Efficacy of Scalp Block in Managing Post Subarachnoid Hemorrhage Headache in Critically Ill Patie… (NCT07307508) | Clinical Trial Compass
RecruitingNot Applicable
Efficacy of Scalp Block in Managing Post Subarachnoid Hemorrhage Headache in Critically Ill Patients. A Single Centre Randomized Controlled Trial
Qatar22 participantsStarted 2025-10-22
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Exclusion criteria
. Patients with aSAH undergoing surgical craniotomy and aneurysmal clipping.
. Non-aneurysmal subarachnoid or other intracranial hemorrhage forms (e.g., Intracerebral hemorrhage).
. SICU admission Glasgow Coma Scale (GCS) of 13 or lower.
. WFNS Score 4 / 5 or requiring mechanical ventilation for more than 24 hrs.
. Patients with known allergy to local anesthetics.
. Admission to ICU \> 7 days after hemorrhage.
. Patients with a documented bleeding disorder.
. Patients with a history of chronic headache disorder or migraine.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this trial is testing scalp block as a way to manage the severe headache that comes after a subarachnoid hemorrhage, could it be an option worth discussing for my situation, and what would my care team need to evaluate to decide?
2The trial is measuring how much opioid medication patients need in the first 24 hours after receiving a scalp block — does that mean my doctor would expect me to still need some opioids, and how does that compare to what I'd receive with standard pain management?
3This is listed as a Phase NA randomized controlled trial, which means some participants will receive the scalp block and others won't — can my doctor explain what the comparison treatment looks like and whether I'd still receive adequate pain relief if I'm in the control group?
4Since this study is specifically for critically ill patients with aneurysmal subarachnoid hemorrhage, can my doctor help me understand whether my current condition and severity level would even make me a realistic candidate to discuss with the research team?
5Are there standard pain management approaches already available for post-subarachnoid hemorrhage headache that my doctor would consider first, and how does participating in this trial compare to those existing options?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Total opioid consumption in the first 24 hours after administration of scalp block.