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Compares treatment options for PDPH
Official title Efficacy of Sphenopalatine Block Compared to Blood Patch in the Management of Post-dural Puncture Headaches
ClinicalTrials.gov ID: NCT07354464
What this study is testing
What is Sphenopalatine Ganglion Block?
Sphenopalatine Ganglion Block is an investigational medicine, given as a treatment applied to the skin, being studied as a potential treatment for pdph.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Patients with post-dural puncture headache meeting the criteria of the International Classification of Headache Disorders (ICHD-3) and persisting...
- Patients aged over 18 years,
- Patients affiliated to a social security health insurance system,
- Patients who have provided written informed consent.
You likely can't join if
- 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...
- Patients with acute porphyria, atrioventricular conduction disorders requiring permanent cardiac pacing not yet implemented, or epilepsy not...
- 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...
See the full eligibility 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.
- 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).
The study team makes the final eligibility decision.
Where it's taking place
- Clermont-Ferrand, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Clermont-Ferrand, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.