Sphenopalatine ganglion block versus epidural blood patch for post-dural puncture headache
Efficacy of Sphenopalatine Block Compared to Blood Patch in the Management of Post-dural Puncture Headaches
This test compares a sphenopalatine ganglion block and an epidural blood patch to see which relieves post-dural puncture headaches better in adults whose pain hasn't improved after 24 hours of usual treatment.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Clermont-Ferrand Academic / other |
| Locations | 1 site (Clermont-Ferrand) |
| Trial ID | NCT07354464 on ClinicalTrials.gov |
What this trial studies
This single-center, randomized phase 3 interventional trial enrolls adults with post-dural puncture headache that persists after 24 hours of conservative care and randomizes them to receive either a sphenopalatine ganglion block or an epidural blood patch. Headache intensity is recorded on a numerical rating scale immediately before the intervention and at 30 minutes, 1 hour, 2 hours, 6 hours, 24 hours, 48 hours and 7 days after treatment, with secondary outcomes collected over 7 days. Outcome assessments are performed by a clinical research associate who is blinded to treatment allocation, and patients are monitored in the post-anesthesia care unit for at least 30 minutes and hospitalized for a minimum of 6 hours. If the assigned treatment is ineffective after 24 hours, a rescue epidural blood patch is permitted regardless of randomization, and follow-up assessments can be completed by telephone if the patient is discharged.
Who should consider this trial
Good fit: Adults (≥18 years) with post-dural puncture headache meeting ICHD-3 criteria that persists after 24 hours of conservative treatment, who can provide written informed consent and are covered by social health insurance, are eligible.
Not a fit: Patients who are pregnant, under legal protection or deprived of liberty, have contraindications to local anesthetics or certain cardiac/neurological conditions, or whose headache resolves with conservative care are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the sphenopalatine ganglion block could offer a less invasive, quicker option that reduces the need for epidural blood patches.
How similar studies have performed: Epidural blood patch is the established gold standard and small prior reports of sphenopalatine ganglion block show promising but mixed results, so clear head-to-head randomized evidence is still limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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).
Where this trial is running
Clermont-Ferrand
- CHU de Clermont-Ferrand — Clermont-Ferrand, France (Recruiting)
Study contacts
- Principal investigator: Adrien Guyot — University Hospital, Clermont-Ferrand
- Study coordinator: Lise Laclautre
- Email: promo_interne_drci@chu-clermontferrand.fr
- Phone: 0473754963
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.