Ignite Creation Date:
2025-12-26 @ 5:18 PM
Ignite Modification Date:
2025-12-31 @ 11:01 PM
Study NCT ID:
NCT01598506
Status:
COMPLETED
Last Update Posted:
2018-01-12
First Post:
2012-05-10
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Intrathecal Hydromorphone for Labor Analgesia
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': 'D004091', 'term': 'Hydromorphone'}], 'ancestors': [{'id': 'D009022', 'term': 'Morphine Derivatives'}, {'id': 'D009019', 'term': 'Morphinans'}, {'id': 'D053610', 'term': 'Opiate Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006572', 'term': 'Heterocyclic Compounds, Bridged-Ring'}, {'id': 'D006576', 'term': 'Heterocyclic Compounds, 4 or More Rings'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D010616', 'term': 'Phenanthrenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'glynde@emory.edu', 'phone': '404-778-3900', 'title': 'Dr. Grant Lynde', 'organization': 'Emory University'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Hydromorphone', 'description': 'Laboring patients receive ED50 of hydromorphone one time intrathecally.\n\nED50 of hydromorphone was 12.7 mcg +/- 3.27.', 'otherNumAtRisk': 22, 'otherNumAffected': 0, 'seriousNumAtRisk': 22, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Pain Score, Visual Analogue Pain Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Hydromorphone', 'description': 'Laboring patients receive ED50 of hydromorphone one time intrathecally.\n\nED50 of hydromorphone was 10.9 (95% CI +/- 1.2 mcg).'}], 'classes': [{'categories': [{'measurements': [{'value': '1.9', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '4'}]}]}], 'paramType': 'MEAN', 'timeFrame': '30 minutes after intrathecal injection', 'description': 'Continuous Visual Analogue Scale 0 - 10 (0=no pain, 10=worst imaginable pain).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Pain Scores, Visual Analogue Pain Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Hydromorphone', 'description': 'Laboring patients receive ED50 of hydromorphone one time intrathecally.\n\nED50 of hydromorphone was 12.7 mcg +/- 3.27.'}], 'classes': [{'categories': [{'measurements': [{'value': '8.6', 'groupId': 'OG000', 'lowerLimit': '7', 'upperLimit': '10'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'description': 'Continuous Visual Analogue Scale 0 - 10 (0=no pain, 10=worst imaginable pain).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Hydromorphone', 'description': 'Laboring patients receive ED50 of hydromorphone one time intrathecally.\n\nED50 of hydromorphone was 12.7 mcg +/- 3.27.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}]}], 'recruitmentDetails': 'Subjects enrolled from January 2013 to November 2013'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Hydromorphone', 'description': 'Laboring patients receive ED50 of hydromorphone one time intrathecally.\n\nED50 of hydromorphone was 12.7 mcg +/- 3.27.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '22', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '22', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '22', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 22}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-12', 'completionDateStruct': {'date': '2014-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-12-14', 'studyFirstSubmitDate': '2012-05-10', 'resultsFirstSubmitDate': '2014-11-04', 'studyFirstSubmitQcDate': '2012-05-14', 'lastUpdatePostDateStruct': {'date': '2018-01-12', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2014-11-04', 'studyFirstPostDateStruct': {'date': '2012-05-15', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-11-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain Score, Visual Analogue Pain Scores', 'timeFrame': '30 minutes after intrathecal injection', 'description': 'Continuous Visual Analogue Scale 0 - 10 (0=no pain, 10=worst imaginable pain).'}], 'secondaryOutcomes': [{'measure': 'Pain Scores, Visual Analogue Pain Scale', 'timeFrame': 'Baseline', 'description': 'Continuous Visual Analogue Scale 0 - 10 (0=no pain, 10=worst imaginable pain).'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Labor Pain']}, 'referencesModule': {'references': [{'pmid': '30290794', 'type': 'DERIVED', 'citation': "O'Reilly-Shah V, Lynde GC. Determination of ED50 and time to effectiveness for intrathecal hydromorphone in laboring patients using Dixon's up-and-down sequential allocation method. BMC Anesthesiol. 2018 Oct 5;18(1):140. doi: 10.1186/s12871-018-0603-8."}]}, 'descriptionModule': {'briefSummary': 'This study will investigate the dose of hydromorphone which will relieve the pain of women in labor when delivered directly in the area around the spinal cord (i.e., intrathecal injection). The primary objective is to determine the dose of intrathecal hydromorphone that results in a pain score of less than 4 out of 10 thirty minutes after intrathecal injection in 50% of women. Secondary objectives include determining this dose at five and ten minutes after injection. Thirty women admitted to labor and delivery for planned vaginal delivery desiring epidural placement will be consented for the study. The starting dose of intrathecal hydromorphone will be 6 mcg. The up-and-down sequential allocation method of statistical analysis will be used, meaning that each subsequent dose will be dependent upon the result obtained from the prior dose - ergo, if the initial subject has pain relief, the second subject will receive 4 mcg (2 mcg less), but if the initial subject does not have pain relief, the second subject will receive 8 mcg (2 mcg more) of hydromorphone.\n\nAfter the intrathecal injection is given and the epidural is placed, visual analogue pain scores will be assessed 60 minutes following injection. A pain score of less than three will be a positive result. A pain score of three or greater will be a negative result. Blood pressure, heart rate, arterial oxygen saturation, fetal heart rate, and any side effects will also be assessed.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy patients\n* Labor\n* Desires pain relief\n\nExclusion Criteria:\n\n* Any comorbidities other than obesity'}, 'identificationModule': {'nctId': 'NCT01598506', 'briefTitle': 'Intrathecal Hydromorphone for Labor Analgesia', 'organization': {'class': 'OTHER', 'fullName': 'Emory University'}, 'officialTitle': 'Determination of the ED50 of Intrathecal Hydromorphone in Laboring Women Using the Up-and-down Sequential Allocation Method', 'orgStudyIdInfo': {'id': 'IRB00054701'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Hydromorphone', 'description': 'Laboring patients receive ED50 of hydromorphone one time intrathecally', 'interventionNames': ['Drug: Hydromorphone']}], 'interventions': [{'name': 'Hydromorphone', 'type': 'DRUG', 'description': 'Hydromorphone will be administered one time intrathecally to laboring patients to determine the ED50 for pain relief.', 'armGroupLabels': ['Hydromorphone']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30303', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Grady Memorial Hospital', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}], 'overallOfficials': [{'name': 'Grant C Lynde, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Emory University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Emory University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Grant Lynde', 'investigatorAffiliation': 'Emory University'}}}}