A Study of Nerve Blocks for Migraines

• Status: Not yet recruiting
• Trial end date: 2023-09-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to see how well blocking those nerves with bupivacaine anesthetic (numbing medication) and low dose methylprednisolone (cortisone-like medicine or steroid) work for treating and preventing migraines.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mayo Clinic
• Treatments: Bupivacaine; Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate

Criteria

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.