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Comparing Sphenopalatine Block Using Lidocaine and Prilocaine to Blood Patch for Patients with Post-Dural Puncture Syndrome

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study examines post-dural puncture syndrome, a condition that occurs when a needle puncture through the protective membrane surrounding the spinal cord causes fluid to leak, leading to severe headaches that worsen when sitting or standing upright. The study will compare two treatment approaches: a sphenopalatine block and a blood patch. The sphenopalatine block involves applying numbing medication through the nose using either XYLOCARD, which contains anhydrous lidocaine hydrochloride, or EMLA cream, which contains both lidocaine and prilocaine. The blood patch is the current standard treatment where a small amount of the patient's own blood is injected near the site of the original puncture to seal the leak. The purpose of the study is to evaluate whether the sphenopalatine block is as effective as the blood patch in managing headaches caused by post-dural puncture syndrome within seven days of treatment.

Patients participating in this study will have experienced persistent headaches for at least 24 hours despite receiving conservative treatment such as rest, fluids, and pain medication. They will receive either the sphenopalatine block or the blood patch procedure. After the treatment, headache intensity will be measured using a scale from zero to ten, where zero means no pain and ten represents the worst possible pain. These measurements will be taken at multiple time points: at the start of the procedure, then at 30 minutes, one hour, two hours, six hours, 24 hours, 48 hours, and seven days after treatment. The treatment period lasts one day, with follow-up assessments continuing for seven days.

The study will also track several other aspects of patient care and recovery. This includes monitoring how much pain medication patients need after the procedure, whether additional treatment with a blood patch becomes necessary, and how long patients need to stay in the hospital during the seven-day period following treatment. Any unwanted effects that occur during the procedure will be recorded, as well as any serious complications. Patient satisfaction with the treatment will be assessed seven days after the procedure using a rating scale. The study aims to determine whether the sphenopalatine block offers a comparable alternative to the blood patch for managing this painful condition.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment and treatment start

    Upon joining the trial, your headache intensity will be measured while you are in an upright position. This measurement uses a numerical verbal scale where 0 means no pain and 10 means the most intense pain possible.

    You will be assigned to receive one of two treatments: either a sphenopalatine block (a procedure that blocks specific nerves in the nose area) or a blood patch (the current standard treatment where a small amount of your blood is injected near the spine).

    If you receive the sphenopalatine block, a numbing cream called EMLA 5 percent cream (containing lidocaine and prilocaine) will be applied inside your nose. Alternatively, a solution called XYLOCARD 50mg/ml (containing lidocaine hydrochloride) may be used. Both medications are administered through the nose to numb the area.

  2. Step 2

    Immediate monitoring after procedure

    Your headache intensity will be assessed at 30 minutes after the procedure.

    Another assessment will be performed at 1 hour after the procedure.

    A further assessment will be conducted at 2 hours after the procedure.

    An additional measurement will be taken at 6 hours after the procedure.

    During this period, any undesirable events that occur during or immediately after the procedure will be recorded.

  3. Step 3

    First day follow-up

    At 24 hours (1 day) after the procedure, your headache intensity will be measured again.

    The amount of pain relief medications you have taken will be recorded. This includes medications such as acetaminophen, nefopam, non-steroidal anti-inflammatory drugs, and morphine. The amounts will be measured in milligrams.

    If needed, a rescue treatment with a blood patch may be performed if your symptoms have not improved sufficiently.

  4. Step 4

    Second day follow-up

    At 48 hours (2 days) after the procedure, your headache intensity will be assessed.

    The total amount of pain relief medications you have used will continue to be recorded.

    Any serious adverse events will be monitored. These include conditions such as radicular compression (nerve pressure), meningitis (infection of the membranes around the brain and spinal cord), or cauda equina syndrome (a rare condition affecting nerves at the base of the spine).

  5. Step 5

    One week follow-up and trial completion

    At 7 days after the procedure, a final assessment of your headache intensity will be performed.

    The total amount of pain relief medications you have taken during the entire 7-day period will be calculated.

    The total duration of hospitalization during these 7 days will be recorded.

    Your satisfaction with the treatment will be assessed using a scale with 5 response options.

    This marks the completion of your participation in the trial for this treatment phase.

Who can join the trial?

5 criteria

  • You must have headaches that started after a spinal puncture, which is a procedure where a needle is inserted into the lower back to access the fluid around the spinal cord. These headaches must meet specific medical criteria defined by international headache classification standards.
  • Your headaches must continue even after receiving conservative treatment for 24 hours. Conservative treatment means basic care such as rest, fluids, and pain medications without any procedures.
  • You must be 18 years of age or older.
  • You must have provided your informed consent, which means you have agreed to participate in the study after understanding what it involves.
  • You must be affiliated with a Social Security scheme, which is a healthcare insurance system.

Who cannot join the trial?

1 criterion

  • No specific exclusion criteria (reasons why you cannot participate) have been listed for this clinical trial at this time
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Investigated drugs

  • Sphenopalatine block

    is a procedure where medication is applied to a specific nerve area in the nose to help relieve headaches that can occur after a spinal procedure. This treatment works by numbing nerves that may be causing the headache pain.

  • Blood patch

    is a procedure where a small amount of your own blood is injected near the area where the spinal procedure was done. This helps seal any leak of spinal fluid that may be causing the headache, allowing the body to heal naturally.

What is already known about the treatment

  • Sphenopalatine Block

    This is a pain relief procedure that involves injecting numbing medication near a cluster of nerves located behind the nose, called the sphenopalatine ganglion. The technique is being studied as an alternative treatment for severe headaches that occur after a spinal tap or epidural procedure, when the needle accidentally punctures the protective covering around the spinal cord. This nerve block works by temporarily stopping pain signals from reaching the brain, potentially providing relief from the intense headaches that can follow these medical procedures. The procedure is currently being compared to the standard treatment called a blood patch to determine which method works better for managing this type of headache.

  • Blood Patch

    This is a medical procedure used to treat severe headaches that develop after a spinal tap or epidural, when spinal fluid leaks through a hole in the protective membrane surrounding the spinal cord. The treatment involves taking a small amount of the patient's own blood and injecting it near the site of the original puncture, where it forms a natural seal or "patch" over the leak. This procedure works by stopping the spinal fluid from leaking out, which relieves the pressure changes in the brain that cause the headache. Blood patch is currently considered the standard treatment for post-dural puncture headaches and is widely accepted in medical practice as an effective solution for this condition.

Investigated diseases

Post-dural Puncture Headache – This condition occurs when cerebrospinal fluid leaks through a hole in the protective membrane surrounding the brain and spinal cord after a procedure involving a needle puncture. The headache typically develops within 48 hours after the puncture and is characterized by pain that worsens when sitting or standing upright and improves when lying down. The pain is caused by decreased cerebrospinal fluid pressure around the brain, which leads to the brain sagging slightly downward. Patients may also experience neck stiffness, nausea, sensitivity to light, and hearing changes. The headache intensity can range from mild discomfort to severe pain that significantly affects daily activities. The condition usually develops following procedures such as spinal anesthesia, epidural anesthesia, or lumbar puncture.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2025-522168-34-00Protocol codeRBHP 2025 GUYOTEstimated enrolment80 patientsSponsorUniversity Hospital Of Clermont-Ferrand

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