NCT06582810ClinicalTrials.gov
Lidocaine Infusion Treatment for Subarachnoid Hemorrhage Headaches
Lidocaine Infusion As A Treatment Modality For Headache Following Non-Traumatic Subarachnoid Hemorrhage: A Prospective, Single-Center, Observational Cohort Study
In brief
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…
Observational20 participants sought1 site1 country
Categories
Registered in 1 registry
- ClinicalTrials.govNCT06582810Open this record at ClinicalTrials.govSynced 2 months ago
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Trial information is shown as published by the registry, in its original language.
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How this study is set up
The points below are drawn from the public registry record for this study. Each one cites the field or sentence it came from. A dash (—) means the record does not state something — not that it is missing or wrong. Many well-run studies, especially small ones, leave some of these blank.
- Present: Registered before enrolment beganFirst posted 2024-09-03; recorded start 2025-01-31
- Present: Has a defined primary outcomeA primary outcome measure is listed in the record
- Present: The primary outcome states a time frameThe primary outcome measure records a time frame
- Not stated: Whether participants are randomly assigned is not stated in the registry recordNo allocation method is recorded
- Not stated: A comparison group is not stated in the registry recordThe record describes a single study arm
- Not stated: Whether the study is blinded is not stated in the registry recordNo masking information is recorded
- Not stated: An ethics committee is not stated in the registry recordThis registry's ingested record has no ethics-committee field
- Not stated: Regulatory oversight (such as an IND or IDE) is not stated in the registry recordThis registry's ingested record has no regulatory-authorisation field
- Not stated: A data monitoring committee is not stated in the registry recordThis registry's ingested record has no data-monitoring-committee fieldA data monitoring committee is not required for many smaller studies, and its absence here is not unusual.
- Present: No cost to participants is mentioned in the recordChecked the summary, description and eligibility text; no cost-to-participant phrase found
- Present: Sponsor has 182 other studies in this databaseCounted from the lead sponsor named in the record (University of Kansas Medical Center)
- Present: Sponsor has posted results for at least one studyBased on the sponsor’s studies in this database
- The record lists 2 conditions.
- Lead sponsor type recorded as: other.
Trial stature
Three independent measures of this study, described from its registry record — not a recommendation about it. A rigorous study by investigators nobody has heard of is better evidence than a weak study led by a famous one. How these are scored.
An exploratory-stage design for a study of this type, judged from its ClinicalTrials.gov record.
How this score is built
- Randomised allocation0/20
Allocation not stated in the record
- Blinding0/20
Masking not stated in the record
- Control arm0/15
No comparator arm stated in the record
- Primary-outcome specificity10/10
Named primary outcome with a defined time frame
- Endpoint type3/10
Surrogate or intermediate endpoint (conservative default)
- Multi-centre0/8
Single site, or site count not stated
- Data monitoring committee0/7
No data monitoring committee stated
- Prospective registration5/5
Registered before the study start date
- Protocol / SAP posted0/5
No protocol or SAP posted to the registry
A pilot-scale study: 20 participants (target), run at 1 site.
How this score is built
- Enrolment10/40
20 participants (target)
- Site count0/25
1 sites
- Country count0/15
Single country
- Planned duration8/10
Planned over about 42 months
- Sponsor scale9/10
University of Kansas Medical Center has led 180 trials in our corpus
We have no verifiable track record for the investigator named on this trial. That is common for early-career investigators and for records held outside ClinicalTrials.gov — it is not a negative signal.
How this score is built
- Investigator standing0/100
No investigator recorded in the registry for this trial
These describe the registry record only, and today we hold ClinicalTrials.gov data. Absent fields lower a score, and absence often reflects registration practice rather than study quality. A high-stature trial is not necessarily safer or a better choice for you — enrolling in a large definitive trial can mean a higher chance of receiving placebo, while a small early-phase study may be the only route to a new therapy.
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.
Conditions
- Subarachnoid; Hemorrhage, Nontraumatic
- Headache
Eligibility
| Sex | All |
|---|---|
| Ages | 18 Years – No maximum |
| Healthy volunteers | No |
| 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. 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).
Eligibility as written in the registry
Eligibility in plain statements
This record's criteria have not been broken into separate statements yet. The registry text above is complete and is the authoritative version.
Study design
| Study type | Observational |
|---|---|
| Phase | Not stated in the registry record |
| Allocation | Not stated in the registry record |
| Intervention model | Not stated in the registry record |
| Primary purpose | Not stated in the registry record |
| Masking | Not stated in the registry record |
| Enrolment | 20 participants sought |
Sponsor and collaborators
- University of Kansas Medical Center Sponsor
- Ascension Health Collaborators
Arms and interventions
- Lidocaine infusion
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.
Outcome measures
Primary outcome
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 infusion
Other outcome
Prevalence of vasospasm
Observe the prevalence of vasospasm in participants that receive lidocaine infusion
Time frame Within the first 7 days participants are receiving treatment
Dates
| Start date | January 31, 2025 (actual) |
|---|---|
| Primary completion | October 1, 2027 (estimated) |
| Completion | July 1, 2028 (estimated) |
| First posted | September 3, 2024 (actual) |
| Last updated | July 10, 2026 |
| Results posted | Not stated in the registry record |
| Status last verified | July 2026 |
Actual means the event happened. Estimated means the sponsor expects it. The two mean different things.
Locations
1 site is recruiting
United States
| Facility | City | State or region | Status |
|---|---|---|---|
| Ascension Via Christi St. Francis | Wichita | Kansas | Recruiting |
Study documents
No documents are linked in this registry record.
Changes over time
No changes have been recorded since we first ingested this record.
A change is recorded each time the sponsor updates the registry record. Status, dates, enrolment and sites appear here as they move.