'OG001', 'title': 'Bupivacaine and Neostigmine 4 mcg/ml', 'description': 'STUDY DRUG INFUSION CONC NEOSTIGMINE 4 MCG/ML\n\nNeostigmine: utilizing 3 different dosages of neostigmine and comparing it to the standard of fentanyl. Infusion runs via PCA throughout labor analgesia.\n\nBupivacaine'}, {'id': 'OG002', 'title': 'Bupivacaine With Neostigmine 2 mcg/ml', 'description': 'STUDY DRUG INFUSION NEOSTIGMINE 2 MCG/ML\n\nNeostigmine: utilizing 3 different dosages of neostigmine and comparing it to the standard of fentanyl. Infusion runs via PCA throughout labor analgesia.\n\nBupivacaine'}, {'id': 'OG003', 'title': 'BUPIVACAINE WITH FENTANYL 2 MCG/ML', 'description': 'Bupivacaine with fentanyl 2 mcg/ml. STANDARD INFUSION\n\nBupivacaine\n\nfentanyl: fentanyl 2 mcg/ml'}], 'classes': [{'categories': [{'measurements': [{'value': '16.2', 'groupId': 'OG000', 'lowerLimit': '12', 'upperLimit': '23'}, {'value': '14.6', 'groupId': 'OG001', 'lowerLimit': '12', 'upperLimit': '18'}, {'value': '15.3', 'groupId': 'OG002', 'lowerLimit': '13', 'upperLimit': '19'}, {'value': '16', 'groupId': 'OG003', 'lowerLimit': '13', 'upperLimit': '21'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'until delivery', 'description': 'Median hourly total bupivacaine consumption. Drug amount consumed per hour of each group (arm)', 'unitOfMeasure': 'milliliters per hour', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'median hourly total bupivacaine consumption in each group, in ml/hr'}, {'type': 'SECONDARY', 'title': 'Nausea', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}, {'value': '35', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Bupivacaine With Neostimgine 8 mcg/ml', 'description': 'STUDY DRUG INFUSION WITH NEOSTIGMINE 8 MCG/ML\n\nNeostigmine: utilizing 3 different dosages of neostigmine and comparing it to the standard of fentanyl. Infusion runs via PCA throughout labor analgesia.\n\nBupivacaine'}, {'id': 'OG001', 'title': 'Bupivacaine and Neostigmine 4 mcg/ml', 'description': 'STUDY DRUG INFUSION CONC NEOSTIGMINE 4 MCG/ML\n\nNeostigmine: utilizing 3 different dosages of neostigmine and comparing it to the standard of fentanyl. Infusion runs via PCA throughout labor analgesia.\n\nBupivacaine'}, {'id': 'OG002', 'title': 'Bupivacaine With Neostigmine 2 mcg/ml', 'description': 'STUDY DRUG INFUSION NEOSTIGMINE 2 MCG/ML\n\nNeostigmine: utilizing 3 different dosages of neostigmine and comparing it to the standard of fentanyl. Infusion runs via PCA throughout labor analgesia.\n\nBupivacaine'}, {'id': 'OG003', 'title': 'BUPIVACAINE WITH FENTANYL 2 MCG/ML', 'description': 'Bupivacaine with fentanyl 2 mcg/ml. STANDARD INFUSION\n\nBupivacaine\n\nfentanyl: fentanyl 2 mcg/ml'}], 'classes': [{'categories': [{'measurements': [{'value': '1.3', 'spread': '2.5', 'groupId': 'OG000'}, {'value': '1.8', 'spread': '3.0', 'groupId': 'OG001'}, {'value': '1.8', 'spread': '3.0', 'groupId': 'OG002'}, {'value': '1.2', 'spread': '2.2', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'until delivery', 'description': 'average maximum nausea score in each group--maternal nausea scored on a 0-no nausea at all up to maximum of 10-worst nausea imaginable', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Sedation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}, {'value': '35', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Bupivacaine With Neostimgine 8 mcg/ml', 'description': 'STUDY DRUG INFUSION WITH NEOSTIGMINE 8 MCG/ML\n\nNeostigmine: utilizing 3 different dosages of neostigmine and comparing it to the standard of fentanyl. Infusion runs via PCA throughout labor analgesia.\n\nBupivacaine'}, {'id': 'OG001', 'title': 'Bupivacaine and Neostigmine 4 mcg/ml', 'description': 'STUDY DRUG INFUSION CONC NEOSTIGMINE 4 MCG/ML\n\nNeostigmine: utilizing 3 different dosages of neostigmine and comparing it to the standard of fentanyl. Infusion runs via PCA throughout labor analgesia.\n\nBupivacaine'}, {'id': 'OG002', 'title': 'Bupivacaine With Neostigmine 2 mcg/ml', 'description': 'STUDY DRUG INFUSION NEOSTIGMINE 2 MCG/ML\n\nNeostigmine: utilizing 3 different dosages of neostigmine and comparing it to the standard of fentanyl. Infusion runs via PCA throughout labor analgesia.\n\nBupivacaine'}, {'id': 'OG003', 'title': 'BUPIVACAINE WITH FENTANYL 2 MCG/ML', 'description': 'Bupivacaine with fentanyl 2 mcg/ml. STANDARD INFUSION\n\nBupivacaine\n\nfentanyl: fentanyl 2 mcg/ml'}], 'classes': [{'categories': [{'measurements': [{'value': '3.3', 'spread': '3.0', 'groupId': 'OG000'}, {'value': '3.4', 'spread': '3.0', 'groupId': 'OG001'}, {'value': '3.3', 'spread': '2.9', 'groupId': 'OG002'}, {'value': '4.1', 'spread': '3.0', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'until delivery', 'description': 'average maternal sedation score measured on a 0-not sleepy at all up to a maximum of 10-extremely sleepy', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Shivering', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}, {'value': '35', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Bupivacaine With Neostimgine 8 mcg/ml', 'description': 'STUDY DRUG INFUSION WITH NEOSTIGMINE 8 MCG/ML\n\nNeostigmine: utilizing 3 different dosages of neostigmine and comparing it to the standard of fentanyl. Infusion runs via PCA throughout labor analgesia.\n\nBupivacaine'}, {'id': 'OG001', 'title': 'Bupivacaine and Neostigmine 4 mcg/ml', 'description': 'STUDY DRUG INFUSION CONC NEOSTIGMINE 4 MCG/ML\n\nNeostigmine: utilizing 3 different dosages of neostigmine and comparing it to the standard of fentanyl. Infusion runs via PCA throughout labor analgesia.\n\nBupivacaine'}, {'id': 'OG002', 'title': 'Bupivacaine With Neostigmine 2 mcg/ml', 'description': 'STUDY DRUG INFUSION NEOSTIGMINE 2 MCG/ML\n\nNeostigmine: utilizing 3 different dosages of neostigmine and comparing it to the standard of fentanyl. Infusion runs via PCA throughout labor analgesia.\n\nBupivacaine'}, {'id': 'OG003', 'title': 'BUPIVACAINE WITH FENTANYL 2 MCG/ML', 'description': 'Bupivacaine with fentanyl 2 mcg/ml. STANDARD INFUSION\n\nBupivacaine\n\nfentanyl: fentanyl 2 mcg/ml'}], 'classes': [{'categories': [{'measurements': [{'value': '0.2', 'spread': '0.4', 'groupId': 'OG000'}, {'value': '0.3', 'spread': '0.4', 'groupId': 'OG001'}, {'value': '0.3', 'spread': '0.5', 'groupId': 'OG002'}, {'value': '0.2', 'spread': '0.4', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'until delivery', 'description': 'maternal occurrence of shivering--Shivering scored on a 0-no shivering at all up to maximum of 10-shivering uncontrollably', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Pruritus', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}, {'value': '35', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Bupivacaine With Neostimgine 8 mcg/ml', 'description': 'STUDY DRUG INFUSION WITH NEOSTIGMINE 8 MCG/ML\n\nNeostigmine: utilizing 3 different dosages of neostigmine and comparing it to the standard of fentanyl. Infusion runs via PCA throughout labor analgesia.\n\nBupivacaine'}, {'id': 'OG001', 'title': 'Bupivacaine and Neostigmine 4 mcg/ml', 'description': 'STUDY DRUG INFUSION CONC NEOSTIGMINE 4 MCG/ML\n\nNeostigmine: utilizing 3 different dosages of neostigmine and comparing it to the standard of fentanyl. Infusion runs via PCA throughout labor analgesia.\n\nBupivacaine'}, {'id': 'OG002', 'title': 'Bupivacaine With Neostigmine 2 mcg/ml', 'description': 'STUDY DRUG INFUSION NEOSTIGMINE 2 MCG/ML\n\nNeostigmine: utilizing 3 different dosages of neostigmine and comparing it to the standard of fentanyl. Infusion runs via PCA throughout labor analgesia.\n\nBupivacaine'}, {'id': 'OG003', 'title': 'BUPIVACAINE WITH FENTANYL 2 MCG/ML', 'description': 'Bupivacaine with fentanyl 2 mcg/ml. STANDARD INFUSION\n\nBupivacaine\n\nfentanyl: fentanyl 2 mcg/ml'}], 'classes': [{'categories': [{'measurements': [{'value': '0.05', 'spread': '0.3', 'groupId': 'OG000'}, {'value': '0.03', 'spread': '0.2', 'groupId': 'OG001'}, {'value': '0.03', 'spread': '0.2', 'groupId': 'OG002'}, {'value': '0.9', 'spread': '1.8', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'until delivery', 'description': 'the occurrence of pruritis (itching) throughout the labor analgesia infusion--the presence of itching rated on a scale of 0-no itching at all up to a maximum of 10- severe itching.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'the presence of itching rated on a scale of 0-no itching at all up to a maximum of 10- severe itching.'}, {'type': 'SECONDARY', 'title': 'Bromage Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}, {'value': '35', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Bupivacaine With Neostimgine 8 mcg/ml', 'description': 'STUDY DRUG INFUSION WITH NEOSTIGMINE 8 MCG/ML\n\nNeostigmine: utilizing 3 different dosages of neostigmine and comparing it to the standard of fentanyl. Infusion runs via PCA throughout labor analgesia.\n\nBupivacaine'}, {'id': 'OG001', 'title': 'Bupivacaine and Neostigmine 4 mcg/ml', 'description': 'STUDY DRUG INFUSION CONC NEOSTIGMINE 4 MCG/ML\n\nNeostigmine: utilizing 3 different dosages of neostigmine and comparing it to the standard of fentanyl. Infusion runs via PCA throughout labor analgesia.\n\nBupivacaine'}, {'id': 'OG002', 'title': 'Bupivacaine With Neostigmine 2 mcg/ml', 'description': 'STUDY DRUG INFUSION NEOSTIGMINE 2 MCG/ML\n\nNeostigmine: utilizing 3 different dosages of neostigmine and comparing it to the standard of fentanyl. Infusion runs via PCA throughout labor analgesia.\n\nBupivacaine'}, {'id': 'OG003', 'title': 'BUPIVACAINE WITH FENTANYL 2 MCG/ML', 'description': 'Bupivacaine with fentanyl 2 mcg/ml. STANDARD INFUSION\n\nBupivacaine\n\nfentanyl: fentanyl 2 mcg/ml'}], 'classes': [{'categories': [{'measurements': [{'value': '0.7', 'spread': '0.7', 'groupId': 'OG000'}, {'value': '1.1', 'spread': '1.4', 'groupId': 'OG001'}, {'value': '1.0', 'spread': '0.9', 'groupId': 'OG002'}, {'value': '0.9', 'spread': '1.3', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'until delivery', 'description': 'the incidence of decreased motor block (Bromage score) documented until delivery. Bromage is defined as 0-freely able to move extremities (no motor block) up to 3-unable to move legs or feet (complete motor block)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Bromage is defined as 0-freely able to move extremities (no motor block) up to 3-unable to move legs or feet (complete motor block)'}, {'type': 'SECONDARY', 'title': 'Patient Satisfaction Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}, {'value': '35', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Bupivacaine With Neostimgine 8 mcg/ml', 'description': 'STUDY DRUG INFUSION WITH NEOSTIGMINE 8 MCG/ML\n\nNeostigmine: utilizing 3 different dosages of neostigmine and comparing it to the standard of fentanyl. Infusion runs via PCA throughout labor analgesia.\n\nBupivacaine'}, {'id': 'OG001', 'title': 'Bupivacaine and Neostigmine 4 mcg/ml', 'description': 'STUDY DRUG INFUSION CONC NEOSTIGMINE 4 MCG/ML\n\nNeostigmine: utilizing 3 different dosages of neostigmine and comparing it to the standard of fentanyl. Infusion runs via PCA throughout labor analgesia.\n\nBupivacaine'}, {'id': 'OG002', 'title': 'Bupivacaine With Neostigmine 2 mcg/ml', 'description': 'STUDY DRUG INFUSION NEOSTIGMINE 2 MCG/ML\n\nNeostigmine: utilizing 3 different dosages of neostigmine and comparing it to the standard of fentanyl. Infusion runs via PCA throughout labor analgesia.\n\nBupivacaine'}, {'id': 'OG003', 'title': 'BUPIVACAINE WITH FENTANYL 2 MCG/ML', 'description': 'Bupivacaine with fentanyl 2 mcg/ml. STANDARD INFUSION\n\nBupivacaine\n\nfentanyl: fentanyl 2 mcg/ml'}], 'classes': [{'categories': [{'measurements': [{'value': '4.5', 'groupId': 'OG000', 'lowerLimit': '3.0', 'upperLimit': '5.0'}, {'value': '4.0', 'groupId': 'OG001', 'lowerLimit': '4.0', 'upperLimit': '5.0'}, {'value': '4.0', 'groupId': 'OG002', 'lowerLimit': '3.0', 'upperLimit': '5.0'}, {'value': '4.0', 'groupId': 'OG003', 'lowerLimit': '3.0', 'upperLimit': '5.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'within 24 hours post delivery', 'description': 'maternal reported satisfaction scores of labor analgesia on a scale of 1-5, with 1-not satisfied at all up to 5 -completely satisfied with labor analgesia', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Cesarean Delivery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}, {'value': '35', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Bupivacaine With Neostimgine 8 mcg/ml', 'description': 'STUDY DRUG INFUSION WITH NEOSTIGMINE 8 MCG/ML\n\nNeostigmine: utilizing 3 different dosages of neostigmine and comparing it to the standard of fentanyl. Infusion runs via PCA throughout labor analgesia.\n\nBupivacaine'}, {'id': 'OG001', 'title': 'Bupivacaine and Neostigmine 4 mcg/ml', 'description': 'STUDY DRUG INFUSION CONC NEOSTIGMINE 4 MCG/ML\n\nNeostigmine: utilizing 3 different dosages of neostigmine and comparing it to the standard of fentanyl. Infusion runs via PCA throughout labor analgesia.\n\nBupivacaine'}, {'id': 'OG002', 'title': 'Bupivacaine With Neostigmine 2 mcg/ml', 'description': 'STUDY DRUG INFUSION NEOSTIGMINE 2 MCG/ML\n\nNeostigmine: utilizing 3 different dosages of neostigmine and comparing it to the standard of fentanyl. Infusion runs via PCA throughout labor analgesia.\n\nBupivacaine'}, {'id': 'OG003', 'title': 'BUPIVACAINE WITH FENTANYL 2 MCG/ML', 'description': 'Bupivacaine with fentanyl 2 mcg/ml. STANDARD INFUSION\n\nBupivacaine\n\nfentanyl: fentanyl 2 mcg/ml'}], 'classes': [{'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'occurence', 'description': 'percentage of subjects in each group requiring a ceserean delivery', 'unitOfMeasure': 'percentage of subjects in each group', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Bupivacaine With Neostimgine 8 mcg/ml', 'description': 'STUDY DRUG INFUSION WITH NEOSTIGMINE 8 MCG/ML\n\nNeostigmine: utilizing 3 different dosages of neostigmine and comparing it to the standard of fentanyl. Infusion runs via PCA throughout labor analgesia.\n\nBupivacaine'}, {'id': 'FG001', 'title': 'Bupivacaine and Neostigmine 4 mcg/ml', 'description': 'STUDY DRUG INFUSION CONC NEOSTIGMINE 4 MCG/ML\n\nNeostigmine: utilizing 3 different dosages of neostigmine and comparing it to the standard of fentanyl. Infusion runs via PCA throughout labor analgesia.\n\nBupivacaine'}, {'id': 'FG002', 'title': 'Bupivacaine With Neostigmine 2 mcg/ml', 'description': 'STUDY DRUG INFUSION NEOSTIGMINE 2 MCG/ML\n\nNeostigmine: utilizing 3 different dosages of neostigmine and comparing it to the standard of fentanyl. Infusion runs via PCA throughout labor analgesia.\n\nBupivacaine'}, {'id': 'FG003', 'title': 'BUPIVACAINE WITH FENTANYL 2 MCG/ML', 'description': 'Bupivacaine with fentanyl 2 mcg/ml. STANDARD INFUSION\n\nBupivacaine\n\nfentanyl: fentanyl 2 mcg/ml'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '53'}, {'groupId': 'FG001', 'numSubjects': '45'}, {'groupId': 'FG002', 'numSubjects': '48'}, {'groupId': 'FG003', 'numSubjects': '54'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '38'}, {'groupId': 'FG001', 'numSubjects': '40'}, {'groupId': 'FG002', 'numSubjects': '38'}, {'groupId': 'FG003', 'numSubjects': '35'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '10'}, {'groupId': 'FG003', 'numSubjects': '19'}]}], 'dropWithdraws': [{'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '11'}]}, {'type': 'failed inclusion criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '2'}]}, {'type': 'missing data', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '4'}]}, {'type': 'technical issue', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'unavailable research staff', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}, {'value': '35', 'groupId': 'BG003'}, {'value': '151', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Bupivacaine With Neostimgine 8 mcg/ml', 'description': 'STUDY DRUG INFUSION WITH NEOSTIGMINE 8 MCG/ML\n\nNeostigmine: utilizing 3 different dosages of neostigmine and comparing it to the standard of fentanyl. Infusion runs via PCA throughout labor analgesia.\n\nBupivacaine'}, {'id': 'BG001', 'title': 'Bupivacaine and Neostigmine 4 mcg/ml', 'description': 'STUDY DRUG INFUSION CONC NEOSTIGMINE 4 MCG/ML\n\nNeostigmine: utilizing 3 different dosages of neostigmine and comparing it to the standard of fentanyl. Infusion runs via PCA throughout labor analgesia.\n\nBupivacaine'}, {'id': 'BG002', 'title': 'Bupivacaine With Neostigmine 2 mcg/ml', 'description': 'STUDY DRUG INFUSION NEOSTIGMINE 2 MCG/ML\n\nNeostigmine: utilizing 3 different dosages of neostigmine and comparing it to the standard of fentanyl. Infusion runs via PCA throughout labor analgesia.\n\nBupivacaine'}, {'id': 'BG003', 'title': 'BUPIVACAINE WITH FENTANYL 2 MCG/ML', 'description': 'Bupivacaine with fentanyl 2 mcg/ml. STANDARD INFUSION\n\nBupivacaine\n\nfentanyl: fentanyl 2 mcg/ml'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '28', 'spread': '5', 'groupId': 'BG000'}, {'value': '27', 'spread': '6', 'groupId': 'BG001'}, {'value': '28', 'spread': '6', 'groupId': 'BG002'}, {'value': '27', 'spread': '6', 'groupId': 'BG003'}, {'value': '27.5', 'spread': '5.75', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '38', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}, {'value': '35', 'groupId': 'BG003'}, {'value': '151', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2013-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-13', 'studyFirstSubmitDate': '2008-10-22', 'resultsFirstSubmitDate': '2016-10-27', 'studyFirstSubmitQcDate': '2008-10-22', 'lastUpdatePostDateStruct': {'date': '2018-09-11', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-02-23', 'studyFirstPostDateStruct': {'date': '2008-10-24', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-04-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2013-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Amount of Drug Consumed Per Hour in Each Group(Arm)', 'timeFrame': 'until delivery', 'description': 'Median hourly total bupivacaine consumption. Drug amount consumed per hour of each group (arm)'}], 'secondaryOutcomes': [{'measure': 'Nausea', 'timeFrame': 'until delivery', 'description': 'average maximum nausea score in each group--maternal nausea scored on a 0-no nausea at all up to maximum of 10-worst nausea imaginable'}, {'measure': 'Sedation', 'timeFrame': 'until delivery', 'description': 'average maternal sedation score measured on a 0-not sleepy at all up to a maximum of 10-extremely sleepy'}, {'measure': 'Shivering', 'timeFrame': 'until delivery', 'description': 'maternal occurrence of shivering--Shivering scored on a 0-no shivering at all up to maximum of 10-shivering uncontrollably'}, {'measure': 'Pruritus', 'timeFrame': 'until delivery', 'description': 'the occurrence of pruritis (itching) throughout the labor analgesia infusion--the presence of itching rated on a scale of 0-no itching at all up to a maximum of 10- severe itching.'}, {'measure': 'Bromage Score', 'timeFrame': 'until delivery', 'description': 'the incidence of decreased motor block (Bromage score) documented until delivery. Bromage is defined as 0-freely able to move extremities (no motor block) up to 3-unable to move legs or feet (complete motor block)'}, {'measure': 'Patient Satisfaction Scores', 'timeFrame': 'within 24 hours post delivery', 'description': 'maternal reported satisfaction scores of labor analgesia on a scale of 1-5, with 1-not satisfied at all up to 5 -completely satisfied with labor analgesia'}, {'measure': 'Cesarean Delivery', 'timeFrame': 'occurence', 'description': 'percentage of subjects in each group requiring a ceserean delivery'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['non narcotic', 'epidural', 'labor pain', 'Non narcotic treatment of labor pain'], 'conditions': ['Labor Pain']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to see which dose of epidural neostigmine is the best additive to use with the numbing medication used in an epidural during labor.', 'detailedDescription': 'This study is examining the use of the non-narcotic medication, neostigmine, in combination with the local anesthetic bupivacaine when compared with the commonly used narcotic fentanyl in providing pain relief with the fewest side effects in labor analgesia.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy pregnancy\n* Term pregnancy ( \\> 37 weeks)\n* Primiparous or multiparous\n* Induction or spontaneous labor greater or = 18 years of age\n* Cervical exam on entry \\</=5 cm\n\nExclusion Criteria:\n\n* Weight \\> 115 kg\n* Non-English speaking\n* IV analgesics within 60 minutes prior to epidural being administered\n* Allergy to local anesthetics or neostigmine'}, 'identificationModule': {'nctId': 'NCT00779467', 'briefTitle': 'Epidural Neostigmine for Labor Pain', 'organization': {'class': 'OTHER', 'fullName': 'Wake Forest University Health Sciences'}, 'officialTitle': 'Epidural Neostigmine Dose Response for the Treatment of Labor Pain', 'orgStudyIdInfo': {'id': 'IRB00005917'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Bupivacaine with Neostimgine 8 mcg/ml', 'description': 'STUDY DRUG INFUSION WITH NEOSTIGMINE 8 MCG/ML', 'interventionNames': ['Drug: Neostigmine', 'Drug: Bupivacaine']}, {'type': 'EXPERIMENTAL', 'label': 'Bupivacaine and Neostigmine 4 mcg/ml', 'description': 'STUDY DRUG INFUSION CONC NEOSTIGMINE 4 MCG/ML', 'interventionNames': ['Drug: Neostigmine', 'Drug: Bupivacaine']}, {'type': 'EXPERIMENTAL', 'label': 'Bupivacaine with Neostigmine 2 mcg/ml', 'description': 'STUDY DRUG INFUSION NEOSTIGMINE 2 MCG/ML', 'interventionNames': ['Drug: Neostigmine', 'Drug: Bupivacaine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'BUPIVACAINE WITH FENTANYL 2 MCG/ML', 'description': 'Bupivacaine with fentanyl 2 mcg/ml. STANDARD INFUSION', 'interventionNames': ['Drug: Bupivacaine', 'Drug: fentanyl']}], 'interventions': [{'name': 'Neostigmine', 'type': 'DRUG', 'description': 'utilizing 3 different dosages of neostigmine and comparing it to the standard of fentanyl. Infusion runs via PCA throughout labor analgesia.', 'armGroupLabels': ['Bupivacaine and Neostigmine 4 mcg/ml', 'Bupivacaine with Neostigmine 2 mcg/ml', 'Bupivacaine with Neostimgine 8 mcg/ml']}, {'name': 'Bupivacaine', 'type': 'DRUG', 'armGroupLabels': ['BUPIVACAINE WITH FENTANYL 2 MCG/ML', 'Bupivacaine and Neostigmine 4 mcg/ml', 'Bupivacaine with Neostigmine 2 mcg/ml', 'Bupivacaine with Neostimgine 8 mcg/ml']}, {'name': 'fentanyl', 'type': 'DRUG', 'description': 'fentanyl 2 mcg/ml', 'armGroupLabels': ['BUPIVACAINE WITH FENTANYL 2 MCG/ML']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27103', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Forsyth Medical Center', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}], 'overallOfficials': [{'name': 'Peter H Pan, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Wake Forest University Health Sciences OB Anesthesia'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wake Forest University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}