Ignite Creation Date:
2025-12-24 @ 9:12 PM
Ignite Modification Date:
2025-12-25 @ 7:01 PM
Study NCT ID:
NCT05552404
Status:
COMPLETED
Last Update Posted:
2023-01-11
First Post:
2022-09-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Postdural Puncture Headache Relief With Aminophylline and SPGB
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000072700', 'term': 'Conservative Treatment'}, {'id': 'D000628', 'term': 'Aminophylline'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D005029', 'term': 'Ethylenediamines'}, {'id': 'D003959', 'term': 'Diamines'}, {'id': 'D011073', 'term': 'Polyamines'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D013806', 'term': 'Theophylline'}, {'id': 'D014970', 'term': 'Xanthines'}, {'id': 'D011688', 'term': 'Purinones'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D004338', 'term': 'Drug Combinations'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 75}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2022-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-01-10', 'studyFirstSubmitDate': '2022-09-16', 'studyFirstSubmitQcDate': '2022-09-20', 'lastUpdatePostDateStruct': {'date': '2023-01-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-09-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the headache severity in the form of Visual Analogue score (VAS) at 12 hours after treatment.', 'timeFrame': 'at 12 hours', 'description': '0 - no pain to 10 - worst pain imaginable'}], 'secondaryOutcomes': [{'measure': 'Patient Global impression of change (PGIC) scale', 'timeFrame': 'at 24 hours', 'description': 'Participant encircles number that match degree of change since the begining of care where 0- much better to 10- much worse and 5- no change.'}, {'measure': 'Adverse effects', 'timeFrame': 'at 24 hours', 'description': 'Recording of adverse effects arrhythmias, agitation, and nasal bleeding.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Anesthesia']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to compare Sphenopalatine ganglion block (SPGB) and aminophylline in the efficacy and safety management of PDPH.', 'detailedDescription': 'Postdural puncture headache (PDPH) is a severe and debilitating complication after regional anesthesia in the obstetric population; The gold standard treatment for PDPH is epidural blood patch, which is an invasive and risky procedure.\n\nThe trans-nasal sphenopalatine ganglion (SPG) block and intravenous aminophylline are promising options for PDPH. So the investigators designed this randomized, double-blind study to compare Sphenopalatine ganglion block (SPGB) and aminophylline in the efficacy and safety management of PDPH.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Obstetric participant', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 - 40 years old female.\n* ASA I -II according to the American society of anesthesiologists.\n* Spinal anesthesia with 22G Quincke needle for cesarean section.\n* PDPH was defined according to the international classification of headache disorders, 3rd edition criteria (ICHD-3) as:\n\n * Headache occurring within 5 days of a lumbar puncture.\n * Orthostatic headache that significantly worsens soon after sitting upright or standing and/or improves after lying horizontally usually accompanied by neck pain, tinnitus, changes in hearing, photophobia, and/or nausea.\n * Exclusion of other causes such as hypertension, preeclampsia, tension headache, migraine, etc.\n\nExclusion Criteria:\n\n* A history of headaches that could interfere with the PDPH diagnosis,\n* A history of central nervous system diseases, including intracranial hemorrhage, seizures, intracranial hypertension, or hydrocephalus\n* A history of cardiovascular diseases, including coronary heart disease, arrhythmias, or hypertension.\n* A history of allergy to or any contraindication for using Aminophylline.\n* Coagulopathy.\n* Nasal septal deviation, polyp, or nasal bleeding.\n* General anesthesia after failed spinal anesthesia.'}, 'identificationModule': {'nctId': 'NCT05552404', 'briefTitle': 'Postdural Puncture Headache Relief With Aminophylline and SPGB', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': 'Trans-nasal Sphenopalatine Ganglion Block Versus Intravenous Aminophylline Injection for Treatment of Postdural Puncture Headache After Caesarean Section Under Spinal Anesthesia', 'orgStudyIdInfo': {'id': 'FMASU R 124/ 2022'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Conservative therapy', 'description': 'will receive conservative therapy such as bed rest, fluids, abdominal binder, oral paracetamol, and caffeine', 'interventionNames': ['Other: conservative therapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Aminophylline', 'description': 'will receive conservative therapy plus Aminophylline (250mg of Aminophylline dissolved in 100ml normal saline for intravenous infusion over 30 minutes)', 'interventionNames': ['Other: conservative therapy', 'Drug: Aminophylline']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'transnasal spheno-palatine ganglion block', 'description': 'will receive the conservative therapy plus transnasal spheno-palatine ganglion block under strict protective and safety measures against COVID-19, using a hollow cotton swab soaked in lidocaine 2% for 5 minutes in each nostril then 0.5ml of lidocaine 2% will be injected slowly through the hollow swab and repeated once after another 5 minutes where the patient will stay in the supine position for 10 minutes.', 'interventionNames': ['Other: conservative therapy', 'Procedure: trans nasal sphenopalatine ganglion block']}], 'interventions': [{'name': 'conservative therapy', 'type': 'OTHER', 'description': 'bed rest, fluids, abdominal binder, oral paracetamol, and caffeine', 'armGroupLabels': ['Aminophylline', 'Conservative therapy', 'transnasal spheno-palatine ganglion block']}, {'name': 'Aminophylline', 'type': 'DRUG', 'description': 'conservative therapy plus Aminophylline (250mg of Aminophylline dissolved in 100ml normal saline for intravenous infusion over 30 minutes)', 'armGroupLabels': ['Aminophylline']}, {'name': 'trans nasal sphenopalatine ganglion block', 'type': 'PROCEDURE', 'description': 'conservative therapy plus sphenopalatine ganglion block SPGB using hollow cotton swab and lidocaine 2%', 'armGroupLabels': ['transnasal spheno-palatine ganglion block']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11591', 'city': 'Cairo', 'country': 'Egypt', 'facility': 'faculty of medicine, Ain Shams University', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'overallOfficials': [{'name': 'tamer S abdelaziz, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Faculty of medicine, Ain Shams University, Cairo, Egypt'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'lecturer of Anesthesia', 'investigatorFullName': 'Tamer Samir Abdelsalam', 'investigatorAffiliation': 'Ain Shams University'}}}}