Lidocaine Infusion Treatment for Subarachnoid Hemorrhage Headaches

University of Kansas

Status: Enrolling

Conditions: Subarachnoid; Hemorrhage, Nontraumatic; Headache

Study type: Observational

Funder types: Other

Identifiers

NCT06582810

RKS20230063

1856VC (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

20 participants in 1 patient group

Lidocaine infusion

Description:

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.