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

Primary Purpose

Migraine Disorders

Status
Completed
Phase
Phase 4
Locations
Turkey
Study Type
Interventional
Intervention
Lidocaine Hydrochloride
Placebo
Sponsored by
Dr. Lutfi Kirdar Kartal Training and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Migraine Disorders focused on measuring migraine attack, nerve blockade, emergency medicine

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Kartal Dr. Lutfi Kırdar City Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Sham Comparator

Arm Label

Group 1

Group 2

Group 3

Group 4

Arm Description

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

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

bilateral great occipital nerve blockade and bilateral supraorbital nerve blockade

saline injection to bilateral great occipital nerve and supraorbital nerve region

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Pain assessment according to Likert type verbal scale
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.

Full Information

First Posted
July 17, 2020
Last Updated
March 13, 2021
Sponsor
Dr. Lutfi Kirdar Kartal Training and Research Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04491474
Brief Title
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

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
August 15, 2020 (Actual)
Primary Completion Date
March 14, 2021 (Actual)
Study Completion Date
March 14, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dr. Lutfi Kirdar Kartal Training and Research Hospital

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine Disorders
Keywords
migraine attack, nerve blockade, emergency medicine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Sequential Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
128 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Active Comparator
Arm Description
bilateral great occipital nerve blockade and bilateral isotonic injection into the supraorbital region.
Arm Title
Group 2
Arm Type
Active Comparator
Arm Description
bilateral supraorbital nerve blockade and bilateral isotonic injection into the great occipital nerve region
Arm Title
Group 3
Arm Type
Active Comparator
Arm Description
bilateral great occipital nerve blockade and bilateral supraorbital nerve blockade
Arm Title
Group 4
Arm Type
Sham Comparator
Arm Description
saline injection to bilateral great occipital nerve and supraorbital nerve region
Intervention Type
Drug
Intervention Name(s)
Lidocaine Hydrochloride
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
There will be injection of %0.9 saline to bilaterally great occipital nerve and to bilaterally supraorbital nerve.
Primary Outcome Measure Information:
Title
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
Description
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.
Time Frame
0-30th minute- 60th minute-120th minute visual analog scale pain measurements.
Secondary Outcome Measure Information:
Title
Pain assessment according to Likert type verbal scale
Description
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.
Time Frame
0 minute and 120th minute

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Facility Information:
Facility Name
Kartal Dr. Lutfi Kırdar City Hospital
City
İstanbul
ZIP/Postal Code
34890
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
İf there is reasonable requests, I can share that time to support investigations about nerve blockade.
IPD Sharing Time Frame
5 year
IPD Sharing Access Criteria
There should be at least 1 study about migraine attacks or nerve blockade.
Citations:
PubMed Identifier
25543956
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.
Results Reference
background
PubMed Identifier
23771276
Citation
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.
Results Reference
background
PubMed Identifier
25600718
Citation
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.
Results Reference
result
PubMed Identifier
17504651
Citation
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.
Results Reference
result
PubMed Identifier
18549410
Citation
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.
Results Reference
result
PubMed Identifier
25415168
Citation
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.
Results Reference
result
PubMed Identifier
27154440
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.
Results Reference
result
PubMed Identifier
30285507
Citation
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.
Results Reference
result
PubMed Identifier
30806518
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.
Results Reference
result

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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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