Lidocaine Infusion Treatment for Subarachnoid Hemorrhage Headaches

NCT06582810 | Recruiting

• 2 other identifiers: RKS202300631856VC
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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. 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. 2.show that intravenous lidocaine infusion is safe in treating headache following non-traumatic subarachnoid hemorrhage;
3. 3.and report vasospasm prevalence in the cohort.

Conditions

Subarachnoid; Hemorrhage, Nontraumatic; Headache

Keywords

Nontraumatic Subarachnoid Hemorrhage; Headache; Lidocaine Infusion

Outcome Measures

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.

  Benefit should be seen within first 24 h of infusion

Other Outcomes (1)

• Prevalence of vasospasm

  Within the first 7 days participants are receiving treatment

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Kansas Medical Center: lead
• Ascension Via Christi Hospitals Wichita, Inc.: collaborator

Study Sites (1)

Ascension Via Christi St. Francis

Wichita, Kansas, 67214, United States

RECRUITING

MeSH Terms

Conditions

Hemorrhage; Headache

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Fernando Salgado, MD

  University of Kansas Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

William L Krogman, MS

CONTACT

316-268-6156; wkrogman@kumc.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 7 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 30, 2024
• First Posted: September 3, 2024
• Study Start: January 31, 2025
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): July 1, 2028
• Last Updated: July 17, 2025

Record last verified: 2025-07

Locations

US (1)