A Randomized Trial of Bilateral Greater Occipital Nerve Blocks Versus Ten Peripheral Nerve Blocks for Acute Relief and Prophylaxis of Episodic Migraine
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- Mayo Clinic
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Elimination of acute headache
研究概览
简要总结
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.
详细描述
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 </= 1/10 at 20 minutes, 2) headache pain freedom at 2 hours, 3) sustained pain freedom at 24 hours, 4) time to pain freedom, 5) prophylaxis of future headache frequency and severity during the 12 weeks after PNBs compared with the four-week run-in period (headache days), and 6) days of work/school/life event absenteeism during the 12 weeks compared with the four-week run-in period.
Background
Peripheral nerve blocks (PNBs) have been studied in randomized trials and have proven beneficial and safe to varying degrees in the treatment of episodic migraine. Most of these studies have evaluated GONBs; two have looked at the combination of GONB and supraorbital nerve block (SONB). No study to date measuring pain relief in acute migraine and prophylaxis reported scalp anesthesia thus making conclusions about effect size of an actual nerve block on acute headache and prophylaxis or conclusions about optimal method, medication dosages and frequency of block(s) difficult.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
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."
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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.
研究组 & 干预措施
Greater Occipital Nerve block group
Subjects will receive bilateral greater occipital nerve blocks for a total of 2 blocks
干预措施: Bupivacaine HCl 0.5% Injectable Solution (Drug)
Greater Occipital Nerve block group
Subjects will receive bilateral greater occipital nerve blocks for a total of 2 blocks
干预措施: Methylprednisolone 40 MG Injection (Drug)
Multiple Peripheral Nerve block group
Subjects will receive 10 nerve blocks to include bilateral greater occipital, lesser occipital, auriculotemporal, supraorbital and supratrochlear nerves.
干预措施: Methylprednisolone 40 MG Injection (Drug)
Multiple Peripheral Nerve block group
Subjects will receive 10 nerve blocks to include bilateral greater occipital, lesser occipital, auriculotemporal, supraorbital and supratrochlear nerves.
干预措施: Bupivacaine HCl 0.5% Injectable Solution (Drug)
结局指标
主要结局
Elimination of acute headache
时间窗: 20 minutes after the last nerve intended for block
Number of subjects to experience an elimination of acute headache (pain freedom) defined as pain 0/10
次要结局
- Average headache days(3 months after peripheral nerve block)
- Days of work/school/life event absenteeism(3 months after peripheral nerve block)
- Headache Pain Reduction(Measured at 20 minutes after confirmation of all nerves blocked)
- Sustained pain freedom(History of headache pain for the prior 24 hours the day after PNB intervention.)
- Time to pain freedom(measurement of pain every 5 minutes during PNBs to measure rapidity of headache resolution)
研究者
Stephen P. Merry
Principal Investigator
Mayo Clinic