Comparison of Great Occipital Nerve and Supraorbital Nerve Blockade Methods at Treatment of Acute Migraine Attack in the Emergency Department

NCT04491474 | Completed Phase 4 DMC

• 1 other identifier: 2020/514/169/20
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

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.

Conditions

Migraine Disorders

Keywords

migraine attack, nerve blockade, emergency medicine

Outcome Measures

Primary Outcomes (1)

• 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

  VAS (Visual Analog Scale) with 100mm length, which writes start and end points, will be used as the pain assessment scale. In this scale, 0 shows the lightest pain in the form of a straight line and 100 mm indicates the most pain. This scale will be described to the participant and asked to mark the intensity of pain on the line. VAS values of the participants for 0 minutes, 30 minutes, 60 minutes and 120 minutes will be taken and evaluated separately. If there is no relief in the pain of the participants at the 30th minute, it is planned to administer meperidine (0.75 mcg / kg) as in similar studies as a recovery therapy(4). These patients will then be excluded from the study. Participants will be discharged after 120 minutes if they express that their pain has passed or they do not need more analgesics.

  0-30th minute- 60th minute-120th minute visual analog scale pain measurements.

Secondary Outcomes (1)

• Pain assessment according to Likert type verbal scale

  0 minute and 120th minute

Study Arms (4)

Group 1

ACTIVE COMPARATOR

bilateral great occipital nerve blockade and bilateral isotonic injection into the supraorbital region.

Drug: Lidocaine Hydrochloride

Group 2

ACTIVE COMPARATOR

bilateral supraorbital nerve blockade and bilateral isotonic injection into the great occipital nerve region

Drug: Lidocaine Hydrochloride

Group 3

ACTIVE COMPARATOR

bilateral great occipital nerve blockade and bilateral supraorbital nerve blockade

Drug: Lidocaine Hydrochloride

Group 4

SHAM COMPARATOR

saline injection to bilateral great occipital nerve and supraorbital nerve region

Drug: Placebo

Interventions

Lidocaine Hydrochloride DRUG

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

Group 1; Group 2; Group 3

Placebo DRUG

There will be injection of %0.9 saline to bilaterally great occipital nerve and to bilaterally supraorbital nerve.

Group 4

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Dr. Lutfi Kirdar Kartal Training and Research Hospital: lead

Study Sites (1)

Kartal Dr. Lutfi Kırdar City Hospital

Istanbul, 34890, Turkey (Türkiye)

Location

Related Publications (9)

• 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.

  PMID: 25543956 BACKGROUND

• Headache Classification Committee of the International Headache Society (IHS). The International Classification of Headache Disorders, 3rd edition (beta version). Cephalalgia. 2013 Jul;33(9):629-808. doi: 10.1177/0333102413485658. No abstract available.

  PMID: 23771276 BACKGROUND

• Marmura MJ, Silberstein SD, Schwedt TJ. The acute treatment of migraine in adults: the american headache society evidence assessment of migraine pharmacotherapies. Headache. 2015 Jan;55(1):3-20. doi: 10.1111/head.12499.

  PMID: 25600718 RESULT

• Ashkenazi A, Levin M. Greater occipital nerve block for migraine and other headaches: is it useful? Curr Pain Headache Rep. 2007 Jun;11(3):231-5. doi: 10.1007/s11916-007-0195-3.

  PMID: 17504651 RESULT

• Young W, Cook B, Malik S, Shaw J, Oshinsky M. The first 5 minutes after greater occipital nerve block. Headache. 2008 Jul;48(7):1126-8. doi: 10.1111/j.1526-4610.2008.01146.x. Epub 2008 Jun 28.

  PMID: 18549410 RESULT

• Govindappagari S, Grossman TB, Dayal AK, Grosberg BM, Vollbracht S, Robbins MS. Peripheral nerve blocks in the treatment of migraine in pregnancy. Obstet Gynecol. 2014 Dec;124(6):1169-1174. doi: 10.1097/AOG.0000000000000555.

  PMID: 25415168 RESULT

• 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.

  PMID: 27154440 RESULT

• Ozer D, Boluk C, Turk Boru U, Altun D, Tasdemir M, Koseoglu Toksoy C. Greater occipital and supraorbital nerve blockade for the preventive treatment of migraine: a single-blind, randomized, placebo-controlled study. Curr Med Res Opin. 2019 May;35(5):909-915. doi: 10.1080/03007995.2018.1532403. Epub 2018 Oct 31.

  PMID: 30285507 RESULT

• 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.

  PMID: 30806518 RESULT

MeSH Terms

Conditions

Migraine Disorders

Interventions

Lidocaine

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Emergency Medicine Specialist

Study Record Dates

• First Submitted: July 17, 2020
• First Posted: July 29, 2020
• Study Start: August 15, 2020
• Primary Completion: March 14, 2021
• Study Completion: March 14, 2021
• Last Updated: March 16, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: 5 year
• Access Criteria: There should be at least 1 study about migraine attacks or nerve blockade.

Locations

TU (1)