Lidocaine Infusion Treatment for Subarachnoid Hemorrhage Headaches

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

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.

Study Overview

• Status: Recruiting
• Conditions: Headache; Subarachnoid; Hemorrhage, Nontraumatic

• Study Type: Observational
• Enrollment (Estimated): 20

Contacts and Locations

• Study Contact: Name: William L Krogman, MS; Phone Number: 316-268-6156; Email: wkrogman@kumc.edu

Study Locations

• United States
  • Kansas
    • Wichita, Kansas, United States, 67214
      • Recruiting
      • Ascension Via Christi St. Francis
      • Contact: William L Krogman, MS; Phone Number: 316-268-6156; Email: wkrogman@kumc.edu
      • Contact: Fernando Salgado, MD; Email: fsalgado33@kumc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• 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).

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Benefit should be seen within first 24 h of infusion

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prevalence of vasospasm	Observe the prevalence of vasospasm in participants that receive lidocaine infusion	Within the first 7 days participants are receiving treatment

Collaborators and Investigators

• Sponsor: University of Kansas Medical Center
• Collaborators: Ascension Via Christi Hospitals Wichita, Inc.
• Investigators: Principal Investigator: Fernando Salgado, MD, University of Kansas Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): January 31, 2025
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): July 1, 2028

Study Registration Dates

• First Submitted: August 30, 2024
• First Submitted That Met QC Criteria: August 30, 2024
• First Posted (Actual): September 3, 2024

Study Record Updates

• Last Update Posted (Actual): July 17, 2025
• Last Update Submitted That Met QC Criteria: July 14, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: Headache; Lidocaine Infusion; Nontraumatic Subarachnoid Hemorrhage
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Intracranial Hemorrhages; Headache; Hemorrhage; Subarachnoid Hemorrhage
• Other Study ID Numbers: RKS20230063; 1856VC (Other Identifier: University of Kansas School of Medicine Wichita)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No