Comparison of Great Occipital Nerve and Supraorbital Nerve Blockade Methods at Treatment of Acute Migraine Attack in the Emergency Department
Từ khóa
trừu tượng
Sự miêu tả
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.
ngày
Xác minh lần cuối: | 06/30/2020 |
Đệ trình đầu tiên: | 07/16/2020 |
Đăng ký ước tính đã được gửi: | 07/26/2020 |
Đăng lần đầu: | 07/28/2020 |
Cập nhật lần cuối được gửi: | 07/26/2020 |
Cập nhật lần cuối đã đăng: | 07/28/2020 |
Ngày bắt đầu nghiên cứu thực tế: | 07/24/2020 |
Ngày hoàn thành chính ước tính: | 09/29/2020 |
Ngày hoàn thành nghiên cứu ước tính: | 12/29/2020 |
Tình trạng hoặc bệnh tật
Can thiệp / điều trị
Drug: Lidocaine Hydrochloride
Drug: Group 4
Giai đoạn
Nhóm cánh tay
Cánh tay | Can thiệp / điều trị |
---|---|
Active Comparator: Group 1 bilateral great occipital nerve blockade and bilateral isotonic injection into the supraorbital region. | |
Active Comparator: Group 2 bilateral supraorbital nerve blockade and bilateral isotonic injection into the great occipital nerve region | |
Active Comparator: Group 3 bilateral great occipital nerve blockade and bilateral supraorbital nerve blockade | |
Sham Comparator: Group 4 saline injection to bilateral great occipital nerve and supraorbital nerve region | Drug: Group 4 There will be injection of %0.9 saline to bilaterally great occipital nerve and to bilaterally supraorbital nerve. |
Đủ tiêu chuẩn
Tuổi đủ điều kiện để học | 18 Years Đến 18 Years |
Giới tính đủ điều kiện để nghiên cứu | All |
Chấp nhận tình nguyện viên lành mạnh | Đúng |
Tiêu chí | 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 |
Kết quả
Các biện pháp kết quả chính
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 [0-30th minute- 60th minute-120th minute visual analog scale pain measurements.]
Các biện pháp kết quả thứ cấp
1. Pain assessment according to Likert type verbal scale [0 minute and 120th minute]