Effects of ultrasound-guided stellate ganglion block on cervical vascular blood flow: study protocol for a randomized controlled trial.

BACKGROUND: The stellate ganglion block (SGB) can lead to vasodilation of the head and neck. However, controversy remains concerning the changes in extracerebral blood flow. The objective of this study is to assess the effects of SGB on the blood flow to the neck.

METHODS: A randomized controlled crossover trial with 38 participants will be conducted. Participants who have primary headaches will be assigned to either group A or B. Patients in group A will receive SGB with 6 ml 1% lidocaine, and after a one-week washout period, they will undergo the second SGB with 6 ml normal saline. In contrast, patients in group B will receive the opposite protocol. Data will be collected at baseline (T0) and at 15 min after the first intervention (T1), 15 min before the second intervention (T2), 15 min after the second intervention (T3) and at a 3-week follow up (T4). T1 is the primary time point for the primary outcome analysis. The primary outcomes include the peak systolic velocity (PSV), the end diastolic velocity (EDV), resistance index (RI) and vessel diameter of the common carotid artery (CCA) and vertebral artery (VA). The secondary outcomes include the rate of ptosis, the rate of conjunctival flushing, and the numerical rating scale (NRS) pain score. Additionally, adverse events (AEs) or serious adverse events (SAEs) will be collected at each assessment point.

DISCUSSION: This study will comprehensively investigate the efficacy of SGB in extracerebral blood flow. Our research may also suggest that SGB will be effective in reducing pain in patients with primary headaches.

TRIAL REGISTRATION: Chinese Clinical Trial Registry, identifier ChiCTR-IOR-17011536 . Registered on 1 June 2017.