Ignite Creation Date:
2025-12-24 @ 9:21 PM
Ignite Modification Date:
2026-02-20 @ 11:49 PM
Study NCT ID:
NCT02020304
Status:
COMPLETED
Last Update Posted:
2018-09-10
First Post:
2013-11-21
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Combined Spinal-Epidural Temperature and Duration of Action
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D048949', 'term': 'Labor Pain'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'vhross@wakehealth.edu', 'phone': '336-718-8278', 'title': 'Vernon H Ross MD', 'organization': 'Wake Forest School of Medicine'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'up to 3 hours after dosing', 'eventGroups': [{'id': 'EG000', 'title': 'Room Temperature', 'description': 'room temperature combined spinal epidural dose (60-75 degrees F)\n\ncombined spinal epidural: Combined Spinal Epidural', 'otherNumAtRisk': 27, 'deathsNumAtRisk': 27, 'otherNumAffected': 0, 'seriousNumAtRisk': 27, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Refrigerated Temperature', 'description': 'refrigerated temperature combined spinal epidural dose (\\~\\<43 degrees F)\n\ncombined spinal epidural: Combined Spinal Epidural', 'otherNumAtRisk': 26, 'deathsNumAtRisk': 26, 'otherNumAffected': 0, 'seriousNumAtRisk': 26, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Room Temperature', 'description': 'room temperature combined spinal epidural dose (60-75 degrees F)\n\ncombined spinal epidural: Combined Spinal Epidural'}, {'id': 'OG001', 'title': 'Refrigerated Temperature', 'description': 'refrigerated temperature combined spinal epidural dose (\\~\\<43 degrees F)\n\ncombined spinal epidural: Combined Spinal Epidural'}], 'classes': [{'categories': [{'measurements': [{'value': '74', 'spread': '29', 'groupId': 'OG000'}, {'value': '81', 'spread': '32', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'up to 3 hours', 'description': 'length of time in minutes the combined spinal epidural dose duration is calculated from the time of administration until the request is made for additional analgesia (\\~1.5-3 hours) post dose. The subjects epidural is then dosed as per standard of care.', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Analgesia Onset-5 Minutes Post Injection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Room Temperature', 'description': 'room temperature combined spinal epidural dose (60-75 degrees F)\n\ncombined spinal epidural: Combined Spinal Epidural'}, {'id': 'OG001', 'title': 'Refrigerated Temperature', 'description': 'refrigerated temperature combined spinal epidural dose (\\~\\<43 degrees F)\n\ncombined spinal epidural: Combined Spinal Epidural'}], 'classes': [{'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'from time of CSE administration', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'number of subjects who achieved a VAS pain score of \\</=3 at 5 minutes after CSE injection'}, {'type': 'SECONDARY', 'title': 'Analgesia Onset-10 Minutes Post Injection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Room Temperature', 'description': 'room temperature combined spinal epidural dose (60-75 degrees F)\n\ncombined spinal epidural: Combined Spinal Epidural'}, {'id': 'OG001', 'title': 'Refrigerated Temperature', 'description': 'refrigerated temperature combined spinal epidural dose (\\~\\<43 degrees F)\n\ncombined spinal epidural: Combined Spinal Epidural'}], 'classes': [{'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'up to 3 hours', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'number of subjects who achieved a VAS pain score of \\</= 3 at 10 minutes after CSE injection'}, {'type': 'SECONDARY', 'title': 'Analgesia Onset-15 Minutes Post Injection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Room Temperature', 'description': 'room temperature combined spinal epidural dose (60-75 degrees F)\n\ncombined spinal epidural: Combined Spinal Epidural'}, {'id': 'OG001', 'title': 'Refrigerated Temperature', 'description': 'refrigerated temperature combined spinal epidural dose (\\~\\<43 degrees F)\n\ncombined spinal epidural: Combined Spinal Epidural'}], 'classes': [{'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'up to 3 hours', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'number of subjects who achieved a VAS pain score of \\</= 3 at 15 minutes after injection'}, {'type': 'SECONDARY', 'title': 'Pruritus', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Room Temperature', 'description': 'room temperature combined spinal epidural dose (60-75 degrees F)\n\ncombined spinal epidural: Combined Spinal Epidural'}, {'id': 'OG001', 'title': 'Refrigerated Temperature', 'description': 'refrigerated temperature combined spinal epidural dose (\\~\\<43 degrees F)\n\ncombined spinal epidural: Combined Spinal Epidural'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'spread': '1', 'groupId': 'OG000'}, {'value': '1', 'spread': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '30 minutes', 'description': 'patients reporting pruritis at 30 minutes after CSE injection, self reported and measured on a scale of 0 (no itching at all) up to 10 (itching as bad as can be imagined)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Room Temperature', 'description': 'room temperature combined spinal epidural dose (60-75 degrees F)\n\ncombined spinal epidural: Combined Spinal Epidural'}, {'id': 'FG001', 'title': 'Refrigerated Temperature', 'description': 'refrigerated temperature combined spinal epidural dose (\\~\\<43 degrees F)\n\ncombined spinal epidural: Combined Spinal Epidural'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '28'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '27'}, {'groupId': 'FG001', 'numSubjects': '26'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Room Temperature', 'description': 'room temperature combined spinal epidural dose (60-75 degrees F)\n\ncombined spinal epidural: Combined Spinal Epidural'}, {'id': 'BG001', 'title': 'Refrigerated Temperature', 'description': 'refrigerated temperature combined spinal epidural dose (\\~\\<43 degrees F)\n\ncombined spinal epidural: Combined Spinal Epidural'}, {'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': '26', 'groupId': 'BG001'}, {'value': '53', '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': '26', 'groupId': 'BG001'}, {'value': '53', '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': '26', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 58}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-08-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-09', 'completionDateStruct': {'date': '2014-05-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-09-07', 'studyFirstSubmitDate': '2013-11-21', 'resultsFirstSubmitDate': '2017-07-25', 'studyFirstSubmitQcDate': '2013-12-18', 'lastUpdatePostDateStruct': {'date': '2018-09-10', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-07-25', 'studyFirstPostDateStruct': {'date': '2013-12-24', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-08-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-05-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time', 'timeFrame': 'up to 3 hours', 'description': 'length of time in minutes the combined spinal epidural dose duration is calculated from the time of administration until the request is made for additional analgesia (\\~1.5-3 hours) post dose. The subjects epidural is then dosed as per standard of care.'}], 'secondaryOutcomes': [{'measure': 'Analgesia Onset-5 Minutes Post Injection', 'timeFrame': 'from time of CSE administration'}, {'measure': 'Analgesia Onset-10 Minutes Post Injection', 'timeFrame': 'up to 3 hours'}, {'measure': 'Analgesia Onset-15 Minutes Post Injection', 'timeFrame': 'up to 3 hours'}, {'measure': 'Pruritus', 'timeFrame': '30 minutes', 'description': 'patients reporting pruritis at 30 minutes after CSE injection, self reported and measured on a scale of 0 (no itching at all) up to 10 (itching as bad as can be imagined)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Combined spinal epidural duration', 'labor pain'], 'conditions': ['Pain']}, 'descriptionModule': {'briefSummary': 'The hypothesis is that a combined spinal-epidural drug at refrigerated temperature will have a shorter period of pain relief than that maintained at room temperature. The temperature of the dose of medication will be measure with an infrared thermometer immediately prior (within 5 minutes) to administration.', 'detailedDescription': 'Subjects will receive a combined spinal epidural medication as per standard of care to treat their labor pain; however, they will be randomized to receive either a dose maintained at room temperature (60-75 degrees F) or one maintained in a refrigerator (\\~\\<43 degrees F). Duration of action will be done by assessments of pain, vital signs, nausea, itching, bromage and fetal heart rate every 15 minutes until the subject requests additional pain medication to treat their labor pain.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* \\>/= 18 years of age not allergic to medications used to treat labor pain \\</= 6cm cervical dilation visual pain score \\>/=3\n\nExclusion Criteria:\n\n* \\<18 years of age \\> 6 cm cervical dilation non-English speaking subjects'}, 'identificationModule': {'nctId': 'NCT02020304', 'briefTitle': 'Combined Spinal-Epidural Temperature and Duration of Action', 'organization': {'class': 'OTHER', 'fullName': 'Wake Forest University Health Sciences'}, 'officialTitle': 'Effect of Temperature of Combined Spinal Epidural Dosing on Duration', 'orgStudyIdInfo': {'id': 'IRB 23933'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Room temperature', 'description': 'room temperature combined spinal epidural dose (60-75 degrees F)', 'interventionNames': ['Drug: combined spinal epidural']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'refrigerated temperature', 'description': 'refrigerated temperature combined spinal epidural dose (\\~\\<43 degrees F)', 'interventionNames': ['Drug: combined spinal epidural']}], 'interventions': [{'name': 'combined spinal epidural', 'type': 'DRUG', 'description': 'Combined Spinal Epidural', 'armGroupLabels': ['Room temperature', 'refrigerated temperature']}]}, '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': 'Vernon Ross, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Wake Forest University Health Sciences'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wake Forest University Health Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}