Efficacy of Nerve Blocks for Episodic Migraine
Recruiting · NCT05734625 · Interventional (participants receive a specific treatment) · Lead sponsor: Mayo Clinic
View the official record on ClinicalTrials.gov →Interventions studied
Bupivacaine HCl 0.5% Injectable SolutionMethylprednisolone 40 MG Injection
What this trial is about
The purpose of this study is to see how well blocking two to ten of the scalp nerves (that give feeling to the scalp and are painful during migraine headaches) with bupivacaine anesthetic (numbing medication) and low dose methylprednisolone (cortisone-like medicine or steroid) work for treating and preventing migraines. Our hypothesis is that the pain of most episodic migraine headaches can be eliminated and prevented for months by blocking the nerves that give pain sensation during a migraine.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Suffering from episodic migraines with and without aura occurring at least four times a month but less than 15 times a month at a severity of 5/10 pain level or greater.
- Willing to not start or stop any new medication to treat or prevent migraines during the six months of the trial.
- History fits the definition of migraine:
- Have a history of episodic headache lasting 4-72 hours with at least 2 of the 4 following: unilateral location, pulsating/throbbing quality, moderate-severe intensity, aggravation by/causing avoidance of routine physical activity, and
- Have a history of at least one of the following: nausea and/or vomiting, photophobia (seek out a dark room during a headache because that feels better), phonophobia (seek out a quiet environment during a headache because that feels better)
Exclusion criteria
- Headache in cheeks (infraorbital nerve distribution) in addition to scalp distribution.
- Women who report being currently pregnant or lactating or are of child-bearing potential or are likely to become pregnant during the medication phase and are unwilling to use a reliable form of contraception. Acceptable forms include:
- Hormonal methods, such as birth control pills, patches, injections, vaginal ring, or implants
- Barrier methods (such as a condom or diaphragm) used with a spermicide (a foam, cream, or gel that kills sperm)
- Intrauterine device (IUD)
- Total hysterectomy or tubal ligation
- Abstinence (no sex)
- Allergy or documented contraindication to amide anesthetics (bupivacaine, lidocaine, ropivacaine, prilocaine, mepivacaine, etidocaine or levobupivacaine) or corticosteroids
- Previously received peripheral nerve blocks (PNBs)
- Currently anticoagulated
- Currently receiving Botox for migraine prophylaxis
- Started on new medication in the prior two months with known migraine-preventive efficacy or planning to start any new medication during the study
- Currently using opiate medications for pain
- History of drug or alcohol abuse within the prior two years
- Have unstable medical or surgical diseases that could impair participation in this study
- History of craniotomies, burr holes, skull fractures and/or have open skull defects
- Patients with implanted nerve stimulators or shunts
- Phobia of needles
- Active skin or soft tissue infection overlying injection sites
- Diagnosis of medication overuse, cervicogenic, post-traumatic, or cluster headaches or history on pre-enrollment questionnaire of cluster headache symptoms.
Where it is running
1 location listed across 1 US state.
- Mayo Clinic in Rochester - Rochester, Minnesota, United States