NCT07374562

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

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
9mo left

Started Feb 2026

Geographic Reach
1 country

1 active site

Status
recruiting

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

Study Progress25%
Feb 2026Feb 2027

First Submitted

Initial submission to the registry

January 21, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 29, 2026

Completed
7 days until next milestone

Study Start

First participant enrolled

February 5, 2026

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2027

Last Updated

February 9, 2026

Status Verified

February 1, 2026

Enrollment Period

12 months

First QC Date

January 21, 2026

Last Update Submit

February 5, 2026

Conditions

Keywords

Long COVIDStellate Ganglion BlockBupivacaine

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

EXPERIMENTAL

Participant receives a right-sided stellate ganglion block under ultrasound guidance, using bupivacaine, performed by an anesthesiologist.

Procedure: Stellate Ganglion Block (Bupivacaine)

Placebo Neck Injection

PLACEBO COMPARATOR

Participant receives a saline injection into the sternocleidomastoid muscle under the same conditions.

Procedure: placebo saline injection

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.

Stellate Ganglion Block with Bupivacaine

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).

Placebo Neck Injection

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

RECRUITING

MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

COVID-19Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesPost-Infectious DisordersChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Central Study Contacts

Marie-Claude Lehoux, Master's degree

CONTACT

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

Locations