Ignite Creation Date:
2025-12-26 @ 1:16 PM
Ignite Modification Date:
2026-01-01 @ 12:57 AM
Study NCT ID:
NCT01844206
Status:
TERMINATED
Last Update Posted:
2015-12-23
First Post:
2013-04-29
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Two Dose Epidural Morphine for Post-cesarean Analgesia
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012965', 'term': 'Sodium Chloride'}], 'ancestors': [{'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'al3196@cumc.columbia.edu', 'phone': '305-582-6077', 'title': 'Dr. Allison Lee', 'organization': 'Columbia University'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Up to 48 hours post-surgery', 'description': 'Women undergoing cesarean section under epidural anesthesia virtually always receive epidural morphine for post-operative analgesia. The 5 women did not experience any unexpected/reportable serious or non-serious adverse effects from the epidural morphine after cesarean section.', 'eventGroups': [{'id': 'EG000', 'title': 'Epidural Morphine', 'description': 'Group receiving 3mg epidural morphine, 24 hours after the initial dose\n\nEpidural Morphine: Patients will be given 3mg epidural morphine, 24 hours after the initial dose.', 'otherNumAtRisk': 5, 'otherNumAffected': 0, 'seriousNumAtRisk': 5, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Epidural Saline', 'description': 'Group receiving epidural saline 6ml, 24 hours after receiving epidural morphine 3mg.\n\nEpidural Saline: Patients will be given epidural saline 6ml, 24 hours after receiving epidural morphine 3 mg.', 'otherNumAtRisk': 5, 'otherNumAffected': 0, 'seriousNumAtRisk': 5, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'The Average Amount of Intravenous Morphine Patients Self-administered in the Second 24 Hours Post-surgery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Epidural Morphine', 'description': 'Group receiving 3mg epidural morphine, 24 hours after the initial dose\n\nEpidural Morphine: Patients will be given 3mg epidural morphine, 24 hours after the initial dose.'}, {'id': 'OG001', 'title': 'Epidural Saline', 'description': 'Group receiving epidural saline 6ml, 24 hours after receiving epidural morphine 3mg.\n\nEpidural Saline: Patients will be given epidural saline 6ml, 24 hours after receiving epidural morphine 3 mg.'}], 'timeFrame': 'Up to 48 hours post-operatively', 'description': 'The primary outcome of this study is the amount (mg) of morphine self-administered by PCA pump during the second 24 hours after surgery. This will be compared by unpaired t-test for two groups.', 'reportingStatus': 'POSTED', 'populationDescription': 'Data could not be summarized to include in the data table because only 5 out of 140 subjects were enrolled prior to study termination, and no data analysis was carried out. As instructed, we are specifying zero ("0") for the Number of Participants Analyzed in each Arm/Group and leaving the data fields blank.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Epidural Morphine', 'description': 'Group receiving 3mg epidural morphine, 24 hours after the initial dose\n\nEpidural Morphine: Patients will be given 3mg epidural morphine, 24 hours after the initial dose.'}, {'id': 'FG001', 'title': 'Epidural Saline', 'description': 'Group receiving epidural saline 6ml, 24 hours after receiving epidural morphine 3mg.\n\nEpidural Saline: Patients will be given epidural saline 6ml, 24 hours after receiving epidural morphine 3 mg.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'comment': 'One patient requested that epidural catheter be removed during the first post-operative day.', 'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Epidural Morphine', 'description': 'Group receiving 3mg epidural morphine, 24 hours after the initial dose\n\nEpidural Morphine: Patients will be given 3mg epidural morphine, 24 hours after the initial dose.'}, {'id': 'BG001', 'title': 'Epidural Saline', 'description': 'Group receiving epidural saline 6ml, 24 hours after receiving epidural morphine 3mg.\n\nEpidural Saline: Patients will be given epidural saline 6ml, 24 hours after receiving epidural morphine 3 mg.'}, {'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': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', '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': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 5}}, 'statusModule': {'whyStopped': 'Slow recruitment of subjects', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2013-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-11', 'completionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-11-19', 'studyFirstSubmitDate': '2013-04-29', 'resultsFirstSubmitDate': '2015-10-16', 'studyFirstSubmitQcDate': '2013-04-29', 'lastUpdatePostDateStruct': {'date': '2015-12-23', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-11-19', 'studyFirstPostDateStruct': {'date': '2013-05-01', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-12-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Average Amount of Intravenous Morphine Patients Self-administered in the Second 24 Hours Post-surgery', 'timeFrame': 'Up to 48 hours post-operatively', 'description': 'The primary outcome of this study is the amount (mg) of morphine self-administered by PCA pump during the second 24 hours after surgery. This will be compared by unpaired t-test for two groups.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Post-cesarean analgesia', 'Second dose of epidural morphine after surgery', 'Post-operative analgesia', 'Self-administered epidural morphine', 'Pain management after cesarean'], 'conditions': ['Pain', 'Morphine Adverse Reaction']}, 'referencesModule': {'references': [{'pmid': '8213024', 'type': 'BACKGROUND', 'citation': 'Zakowski MI, Ramanathan S, Turndorf H. A two-dose epidural morphine regimen in cesarean section patients: pharmacokinetic profile. Acta Anaesthesiol Scand. 1993 Aug;37(6):584-9. doi: 10.1111/j.1399-6576.1993.tb03769.x.'}, {'pmid': '10735794', 'type': 'BACKGROUND', 'citation': 'Palmer CM, Nogami WM, Van Maren G, Alves DM. Postcesarean epidural morphine: a dose-response study. Anesth Analg. 2000 Apr;90(4):887-91. doi: 10.1097/00000539-200004000-00021.'}]}, 'descriptionModule': {'briefSummary': 'The investigators aim to assess the analgesic effect of a two-dose epidural morphine regimen for 2nd day post-cesarean pain, as part of a multimodal analgesia regimen, which includes scheduled Nonsteroidal anti-inflammatory drugs (NSAIDs). The investigators hypothesize that administration of a second dose of epidural morphine 3 mg, 24 hours after an initial intraoperative dose, will provide superior post-cesarean analgesia during the 2nd 24 hours after surgery, compared to a single epidural morphine dose regimen. The primary outcome will be the amount of intravenous morphine patients self-administer during the 2nd 24 hours post-surgery.', 'detailedDescription': 'This will be a randomized, double-blinded placebo-controlled study. In this study, women who underwent cesarean section with epidural anesthesia will receive 3 mg of epidural morphine intraoperatively, and have the epidural catheter left in place. Patients will be randomized to receive either epidural saline or epidural morphine 3 mg at 18 - 24 hours after the first dose of epidural morphine, following which the epidural catheter will be removed. It is standard of care at our institution for women undergoing cesarean section with epidural anesthesia to receive epidural morphine 3 mg. What is not typically carried out is to give a second dose of epidural morphine 3mg.\n\nThe randomization will be carried out by a computerized block randomization table; the proportion for the 2 groups will be 1:1. The primary outcome will be the amount of intravenous morphine patients self-administer in the second 24 hours after surgery. Secondary outcomes will include pain scores every 6 hours, satisfaction with analgesia, side effects (itching, nausea/vomiting).'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women undergoing cesarean section under epidural anesthesia.\n\nExclusion Criteria:\n\n* Emergent cesarean section\n* Coagulopathy\n* Failed epidural anesthesia or patchy block\n* General anesthesia\n* Use of epidural chloroprocaine\n* Allergy or contraindication to Non-steroidal anti-inflammatory drug (NSAIDs)\n* Severe opioid side effects\n* History of chronic opioid use\n* History of chronic pain\n* History of obstructive sleep apnea\n* Morbid obesity (Body Mass Index (BMI)\\>45 kg/m2)\n* Height under 4\' 10" (147 cm)\n* Documented dural puncture by the epidural (Tuohy) needle\n* Preeclampsia\n* Other significant medical disease (American Society of Anesthesiologists (ASA) 3 or more).'}, 'identificationModule': {'nctId': 'NCT01844206', 'briefTitle': 'Two Dose Epidural Morphine for Post-cesarean Analgesia', 'organization': {'class': 'OTHER', 'fullName': 'Columbia University'}, 'officialTitle': 'Two Dose Epidural Morphine for Post-cesarean Analgesia', 'orgStudyIdInfo': {'id': 'AAAL3857'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Epidural Morphine', 'description': 'Group receiving 3mg epidural morphine, 24 hours after the initial dose', 'interventionNames': ['Drug: Epidural Morphine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Epidural Saline', 'description': 'Group receiving epidural saline 6ml, 24 hours after receiving epidural morphine 3mg.', 'interventionNames': ['Drug: Epidural Saline']}], 'interventions': [{'name': 'Epidural Morphine', 'type': 'DRUG', 'otherNames': ['DepoDur'], 'description': 'Patients will be given 3mg epidural morphine, 24 hours after the initial dose.', 'armGroupLabels': ['Epidural Morphine']}, {'name': 'Epidural Saline', 'type': 'DRUG', 'otherNames': ['Sodium Chloride Solution'], 'description': 'Patients will be given epidural saline 6ml, 24 hours after receiving epidural morphine 3 mg.', 'armGroupLabels': ['Epidural Saline']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'New York Presbyterian Hospital', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Allison Lee, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Columbia University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Columbia University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Anesthesiology', 'investigatorFullName': 'Allison Lee', 'investigatorAffiliation': 'Columbia University'}}}}