Stellate Ganglion Block for Long COVID Symptoms: A Randomized Controlled Trial

Официальное название

Effect of Stellate Ganglion Block Treatment on Long COVID Symptoms: A Single-Blind, Single-Center Randomized Controlled Trial (STAR-CO)

Обзор

This single-center, randomized, controlled, single-blind clinical trial evaluates whether a stellate ganglion block (SGB) using bupivacaine can improve persistent symptoms in adults with long COVID. Participants are assigned in a 1:1 ratio to receive either an ultrasound-guided right-sided SGB or a placebo saline injection delivered to the sternocleidomastoid muscle. After the intervention, participants are followed for 26 weeks with scheduled evaluations that include symptom questionnaires and functional tests. The study assesses changes in functional status, fatigue, cognitive complaints, quality of life, dyspnea, lower-limb endurance, and orthostatic tolerance over time. Safety is monitored throughout all follow-up visits. Approximately 40 participants meeting predefined eligibility criteria will be enrolled. This trial seeks to determine whether a single stellate ganglion block has an effect on persistent long-COVID symptoms compared with placebo.The results will help determine the therapeutic value of SGB in the management of long COVID and inform future research and clinical practice.

Вмешательства

• Процедура Stellate Ganglion Block (Bupivacaine)
  A single ultrasound-guided stellate ganglion block is administered on the right side of the neck under sterile conditions by an anesthesiologist. The needle is positioned between the longus colli muscle and the right carotid artery, and 7 mL of 0.5% bupivacaine is injected. Correct placement is verified by ultrasound and confirmed clinically by the expected appearance of Claude Bernard-Horner syndrome following the injection. Participants are observed for approximately 30 minutes after the proce
• Процедура placebo saline injection
  A single placebo injection of 6-8 mL of 0.9% normal saline is administered into the right sternocleidomastoid muscle. The procedure uses the same patient positioning, sterile preparation, and ultrasound guidance as the active arm; however, the needle is intentionally placed in the muscle, away from the stellate ganglion, and does not produce a stellate ganglion block (i.e., cannot cause Claude Bernard-Horner syndrome).

Первичные конечные точки

• Post-COVID-19 Functional Status Scale (PCFS) [Срок оценки: 4 weeks after the intervention]
• Fatigue Severity Scale (FSS) [Срок оценки: 4 weeks after the intervention]
• Brain Fog Scale (BFS) [Срок оценки: 4 weeks after the intervention]

Вторичные конечные точки (4)

• Health-Related Quality of Life (SF-36) [Срок оценки: 4 weeks after the intervention]
• Dyspnea Severity (mMRC Scale) [Срок оценки: 4 weeks after the intervention]
• Lower-Limb Muscle Endurance (1-Minute Sit-to-Stand Test) [Срок оценки: 4 weeks after the intervention]
• Orthostatic Intolerance (NASA Lean Test) [Срок оценки: 4 weeks after the intervention]

Критерии участия

Критерии включения

• Adults aged 18 years and older
• Positive COVID-19 test confirmed by RT-PCR, antibody test, or antigen test at least 3 months prior to randomization, OR presumed COVID-19 evaluated by the site investigator (no positive test required) with an acute illness occurring after October 15, 2019 and at least 3 months prior to randomization.
• Persistent symptoms ≥12 weeks after onset of acute COVID-19 AND symptoms lasting at least 2 months. The onset date is defined as the earliest of: date of first positive test, date of first symptoms
• Post-COVID Functional Status Scale score ≥2.
• Persistent dyspnea ≥2/4 on the mMRC scale at least 12 weeks post-infection.
• Persistent COVID-19-related symptoms at the time of randomization.
• If taking medications for fatigue or cognition (e.g., sildenafil, modafinil, armodafinil, guanfacine, N-acetylcysteine, stimulants for ADHD), these must have been initiated and stable for ≥4 weeks prior to randomization. Participants are asked not to stop or alter these medications during the study if possible.
• Able and willing to provide written informed consent.
• Able to read and understand French.

Критерии исключения

• Prior diagnosis of myalgic encephalomyelitis (ME) or fibromyalgia
• Being on sick leave or disability at the time of the original acute COVID-19 infection.
• Pregnancy or breastfeeding.
• Myocardial infarction within the last 12 weeks.
• Use of anticoagulant therapy.
• Glaucoma.
• Emphysema requiring home oxygen.
• Cardiac conduction abnormalities.
• Known hypersensitivity to bupivacaine.
• Previous stellate ganglion block (SGB) procedure.
• Any condition that, in the judgment of the medical investigator, makes the patient not a candidate for the proposed treatment.

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

Канада · 1 центр

• Centre hospitalier affilié universitaire régional — Trois-Rivières

Идентификаторы

NCT: NCT07374562 · 2026-898 · 1028

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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