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NCT Number: NCT06582810

Lidocaine Infusion Treatment for Subarachnoid Hemorrhage Headaches

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.

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Key information

Conditions

Subarachnoid; Hemorrhage, Nontraumatic Headache Hemorrhage Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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;
  • Contraindications to lidocaine (significant cardiac disease, arrhythmia, seizures, previous allergic reaction to lidocaine

Treatment and study plan

Primary outcomes

  1. Reduction of pain

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

    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.

Other outcomes

  1. Prevalence of vasospasm

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

    Observe the prevalence of vasospasm in participants that receive lidocaine infusion

Study contacts

Contact information is provided by the study sponsor or research team.

William L Krogman, MS

CONTACT

[email protected]

316-268-6156

Sponsors and collaborators

Lead sponsor

University of Kansas Medical Center

Other

Collaborators

  • Ascension Health

Registry information

Official study title

Lidocaine Infusion As A Treatment Modality For Headache Following Non-Traumatic Subarachnoid Hemorrhage: A Prospective, Single-Center, Observational Cohort Study

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Sep 3, 2024
Registry last updated
Jul 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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