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

NCT07307508 | Recruiting DMC

• 1 other identifier: MRC-01-23-789
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Aneurysmal Subarachnoid Hemorrhage (aSAH); Headache Disorders

Keywords

Subarachnoid Hemorrhage Headache; Aneurysmal Subarachnoid Hemorrhage; Cerebral Aneurysm; SAH-associated headache; Scalp Block; Levobupivacaine; Opioid Consumption; Neurocritical Care

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

  24 hours after intervention

Study Arms (2)

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

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

Other: Conventional analgesic therapy

Interventions

Levobupivacaine Scalp block PROCEDURE

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.

Intervention arm (Scalp Block with Levobupivacaine)

Conventional analgesic therapy OTHER

The control group will recieve conventional therapy comprising regular intravenous paracetamol 1 gram every 6 hours intravenously plus fentanyl patient-controlled analgesia

Control arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.
• Pregnancy

Sponsors & Collaborators

• Hamad Medical Corporation: lead

Study Sites (1)

Hamad Medical Corporation

Doha, Qatar

RECRUITING

MeSH Terms

Conditions

Subarachnoid Hemorrhage; Headache Disorders; Intracranial Aneurysm

Condition Hierarchy (Ancestors)

Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Intracranial Arterial Diseases; Aneurysm

Study Officials

• Sohel Mohamed Ahmed, Consultant

  Hamad Medical Corporation

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sohel Mohamed Ahmed, Consultant

CONTACT

+97450586481; SAhmed65@hamad.qa

Abdelrahman Balal, Clinical Fellow

CONTACT

+97455993382; abalal@hamad.qa

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: All patients enrolled in the study will be blinded to the group randomization. However, the investigators will not be blinded to group assignments.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: December 14, 2025
• First Posted: December 29, 2025
• Study Start: October 22, 2025
• Primary Completion (Estimated): July 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: December 29, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

QA (1)