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

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ClinicalTrials.gov Identifier: NCT04491474
Recruitment Status : Completed
First Posted : July 29, 2020
Last Update Posted : March 16, 2021
Sponsor:
Information provided by (Responsible Party):
Nihat Mujdat Hokenek, Dr. Lutfi Kirdar Kartal Training and Research Hospital

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.

Condition or disease Intervention/treatment Phase
Migraine Disorders Drug: Lidocaine Hydrochloride Drug: Placebo Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 128 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Triple (Participant, Care Provider, Investigator)
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 : August 15, 2020
Actual Primary Completion Date : March 14, 2021
Actual Study Completion Date : March 14, 2021

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Migraine
MedlinePlus related topics: Migraine

Arm Intervention/treatment
Active Comparator: Group 1
bilateral great occipital nerve blockade and bilateral isotonic injection into the supraorbital region.
Drug: Lidocaine Hydrochloride
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

Active Comparator: Group 2
bilateral supraorbital nerve blockade and bilateral isotonic injection into the great occipital nerve region
Drug: Lidocaine Hydrochloride
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

Active Comparator: Group 3
bilateral great occipital nerve blockade and bilateral supraorbital nerve blockade
Drug: Lidocaine Hydrochloride
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

Sham Comparator: Group 4
saline injection to bilateral great occipital nerve and supraorbital nerve region
Drug: Placebo
There will be injection of %0.9 saline to bilaterally great occipital nerve and to bilaterally supraorbital nerve.




Primary Outcome Measures :
  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 [ Time Frame: 0-30th minute- 60th minute-120th minute visual analog scale pain measurements. ]

    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.



Secondary Outcome Measures :
  1. Pain assessment according to Likert type verbal scale [ Time Frame: 0 minute and 120th minute ]
    Secondary the participants will be asked about their responses to treatment with a scoring method from 1 to 5 according to Likert-type verbal scale, which is a verbal assessment method at 0 and 120 minutes of treatment. On this scale, they will be asked to say 1: I have a lot of pain, 2: I have a pain, 3: moderate relief, 4: I am good, 5: I am very good, and they will be asked to choose a number to evaluate their pain. This will also be recorded.



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04491474


Locations
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Turkey
Kartal Dr. Lutfi Kırdar City Hospital
İstanbul, Turkey, 34890
Sponsors and Collaborators
Dr. Lutfi Kirdar Kartal Training and Research Hospital
Publications of Results:

Other Publications:
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Responsible Party: Nihat Mujdat Hokenek, Emergency Medicine Specialist, Dr. Lutfi Kirdar Kartal Training and Research Hospital
ClinicalTrials.gov Identifier: NCT04491474    
Other Study ID Numbers: 2020/514/169/20
First Posted: July 29, 2020    Key Record Dates
Last Update Posted: March 16, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: İf there is reasonable requests, I can share that time to support investigations about nerve blockade.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: 5 year
Access Criteria: There should be at least 1 study about migraine attacks or nerve blockade.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Nihat Mujdat Hokenek, Dr. Lutfi Kirdar Kartal Training and Research Hospital:
migraine attack, nerve blockade, emergency medicine
Additional relevant MeSH terms:
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Migraine Disorders
Emergencies
Disease Attributes
Pathologic Processes
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action