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Study on the Effectiveness of Lidocaine Hydrochloride and Sodium Chloride for Treating Headaches in Patients with Spontaneous Brain Bleeding

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 clinical trial is focused on studying the effectiveness of a treatment for headaches caused by a type of bleeding in the brain known as spontaneous subarachnoid hemorrhage. This condition can lead to severe headache pain, and the study aims to explore a treatment method called a bilateral greater occipital nerve block. This involves using an injection to block pain signals in the nerves at the back of the head, which may help reduce headache pain.

The treatment being tested involves two main substances. The first is lidocaine hydrochloride, a local anesthetic that helps numb the area to reduce pain. The second is sodium chloride, commonly known as salt, which is used as a solvent to help deliver the lidocaine. Both substances are administered through a subcutaneous injection, which means they are injected just under the skin.

The purpose of the study is to determine how effective this nerve block treatment is in managing headache pain related to spontaneous subarachnoid hemorrhage. Participants in the study will receive the treatment and their headache pain will be monitored to see if there is a significant reduction in pain levels. The study will help understand if this approach can provide relief for those suffering from this type of headache.

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

    Joining the study

    Upon joining the study, you will be required to provide a signed informed consent. This consent confirms your understanding and agreement to participate in the trial.

    You will be admitted to the Semicritical Care Unit or Intensive Care Unit (ICU) at the Hospital de la Santa Creu i Sant Pau. This is necessary for monitoring and managing your condition.

  2. Step 2

    Initial assessment

    An initial assessment will be conducted to evaluate your condition. This includes checking your eligibility based on the Hunt and Hess scale, which measures the severity of your condition.

    Your medical history and current health status will be reviewed to ensure you meet the criteria for participation.

  3. Step 3

    Treatment administration

    You will receive a **bilateral greater occipital nerve block**. This involves an injection of a solution containing **lidocaine hydrochloride** and **sodium chloride** into the back of your head.

    The injection is administered subcutaneously, meaning it is given under the skin. This procedure aims to reduce headache pain related to spontaneous subarachnoid hemorrhage (SAH).

  4. Step 4

    Monitoring and evaluation

    After the procedure, your headache pain will be monitored using the Numerical Pain Rating Scale (NPRS). This scale helps measure the intensity of your pain.

    The primary goal is to achieve at least a 30% reduction in headache pain within one hour after the procedure. An optimal effect is defined as a 50% reduction or more.

  5. Step 5

    Follow-up

    Further follow-up assessments will be conducted to monitor your progress and any changes in your condition.

    These assessments will help determine the overall effectiveness of the treatment in managing your headache pain.

Who can join the trial?

6 criteria

  • Patients must have a type of bleeding in the brain called spontaneous subarachnoid hemorrhage (SAH).
  • Patients should have a specific type of SAH, either diffuse or perimesencephalic.
  • Patients must be admitted to a special care unit, such as a Semicritical Care Unit or Intensive Care Unit (ICU).
  • Patients must have a score of 1 to 3 on the Hunt and Hess scale, which is a system used to measure the severity of SAH.
  • Patients or their representatives must provide signed informed consent, which means they agree to participate in the study after understanding all the details.
  • Both male and female patients can participate.

Who cannot join the trial?

3 criteria

  • Patients who have any other type of headache not related to **spontaneous subarachnoid hemorrhage (SAH)**. SAH is a type of bleeding in the space around the brain.
  • Patients who are not within the specified age range for the study.
  • Patients who are part of a vulnerable population, which means groups of people who might need special protection or care.
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Investigated drugs

Bilateral Greater Occipital Nerve Block is a procedure used to help relieve headache pain. In this treatment, a small amount of medication is injected near the greater occipital nerves, which are located at the back of the head. These nerves can be involved in causing headaches, especially after a condition like a spontaneous subarachnoid hemorrhage, which is a type of bleeding in the brain. By blocking these nerves, the treatment aims to reduce or eliminate headache pain, providing relief to the patient.

What is already known about the treatment

Bilateral Greater Occipital Nerve Block – This treatment is administered through an injection, targeting the greater occipital nerves located at the back of the head. It is currently being studied for its effectiveness in treating headaches caused by spontaneous subarachnoid hemorrhage (SAH), a type of bleeding in the brain. The main therapeutic use is to relieve headache pain associated with SAH. The mechanism involves blocking nerve signals that contribute to headache pain, providing relief by numbing the area. It is classified as a nerve block procedure in pharmacology.

Investigated diseases

Spontaneous Subarachnoid Hemorrhage – This condition occurs when there is bleeding in the space between the brain and the surrounding membrane, known as the subarachnoid space. It often results from a ruptured aneurysm, which is a weakened area in a blood vessel. The bleeding can increase pressure on the brain, leading to sudden and severe headache, often described as the worst headache ever experienced. Other symptoms may include neck stiffness, nausea, vomiting, and sensitivity to light. As the condition progresses, it can cause confusion, drowsiness, or even loss of consciousness. The bleeding can also lead to complications such as rebleeding or vasospasm, which is the narrowing of blood vessels.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2025-520619-15-00Estimated enrolment40 patientsSponsorFundacio Institut De Recerca De L'Hospital De La Santa Creu I Sant Pau

sourced from the EU Clinical Trials Register and site verification

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).