Ultrasound Guided Block of Stellate Ganglion Versus Greater Occipital Nerve in Resistant Migraine and Correlation to Calcitonin Gene Related Peptide

Официальное название

Efficacy of Ultrasound Guided Block of Stellate Ganglion Versus Greater Occipital Nerve in Chronic Resistant Migraine Patients and Its Correlation to Calcitonin Gene Related Peptide (CGRP)

Обзор

To investigate the efficacy of Ultrasound guided Stellate Ganglion block in chronic resistant migraine patients in comparison to Greater Occipital Nerve Block correlating its effect to serum CGRP level.

Подробное описание

40 Patients diagnosed with Chronic resistant migraine to 2 anti-migraine drugs for 3 months will be evaluated for inclusion and exclusion. Eligible patients with resistance or intolerability to 2 drugs or more will be classified into two groups by using simple randomization methods through Using a computer-generated random number sequence.

Each group will contain 20 patients one group will undergo ultrasound guided bilateral Greater Occipital nerve Block and the other group will undergo ultrasound guided bilateral Stellate Ganglion Block

Вмешательства

• Процедура ultrasound guided Greater occipital nerve block
  Patients will be positioned in a prone position with their neck slightly flexed. The trapezius , semispinalis, obliqus capitis muscles will be revealed on short-axis view. A 25- or 21 gauge is used, with puncture point 1-1.5 cm away from the ultrasound probe. Under the guidance of the ultrasound, GOB will performed by injection using 40 mg triamcinolone and 1ml of 2% lidocaine.
• Процедура Ultrasound guided Stellate ganglion block
  Patients are positioned in a lateral position with their necks slightly hyperextended. Assisted by ultrasound imaging equipment the C7 level is confirmed. The thyroid gland, carotid artery, compressible internal jugular vein, vertebral artery, brachial plexus and the oval-shaped structure of the longus collis muscle are revealed on this short-axis view. A 25- or 21 gauge is used and the puncture point is 1-1.5 cm away from the ultrasound probe The tip of the needle reach the surface of the long

Первичные конечные точки

• Changes in Headache impact test (HIT-6) [Срок оценки: 3 months]
• changes in Migraine disability assessment test (MIDAS) [Срок оценки: 3 months]
• changes in Numeric Rating Scale (NRS) [Срок оценки: 3 months]

Вторичные конечные точки (1)

• Changes in circulating CGRP level [Срок оценки: 1 month]

Критерии участия

Критерии включения

• Individuals diagnosed with chronic resistant migraine after using or intolerability to 2 or more of anti-migraine drugs for at least 3 months

Критерии исключения

• Patients with a space-occupying lesion.
• Coagulation disorders.
• Systemic or local infection and drug allergies.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Египет · 1 центр

• Ain Shams University Hospital — Cairo

Идентификаторы

NCT: NCT06662461 · FMASU MD14/2024

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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