Actively Recruiting
Efficacy of Sphenopalatine Block Compared to Blood Patch in the Management of Post-dural Puncture Headaches
Led by University Hospital, Clermont-Ferrand · Updated on 2026-02-27
80
Participants Needed
1
Research Sites
101 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 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. An 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.
CONDITIONS
Official Title
Efficacy of Sphenopalatine Block Compared to Blood Patch in the Management of Post-dural Puncture Headaches
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with post-dural puncture headache according to ICHD-3 criteria persisting after 24 hours of conservative treatment
- Patients aged over 18 years
- Patients affiliated with a social security health insurance system
- Patients who have provided written informed consent
You will not qualify if you...
- Patients under legal protection, deprived of liberty, or under judicial safeguard
- Pregnant patients
- Patients allergic to lidocaine, prilocaine, or other amide-type local anesthetics or drug excipients
- Patients with acute porphyria, certain heart conduction disorders without a pacemaker, or uncontrolled epilepsy
- Patients on antiarrhythmic drugs associated with torsades de pointes
- Patients with atypical post-dural puncture headache suggesting complications
- Patients with chronic headaches needing preventive treatment
- Patients with history of spinal surgery preventing epidural blood patch
- Patients with contraindications to epidural blood patch (infection, low platelets, coagulation issues, neurological disease)
- Patients with contraindications to sphenopalatine ganglion block (nasal polyposis, rhinopharyngitis, deviated nasal septum)
AI-Screening
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Trial Site Locations
Total: 1 location
1
CHU de Clermont-Ferrand
Clermont-Ferrand, France
Actively Recruiting
Research Team
L
Lise Laclautre
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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