Sphenopalatine ganglion block versus epidural blood patch for post-dural puncture headache

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Epidural hydroxyethyl starch to prevent post-dural puncture headache in parturients

  This study tests whether filling the epidural space with hydroxyethyl starch can help prevent post-dural puncture headaches in women who had an accidental dural puncture during epidural anesthesia for labor or cesarean delivery.

  Recruiting Peking University First Hospital · Beijing, Beijing Municipality and 3 other locations · NCT07914790

• Predicting Post-Dural Puncture Headache After Spinal Anesthesia in Cesarean Deliveries

  This study tests whether changes in optic nerve sheath diameter after spinal anesthesia can predict who will develop a post-dural puncture headache in pregnant women having an elective cesarean.

  Recruiting Ordu University · Ordu, Altinordu · NCT07729449

• Treating post-dural puncture headache with theophylline, sumatriptan, or gabapentin

  This trial will try theophylline, sumatriptan, and gabapentin to see which best relieves moderate-to-severe post-dural puncture headache in adults aged 21–50.

  Recruiting Tanta University · Tanta, El-Gharbia · NCT07515456

• Nebulized neostigmine/atropine versus nebulized lidocaine for post-dural puncture headache after cesarean delivery

  This trial tests whether inhaled (nebulized) neostigmine with atropine relieves post-dural puncture headache better than inhaled lidocaine in women who develop headache after spinal anesthesia for elective cesarean delivery.

  Recruiting Early Phase 1 Minia University · Minya · NCT06824025

• Exploring causes and treatments for postural puncture headache

  This study is trying to understand what causes post-dural puncture headaches and how treatments like epidural blood patches can help people who get them after a lumbar puncture.

  Recruiting Umeå University · Umeå, Västerbotten County · NCT06253754

• Impact of altitude on headaches after cesarean delivery

  This study is testing how living at different altitudes affects the headaches that women experience after having a cesarean delivery with spinal anesthesia.

  Recruiting at 2 sites B.P. Koirala Institute of Health Sciences · Jumla, Karnali and 1 other locations · NCT05804448

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.