Aneurysmal Subarachnoid Hemorrhage (aSAH)SAH-BLOCKNCT07307508
Efficacy of Scalp Block in Managing Post Subarachnoid Hemorrhage Headache in Critically Ill Patients. A Single Centre Randomized Controlled Trial
A study testing Levobupivacaine Scalp block and Conventional analgesic therapy in people with Aneurysmal Subarachnoid Hemorrhage (aSAH) and Headache Disorders, run by Hamad Medical Corporation at 1 site in Qatar.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aneurysmal Subarachnoid Hemorrhage (aSAH), Headache Disorders
- What is being tested?
- Levobupivacaine Scalp block and Conventional analgesic therapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteQatar
- Study dates
- 22 Oct 2025to 30 Dec 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Show all 9Show fewer
- Patients with a documented bleeding disorder.
- Patients with a history of chronic headache disorder or migraine.
- Pregnancy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Qatar1 site, 1 recruiting
- Recruiting
Hamad Medical Corporation
Doha
Sohel Gamal, Consultant, +97450586481, SAhmed65@hamad.qa
Abdelrahman Balal, MD, +97455993382, abalal@hamad.qa
About this study
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.
Read the detailed description
Despite its high prevalence, associated morbidity, and effects on the quality of life of aSAH-associated headache, epidemiological studies of its timing, severity, characteristics, and usual treatments are lacking. A prospective study in 2013 has shown that headache was the second-leading cause of 30-day hospital readmission after SAH. Long-term follow-up data indicate that headaches may persist after SAH for 2 to 9 years. Persistent headache leads to poor quality of life, increased therapy costs, delayed return to work, and increased incidence of depression.
Although there is evidence indicating that headaches related to subarachnoid hemorrhage (SAH) result in hospital readmissions and cause long-term suffering, there is a lack of data guiding the management of headaches in the critical care setting. Current national and international guidelines from the American Heart Association and the Neurocritical Care Society do not offer evidence-based recommendations for managing headaches. Furthermore, the exact mechanism of headache pain after subarachnoid hemorrhage remains elusive. Some researchers have postulated that this pain may be caused by hemolysis's inflammatory byproducts, resulting in meningeal irritation in the subarachnoid space. Additionally, central pain sensitization mediated by N-methyl-d-aspartate (NMDA) receptors may cause hyperalgesia after SAH. The lack of a definitive mechanism makes selecting Pharmacotherapeutics is a significant challenge. Innovative, opioid-sparing treatment strategies for managing SAH-associated headaches are warranted based on the need to monitor neurological examinations, avoid over-sedation, and alleviate discomfort in SAH patients with headaches. Opioids, often in escalating doses, remain the mainstay of therapy, in addition to other medications such as paracetamol, ketorolac, and dihydrocodeine. However, major limitations of this approach include depressed consciousness and respiratory drive, nausea, ileus, urinary retention, hypotension, and the high potential for tolerance and addiction. Headache management often remains suboptimal despite steady consumption of analgesics. Despite these obvious drawbacks, providers continue to rely on opioid therapy.
Review articles typically mention headaches after SAH without making specific Recommendations for managing the headache after the initial episode. However, a recent study evaluating Pterygopalatine Fossa Blockade (PPF) as a novel, narcotic-sparing treatment for headache in seven patients with SAH showed that the worst pain recorded in the 24 hours before the block was significantly higher than in the period four hours after the block (9.1 vs 3.1; p 0.0156), and in the period eight hours after the block (9.1 vs 2.8; = p 0.0313). The only complication was minor oozing from the needle insertion sites, which subsided completely with gauze pressure within 1 minute. In this study, we aim to assess the impact of scalp blocks in reducing headaches associated with aneurysmal subarachnoid hemorrhage in patients undergoing endovascular treatment of the aneurysm (coiling or flow diversion). To our knowledge, this will be the first randomized controlled trial to examine the role of scalp block in alleviating headaches associated with aSAH.
- Being tested
- Levobupivacaine Scalp block, Conventional analgesic therapy
- Keywords
- Subarachnoid Hemorrhage Headache, Aneurysmal Subarachnoid Hemorrhage, Cerebral Aneurysm, SAH-associated headache, Scalp Block, Levobupivacaine, Opioid Consumption, Neurocritical Care
- Medical subject headings
- Subarachnoid Hemorrhage, Headache Disorders, Intracranial Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Levobupivacaine Scalp blockProcedure or surgery
Scalp block will be administered using 20 ml of 0.5% Levobupivacaine In addition to conventional analgesic therapy. It will be performed using an aseptic technique by a privileged anesthesiologist or intensivist after the endovascular coiling, while the patient is under general anesthesia, before extubation. The scalp block will be administered using anatomical landmarks over the supraorbital and supratrochlear nerve, auriculotemporal nerve, zygomaticotemporal nerve, greater occipital nerve, and lesser occipital nerve.
Conventional analgesic therapyOther
The control group will recieve conventional therapy comprising regular intravenous paracetamol 1 gram every 6 hours intravenously plus fentanyl patient-controlled analgesia
| Study group | Role | What they receive |
|---|---|---|
| Intervention arm (Scalp Block with Levobupivacaine) | Experimental | Patients randomized to the intervention group will receive a scalp block using 20 ml of 0.5% Levobupivacaine after endovascular intervention and before extubation. In addition to conventional pain managment Receives: Procedure: Levobupivacaine Scalp block |
| Control arm | Active comparator | Patients in the control group will receive no scalp block. Only conventional pain management will be given Receives: Other: Conventional analgesic therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total opioid consumption in the first 24 hours after administration of scalp block.
Total opioid dose administered within the first 24 hours following the scalp block + Standard care (intervention arm) Vs standard care alone (control arm). To calculate a uniform metric to quantify the daily total opioid dose per patient per day, the recorded amounts of the various opioid agents will be converted to their intravenous morphine equivalent by using standard conversion factors. The total resultant dosage will be calculated as the sum of all converted doses for each patient for each day in the study interval and presented as a morphine-equivalent dose. The maximum and median daily opioid dosage will be determined by examining these aggregated daily.
Measured: 24 hours after intervention
Secondary outcomes (1)
Median numeric rating scores (NRS) pain scores in the first 24 hours after the administration of scalp block.
Numeric Rating scores (NRS) is a tool to assess the severity of pain/headaches from zero to ten, where zero is no pain, and 10 is the worst pain possible. The patient-controlled analgesia (PCA) device is a device used to administer set doses of opioids with a safety lockout to prevent overdosing. However, the device is capable of registering the number of demands made by the patients even if no dose is delivered (i.e. demand made within lockout time). The recorded demand will be used as a surrogate for pain intensity
Measured: 24 hours after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2025
- Study start22 Oct 2025
- Primary completion30 Jul 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aneurysmal Subarachnoid Hemorrhage (aSAH)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study involves a two-arm, randomized, parallel assignment. Recruited patients in the intervention group will receive a scalp block using 20 ml of 0.5% Levobupivacaine, while the control group will not receive any scalp block. The scalp block will be performed using an aseptic technique by a privileged anesthesiologist or intensivist after the endovascular coiling, while the patient is under general anesthesia, before extubation. All patients enrolled in the study will be blinded to the group randomization. However, the investigators will not be blinded to group assignments.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hamad Medical Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sohel Mohamed Ahmed, Consultant, Principal investigator, Hamad Medical Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07307508
- Sponsor's protocol ID
- MRC-01-23-789
- Other IDs
- MRC-01-23-789
- Acronym
- SAH-BLOCK
- Status last verified
- Dec 2025
- First submitted
- 14 Dec 2025
- Last updated
- 29 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to institutional policies at Hamad Medical Corporation and local regulatory restrictions. Only final results will be reported in publications and presentations.