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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
France
CHU de Clermont-Ferrand
RECRUITING
Clermont-ferrand
Contact Information
Primary
Lise Laclautre
promo_interne_drci@chu-clermontferrand.fr
0473754963
Time Frame
Start Date: 2026-02-19
Estimated Completion Date: 2028-02
Participants
Target number of participants: 80
Treatments
Active_comparator: Blood patch
Clinicians perform an epidural blood patch following current clinical guidelines.
Experimental: Sphenopalatin ganglion block
Clinicians perform a sphenopalatin ganglion block following current clinical guidelines.
Sponsors
Leads: University Hospital, Clermont-Ferrand

This content was sourced from clinicaltrials.gov