Lidocaine and Steroids for Headache
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests whether an infusion of lidocaine, with or without steroids, can relieve severe headaches following a spontaneous subarachnoid hemorrhage (SAH). SAH, a type of brain bleeding, often causes intense headaches. Participants will receive either lidocaine alone, a combination of lidocaine and the steroid dexamethasone, or no injection to determine which option is most effective and safe. Individuals diagnosed with aneurysmal SAH who experience severe headaches may be suitable candidates. The trial aims to discover better treatments for these painful headaches. As a Phase 2 trial, the research focuses on evaluating the treatment's effectiveness in an initial, smaller group.
Do I have to stop taking my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that lidocaine is generally safe in medical settings. Common side effects include headaches, dizziness, and drowsiness, which are usually mild and resolve on their own. One study found that lidocaine infusions were well-tolerated by teenagers and young adults, with only mild side effects like headaches and dizziness.
When combined with dexamethasone, studies indicate that this mixture can enhance pain relief and extend its duration. The combination is generally safe when used correctly, though side effects can occur.
Overall, both lidocaine alone and with dexamethasone have demonstrated safety in controlled settings, but awareness of possible mild side effects is important.12345Why are researchers excited about this trial's treatments?
Researchers are excited about these treatments for headaches because they explore unique combinations that could enhance pain relief. Standard treatments often include over-the-counter pain relievers or prescription medications like triptans. However, this trial investigates the combination of lidocaine, a local anesthetic, and dexamethasone, a steroid that reduces inflammation, which may offer faster and more targeted relief. The lidocaine and dexamethasone combo has the potential to act on both pain and inflammation simultaneously, which is different from many current treatments. This dual action could be key in providing quicker and possibly more effective headache management.
What evidence suggests that this trial's treatments could be effective for severe headaches in patients with spontaneous subarachnoid hemorrhage?
Research has shown that injecting lidocaine into a specific artery in the head can help reduce headaches. One study found that patients experienced fewer headache days after this treatment. In this trial, participants may receive either lidocaine alone or a combination of lidocaine and dexamethasone. The combination has shown promise, as almost all patients in one study experienced complete relief from headaches. Dexamethasone alone is also known to reduce the recurrence of headaches. These findings suggest that both lidocaine and the lidocaine-dexamethasone combination could be effective for severe headaches in certain situations.678910
Who Is on the Research Team?
Kan Peter, MD
Principal Investigator
University of Texas Medical Branch, Galveston
Are You a Good Fit for This Trial?
This trial is for patients with severe headaches due to spontaneous subarachnoid hemorrhage (SAH). It's aimed at those who may have opioid addiction or dependence, as the treatment could potentially reduce the need for opioids. Specific eligibility criteria are not provided.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo a standard brain angiogram and may receive lidocaine, lidocaine with dexamethasone, or no injection during the procedure
Follow-up
Participants are monitored for changes in pain and medication use, with follow-up visits to track outcomes and side effects
What Are the Treatments Tested in This Trial?
Interventions
- Dexamethasone
- Lidocaine
Trial Overview
The study tests if infusing lidocaine alone, or combined with dexamethasone steroids into the middle meningeal artery can alleviate headache pain in SAH patients. The safety of these treatments is also being evaluated.
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
Active Control
The participant will receive Lidocaine (50 mg) + Dexamethasone (10 mg bilaterally)
The participants will receive 50 mg of lidocaine.
The participant will not receive an injection.
Find a Clinic Near You
Who Is Running the Clinical Trial?
The University of Texas Medical Branch, Galveston
Lead Sponsor
Citations
Intranasal lidocaine for acute migraine: A meta-analysis of ...
Intranasal lidocaine has been shown to be effective in treating patients with acute migraines; however, its efficacy is still controversial.
A Phase 1 Clinical Trial for Safety
Ninety percent (9/10) received treatment. One patient was lost to follow‐up before treatment, and 1 patient was lost to 3‐month follow‐up.
A single infusion of intravenous lidocaine for primary ...
The main efficacy outcome was change in headache/facial pain intensity using a verbal rating scale (VRS) 0–10. Patients were considered ...
Bilateral Middle Meningeal Artery Lidocaine Infusion for ...
To observe a ≥50% reduction in monthly migraine headache days in one month post intra-arterial lidocaine infusion into the bilateral middle meningeal artery.
Is intravenous lidocaine clinically effective in acute migraine?
At 20 min, the mean pain intensity score was 80% of initial intensity in the lidocaine group and 82% in the placebo group. The difference was not statistically ...
6.
imgcdn.mckesson.com
imgcdn.mckesson.com/CumulusWeb/Click_and_learn/SDS_SPMDDV_LIDOCAINE_HCL_AMP_PF_1_PERCENT_5ML.pdfProduct Name: 1% Lidocaine Hydrochloride Injection, USP
SAFETY DATA SHEET. 1. IDENTIFICATION. Product Identifier (Name). 1 ... In normal clinical use, adverse effects may include fever, headaches, ...
Lidocaine Hydrochloride Injection, USP, 1% & 2%
May cause skin irritation. Inhalation of vapors may cause respiratory irritation and central nervous system effects such as headache, dizziness, drowsiness,.
8.
mayoclinic.org
mayoclinic.org/drugs-supplements/lidocaine-topical-application-route/description/drg-20072776Lidocaine (topical application route) - Side effects & dosage
Lidocaine topical jelly or ointment is used on different parts of the body to cause numbness or loss of feeling for patients having certain medical procedures.
Lidocaine Hydrochloride Injection 1. CHEMICAL ...
In normal clinical use, adverse effects may include fever, headaches, agitation, tingling of extremities, general hypotension, bradycardia,.
Safety, tolerability, and short-term efficacy of intravenous ...
Conclusions: Our limited experience suggests that lidocaine infusions are well tolerated in the adolescent and young adult pain population, with side effects ...
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