Dr. Lutfi Kirdar Kartal Training and Research Hospital
Nihat Mujdat Hokenek
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.
Migraine Disorders
Lidocaine Hydrochloride
Placebo
PHASE4
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.
| Study Type : | INTERVENTIONAL |
| Estimated Enrollment : | 128 participants |
| Masking : | TRIPLE |
| Primary Purpose : | TREATMENT |
| Official Title : | Comparison of Great Occipital Nerve and Supraorbital Nerve Blockade Treatment Methods Individually and in Combination With Placebo in an Acute Migraine Attack in the Emergency Department, a Prospective, Double Blind, Randomized Controlled Study |
| Actual Study Start Date : | 2020-08-15 |
| Estimated Primary Completion Date : | 2021-03-14 |
| Estimated Study Completion Date : | 2021-03-14 |
Information not available for Arms and Intervention/treatment
| Ages Eligible for Study: | 18 Years to 50 Years |
| Sexes Eligible for Study: | ALL |
| Accepts Healthy Volunteers: |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
Not yet recruiting
Kartal Dr. Lutfi Kırdar City Hospital
İstanbul, Turkey, 34890