NCT06891118

Stellate Ganglion Blockade for Refractory Chronic Migraine

Ultrasound-Guided Stellate Ganglion Block for Refractory Chronic Migraine: A Prospective Evaluation

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: Ankara City Hospital Bilkent · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

Stellate Ganglion Block (SGB) is an interventional anesthetic technique used to treat pain conditions affecting the head, face, neck, and upper extremities by temporarily blocking sympathetic nerve output. Ultrasound guidance improves anatomical visualization and enhances procedural safety. Emerging evidence suggests that repeated ultrasound-guided SGB may reduce headache intensity and frequency in migraine patients and may improve migraine-related disability. However, limited data exist regarding its role in highly treatment-resistant chronic migraine, particularly in patients who have not responded adequately to preventive pharmacological therapies and peripheral nerve block interventions. The primary objective of this study is to evaluate the clinical efficacy of ultrasound-guided SGB in patients with treatment-resistant chronic migraine. Secondary objectives include assessing changes in migraine-related disability and monitoring potential adverse events.

Detailed description

Migraine is a common neurological disorder, and approximately 8% of patients develop chronic migraine (CM), defined as headache occurring on 15 or more days per month for more than three months, with at least 8 days fulfilling migraine criteria. Chronic migraine is associated with substantial disability and reduced quality of life. In patients who do not respond adequately to preventive pharmacological therapies, interventional procedures such as greater occipital nerve blocks, sphenopalatine ganglion blocks, pulsed radiofrequency procedures, and botulinum toxin injections may be considered. However, a subset of patients continues to experience persistent and disabling symptoms despite these interventions. The stellate ganglion is formed by the fusion of the inferior cervical and first thoracic sympathetic ganglia and plays a key role in cervical sympathetic outflow. Stellate ganglion block (SGB) involves the injection of local anesthetic around the stellate ganglion to temporarily inhibit sympathetic activity. Ultrasound guidance allows real-time visualization of anatomical structures, reduces the risk of vascular injury, and avoids radiation exposure. In this study, SGB is performed under sterile conditions with continuous monitoring and real-time ultrasound guidance. A linear ultrasound probe is positioned at the level of the sixth cervical vertebra to identify relevant anatomical structures. A 25-gauge needle is advanced using an in-plane technique, and 5 mL of 1% lidocaine is administered after confirming correct placement. For bilateral headache, alternating bilateral applications are performed with an interval between sides. The primary aim of the study is to evaluate the effect of ultrasound-guided SGB on Monthly Headache Days in patients with treatment-resistant chronic migraine. Secondary aims include evaluation of pain intensity, headache-related disability, analgesic use, patient-reported global improvement, and safety outcomes. The protocol was amended with institutional ethics committee approval prior to completion of data analysis to extend follow-up to six months and to redefine the primary outcome as change in Monthly Headache Days.

Conditions

• Headache, Migraine
• Chronic Migraine Headache

Interventions

Type	Name	Description
PROCEDURE	Stellate gangion blockade %1 5 mL	SGB is performed under sterile conditions in the operating room, with the patient's intravenous line established, monitored during the procedure, and ultrasound guidance used simultaneously. The patient is positioned supine, with the neck slightly hyperextended and the head slightly turned to the opposite side. After the skin is cleaned with an antiseptic solution and the probe is sterilized, a linear ultrasound probe is placed transversely at the level of the sixth cervical vertebra (C6). The relevant anatomical landmarks, including the internal carotid artery, internal jugular vein, thyroid tissue, longus colli muscle, prevertebral fascia, C6 transverse process (Chassaignac's tubercle), C6 nerve root, and vertebral artery, are visualized. Avoiding vascular structures and thyroid tissue, a 25-gauge 38 mm sterile needle is advanced with a lateral approach using the in-plane technique, ensuring the needle tip is just below the surface of the longus colli m

Timeline

• Start date: 2024-03-06
• Primary completion: 2025-12-30
• Completion: 2025-12-30
• First posted: 2025-03-24
• Last updated: 2026-02-27

Locations

1 site across 1 country: Turkey (Türkiye)