This single-center, randomized, controlled, single-blind clinical trial evaluates whethera stellate ganglion block (SGB) using bupivacaine can improve persistent symptoms inadults with long COVID. Participants are assigned in a 1:1 ratio to receive either anultrasound-guided right-sided SGB or a placebo saline injection delivered to thesternocleidomastoid muscle. After the intervention, participants are followed for 26weeks with scheduled evaluations that include symptom questionnaires and functionaltests.The study assesses changes in functional status, fatigue, cognitive complaints, qualityof life, dyspnea, lower-limb endurance, and orthostatic tolerance over time. Safety ismonitored throughout all follow-up visits. Approximately 40 participants meetingpredefined eligibility criteria will be enrolled. This trial seeks to determine whether asingle stellate ganglion block has an effect on persistent long-COVID symptoms comparedwith placebo.The results will help determine the therapeutic value of SGB in themanagement of long COVID and inform future research and clinical practice.
Not Provided
Procedure: 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 procedure.
Procedure: 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).
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Centre hospitalier affilié universitaire régional
Trois-Rivières, Quebec, Canada
Investigator: Marie-Claude Lehoux, Master's degree
Contact: 819 697-3333
marie-claude.lehoux@ssss.gouv.qc.ca
Marie-Claude Lehoux, Master's degree
819 697-3333 - 60753
marie-claude.lehoux@ssss.gouv.qc.ca
Éva Mathieu, Ph.D
819 697-3333 - 60756
eva.mathieu@ssss.gouv.qc.ca
Not Provided