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Recruiting NCT07307508

Efficacy of Scalp Block in Managing Post Subarachnoid Hemorrhage Headache in Critically Ill Patients. A Single Centre Randomized Controlled Trial

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Trial Parameters

Condition Aneurysmal Subarachnoid Hemorrhage (aSAH)
Sponsor Hamad Medical Corporation
Study Type INTERVENTIONAL
Phase N/A
Enrollment 22
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2025-10-22
Completion 2026-07-30
Interventions
Levobupivacaine Scalp blockConventional analgesic therapy

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Brief Summary

Subarachnoid hemorrhage (SAH) is a devastating neurological disorder associated with significant mortality and morbidity rates, arising not just from the hemorrhage itself but also because of the catastrophic multisystem sequelae that can accompany the condition. Rupture of an intracranial aneurysm accounts for up to 85% of instances of SAH, occurring in approximately 3 to 25 people per 100,000 annually in most populations. Treatment of aneurysmal SAH (aSAH) includes prevention of re-bleeding, evacuation of space-occupying hematomas, management of hydrocephalus, and prevention of secondary cerebral insult. Severe headache is the predominant characteristic symptom of aSAH, developing almost instantaneously at ictus in 50% of cases and continuing into the first days. Its severity has a variety of physiological and psychological effects on the patient. Scalp blocks have been suggested to alleviate this headache in case series. However, there is no strong evidence supporting this intervention. In this study, we aim to assess the impact of scalp blocks on headache reduction in patients undergoing endovascular treatment of an aneurysm (coiling or flow diversion) with aneurysmal subarachnoid bleeding.

Eligibility Criteria

Inclusion Criteria: * All adults \> 18 years who are admitted to the Surgical Intensive Care Unit (SICU) with a confirmed diagnosis of aneurysmal subarachnoid hemorrhage, undergoing endovascular treatment of the aneurysm (coiling/flow diversion). Exclusion Criteria: 1. Patients with aSAH undergoing surgical craniotomy and aneurysmal clipping. 2. Non-aneurysmal subarachnoid or other intracranial hemorrhage forms (e.g., Intracerebral hemorrhage). 3. SICU admission Glasgow Coma Scale (GCS) of 13 or lower. 4. WFNS Score 4 / 5 or requiring mechanical ventilation for more than 24 hrs. 5. Patients with known allergy to local anesthetics. 6. Admission to ICU \> 7 days after hemorrhage. 7. Patients with a documented bleeding disorder. 8. Patients with a history of chronic headache disorder or migraine. 9. Pregnancy

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