Lidocaine Infusion Treatment for Subarachnoid Hemorrhage Headaches

NCT ID: NCT06582810

Last Updated: 2025-07-17

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 20 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-01-31
• Study Completion Date: 2028-07-31

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 Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ascension Via Christi Hospitals Wichita, Inc.

OTHER

Sponsor Role: collaborator

University of Kansas Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Fernando Salgado, MD

Role: PRINCIPAL_INVESTIGATOR

University of Kansas Medical Center

Locations

Ascension Via Christi St. Francis

Wichita, Kansas, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

William L Krogman, MS

Role: CONTACT

wkrogman@kumc.edu

316-268-6156

Facility Contacts

William L Krogman, MS

Role: primary

wkrogman@kumc.edu

316-268-6156

Fernando Salgado, MD

Role: backup

fsalgado33@kumc.edu

Other Identifiers

1856VC

Identifier Type: OTHER

Identifier Source: secondary_id

RKS20230063

Identifier Type: -

Identifier Source: org_study_id