Recruiting

Lidocaine

Sponsor:

University of Kansas Medical Center

Code:

NCT06582810

Conditions

Subarachnoid; Hemorrhage, Nontraumatic

Headache

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

Brief 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.

Conditions

Subarachnoid; Hemorrhage, Nontraumatic

Headache

Study ID

NCT06582810

Start date

Jan 31, 2025

Status verified date

Jul, 2026

Completion date

Jul, 2028

Anticipated

Primary completion date

Oct, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

20 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Primary outcome measure

  • Reduction of pain [ Time Frame: Benefit should be seen within first 24 h of infusion ]

Central Contacts and Locations

Central contacts

William L Krogman, MS

316-268-6156wkrogman@kumc.edu

Locations

Ascension Via Christi St. Francis

Recruiting

Wichita, Kansas, United States, 67214

Contacts

William L Krogman, MS

316-268-6156wkrogman@kumc.edu

Fernando Salgado, MD

fsalgado33@kumc.edu

More Information

Sponsor

University of Kansas Medical Center

Last update posted

Jul 10, 2026

Last verified

Jul, 2026

Keywords

  • Nontraumatic Subarachnoid Hemorrhage
  • Headache
  • Lidocaine Infusion

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Kansas Medical Center on 2026-07-10.