Greater Occipital Nerve Block for Migraine Prophylaxis
Condition: Migraine Headache
MeSH terms: Migraine Disorders; Headache
Intervention: bupivicaine; normal saline; methylprednisolone; lidocaine
Intervention description: 2.5 mL 0.5% bupivicaine; 2.75 mL normal saline; 0.5 mL 20 mg methylprednisolone; 0.25 mL 1% lidocaine
Intervention MeSH terms: Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Lidocaine; Bupivacaine; Prednisolone hemisuccinate; Prednisolone phosphate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 70.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      Migraine is a common neurological condition that can be disabling, particularly if chronic.
      Greater occipital nerve (GON) block has been utilized for decades for the treatment of
      migraine in the absence of a single randomized, placebo-controlled trial documenting its
      effectiveness.

      Hypothesis: Greater occipital nerve block reduces the frequency of days with moderate or
      severe headache in patients with episodic or chronic migraine.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects meet diagnostic criteria for episodic migraine or chronic migraine according
             to the International Headache Classification II (ICHD-II)

          -  Migraine sufferers who experience at least 1 attack per week

          -  Able to read and understand the requirements of the study, abide by any restrictions,
             and return for the required examinations

          -  Able and willing to sign an informed consent statement

          -  Subjects must be in generally good health as confirmed by medical history, medication
             review, baseline physical examination, vital signs and clinical laboratory
             evaluations.

        Exclusion Criteria:

          -  Subjects with continuous headache (no headache free periods)

          -  Subjects using maintenance opioid medication

          -  Subjects who have started a medication with prophylactic migraine efficacy within the
             past 2 months

          -  Known hypersensitivity or allergic reaction to any of study ingredients (lidocaine,
             bupivicaine, any local anesthetics, and corticosteroids) or betadine.

          -  Use of any investigational medication within 90 days of the initial screening visit
             and/or concurrent enrolment in an investigational study

          -  Injection site infection or systemic infection at the injection visit (afebrile at
             time of injection)

          -  Presence of cranial bone defect

          -  Subjects with chronic cluster headache, new daily persistent headache, hemicrania
             continua, or chronic tension type headache

          -  Subjects with a history of an unstable medical condition (e.g. cardiovascular,
             hepatic, renal, endocrine) that may impair their reliable participation in the study
             or necessitate the use of medications not permitted in this study

          -  Subjects with a history (within the past 6 months) of a major psychiatric disorder
             that in the opinion of the investigator may preclude the subject from completed the
             requirements of the study

          -  Female subjects who are pregnant or nursing

          -  Subjects with a history of drug or alcohol abuse within the past 2 years

          -  Subjects with a history of poor compliance with past drug therapies, as judged by the
             investigator.