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Clinical Trials/NCT06582810
NCT06582810
Recruiting
Not Applicable

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

University of Kansas Medical Center1 site in 1 country20 target enrollmentJanuary 31, 2025

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Subarachnoid; Hemorrhage, Nontraumatic
Sponsor
University of Kansas Medical Center
Enrollment
20
Locations
1
Primary Endpoint
Reduction of pain
Status
Recruiting
Last Updated
9 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 31, 2025
End Date
July 1, 2028
Last Updated
9 months ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

Reduction of pain

Time Frame: Benefit should be seen within first 24 h of infusion

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.

Study Sites (1)

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