Stellate Ganglion Block for Long COVID Symptoms: A Randomized Controlled Trial
STAR-CO
Effect of Stellate Ganglion Block Treatment on Long COVID Symptoms: A Single-Blind, Single-Center Randomized Controlled Trial (STAR-CO)
2 other identifiers
interventional
40
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Feb 2026
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 21, 2026
CompletedFirst Posted
Study publicly available on registry
January 29, 2026
CompletedStudy Start
First participant enrolled
February 5, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 1, 2027
February 9, 2026
February 1, 2026
12 months
January 21, 2026
February 5, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Post-COVID-19 Functional Status Scale (PCFS)
The PCFS measures limitations in daily functioning related to persistent post-COVID-19 symptoms. Scores range from 0 (no functional limitation) to 4 (severe functional limitation). Assesses changes in functional status over time.
4 weeks after the intervention
Fatigue Severity Scale (FSS)
The FSS is a validated 9-item questionnaire assessing the impact of fatigue on daily activities, motivation, and functioning. Each item is scored from 1 to 7; higher scores indicate greater fatigue severity. Clinically significant change is defined as ≥0.45 points.
4 weeks after the intervention
Brain Fog Scale (BFS)
The BFS is a 23-item questionnaire evaluating cognitive symptoms associated with Long COVID, including mental fatigue, cognitive clarity, logical thinking, and concentration. Total scores range from 0 to 92, with higher scores indicating more severe cognitive impairment.
4 weeks after the intervention
Secondary Outcomes (4)
Health-Related Quality of Life (SF-36)
4 weeks after the intervention
Dyspnea Severity (mMRC Scale)
4 weeks after the intervention
Lower-Limb Muscle Endurance (1-Minute Sit-to-Stand Test)
4 weeks after the intervention
Orthostatic Intolerance (NASA Lean Test)
4 weeks after the intervention
Study Arms (2)
Stellate Ganglion Block with Bupivacaine
EXPERIMENTALParticipant receives a right-sided stellate ganglion block under ultrasound guidance, using bupivacaine, performed by an anesthesiologist.
Placebo Neck Injection
PLACEBO COMPARATORParticipant receives a saline injection into the sternocleidomastoid muscle under the same conditions.
Interventions
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.
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).
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Centre hospitalier affilié universitaire régional
Trois-Rivières, Quebec, G8Z 3R9, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Masking Details
- The statistician performing the data analysis will also be masked to group assignment.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
January 21, 2026
First Posted
January 29, 2026
Study Start
February 5, 2026
Primary Completion (Estimated)
February 1, 2027
Study Completion (Estimated)
February 1, 2027
Last Updated
February 9, 2026
Record last verified: 2026-02