ANHYDROUS LIDOCAINE HYDROCHLORIDE for Post-dural puncture syndrome

Inclusion criteria

• {"criterion_text":"- Presence of post-dural-puncture headaches meeting the criteria of the International Classification of Headache Disorders (ICHD-3)\n- Present persistent headaches after 24 hours of conservative treatment.\n- Patients older than 18 years\n- Patients who have given their informed consent\n- Patients affiliated with a Social Security scheme."}

Exclusion criteria

• {"criterion_text":"- Patients under protection measures (guardianship or curatorship) or deprived of liberty (prisoners)\n- Pregnant patients\n- Patients presenting an allergy to one of the medications used in the protocol\n- Patients presenting with a clinical picture of atypical post-dural puncture headache that may suggest a post-puncture complication (consciousness disorder, focal neurological deficit, epilepsy, visual disturbance...)\n- Patients presenting with chronic headaches requiring preventive treatment\n- Patients with a history of spine surgery preventing the realization of the blood patch\n- Patients with a contraindication for the blood patch procedure (local or systemic infection, platelets < 80 G/L, coagulation disorder, progressive neurological disease)\n- Patients with a contraindication for performing the sphenopalatine block (nasal polyps, rhinopharyngitis, deviation of the nasal septum)."}

Primary endpoints

• {"endpoint_text":"- 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.","definition_or_measurement_approach":"Headache intensity measured using a numerical verbal scale (NVS) from 0 (no pain) to 10 (worst possible pain) at baseline (beginning of intervention) and at 30 minutes, 1 hour, 2 hours, 6 hours, 24 hours, 48 hours and 7 days post-procedure."}

Secondary endpoints

• {"endpoint_text":"- The consumption of analgesics (Acétaminophen, Nefopam, NSAIDs, morphine) in milligrams after the procedure and for 7 days.","definition_or_measurement_approach":"Total consumption of specified analgesics (paracetamol/acetaminophen, nefopam, NSAIDs, morphine) measured in milligrams after the procedure and during the 7-day post-procedure period."}
• {"endpoint_text":"- The need for a rescue treatment with a blood patch after the first procedure","definition_or_measurement_approach":"Binary outcome indicating whether a patient required a rescue blood patch procedure following the initial assigned procedure."}
• {"endpoint_text":"- The duration of hospitalization during the 7 days post-intervention","definition_or_measurement_approach":"Length of hospital stay measured during the 7 days following the intervention."}
• {"endpoint_text":"- 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.","definition_or_measurement_approach":"Headache intensity at listed timepoints measured using the numerical verbal scale (0-10 NVS)."}
• {"endpoint_text":"- The undesirable events during the performance of the procedure","definition_or_measurement_approach":"Recording and categorisation of adverse events occurring during the procedure (procedure-related undesirable events)."}
• {"endpoint_text":"- Serious adverse events (radicular compression, meningitis, cauda equina syndrome...),","definition_or_measurement_approach":"Recording of serious adverse events including specified examples (radicular compression, meningitis, cauda equina syndrome) during follow-up."}
• {"endpoint_text":"- Patient satisfaction assessed at 7 days after treatment using a 5-item Likert scale","definition_or_measurement_approach":"Patient-reported satisfaction measured at 7 days post-treatment using a 5-item Likert scale."}

France

Earliest CTIS Part Ii Submission Date

13-10-2025

Latest Decision Or Authorization Date

12-11-2025

Processing Time Days

30

Number Of Sites

1

Number Of Participants

80

Primary sponsor

Full Name

University Hospital Of Clermont-Ferrand

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France