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Recruiting NCT06582810

Lidocaine Infusion Treatment for Subarachnoid Hemorrhage Headaches

Observational Subarachnoid; Hemorrhage, Nontraumatic Headache

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Subarachnoid; Hemorrhage, Nontraumatic, Headache. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Primary outcome measures

  • Reduction of pain [Time frame: Benefit should be seen within first 24 h of infusion]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • Ascension Via Christi St. Francis — Wichita

Identifiers

NCT: NCT06582810 · RKS20230063 · 1856VC

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗