Clinical trial NCT06582810: Lidocaine Infusion Treatment for Subarachnoid Hemorrhage Headaches
Official title: Lidocaine Infusion As A Treatment Modality For Headache Following Non-Traumatic Subarachnoid Hemorrhage: A Prospective, Single-Center, Observational Cohort Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Subarachnoid; Hemorrhage, Nontraumatic
Headache
Keywords: Nontraumatic Subarachnoid Hemorrhage
Headache
Lidocaine Infusion
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
Collaborators: name: Ascension Via Christi Hospitals Wichita, Inc.
First posted: 2024-09-03
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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. We will exclude incarcerated patients and pregnant women from the study, but we will include patients that cannot consent themselves, as long as they meet the inclusion criteria, we can gain consent from their legal guardian/representative, and they can report their numeric pain score for the full length of the study (every 2 h they are awake for up to 7 days).

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Reduction of pain
timeFrame: Benefit should be seen within first 24 h of infusion
Secondary outcomes:
Other outcomes:
measure: Prevalence of vasospasm
timeFrame: Within the first 7 days participants are receiving treatment
Locations:
Study officials:
affiliation: University of Kansas Medical Center
name: Fernando Salgado, MD
role: PRINCIPAL_INVESTIGATOR
References: