Ignite Creation Date:
2025-12-25 @ 4:36 AM
Ignite Modification Date:
2026-04-23 @ 5:13 PM
Study NCT ID:
NCT02984618
Status:
TERMINATED
Last Update Posted:
2020-02-28
First Post:
2016-12-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sphenopalatine Block or Epidural Bloodpatch for Post Dural Puncture Headache: Randomized Controlled Trial
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': 'D059387', 'term': 'Sphenopalatine Ganglion Block'}, {'id': 'D017217', 'term': 'Blood Patch, Epidural'}], 'ancestors': [{'id': 'D001340', 'term': 'Autonomic Nerve Block'}, {'id': 'D009407', 'term': 'Nerve Block'}, {'id': 'D000765', 'term': 'Anesthesia, Conduction'}, {'id': 'D000758', 'term': 'Anesthesia'}, {'id': 'D000760', 'term': 'Anesthesia and Analgesia'}, {'id': 'D003714', 'term': 'Denervation'}, {'id': 'D019635', 'term': 'Neurosurgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D001691', 'term': 'Biological Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D007268', 'term': 'Injections, Epidural'}, {'id': 'D007278', 'term': 'Injections, Spinal'}, {'id': 'D007267', 'term': 'Injections'}, {'id': 'D004333', 'term': 'Drug Administration Routes'}, {'id': 'D004358', 'term': 'Drug Therapy'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 19}}, 'statusModule': {'whyStopped': 'High recurrence of headache in SPG group.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2016-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2019-12-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-02-26', 'studyFirstSubmitDate': '2016-12-03', 'studyFirstSubmitQcDate': '2016-12-06', 'lastUpdatePostDateStruct': {'date': '2020-02-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-12-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-12-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Pain relief survival', 'timeFrame': 'Incidence of new headache onset during the first two weeks', 'description': 'Patients will be contacted for the first two weeks for monitoring new headache onsets.'}], 'primaryOutcomes': [{'measure': 'Pain relief', 'timeFrame': 'Pain reduction to no pain or low pain within 30 minutes of the intervention.', 'description': 'Pain assessed by categorical verbal scale (no pain, low pain, moderate pain or severe pain) 30 minutes after the procedure.'}], 'secondaryOutcomes': [{'measure': 'Tinitus', 'timeFrame': 'Incidence (dichotomic) of tinutus within 24 hours after the procedure.'}, {'measure': 'Low back pain', 'timeFrame': 'Incidence (dichotomic) of low back pain within 24 hours after the procedure.'}, {'measure': 'Sore throat', 'timeFrame': 'Incidence (dichotomic) of sore throat within 24 hours after the procedure.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Post-Dural Puncture Headache']}, 'descriptionModule': {'briefSummary': 'Introduction: Recently sphenopalatine block emerged as an alternative to epidural blood patch for post dural puncture headache but the investigators do not know if it has significant efficacy when compared to epidural blood patch. Method: randomized trial where patients will randomly receive either sphenopalatine block or epidural blood patch. Pain relief to no pain or low intensity pain will be the main outcome', 'detailedDescription': 'Introduction: Recently sphenopalatine block emerged as an alternative to epidural blood patch for post dural puncture headache but the investigators do not know if it has significant efficacy when compared to epidural blood patch. Method: randomized clinical trial where patients with moderate to severe post dural puncture pain will randomly receive either sphenopalatine block or epidural blood patch. Pain relief to no pain or low intensity pain will be the main outcome. Pain recurrence, survival without pain and side effects (tinitus, low back pain, new dural puncture, sore throat) will be secondary outcomes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnostic criteria for post dural puncture headache\n* Moderate to severe post dural puncture headache\n\nExclusion Criteria:\n\n* Procedure failures: new dural puncture on epidural blood patch trial, unable to find epidural space, intolerance to insertion of nasal swabs.\n* Follow up loss'}, 'identificationModule': {'nctId': 'NCT02984618', 'briefTitle': 'Sphenopalatine Block or Epidural Bloodpatch for Post Dural Puncture Headache: Randomized Controlled Trial', 'organization': {'class': 'OTHER', 'fullName': 'Brasilia University Hospital'}, 'officialTitle': 'Gabriel Guimaraes: Sphenopalatine Block or Epidural Bloodpatch for Post Dural Puncture Headache: Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'CAAE: 60693416.0.0000.5558'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment group', 'description': 'Patients will receive sphenopalatine ganglion block with ropivacaine 0.375% 3ml on each side', 'interventionNames': ['Procedure: Sphenopalatine ganglion block']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control group', 'description': 'Patients will receive classic epidural blood patch with 20ml of autologous blood', 'interventionNames': ['Procedure: Epidural blood patch']}], 'interventions': [{'name': 'Sphenopalatine ganglion block', 'type': 'PROCEDURE', 'description': 'Cotton- tipped applicators inserted up through the nose followed by infusion of ligdocaine through the applicators.', 'armGroupLabels': ['Treatment group']}, {'name': 'Epidural blood patch', 'type': 'PROCEDURE', 'description': 'Autologous sterile blood (20ml) will be infused in the lombar epidural space.', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '70000000', 'city': 'BrasÃlia', 'state': 'Federal District', 'country': 'Brazil', 'facility': 'Hospital Universitário de Brasilia', 'geoPoint': {'lat': -15.77972, 'lon': -47.92972}}], 'overallOfficials': [{'name': 'Gabriel MN Guimaraes, MsC, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universidade de Brasilia'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Brasilia University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Substitute professor of Anesthesiology', 'investigatorFullName': 'Gabriel Magalhaes Nunes Guimaraes', 'investigatorAffiliation': 'Brasilia University Hospital'}}}}