Lidocaine Infusion Treatment for Subarachnoid Hemorrhage Headaches

Not yet recruiting

• Conditions: Subarachnoid; Hemorrhage, Nontraumatic; Headache

• Registration Number: NCT06582810
• Lead Sponsor: University of Kansas Medical Center

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, we 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 they are awake for a maximum of seven days. Monitoring for vasospasm will occur as part of their regular medical care.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-08
• Study First Submitted: 2024-08-30
• Study First Submitted QC: 2024-08-30
• Last Update Submitted: 2024-08-30
• Study First Posted: 2024-09-03
• Last Update Posted: 2024-09-03
• Study Start: 2024-10
• Primary Completion: 2027-10
• Study Completion: 2028-07

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

For study recruitment, patients must be 18 years or older, have a favorable neurological status defined as Hunt and Hess score ≤ 3 (as it accounts for patient awareness), can communicate numeric pain scores, and are diagnosed with non-traumatic subarachnoid hemorrhage.

Exclusion Criteria

Patients will be excluded from study consideration if they are diagnosed with traumatic subarachnoid hemorrhage, if they are < 18 years of age, if numeric pain scores could not be captured for > 3 days of hospitalization, if they 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, or contraindications to lidocaine (significant cardiac disease, arrhythmia, seizures, previous allergic reaction to lidocaine.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Reduction of pain	Benefit should be seen within first 24 h of infusion	Reduction of pain ≥ 2 points in the numeric pain score after lidocaine infusion treatment.