Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Hypothesis: Multiple peripheral nerve blocks provide more complete acute headache relief and better headache prophylaxis in episodic migraine than greater occipital nerve blocks alone.
Aims, purpose, or objectives:
The primary endpoint will be pain freedom at 20 minutes after confirmation that all nerve blocks were successful. The secondary endpoints will be 1) headache pain severity \
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Greater Occipital Nerve block group | Experimental | Subjects will receive bilateral greater occipital nerve blocks for a total of 2 blocks |
|
| Multiple Peripheral Nerve block group | Experimental | Subjects will receive 10 nerve blocks to include bilateral greater occipital, lesser occipital, auriculotemporal, supraorbital and supratrochlear nerves. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bupivacaine HCl 0.5% Injectable Solution | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Elimination of acute headache | Number of subjects to experience an elimination of acute headache (pain freedom) defined as pain 0/10 | 20 minutes after the last nerve intended for block |
| Measure | Description | Time Frame |
|---|---|---|
| Days of work/school/life event absenteeism | Number of days subjects miss work, school or life events due to headaches following peripheral nerve block | 3 months after peripheral nerve block |
| Headache Pain Reduction |
| Measure | Description | Time Frame |
|---|---|---|
| Average headache days | Number of days subjects experience headaches after peripheral nerve block | 3 months after peripheral nerve block |
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:
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:
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Family Medicine Research Study Coordinators | Contact | 507-422-6823 | RSTFMSC@mayo.edu |
| Name | Affiliation | Role |
|---|---|---|
| Stephen Merry, MD, MPH | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Rochester | Recruiting | Rochester | Minnesota | 55905 | United States |
Not provided
| Label | URL |
|---|---|
| Mayo Clinic clinical trials search page | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| D008775 | Methylprednisolone |
| D007267 | Injections |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
Not provided
Not provided
Pragmatic randomized comparison trial
Not provided
Not provided
Research subjects will be informed that they are in a trial of nerve blocks in treatment and prevention of migraine headache and may receive up to 10 nerve blocks. The language of consenting will seek to minimize bias by seeking to avoid suggesting that more blocks are better than less as follows: "There are small and large nerves all over the front, back and sides of your head that can contribute to a migraine headache. In this study, subjects will get nerve blocks in various combinations of one or two or up to 10 nerves at a time. The nerves blocked may or may not respond to the location of your pain."
|
| Methylprednisolone 40 MG Injection | Drug | 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. |
|
Headache pain NRS 0-1/10 severity
| Measured at 20 minutes after confirmation of all nerves blocked |
| Sustained pain freedom | Patient report of any headache pain (yes/no) on electronic questionnaire the day after the PNBs | History of headache pain for the prior 24 hours the day after PNB intervention. |
| Time to pain freedom | Time between PNBs and when headache reaches 0/10 NRS | measurement of pain every 5 minutes during PNBs to measure rapidity of headache resolution |
| D000588 |
| Amines |
| D011239 | Prednisolone |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |