Lidocaine Infusion Treatment for Subarachnoid Hemorrhage Headaches
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Kansas Medical Center
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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;
Trial 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. The investigators will exclude incarcerated patients and pregnant women from the study, but the investigators will include patients that cannot consent themselves, as long as the patient meets the inclusion criteria, the investigators can gain consent from the patient's legal guardian/representative, and the patient can report a numeric pain score for the full length of the study (every 2 h the patient is awake for up to 7 days).
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
20 Participants
are grouped into 1 trial groupGroup A: Lidocaine infusion
Trial outcomes
Primary outcomes
1
Reduction of pain
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.
Time frame
Benefit should be seen within first 24 h of infusionOther outcomes
1
Prevalence of vasospasm
Observe the prevalence of vasospasm in participants that receive lidocaine infusion
Time frame
Within the first 7 days participants are receiving treatmentSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Kansas Medical Center
Lead sponsor
Ascension Health
Collaborator
Source ClinicalTrials.gov