Scalp block for headache after aneurysmal subarachnoid hemorrhage in ICU patients
Efficacy of Scalp Block in Managing Post Subarachnoid Hemorrhage Headache in Critically Ill Patients. A Single Centre Randomized Controlled Trial
We are testing whether a levobupivacaine scalp block added to standard pain medicines can reduce severe headache in adults in the ICU after aneurysmal subarachnoid hemorrhage treated endovascularly.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 22 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Hamad Medical Corporation Industry-sponsored |
| Locations | 1 site (Doha) |
| Trial ID | NCT07307508 on ClinicalTrials.gov |
What this trial studies
This single-center randomized controlled trial at Hamad Medical Corporation compares a levobupivacaine scalp block plus conventional analgesic therapy versus conventional analgesics alone for adults with aneurysmal subarachnoid hemorrhage treated by endovascular methods. Eligible participants are adults admitted to the surgical ICU who are awake and meet neurological stability criteria, while patients with surgical clipping, chronic headache disorders, bleeding disorders, pregnancy, or local anesthetic allergy are excluded. The intervention delivers regional scalp anesthesia and investigators will measure headache severity, opioid consumption, ICU course, and adverse events during hospitalization. Patients are randomly assigned to one of the two arms and treated according to standardized analgesic protocols.
Who should consider this trial
Good fit: Adults over 18 admitted to the SICU with aneurysmal subarachnoid hemorrhage who underwent endovascular aneurysm treatment, are neurologically stable/awake (GCS >13), and have no chronic headache, bleeding disorder, pregnancy, or allergy to local anesthetics.
Not a fit: Patients who had surgical clipping, non-aneurysmal hemorrhage, low consciousness (GCS ≤13 or WFNS 4–5), prolonged mechanical ventilation, chronic headache disorders, bleeding disorders, pregnancy, or local anesthetic allergy are excluded and unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, this approach could provide faster and stronger headache relief and reduce opioid use and ICU-related complications after aSAH.
How similar studies have performed: Small case series and observational reports have suggested scalp blocks can relieve post-SAH headache, but randomized controlled evidence is currently lacking.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Doha
- Hamad Medical Corporation — Doha, Qatar (Recruiting)
Study contacts
- Principal investigator: Sohel Mohamed Ahmed, Consultant — Hamad Medical Corporation
- Study coordinator: Sohel Mohamed Ahmed, Consultant
- Email: SAhmed65@hamad.qa
- Phone: +97450586481
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.