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BRECHE : Efficacy of sphenopalatine block compared to blood patch in the management of post-dural puncture syndrome.

Status
Not yet recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2025-522168-34-00
Acronym
RBHP 2025 GUYOT
Enrollment
80
Registered
2025-11-12
Start date
Unknown
Completion date
Unknown
Last updated
2025-11-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post-dural puncture syndrome

Brief summary

Evolution of headache intensity in the upright position assessed using a numerical verbal scale (NVS) from 0 (no pain) to 10 (the most intense pain possible) at the beginning of the intervention, at 30 minutes, 1 hour, 2 hours, 6 hours, 24 hours, 48 hours, and 7 days after the performance of the sphenopalatine block or blood patch.

Detailed description

The consumption of analgesics (Acétaminophen, Nefopam, NSAIDs, morphine) in milligrams after the procedure and for 7 days., The need for a rescue treatment with a blood patch after the first procedure, The duration of hospitalization during the 7 days post-intervention, The intensity of headaches at 30 minutes, at 1 hour, at 2 hours, at 6 hours, at 24 hours, at 48 hours, and at 7 days., The undesirable events during the performance of the procedure, Serious adverse events (radicular compression, meningitis, cauda equina syndrome...),, Patient satisfaction assessed at 7 days after treatment using a 5-item Likert scale

Interventions

Sponsors

University Hospital Of Clermont-Ferrand
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Evolution of headache intensity in the upright position assessed using a numerical verbal scale (NVS) from 0 (no pain) to 10 (the most intense pain possible) at the beginning of the intervention, at 30 minutes, 1 hour, 2 hours, 6 hours, 24 hours, 48 hours, and 7 days after the performance of the sphenopalatine block or blood patch.

Secondary

MeasureTime frame
The consumption of analgesics (Acétaminophen, Nefopam, NSAIDs, morphine) in milligrams after the procedure and for 7 days., The need for a rescue treatment with a blood patch after the first procedure, The duration of hospitalization during the 7 days post-intervention, The intensity of headaches at 30 minutes, at 1 hour, at 2 hours, at 6 hours, at 24 hours, at 48 hours, and at 7 days., The undesirable events during the performance of the procedure, Serious adverse events (radicular compression, meningitis, cauda equina syndrome...),, Patient satisfaction assessed at 7 days after treatment using a 5-item Likert scale

Countries

France

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026