Comparison of Great Occipital Nerve and Supraorbital Nerve Blockade Methods at Treatment of Acute Migraine Attack in the Emergency Department
Condition: Migraine Disorders
MeSH terms: Migraine Disorders; Emergencies
Study type: Interventional
Phase: Phase 4

Summary: 
      Aim Acute migraine attack is a clinical condition that is frequently encountered in emergency
      departments and varies from patient to patient in terms of treatment modalities. There are
      many different treatments whose effectiveness has been proven by concrete evidence(1). Drug
      treatments applied to patients are generally given intravenously or intramuscularly.
      Non-steroidal anti-inflammatory drugs, metoclopramide and intravenous magnesium therapy is
      generally used for treatment in emergency departments (1). The effectiveness of supraorbital
      nerve blockade and great occipital nerve blockade in migraine treatment and prophylaxis has
      been proven in many studies(2-6). The aim of this study is to discuss the effectiveness of
      supraorbital and great occipital nerve blockade treatments in acute migraine attack, when
      combined or used individually.
    

Detailed description: 
      Study Design The study was designed as a double-blind, prospective, randomized controlled
      clinical trial.

      First of all patients who meet the International Headache Society (IHS CLASSIFICATION ICHD-3)
      migraine with or without aura criteria will be included to the study (7). Secondary it is
      mandatory to meet our inclusion criteria, and not to include exclusion criteria, with written
      informed consent to be in the study. The study will be carried out with 160 patients.

      Patients who meet these conditions will be randomly divided into 4 groups. First group
      bilateral GON blockade and bilateral isotonic injection into the SON region,second group
      bilateral SON blockade and bilateral isotonic injection into the GON region,Group 3 bilateral
      GON blockade and bilateral SON blockade and last investigators planned to give bilateral GON
      and SON region saline injection to group 4.

      While performing these procedures, 1 ml of 2% lidocaine and 1 ml of saline will be used for 2
      ml of 1% lidocaine for nerve block. Also 2 ml of saline will be used for placebo effect. For
      blocking the GON region 0.75 ml of 1% lidocaine will be applied and 0.75 ml of saline for
      placebo effect(8). During applying to the SON region 0.25 ml of 1% lidocaine for blockage and
      0.25 ml of saline for placebo effect will be used(8). The GON injection site was planned to
      be 2 cm lateral and 2 cm below the occipital protrusion and the SON injection site was
      planned as the area with frontal incisor in the orbital arch (8).

      Patients will be followed up in the emergency room for 120 minutes. In the study, 1 large box
      will be used to ensure double blindness and randomization. There will be 2 more small boxes
      in it. Small boxes will be named as '' G '' and '' S '' containing the names of the nerve
      regions. There will be 8 injectors in each small box. There will be 8 syringes in each small
      box, 4 of them containing saline and 4 contains 1% lidocaine. The injectors will be numbered
      with the name of the box in which they are located (such as G1, G2… G8 or S1, S2… S8). In the
      study, 8 patients will be treated daily. In the following days, injector numbers will be
      written as numbers in progress (such as G9, G10..G16 and S9, S10… S16). The contents of these
      injectors prepared by the pharmacist will also be recorded by the pharmacist. Envelopes with
      random number injector combinations will be offered to patients. The combination in the
      envelope chosen by the patient will be applied. Injector numbers will be recorded to the data
      form. When the study is finished, these numbers will be checked and it will be determined
      which patient is given which treatment.
    

Intervention name(s): Lidocaine Hydrochloride; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): While performing these procedures, 1 ml of 2% lidocaine hydrochloride and 1 ml of %0.9 saline will be used for creating a solution of 2 ml of 1% lidocaine for nerve block. Also 2 ml of saline will be used for placebo effect. For blocking the GON region 0.75 ml of 1% lidocaine will be applied and 0.75 ml of saline for placebo effect(8). During applying to the SON region 0.25 ml of 1% lidocaine for blockage and 0.25 ml of saline for placebo effect will be used(8). The GON injection site was planned to be 2 cm lateral and 2 cm below the occipital protrusion and the SON injection site was planned as the area with frontal incisor in the orbital arch; There will be injection of %0.9 saline to bilaterally great occipital nerve and to bilaterally supraorbital nerve.
Intervention MeSH terms: Lidocaine
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: migraine attack, nerve blockade, emergency medicine