Study on the Effectiveness of Sphenopalatine Block for Headache Relief in Patients with Subarachnoid Hemorrhage Using Lidocaine Hydrochloride

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What is this study about?

This clinical trial is focused on studying the effectiveness of a treatment method called the sphenopalatine block for managing headaches in patients who have experienced a subarachnoid hemorrhage. A subarachnoid hemorrhage is a type of bleeding that occurs in the space surrounding the brain, often leading to severe headaches. The study aims to demonstrate a 50% reduction in the use of morphine, a common pain relief medication, during the first 72 hours after a procedure called cerebral arteriography, which is an imaging test used to look at the blood vessels in the brain.

Participants in the study will receive either the sphenopalatine block or a placebo to assess the effectiveness of the block in reducing headache pain and morphine consumption. The study will also monitor any complications that may arise from the sphenopalatine block technique, such as soft palate anesthesia, nosebleeds, or temporary hearing loss. The trial will involve several medications, including morphine hydrochloride, lidocaine hydrochloride, nefopam hydrochloride, and paracetamol, which are used for pain management.

The study will take place over a period of time, with participants being monitored for their pain levels and overall satisfaction with pain management. The goal is to improve pain management strategies for patients with subarachnoid hemorrhage, potentially reducing the need for strong pain medications like morphine. The trial is expected to start recruiting participants in early 2025 and aims to conclude by mid-2029.

1 joining the study

Upon joining the study, eligibility is confirmed based on specific criteria such as age (18 years or older), diagnosis of non-traumatic subarachnoid hemorrhage (SAH), and certain pain levels despite usual pain relief medications.

2 initial assessment

An initial assessment is conducted to evaluate the current condition, including pain levels and overall health status. This helps in determining the baseline for the study.

3 treatment phase

During the treatment phase, a procedure called a sphenopalatine block is administered. This is intended to reduce the need for morphine by 50% within the first 72 hours after a brain imaging procedure called cerebral arteriography.

Medications used include morphine hydrochloride (injection), lidocaine hydrochloride (oral gel and injection), nefopam hydrochloride (injection), and paracetamol (infusion).

4 monitoring and evaluation

Pain levels and morphine consumption are monitored closely for the first 72 hours. The goal is to assess the effectiveness of the sphenopalatine block in reducing pain and morphine use.

Secondary evaluations include daily morphine consumption, potential complications from the procedure, and overall satisfaction with pain management.

5 follow-up assessments

Follow-up assessments are conducted to evaluate long-term outcomes, including pain levels at 7 days and 28 days, and satisfaction with pain management.

Additional assessments may include any complications experienced and the effectiveness of the sphenopalatine block over time.

6 completion of the study

Upon completion of the study, a final evaluation is conducted to summarize the findings and assess the overall impact of the treatment on pain management.

Who Can Join the Study?

Must be 18 years or older.
Must have a non-traumatic subarachnoid hemorrhage (SAH), which means bleeding in the space around the brain not caused by an injury, with or without an aneurysm (a bulge in a blood vessel) seen on brain imaging.
Must have WFNS scores of 1 or 2, which are scores used to assess the severity of the condition.
Must be awake and not on a breathing machine after a radiological procedure.
Must be experiencing pain greater than 3 out of 10 on a pain scale, even after taking usual pain medications like Paracetamol and Acupan.
Must be affiliated with or benefiting from a social security scheme.

Who Cannot Join the Study?

Patients who have a condition called subarachnoid hemorrhage, which is bleeding in the space around the brain.
Patients who are not within the specified age range for the study.
Patients who are not part of the specific clinical trial group required for the study.
Patients who are considered part of a vulnerable population, meaning they might need special protection or care.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

Site Name	City	Country	Status
CHU Grenoble Alpes	La Tronche	France

Other Sites

No sites found in this category

Trial status

Country	Status	Recruitment Start
France	Recruiting	06.01.2025

Trial locations

Investigated drugs:

Morphine is a medication used to relieve severe pain. In this trial, it is used to manage pain in patients who have experienced a non-traumatic subarachnoid hemorrhage. The study aims to reduce the amount of morphine needed by using another therapy.

Sphenopalatine Block is a procedure used to relieve headache pain. It involves numbing a specific nerve area in the face, which can help reduce pain. In this trial, the sphenopalatine block is being evaluated for its effectiveness in reducing the need for morphine in patients with headaches following a non-traumatic subarachnoid hemorrhage.

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 lead to increased pressure on the brain, causing severe headaches, neck stiffness, and sensitivity to light. As the condition progresses, it may result in confusion, seizures, or loss of consciousness. The bleeding can disrupt normal brain function and may lead to complications such as vasospasm, where blood vessels constrict and reduce blood flow. Early recognition and management are crucial to prevent further complications.

Trial ID:

2024-514282-19-00

Protocol code:

38RC23.0226 SATURN

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on the Effectiveness of Sphenopalatine Block for Headache Relief in Patients with Subarachnoid Hemorrhage Using Lidocaine Hydrochloride

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?