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RecruitingNCT06582810Updated Jul 10, 2026

Lidocaine Infusion Treatment for Subarachnoid Hemorrhage Headaches

An observational study in Subarachnoid; Hemorrhage, Nontraumatic and Headache, sponsored by University of Kansas Medical Center. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-10.

Sponsored by University of Kansas Medical Center · Observational

From the registry’s dates

  • Started Jan 2025; still recruiting 1 year 9 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
20
Ages
18 Years and older
Sex
All
01

Study summary

The goal of this observational study is to evaluate intravenous lidocaine efficacy and safety in treating headache following non-traumatic subarachnoid hemorrhage. Through this prospective analysis, the investigators hope to:

  1. show that intravenous lidocaine infusion causes a clinically significant reduction in pain scores in patients with moderate/severe headache pain following non-traumatic subarachnoid hemorrhage;
  2. show that intravenous lidocaine infusion is safe in treating headache following non-traumatic subarachnoid hemorrhage;
  3. and report vasospasm prevalence in the cohort.

Participants will receive lidocaine infusion as treatment for non-traumatic subarachnoid hemorrhage headache and provide pain scores (on a numeric pain scale) every two hours the patients are awake for a maximum of seven days. Monitoring for vasospasm will occur as part of the patients regular medical care.

02

Conditions studied

  • Subarachnoid; Hemorrhage, Nontraumatic
  • Headache

Keywords

  • Nontraumatic Subarachnoid Hemorrhage
  • Headache
  • Lidocaine Infusion
03

In context

Hemorrhage

1,383 studies on the registry are indexed under Hemorrhage; 244 are open to participants now.

This study's planned enrollment of 20 is below the median of 215 across 397 observational studies indexed under Hemorrhage.

Browse Hemorrhage studies →

Lead sponsor

University of Kansas Medical Center is the lead sponsor of 492 studies on the registry; 110 are open to participants now.

Of its 38 completed or terminated interventional studies of FDA-regulated products, 24 (63%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients will be recruited once a diagnosis of non-traumatic subarachnoid hemorrhage has been confirmed and the patients meet the inclusion criteria for the study. The investigators will exclude incarcerated patients and pregnant women from the study, but the investigators will include patients that cannot consent themselves, as long as the patient meets the inclusion criteria, the investigators can gain consent from the patient's legal guardian/representative, and the patient can report a numeric pain score for the full length of the study (every 2 h the patient is awake for up to 7 days).

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.

Inclusion criteria

  • Patients > 18 years;
  • Have a favorable neurological status defined as Hunt and Hess score ≤ 3 (as it accounts for patient awareness);
  • Can communicate numeric pain scores;
  • Are diagnosed with non-traumatic subarachnoid hemorrhage

Exclusion criteria

Exclusion Criteria:

  • The patient is diagnosed with traumatic subarachnoid hemorrhage;
  • If the patient is \< 18 years of age;
  • If numeric pain scores could not be captured for > 3 days of hospitalization;
  • If the patient had a prior aneurysm;
  • Chronic pain not associated with non-traumatic subarachnoid hemorrhage diagnosis;
  • A disability before the stroke (> 2 on modified Rankin Scale score);
  • A Hunt and Hess score > 3;
  • to lidocaine (significant cardiac disease, arrhythmia, seizures, previous allergic reaction to lidocaine
Terms in these criteria, in plain language(1)

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.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
20 participants (estimated)
Target follow-up
7 Days
Patient registry
Yes

Groups and cohorts

  • Lidocaine infusion

    Patients will receive a 100 mg intravenous lidocaine bolus followed by an initial infusion at a rate of 2 mg∙kg -1∙h-1 based on ideal body weight. Lidocaine infusions will continue for a minimum of 1 h post-bolus. If headache numeric pain score decreases at all after initiation of infusion, then the rate will drop to 1 mg∙kg -1∙h-1. If headache numeric pain score starts increasing again, then the rate will return to 2 mg∙kg -1∙h-1, otherwise it will remain at 1 mg∙kg -1∙h-1 for up to 48 h.

06

What researchers measure

Primary outcomes

  1. Reduction of pain

    Reduction of pain ≥ 2 points in the numeric pain score after lidocaine infusion treatment. The numeric pain score is a score rating severity of pain from 0 to 10, with higher scores meaning worse pain. The reduction in pain scores indicates a decrease in severity of pain.

    Time frame: Benefit should be seen within first 24 h of infusion

Other outcomes

  1. Prevalence of vasospasm

    Observe the prevalence of vasospasm in participants that receive lidocaine infusion

    Time frame: Within the first 7 days participants are receiving treatment

07

Study locations

1 of 1 sites recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jan 2025 (actual). Primary completion is estimated for Oct 2027, 33 months after the start.

Of 133 non-industry observational studies under Hemorrhage, half reached primary completion within 37 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 78. This study's planned 33 months is below that.

Counting every sponsor, half of 157 studies reached it within 33 months; a quarter within 14 and three quarters within 71.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 30, 2024
First posted
Sep 3, 2024
StartActual
Jan 31, 2025
Primary completionEst.
Oct 2027
CompletionEst.
Jul 2028
Last update
Jul 10, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 10, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06582810
Collaborators
Ascension Health
Responsible party
Sponsor
First posted
Sep 3, 2024
Start date
Jan 31, 2025
Primary completion
Oct 2027 (estimated)
Completion
Jul 2028 (estimated)
Last update
Jul 10, 2026

Study contacts

William L Krogman, MS
Contact
wkrogman@kumc.edu
316-268-6156
Fernando Salgado, MD
principal investigator · University of Kansas Medical Center

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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