Ignite Creation Date:
2025-12-25 @ 3:17 AM
Ignite Modification Date:
2026-01-15 @ 7:44 PM
Study NCT ID:
NCT02181205
Status:
WITHDRAWN
Last Update Posted:
2017-11-08
First Post:
2014-07-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sphenopalatine Ganglion Block for Post-Dural Puncture Headache
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051299', 'term': 'Post-Dural Puncture Headache'}], 'ancestors': [{'id': 'D051271', 'term': 'Headache Disorders, Secondary'}, {'id': 'D020773', 'term': 'Headache Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002045', 'term': 'Bupivacaine'}], 'ancestors': [{'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'no eligible participant , technical difficulty, feasiblity', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2014-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'completionDateStruct': {'date': '2016-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-11-06', 'studyFirstSubmitDate': '2014-07-01', 'studyFirstSubmitQcDate': '2014-07-02', 'lastUpdatePostDateStruct': {'date': '2017-11-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-07-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'verbal pain score', 'timeFrame': '1 hour', 'description': 'a reduction in headache verbal pain score by 3'}], 'secondaryOutcomes': [{'measure': 'epidural blood patch', 'timeFrame': '7 days', 'description': 'evaluating the decrease in the necessity of an epidural blood patch to treat the postdural puncture headache'}, {'measure': 'patient satisfaction', 'timeFrame': '1 hour', 'description': 'patient satisfaction with headache pain relief at 1 hour post treatment'}, {'measure': 'pain score', 'timeFrame': '30 minutes', 'description': 'verbal pain score 30 minutes post study treatment'}, {'measure': 'pain score', 'timeFrame': '7 days', 'description': 'verbal pain score 7 days post study treatment'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Postdural Puncture Headache', 'Sphenopalatine Ganglion Block']}, 'descriptionModule': {'briefSummary': 'The investigators are attempting to determine a less invasive method of treatment for postdural puncture headaches that can occur after regional anesthesia. The investigators will be evaluating the relief of headache with those subjects receiving treatment with a sphenopalatine ganglion block with bupivacaine versus placebo, evaluating the incidence of epidural blood patch, pain score of headache at 1 hour, then 24, 48, and 72 hours lower with post study treatment versus placebo, and potential side effects of those patients receiving study therapy as well as epidural blood patch.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* American Society of Anesthesiologists assigned class I-III\n* age \\>/= 18 years\n* experiencing a postdural puncture headache within 7 days of neuraxial analgesia rated \\>3/10 pain score\n\nExclusion Criteria:\n\n* allergy to study medications \\<18 years of age pain score on presentation \\</=3/10 for headache'}, 'identificationModule': {'nctId': 'NCT02181205', 'briefTitle': 'Sphenopalatine Ganglion Block for Post-Dural Puncture Headache', 'organization': {'class': 'OTHER', 'fullName': 'Wake Forest University Health Sciences'}, 'officialTitle': 'Sphenopalatine Ganglion Block for Treatment of Postdural Puncture Headache: A Prospective Randomized Double Blind Placebo Controlled Study', 'orgStudyIdInfo': {'id': '14-024'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'placebo', 'description': 'sphenopalatine ganglion block performed with normal saline as the placebo', 'interventionNames': ['Drug: placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'bupivacaine', 'description': 'sphenopalatine ganglion block performed with bupivacaine', 'interventionNames': ['Drug: bupivacaine']}], 'interventions': [{'name': 'bupivacaine', 'type': 'DRUG', 'armGroupLabels': ['bupivacaine']}, {'name': 'placebo', 'type': 'DRUG', 'armGroupLabels': ['placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27103', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Novant Health Forsyth Medical Center', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}], 'overallOfficials': [{'name': 'Peter H Pan, MD, MSEE', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Wake Forest School of Medicine-Anesthesiology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wake Forest University Health Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}