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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorHamad Medical Corporation

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Levobupivacaine Scalp block

    Procedure/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 therapy

    Other intervention

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

Treatment groups

22 Participants
are divided into 2 treatment groups
Group A: Intervention arm (Scalp Block with Levobupivacaine)Experimental treatment 1 intervention
Group B: Control armActive comparator 1 intervention

Trial outcomes

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.

Time frame
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

Time frame
24 hours after intervention

Other outcomes

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