跳至主要内容
临床试验/NCT07763678
NCT07763678尚未招募4 期

Efficacy of Ultrasound-Guided Combined Greater Occipital Nerve Block and Greater Auricular Nerve Block Versus Greater Occipital Nerve Block Alone in the Management of Chronic Migraine

Assiut University0 个研究点目标入组 80 人开始时间: 2026年9月1日最近更新:
适应症
干预措施

试验速览

阶段
4 期
状态
尚未招募
入组人数
80
主要终点
Visual Analog Scale (VAS) pain score

研究概览

简要总结

Migraine is one of the most prevalent neurological disorders worldwide and remains a leading cause of disability, particularly among individuals of working age. Chronic migraine affects approximately 1-2% of the global population and is associated with substantial impairment in quality of life, reduced work productivity, and increased healthcare utilization . Despite recent advances in migraine management, including calcitonin gene-related peptide (CGRP)-targeted monoclonal antibodies and gepants, many patients continue to experience inadequate symptom control, treatment intolerance, or limited access to these therapies . Consequently, peripheral nerve blocks have emerged as effective non-pharmacological treatment options for patients with refractory migraine and other primary headache disorders .

Among the available interventional techniques, the greater occipital nerve block (GONB) is one of the most widely used procedures for both acute and preventive treatment of migraine. The therapeutic effect of GONB is believed to result from modulation of nociceptive transmission within the trigeminocervical complex, thereby reducing central sensitization and interrupting convergence between cervical and trigeminal afferents. Several randomized clinical trials and systematic reviews have demonstrated that GONB significantly reduces headache intensity, headache frequency, analgesic consumption, and migraine-related disability while maintaining an excellent safety profile .

Migraine pain often involves overlapping sensory territories supplied by interconnected peripheral nerves. The greater auricular nerve (GAN), a superficial sensory branch of the cervical plexus arising from the C2 and C3 spinal nerves, supplies the skin over the parotid region, mastoid process, lower auricle, and angle of the mandible . Because cervical sensory afferents converge with trigeminal nociceptive pathways within the trigeminocervical complex, the GAN may contribute to peripheral nociceptive transmission involved in migraine pathophysiology . Combined blockade of multiple cervical sensory nerves may therefore provide broader interruption of peripheral nociceptive input, potentially enhancing analgesic efficacy and reducing central sensitization . Ultrasound-guided GONB has been shown to produce greater procedural accuracy and consistent clinical outcomes than landmark-guided techniques .

Despite the increasing use of peripheral nerve blocks in headache medicine, evidence regarding the additional benefit of combining a greater auricular nerve block with the standard greater occipital nerve block remains limited. To the best of our knowledge, no prospective randomized double-blind clinical trial has directly compared ultrasound-guided combined GONB and GAN block with GONB alone in patients with chronic migraine.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

盲法说明

Masking Description

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Adults aged ≥18 years.
  • •Diagnosis of chronic migraine according to ICHD-3 criteria (1).
  • •Patients free from major neurological or psychiatric disorders that may interfere with headache assessment or study participation (3,4).
  • •Ability to provide written informed consent and comply with study procedures.

排除标准

  • •Age <18 years.
  • •Medication-overuse headache according to ICHD-3 criteria .
  • •Acute migraine medication use within 24 hours before intervention .
  • •Previous trauma or surgery involving the occipital region .
  • •Known hypersensitivity to local anesthetic agents.
  • •Local skin infection, dermatological disease, or impaired occipital sensation at the injection site.
  • •Bleeding diathesis, anticoagulan؛t therapy, or skull defect contraindicating peripheral nerve block .

研究组 & 干预措施

GONB group

Active Comparator

Patients will receive bilateral ultrasound-guided greater occipital nerve block using a standardized ultrasound-guided technique

干预措施: greater occipital nerve block (Procedure)

GONB + GAN group

Active Comparator

Patients will receive bilateral ultrasound-guided combined greater occipital nerve block and greater auricular nerve block. Ultrasound guidance will be used to optimize needle placement, improve local anesthetic distribution, and minimize complications

干预措施: greater occipital nerve block (Procedure)

GONB + GAN group

Active Comparator

Patients will receive bilateral ultrasound-guided combined greater occipital nerve block and greater auricular nerve block. Ultrasound guidance will be used to optimize needle placement, improve local anesthetic distribution, and minimize complications

干预措施: Greater Auricular Nerve Block (Procedure)

结局指标

主要结局

Visual Analog Scale (VAS) pain score

时间窗: 30 days

change in Visual Analog Scale (VAS) pain score .the Visual Analogue Scale (VAS) for pain is a continuous 10-centimeter (100 mm) line with word anchors at each end. The left side reads "no pain" (0) and the right side reads "worst imaginable pain" (10 or 100). Patients make a mark on the line to show their pain level

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ahmed Mostafa Ahmed Mamdouh

Resident doctor at Anesthesia, Intensive Care and Pain Management

Assiut University

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