Ignite Creation Date:
2025-12-24 @ 11:08 PM
Ignite Modification Date:
2026-02-20 @ 10:46 PM
Study NCT ID:
NCT02412969
Status:
COMPLETED
Last Update Posted:
2016-08-17
First Post:
2014-08-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Dural Puncture Epidural Versus Traditional Lumbar Epidural on Onset of Labor Analgesia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 101}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-08', 'completionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-08-16', 'studyFirstSubmitDate': '2014-08-22', 'studyFirstSubmitQcDate': '2015-04-08', 'lastUpdatePostDateStruct': {'date': '2016-08-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-04-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Compare time of onset of labor analgesia Dural Puncture vs Lumbar Puncture', 'timeFrame': 'two days post delivery'}], 'secondaryOutcomes': [{'measure': 'Incidence of Side Effect', 'timeFrame': 'two days post delivery', 'description': 'Incidence of maternal motor block, hypotension, pruritis, headache, patient satisfaction and fetal bradycardia.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Labor Pain', 'Labor Analgesia']}, 'descriptionModule': {'briefSummary': 'This study is to examine the onset of pain relief with two different methods of labor epidural. The traditional labor epidural involves the placement of numbing and anti-pain medicine in the epidural space which surrounds the spinal cord. In order to take effect, the medication has to cross a layer of tissue called the dura. In the current study, the same medications are placed in the epidural space after the dura is punctured with a fine needle. This research, will help evaluate whether this technique will result in earlier onset of pain relief.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pregnant patients in active painful labor\n* ASA I and II parturients\n* Women Ages 18+ to 40\n* Patients who have labor epidural as part of their labor plan will be recruited\n\nExclusion Criteria:\n\n* Patients admitted to the Labor and Delivery Suite who are committed to have a delivery with the current admission but who do not want a labor epidural\n* Patients with the following: bleeding disorders, infection at the site of epidural placement, generalized sepsis, stenotic heart valve lesions, increased intracranial pressure, patients with hypovolemia, and patient refusal\n* Parturients with chronic pain syndromes\n* Patients on MAO inhibitors\n* Patients with allergies to bupivacaine and fentanyl (and other amide local anesthetics) patients with substance abuse history will be excluded\n* Non English-speaking patients will be excluded'}, 'identificationModule': {'nctId': 'NCT02412969', 'briefTitle': 'Impact of Dural Puncture Epidural Versus Traditional Lumbar Epidural on Onset of Labor Analgesia', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of South Carolina'}, 'officialTitle': 'Impact of Dural Puncture Epidural Versus Traditional Lumbar Epidural on Onset of Labor Analgesia', 'orgStudyIdInfo': {'id': 'Pro00034219'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Lumbar Epidural', 'description': 'Control group will have standard of care Lumbar Epidural', 'interventionNames': ['Procedure: Lumbar Epidural']}, {'type': 'EXPERIMENTAL', 'label': 'Dural Puncture Epidural', 'description': 'Will receive Dural Puncture Epidural', 'interventionNames': ['Procedure: Dural Puncture Epidural']}], 'interventions': [{'name': 'Lumbar Epidural', 'type': 'PROCEDURE', 'description': 'control group will receive lumbar puncture epidural', 'armGroupLabels': ['Lumbar Epidural']}, {'name': 'Dural Puncture Epidural', 'type': 'PROCEDURE', 'description': 'intervention group will receive a dural puncture epidural', 'armGroupLabels': ['Dural Puncture Epidural']}]}, 'contactsLocationsModule': {'locations': [{'zip': '29425', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Medical University of South Carolina', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of South Carolina', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor and Director of OB Anesthesia', 'investigatorFullName': 'Latha Hebbar', 'investigatorAffiliation': 'Medical University of South Carolina'}}}}