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

The primary objective is to evaluate the effectiveness of the sphenopalatine block for the management of post-dural puncture headaches compared to the current standard treatment, the blood patch, within 7 days. This comparison is clinically relevant as it assesses whether an alternative interventional technique can provide effective relief for patients experiencing post-dural puncture syndrome, a complication commonly associated with neuraxial anesthesia or diagnostic lumbar puncture.

The secondary objectives include:

• Comparison of analgesic consumption between patients treated with the sphenopalatine block technique versus the blood patch.

• Comparison of the need to resort to a rescue treatment for patients treated with the sphenopalatine block technique versus the blood patch.

• Comparison of the duration of hospitalization of patients treated with the sphenopalatine block technique versus the blood patch.

• Comparison of the intensity of headaches at different time points in patients treated with the sphenopalatine block technique versus the blood patch.

• Comparison of the occurrence of adverse events during the performance of the procedure between the sphenopalatine block technique and the blood patch.

• Comparison of the occurrence of serious adverse events between patients treated with the sphenopalatine block technique and those treated with the blood patch.

• Comparison of patient satisfaction between those treated with the sphenopalatine block technique and those treated with the blood patch.

The sponsor did not provide information regarding the total number of participants enrolled in this clinical trial. The study population includes both **male** and **female** adults aged 18 years and older who have been diagnosed with **post-dural puncture syndrome**. Eligible participants must present with **post-dural-puncture headaches** that meet the criteria established by the International Classification of Headache Disorders (ICHD-3) and demonstrate persistent headaches following 24 hours of conservative treatment. The trial involves patients who are affiliated with a Social Security scheme and have provided informed consent for participation. The study population includes individuals classified as vulnerable populations. No specific information regarding lifestyle considerations such as diet, physical activity, or habits was provided by the sponsor.

This clinical trial evaluates the effectiveness of sphenopalatine block compared to blood patch in the management of post-dural puncture syndrome. The study is designed as a phase IV comparative trial investigating the sphenopalatine block against the current standard treatment. The investigational medicinal products include XYLOCARD 50mg/ml solution for infusion containing anhydrous lidocaine hydrochloride and EMLA 5 percent cream containing lidocaine and prilocaine, both administered via intranasal use as anesthetics. The maximum daily dose for XYLOCARD is 200 mg and for EMLA cream is 5 grams, with a maximum treatment period of one day for each product.

Eligible participants must be adults aged 18 years or older presenting with post-dural puncture headaches that meet the criteria of the International Classification of Headache Disorders (ICHD-3) and demonstrate persistent headaches after 24 hours of conservative treatment. Participants must provide informed consent and be affiliated with a Social Security scheme. The primary endpoint assesses the evolution of headache intensity in the upright position using a numerical verbal scale ranging from 0 (no pain) to 10 (the most intense pain possible). Measurements are taken at baseline, 30 minutes, 1 hour, 2 hours, 6 hours, 24 hours, 48 hours, and 7 days following the intervention.

Secondary endpoints include the consumption of analgesics (acetaminophen, nefopam, NSAIDs, morphine) measured in milligrams after the procedure and for 7 days, the need for rescue treatment with blood patch after the first procedure, duration of hospitalization during the 7-day post-intervention period, headache intensity at specified time points, adverse events during the procedure, serious adverse events such as radicular compression, meningitis, or cauda equina syndrome, and patient satisfaction assessed at 7 days using a 5-item Likert scale. The trial is scheduled to commence recruitment on December 31, 2025, with an estimated completion date of February 1, 2028. Participant involvement extends for 7 days following the intervention. Conditions that may lead to early termination from the study are not specified in the available protocol information.

The experimental treatment consists of two medicinal products administered via intranasal route for the management of post-dural puncture headaches through sphenopalatine block. Both products function as anesthetics and are administered for a maximum treatment period of one day.

**XYLOCARD® 50mg/ml** is a **solution for infusion** containing **anhydrous lidocaine hydrochloride** as the active substance of chemical origin. The product is manufactured by ASPEN PHARMA TRADING LIMITED and holds marketing authorization number 6 110 009 3 in France. For this clinical trial, the product is administered via **intranasal use**, which differs from its authorized indication for ventricular rhythm disorders administered by perfusion. The maximum daily dose is **200 mg**, with a maximum total dose of **200 mg** over the treatment period. The product is classified under ATC code C01BB01 (lidocaine).

**EMLA® 5 POUR CENT** is a **cream** formulation containing two active substances: **lidocaine** and **prilocaine**, both of chemical origin. The product is manufactured by ASPEN PHARMA TRADING LIMITED and holds marketing authorization number 34009 556 936 0 4 in France, with mutual recognition procedure number FI/H/0886/001. For this clinical trial, the product is administered via **intranasal use**. The maximum daily dose is **5 grams**, with a maximum total dose of **5 grams** over the treatment period. The product is classified under ATC code N01BB20 (combinations).

The study compares the effectiveness of the sphenopalatine block using these experimental medications against the current standard treatment, the **blood patch**, for managing post-dural puncture syndrome within seven days. The blood patch serves as the comparator treatment representing standard-of-care therapy for this condition.

The primary efficacy endpoint will be assessed through the evolution of headache intensity in the upright position, measured using a numerical verbal scale ranging from 0, indicating no pain, to 10, representing the most intense pain possible. This assessment will be conducted at the beginning of the intervention and at multiple subsequent timepoints: 30 minutes, 1 hour, 2 hours, 6 hours, 24 hours, 48 hours, and 7 days following the performance of the sphenopalatine block or blood patch.

Secondary efficacy parameters will include the consumption of analgesics, specifically acetaminophen, nefopam, nonsteroidal anti-inflammatory drugs, and morphine, quantified in milligrams after the procedure and throughout the 7-day follow-up period. Additional secondary endpoints comprise the need for rescue treatment with a blood patch after the initial procedure, the duration of hospitalization during the 7 days post-intervention, and the intensity of headaches at the designated timepoints of 30 minutes, 1 hour, 2 hours, 6 hours, 24 hours, 48 hours, and 7 days. The occurrence of undesirable events during the performance of the procedure and serious adverse events, such as radicular compression, meningitis, or cauda equina syndrome, will also be evaluated. Patient satisfaction will be assessed at 7 days after treatment using a 5-item Likert scale.