IA Lidocaine and Methylprednisolone for Headache Associated With Subarachnoid Hemorrhage

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorDaniel Raper, MBBS

About this trial

Subarachnoid hemorrhage (SAH) is a type of bleeding around the brain that can cause sudden and severe headaches. These headaches can be debilitating and persist for weeks, significantly impacting a patient's comfort and recovery. Many patients require opioids for pain control, which can lead to side effects such as drowsiness, constipation, and dependency. There is a need for new treatment strategies to help relieve this pain while minimizing side effects.

This clinical study is designed to evaluate whether an injection of two medications (lidocaine and methylprednisolone) directly into the middle meningeal artery (MMA) can help reduce headache severity in patients who recently experienced a SAH. The medications will be given through a minimally invasive procedure performed during a routine angiogram, a type of imaging test already commonly used in SAH patients. The main goals of the study are to determine whether this treatment approach is safe, helps to reduce the severity of headaches, and decreases the need for opioid pain medications. Eligible patients will be those recently diagnosed with persistent headache symptoms and SAH who are undergoing routine cerebral angiogram, during which the medications are infused into the MMA. Participants will be monitored for pain levels using the Headache Impact Test (HIT-6) and 11-point Numeric Rating Scale (NRS), and for changes in their functional recovery using standard neurologic scales. The results of this study may provide early evidence to support new treatment options for patients suffering from difficult-to-control headaches after a SAH.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adults aged ≥18 years with confirmed SAH via computed tomography or magnetic resonance imaging

Undergoing DSA as part of routine diagnostic or therapeutic care

Experiencing headaches with baseline severity assessable using Headache Impact Test (HIT-6) questionnaire and 11-point Numeric Rating Scale (NRS)

Conscious patients who can understand and sign informed consent form

Disqualifiers

Known allergy or hypersensitivity to lidocaine or amide-type anesthetics

Known allergy or hypersensitivity to Intralipid® (intravenous fat emulsion) or any of its components, including egg phospholipids or soy-based products

Known allergy or hypersensitivity to methylprednisolone, corticosteroids, any component of the Solu-Medrol® formulation

Diagnostic abnormalities at baseline, including ECG abnormalities (e.g., prolonged PR/QTc intervals, heart block, arrhythmias)

Trial design

Design model

Single group

Treatments tested in this trial

  • Lidocaine hydrochloride

    Drug

    A total of 20 mg injected in 10 mg doses will be administered over 5 min into the frontal and parietal branches of each MMA, resulting in a cumulative dose of 40 mg per MMA. The injection will be performed bilaterally, yielding a total dose of 80 mg per patient.

  • Methylprednisolone sodium succinate

    Drug

    A total of 10 mg were injected over 5 min into the frontal and parietal branches of each MMA, resulting in a cumulative dose of 20 mg per MMA, yielding a total dose of 40 mg per patient.

Treatment groups

25 Participants
are divided into 1 treatment group
Group A: Treatment CohortExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Headache Severity

Headache Impact Test-6 (HIT-6) score from baseline (pre-intervention) to 12 weeks postoperatively. Scores range from 36 (no impact) to 78 (severe impact), with higher scores indicating a greater negative impact.

Time frame
From baseline to 12-week follow-up

Secondary outcomes

1

Headache intensity

11-point Numeric Rating Scale (NRS) score from baseline (pre-intervention) to 12 weeks postoperatively. Scores range from 0 (no pain) to 10 (worst possible pain), with higher scores indicating a greater negative impact.

Time frame
From baseline to 12-week follow-up
2

Opioid Use

Total opioid use will be recorded during hospital stay and follow-up.

Time frame
From admission to 12-week follow-up
3

Functional Outcome

Functional status will be assessed using the modified Rankin Scale at discharge and follow-up. Scores range from 0 (no symptoms) to 6 (death), with lower scores indicating better outcomes.

Time frame
From discharge to 12-week follow-up
4

Adverse Events Related to Intra-Arterial Injection

All procedural and post-procedural complications will be monitored, including symptoms of lidocaine toxicity, new neurological deficits, worsening headache, hemodynamic instability, or allergic reactions. Events will be categorized by severity and attribution to the intervention.

Time frame
From discharge to 12-week follow-up

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Daniel Raper, MBBS

Lead sponsor

University of California, San Francisco

Sponsor institution