A Phase 2 interventional study of Lidocaine hydrochloride and Isotonic saline in Headaches Associated With Subarachnoid Hemorrhage (SAH), sponsored by Rigshospitalet, Denmark. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-11.
Sponsored by Rigshospitalet, Denmark · Phase 2, Interventional, and Treatment
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.
The MIL-SAH trial is a multicenter, randomized, double-blind, placebo-controlled clinical trial evaluating whether middle meningeal artery (MMA) infusion of lidocaine reduces headache severity in patients with aneurysmal subarachnoid hemorrhage (SAH). Adult patients with SAH undergoing endovascular aneurysm treatment are randomized to receive either bilateral MMA lidocaine infusion or placebo immediately after successful aneurysm securement.
SAH-related headaches are frequently severe, persistent, and difficult to control with current analgesic strategies, which often rely on opioids. Preliminary case series have suggested that MMA lidocaine infusion may reduce headache severity with few adverse effects, but randomized clinical trials to support this is currently lacking. This trial aims to provide robust data on the efficacy and safety of this novel treatment approach.
510 studies on the registry are indexed under Subarachnoid Hemorrhage; 128 are open to participants now.
This study's planned enrollment of 90 is above the median of 57 across 264 interventional studies indexed under Subarachnoid Hemorrhage.
Browse Subarachnoid Hemorrhage studies →Rigshospitalet, Denmark is the lead sponsor of 1,007 studies on the registry; 175 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion criteria
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The participants will receive 50 mg of lidocaine in each middle meningeal artery
Drug: Lidocaine hydrochloride
The participants will receive isotonic saline in each middle meningeal artery
Drug: Isotonic saline
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.
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.
Headache Severity
Daily maximum headache severity over the first 72 hours following the trial intervention
Time frame: From 0 to 72 hours postprocedure
Headache relief
Proportion of participants with headache relief (none to mild headache, NRS≤3) at 2 hours following the trial intervention
Time frame: From baseline to 2 hours postprocedure
Opioid consumption
Total opioid consumption (oral morphine equivalents) during the first 72 hours following the trial intervention
Time frame: From 0-72 hours postprocedure
Patient global assessment
Patient global assessment (PGA) score at 72 hours following the trial intervention. Participants will be asked to respond to the question, "Overall, how do you feel about your level of headache control since the treatment?" using a 5-point scale (poor, fair, good, very good, or excellent).
Time frame: From 0 to 72 hours postprocedure
Adverse Events Related to Intraarterial Lidocaine Injection
Proportion of participants with new onset of facial paresis, facial numbness, diplopia, blurry vision, or dizziness during the first 24 hours following the trial intervention
Time frame: From 0 to 24 hours postprocedure
No study locations are listed for this record.
Plan to share: Yes
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Lidocaine