MMA Infusion of Lidocaine for Treatment of Headache in Patients With Aneurysmal SAH

NCT07816159 | Not Yet Recruiting Phase 2 FDA Drug

• 4 other identifiers: p-2026-22097E-24086-04Pilot Research Grant2026-526092-36-00
• Study Type: interventional
• Target: 90
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of the MIL-SAH trial is to evaluate the efficacy and safety of middle meningeal artery (MMA) lidocaine infusion for the treatment of headache in patients with aneurysmal subarachnoid hemorrhage (SAH). The trial aims to determine whether MMA lidocaine infusion reduces headache severity during the first 72 hours following endovascular aneurysm treatment compared with placebo.

Conditions

Headaches Associated With Subarachnoid Hemorrhage (SAH)

Keywords

subarachnoid hemorrhage; lidocaine; middle meningeal artery; SAH; MMA; headache

Outcome Measures

Primary Outcomes (1)

• Headache Severity

  Daily maximum headache severity over the first 72 hours following the trial intervention

  From 0 to 72 hours postprocedure

Secondary Outcomes (4)

• Headache relief

  From baseline to 2 hours postprocedure

• Opioid consumption

  From 0-72 hours postprocedure

• Patient global assessment

  From 0 to 72 hours postprocedure

• Adverse Events Related to Intraarterial Lidocaine Injection

  From 0 to 24 hours postprocedure

Study Arms (2)

MMA lidocaine

EXPERIMENTAL

The participants will receive 50 mg of lidocaine in each middle meningeal artery

Drug: Lidocaine hydrochloride

MMA isotonic saline

PLACEBO COMPARATOR

The participants will receive isotonic saline in each middle meningeal artery

Drug: Isotonic saline

Interventions

Lidocaine hydrochloride DRUG

Participants will receive lidocaine hydrochloride at a dose of 50 mg per side (10 mg/mL; 5 mL). The infusion is delivered into each MMA over 5 minutes by manual injection, resulting in a total injection time of approximately 10 minutes and a total lidocaine hydrochloride dose of 100 mg. The trial intervention is performed only during the endovascular treatment session. There is no repeated dosing of trial medication.

MMA lidocaine

Isotonic saline DRUG

Participants will receive 5 mL of isotonic saline per side. The infusion is delivered into each MMA over 5 minutes by manual injection, resulting in a total injection time of approximately 10 minutes. The trial intervention is performed only during the endovascular treatment session. There is no repeated dosing of trial medication.

MMA isotonic saline

Eligibility Criteria

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

You may qualify if:

• Age ≥ 18 years
• Imaging showing a SAH and intracranial aneurysm
• Undergo endovascular therapy within 72 hours\*
• Glasgow coma scale (GCS) score of 14-15
• Maximum headache severity of NRS score ≥ 4 at a time \> 1 hour after ictus or the ad-ministration of opioids due to headache

You may not qualify if:

• The patient is unable to understand information provided in the national language or English
• Known allergies to amide-type local anesthetics or iodinated contrast media
• Pregnancy or lactation
• Severe hepatic impairment
• History of epilepsy
• History of chronic opioid use
• Renal impairment with eGFR \< 30 mL/min/1.73m2
• Current treatment with class III antiarrhythmics (e.g. amiodarone)
• Atrioventricular block of II and III degree
• Unsuccessful endovascular aneurysm securement or procedural complications

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead

MeSH Terms

Conditions

Subarachnoid Hemorrhage; Headache

Interventions

Lidocaine; Sodium Chloride

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; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Central Study Contacts

Rasmus H Dahl

CONTACT

35456491; rasmus.holmboe.dahl@regionh.dk

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: September 7, 2026
• First Posted: September 11, 2026
• Study Start (Estimated): December 1, 2026
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): February 1, 2030
• Last Updated: September 11, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share