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Efficacy of Sphenopalatine Block Compared to Blood Patch in the Management of Post-dural Puncture Headaches

RecruitingPhase 3Ages 18 Years - anyAllUniversity Hospital, Clermont-Ferrand
NCT07354464 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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. PDPH 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. A 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

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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, * Patients aged over 18 years, * Patients affiliated to a social security health insurance system, * Patients who have provided written informed consent. Exclusion Criteria: * Patients under legal protection (guardianship or curatorship), deprived of liberty (prisoners), or under judicial safeguard, * Pregnant patients, * 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, * Patients with acute porphyria, atrioventricular conduction disorders requiring permanent cardiac pacing not yet implemented, or epilepsy not controlled by treatment, * Patients receiving antiarrhythmic therapy associated with torsades de pointes (amiodarone, disopyramide, quinidine derivatives, sotalol, etc.), * Patients with atypical post-dural puncture headache suggestive of a post-dural puncture complication (altered consciousness, focal neurological deficit, seizures, visual disturbances, etc.), * Patients with chronic headaches requiring preventive treatment, * Patients with a history of spinal surgery precluding the performance of an epidural blood patch, * Patients with contraindications to epidural blood patch (local or systemic infection, platelet count \< 80 G/L, coagulation disorders, progressive neurological disease), * Patients with contraindications to sphenopalatine ganglion block (nasal polyposis, rhinopharyngitis, deviated nasal septum).
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What it tests

  • Sphenopalatine Ganglion Block
  • Blood patch
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Where

1 site
CHU de Clermont-Ferrand
Clermont-Ferrand, France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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