[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100620195":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":30,"centralContacts":34,"locations":40,"responsibleParty":56,"collaborators":26,"id":58,"slug":59,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":62,"acronym":63,"eligibilityCriteria":64,"healthyVolunteers":60,"sex":65,"minAge":66,"maxAge":26,"enrollmentInfo":67,"targetDuration":26,"studyType":70,"phases":71,"briefSummary":73,"conditions":74,"keywords":77,"overallStatus":43,"whyStopped":26,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":87},{"fullName":5,"class":6},"University Hospital, Clermont-Ferrand","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Blood patch","ACTIVE_COMPARATOR","Clinicians perform an epidural blood patch following current clinical guidelines.",[13],"Drug: Blood patch",{"label":15,"type":16,"description":17,"interventionNames":18},"Sphenopalatin ganglion block","EXPERIMENTAL","Clinicians perform a sphenopalatin ganglion block following current clinical guidelines.",[19],"Drug: Sphenopalatine Ganglion Block",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Sphenopalatine Ganglion Block","The sphenopalatine ganglion block is performed in the post-anesthesia care unit (PACU). The patient is continuously monitored, including measurement of oxygen saturation, heart rate, and arterial blood pressure. The patient is placed in the supine position with the head extended. The anesthesiologist inserts a cotton-tipped applicator (sterile microbiology swab) soaked with 2.5% lidocaine cream into each nasal cavity until bony contact is reached. Subsequently, 1 mL of 5% injectable lidocaine is administered into each nasal cavity. The cotton-tipped applicators are left in place for 10 minutes and then removed. If headache persists upon patient mobilization to the upright position, the sphenopalatine ganglion block may be repeated a second time.",[15],null,{"type":22,"name":9,"description":28,"armGroupLabels":29,"otherNames":26},"The epidural blood patch is performed in the post-anesthesia care unit (PACU). The patient is continuously monitored, with measurement of oxygen saturation, heart rate, and arterial blood pressure. The patient is seated at the edge of the bed, with the anesthesiologist positioned behind the patient. The procedure is carried out in strict adherence to aseptic techniques. The puncture is ideally performed at the L3-L4 or L4-L5 interspace, preferably at or below the level of the initial puncture. Local anesthesia is achieved using 1% injectable lidocaine at the puncture site. The epidural space is identified using the loss-of-resistance technique with saline. Once the epidural space has been identified, peripheral venous blood is collected and slowly injected into the epidural space until the patient reports a sensation of pressure or lumbar pain, with a maximum volume of 30 mL. The patient is then placed in the strict supine position and monitored for at least 30 minutes in the PACU.",[9],[31],{"name":32,"affiliation":5,"role":33},"Adrien Guyot","PRINCIPAL_INVESTIGATOR",[35],{"name":36,"role":37,"phone":38,"phoneExt":26,"email":39},"Lise Laclautre","CONTACT","0473754963","promo_interne_drci@chu-clermontferrand.fr",[41],{"facility":42,"status":43,"city":44,"state":26,"zip":26,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"CHU de Clermont-Ferrand","RECRUITING","Clermont-Ferrand","France","FR",{"type":48,"coordinates":49},"Point",[50,51],3.08682,45.77969,{"lat":51,"lon":50},[54,55],{"name":36,"role":37,"phone":38,"phoneExt":26,"email":39},{"name":32,"role":33,"phone":26,"phoneExt":26,"email":26},{"type":57,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100620195","phase-3-efficacy-of-sphenopalatine-block-compared-to-blood-patch-in-the-management-of-post-dural-puncture-headaches-100620195",false,"NCT07354464","Efficacy of Sphenopalatine Block Compared to Blood Patch in the Management of Post-dural Puncture Headaches","BRECHE","Inclusion Criteria:\n\n* Patients with post-dural puncture headache meeting the criteria of the International Classification of Headache Disorders (ICHD-3) and persisting after 24 hours of conservative treatment,\n* Patients aged over 18 years,\n* Patients affiliated to a social security health insurance system,\n* Patients who have provided written informed consent.\n\nExclusion Criteria:\n\n* Patients under legal protection (guardianship or curatorship), deprived of liberty (prisoners), or under judicial safeguard,\n* Pregnant patients,\n* Patients with hypersensitivity to lidocaine, prilocaine, local anesthetics of the amide type, or to any of the excipients listed in the composition of the drugs used in the protocol,\n* Patients with acute porphyria, atrioventricular conduction disorders requiring permanent cardiac pacing not yet implemented, or epilepsy not controlled by treatment,\n* Patients receiving antiarrhythmic therapy associated with torsades de pointes (amiodarone, disopyramide, quinidine derivatives, sotalol, etc.),\n* Patients with atypical post-dural puncture headache suggestive of a post-dural puncture complication (altered consciousness, focal neurological deficit, seizures, visual disturbances, etc.),\n* Patients with chronic headaches requiring preventive treatment,\n* Patients with a history of spinal surgery precluding the performance of an epidural blood patch,\n* Patients with contraindications to epidural blood patch (local or systemic infection, platelet count \\\u003C 80 G\u002FL, coagulation disorders, progressive neurological disease),\n* Patients with contraindications to sphenopalatine ganglion block (nasal polyposis, rhinopharyngitis, deviated nasal septum).","ALL","18 Years",{"count":68,"type":69},80,"ESTIMATED","INTERVENTIONAL",[72],"PHASE3","Post-dural puncture headache (PDPH) is an iatrogenic complication following a dural puncture, which may occur after lumbar puncture, spinal or epidural anesthesia. These headaches are defined as positional headaches, which worsen in the upright position and improve in the supine position, occurring within 5 days after a dural puncture.\n\nPDPH is disabling, particularly in the postpartum period and is often associated with symptoms such as nausea, vomiting, neck stiffness, photophobia, and hearing loss. While serious immediate complications (e.g., subdural hematoma, cerebral venous thrombosis) are rare, long-term consequences - including chronic headaches, neck or low back pain and depression, have been described.\n\nA conservative treatment is usually started during the first 24 hours, but it often proves insufficient, leading to the use of an additional epidural blood patch therapy. While considered as the gold standard, this procedure is invasive and presents limitations. The effectiveness of the epidural blood patch is variable (33-91 %), and the need for a second blood patch is not uncommon. The risks associated with the procedure include second dural puncture, low back pain, vasovagal syncope and paresthesia. Serious complications could occur with reported cases of aseptic meningitis or acute subdural hematoma.\n\nAn emerging alternative is the sphenopalatine ganglion block that is a less invasive procedure showing promising results. Several recent trials suggested the safety, feasibilty and efficacy of this intervention with excellent tolerance. Then, we aim to compare the efficacy and safety of these procedures in a randomized controlled trial.",[75,76],"PDPH","Post Dural Puncture Headache",[76,9,15],"2026-02-26",{"date":80,"type":81},"2026-02-27","ACTUAL",{"date":83,"type":81},"2026-02-19",{"date":85,"type":69},"2028-02",{"name":5,"class":6},1]