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Clinical Trials in the EU / 2025-522168-34-00
Completed Phase II

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

2025-522168-34-00 · tracked via the Priya Life Science EU tracker
Sponsor
University Hospital Of Clermont-Ferrand
Sponsor type
Hospital/Clinic/Other health care facility
Therapeutic area
Therapeutics
Decision date
12/11/2025
Enrollment target
80
Sites
France

Condition studied

Post-dural puncture syndrome

Investigational medicinal product(s)

XYLOCARD® 50mg/mlsolution injectable pour perfusionEMLA® 5 POUR CENTcrème

Eligibility

Age group
65+ years, 18-64 years
Sex
Female, Male

Primary endpoint

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.

Endpoint detail

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

Official registry record

This page summarises publicly available CTIS data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View 2025-522168-34-00 on CTIS ↗ ← All trials in the EU