PMID- 30086776 OWN - NLM STAT- MEDLINE DCOM- 20190314 LR - 20190314 IS - 1745-6215 (Electronic) IS - 1745-6215 (Linking) VI - 19 IP - 1 DP - 2018 Aug 7 TI - Effects of ultrasound-guided stellate ganglion block on cervical vascular blood flow: study protocol for a randomized controlled trial. PG - 426 LID - 10.1186/s13063-018-2736-y [doi] LID - 426 AB - 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. FAU - Pu, Shaofeng AU - Pu S AD - Department of Pain Management, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, 600 Yi Shan Rd, Shanghai, 200233, People's Republic of China. FAU - Chen, Jie AU - Chen J AD - Department of Ultrasound in Medicine, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, Shanghai Institute of Ultrasound in Medicine, Shanghai, 200233, China. FAU - Gu, Xing AU - Gu X AD - Department of Gynaecology and Obstetrics, the Affiliated Kunshan First People's Hospital, Jiangsu University, Kunshan, 215300, China. FAU - Xu, Yongming AU - Xu Y AD - Department of Pain Management, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, 600 Yi Shan Rd, Shanghai, 200233, People's Republic of China. FAU - Wu, Junzhen AU - Wu J AD - Department of Pain Management, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, 600 Yi Shan Rd, Shanghai, 200233, People's Republic of China. FAU - Lv, Yingying AU - Lv Y AD - Department of Pain Management, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, 600 Yi Shan Rd, Shanghai, 200233, People's Republic of China. FAU - Du, Dongping AU - Du D AD - Department of Pain Management, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, 600 Yi Shan Rd, Shanghai, 200233, People's Republic of China. dudp@sjtu.edu.cn. LA - eng GR - 81370933/the General Program of National Natural Science Foundation of China/ GR - 81672237/the General Program of National Natural Science Foundation of China/ PT - Clinical Trial Protocol PT - Journal Article DEP - 20180807 PL - England TA - Trials JT - Trials JID - 101263253 RN - 0 (Anesthetics, Local) RN - 98PI200987 (Lidocaine) SB - IM MH - Adolescent MH - Adult MH - Aged MH - Anesthetics, Local/*administration & dosage/adverse effects MH - Blood Flow Velocity MH - Carotid Artery, Common/diagnostic imaging/*physiopathology MH - Cerebrovascular Circulation MH - China MH - Cross-Over Studies MH - Female MH - Headache Disorders, Primary/diagnosis/physiopathology/*therapy MH - Humans MH - Lidocaine/*administration & dosage/adverse effects MH - Male MH - Middle Aged MH - Neck/*blood supply MH - Nerve Block/adverse effects/*methods MH - Prospective Studies MH - Randomized Controlled Trials as Topic MH - Regional Blood Flow MH - Stellate Ganglion/diagnostic imaging/*drug effects MH - Time Factors MH - Treatment Outcome MH - *Ultrasonography, Interventional MH - Vasodilation MH - Vertebral Artery/diagnostic imaging/*physiopathology MH - Young Adult PMC - PMC6081863 OTO - NOTNLM OT - Blood flow OT - Primary headaches OT - Randomized control crossover trial OT - Stellate ganglion block COIS- ETHICS APPROVAL AND CONSENT TO PARTICIPATE: This research project was approved by the Ethical Committee of Shanghai Jiao Tong University Affiliated Sixth People's Hospital, China in June 2016 (approval number 2016-44). The study was registered in ChiCTR (Chinese Clinical Trial Registry, ChiCTR-IOR-17011536) on 1 June 2017 (http://www.chictr.org.cn/index.aspx). Informed consent will be obtained from all potential participants before trial commencement. CONSENT FOR PUBLICATION: Not applicable. COMPETING INTERESTS: The authors declare that they have no competing interests. PUBLISHER'S NOTE: Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations. EDAT- 2018/08/09 06:00 MHDA- 2019/03/15 06:00 PMCR- 2018/08/07 CRDT- 2018/08/09 06:00 PHST- 2017/10/14 00:00 [received] PHST- 2018/06/08 00:00 [accepted] PHST- 2018/08/09 06:00 [entrez] PHST- 2018/08/09 06:00 [pubmed] PHST- 2019/03/15 06:00 [medline] PHST- 2018/08/07 00:00 [pmc-release] AID - 10.1186/s13063-018-2736-y [pii] AID - 2736 [pii] AID - 10.1186/s13063-018-2736-y [doi] PST - epublish SO - Trials. 2018 Aug 7;19(1):426. doi: 10.1186/s13063-018-2736-y.