Efficacy of Nerve Blocks for Episodic Migraine

Launched by MAYO CLINIC · Feb 9, 2023

Keywords

ClinConnect Summary

This clinical trial is studying the effectiveness of a treatment for episodic migraines, which are headaches that occur less frequently and can be quite painful. The researchers are investigating whether blocking certain nerves in the scalp with a numbing medication called bupivacaine, along with a low dose of a steroid, can help relieve migraine pain and possibly prevent future headaches for several months. The hope is that this approach will significantly reduce the pain caused by migraines for many people.

To participate in this study, individuals must experience migraines at least four times a month but less than 15 times a month, with a pain level of 5 or more on a scale of 10. Participants need to be willing to avoid starting any new migraine treatments during the six months of the trial. However, there are several criteria that would exclude someone from joining, such as having certain other types of headaches, being pregnant or breastfeeding, or having allergies to the medications being used. If eligible, participants can expect to receive the nerve block treatment and will be monitored for its effects on their migraine symptoms over the course of the study.

Gender

ALL

Eligibility 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.