Recruiting
Phase 2

Nerve Blocks

Sponsor:

Mayo Clinic

Code:

NCT05734625

Conditions

Episodic Migraine

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Bupivacaine HCl 0.5% Injectable Solution

Methylprednisolone 40 MG Injection

Study Details

Brief summary:

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.

Conditions

Episodic Migraine

Study ID

NCT05734625

Start date

Jul 10, 2023

Status verified date

Jun, 2026

Completion date

Jul, 2027

Anticipated

Primary completion date

Feb, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Greater Occipital Nerve block group

Subjects will receive bilateral greater occipital nerve blocks for a total of 2 blocks

experimental: Multiple Peripheral Nerve block group

Subjects will receive 10 nerve blocks to include bilateral greater occipital, lesser occipital, auriculotemporal, supraorbital and supratrochlear nerves.

Interventions

Bupivacaine HCl 0.5% Injectable Solution

Will receive 0.5 ml (supratrochlear) to 1.0 ml (supraorbital, auriculotemporal) to 1.25 ml (greater and lesser occipital) for each nerve block. Will receive 0.25 ml or 10 mg methylprednisolone to each greater and lesser occipital nerve in the MPNB arm and 0.5 ml or 20 mg methylprednisolone to both greater occipital nerves in the GONB arm.

Methylprednisolone 40 MG Injection

Will receive 10 mg (0.25 ml) mixed with 1.25 ml Bupivacaine 0.5% for each greater and lesser occipital nerve block if MPNB group or 20 mg (0.5 ml) methylprednisolone in each GON if GONB group.

Primary outcome measure

  • Elimination of acute headache [ Time Frame: 20 minutes after the last nerve intended for block ]

Central Contacts and Locations

Central contacts

Family Medicine Research Study Coordinators

507-422-6823RSTFMSC@mayo.edu

Locations

Mayo Clinic in Rochester

Recruiting

Rochester, Minnesota, United States, 55905

More Information

Sponsor

Mayo Clinic

Last update posted

Jun 16, 2026

Last verified

Jun, 2026

Keywords

  • episodic migraine
  • peripheral nerve block
  • greater occipital nerve block
  • lesser occipital nerve block
  • auriculotemporal nerve block
  • supraorbital nerve block
  • supratrochlear nerve block

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-06-16.