Clinical trial NCT04491474: Comparison of Great Occipital Nerve and Supraorbital Nerve Blockade Methods at Treatment of Acute Migraine Attack in the Emergency Department
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Migraine Disorders
Keywords: migraine attack, nerve blockade, emergency medicine
Lead sponsor: Dr. Lutfi Kirdar Kartal Training and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2020-07-29
Enrollment: 128
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

1. Meeting the criteria of International Headache Society (IHS CLASSIFICATION ICHD-3) migraine criteria with or without aura
2. Not taking medication before applying to the hospital
3. Over 18 years
4. Under 50 years
5. Patients with a history of migraine
6. The number of migraine attacks per month should be between 2 and 8
7. Having a headache-free period of at least 48 hours between migraine attacks
8. Diagnosis of migraine at least 1 year ago
9. Migraine prophylaxis is finished and the last dose should be taken 1 month or more

Exclusion Criteria:

1. Pregnancy
2. Epilepsy, History of Arrhythmia
3. Implantation in the skull, Cardiac pacemaker
4. Patients with a brain tumor or in an acute cerebrovascular accident clinic
5. Patients with a history of head injury
6. Past medical history of psychiatric illness
7. Patients with a fever\> 38, Patients with suspected meningitis
8. Patients with acute changes of consciousness or signs of meningeal irritation
9. Hypertension (Patients with Blood Pressure\> 160/110)
10. Headaches due to excessive drug use
11. Patients with headache\> 15 days monthly

Primary outcomes:
measure: Comparison of great occipital nerve and supraorbital nerve blockade methods at treatment of acute migraine attack in the emergency department, a prospective randomized controlled double blind study
timeFrame: 0-30th minute- 60th minute-120th minute visual analog scale pain measurements.
Secondary outcomes:
measure: Pain assessment according to Likert type verbal scale
timeFrame: 0 minute and 120th minute
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: Kartal Dr. Lutfi Kırdar City Hospital
Study officials:
References:
citation: Ruiz Pinero M, Mulero Carrillo P, Pedraza Hueso MI, de la Cruz Rodriguez C, Lopez Mesonero L, Guerrero Peral AL. Pericranial nerve blockade as a preventive treatment for migraine: Experience in 60 patients. Neurologia. 2016 Sep;31(7):445-51. doi: 10.1016/j.nrl.2014.10.001. Epub 2014 Dec 24. English, Spanish.
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citation: Okmen K, Dagistan Y, Dagistan E, Kaplan N, Cancan E. Efficacy of the greater occipital nerve block in recurrent migraine type headaches. Neurol Neurochir Pol. 2016;50(3):151-4. doi: 10.1016/j.pjnns.2016.01.015. Epub 2016 Feb 6.
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citation: Diener HC, Tassorelli C, Dodick DW, Silberstein SD, Lipton RB, Ashina M, Becker WJ, Ferrari MD, Goadsby PJ, Pozo-Rosich P, Wang SJ, Mandrekar J; International Headache Society Clinical Trials Standing Committee. Guidelines of the International Headache Society for controlled trials of acute treatment of migraine attacks in adults: Fourth edition. Cephalalgia. 2019 May;39(6):687-710. doi: 10.1177/0333102419828967. Epub 2019 Feb 26.