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| ID | Type | Description | Link |
|---|---|---|---|
| 1028 | Registry Identifier | Base de données des projets de recherche du CIUSSS-MCQ |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stellate Ganglion Block with Bupivacaine | Experimental | Participant receives a right-sided stellate ganglion block under ultrasound guidance, using bupivacaine, performed by an anesthesiologist. |
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| Placebo Neck Injection | Placebo Comparator | Participant receives a saline injection into the sternocleidomastoid muscle under the same conditions. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stellate Ganglion Block (Bupivacaine) | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Health-Related Quality of Life (SF-36) | The SF-36 is a validated 36-item questionnaire assessing eight domains of health-related quality of life, including physical functioning, limitations due to physical or emotional problems, pain, general health, vitality, social functioning, and mental health. Higher scores reflect better perceived health and functioning. | 4 weeks after the intervention |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marie-Claude Lehoux, Master's degree | Contact | 819 697-3333 | 60753 | marie-claude.lehoux@ssss.gouv.qc.ca |
| Éva Mathieu, Ph.D | Contact | 819 697-3333 | 60756 | eva.mathieu@ssss.gouv.qc.ca |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre hospitalier affilié universitaire régional | Recruiting | Trois-Rivières | Quebec | G8Z 3R9 | Canada |
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| ID | Term |
|---|---|
| D000094024 | Post-Acute COVID-19 Syndrome |
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
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| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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The statistician performing the data analysis will also be masked to group assignment.
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| placebo saline injection | 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). |
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| Dyspnea Severity (mMRC Scale) | The modified Medical Research Council (mMRC) Dyspnea Scale is a 0-4 grading system that assesses the degree to which breathlessness limits daily activities. Higher grades indicate greater functional limitation due to dyspnea. It is the only validated French-language scale measuring dyspnea in daily activities. | 4 weeks after the intervention |
| Lower-Limb Muscle Endurance (1-Minute Sit-to-Stand Test) | The 1-Minute Sit-to-Stand Test (1STST) measures lower-limb muscular endurance by counting the number of sit-to-stand repetitions a participant completes in one minute from a standard chair without armrests. It is reliable, sensitive, and well-tolerated in populations with impaired physical capacity. Higher counts indicate better endurance. | 4 weeks after the intervention |
| Orthostatic Intolerance (NASA Lean Test) | The NASA Lean Test assesses orthostatic intolerance by measuring heart rate and blood pressure changes during 10 minutes of standing with the back supported against a wall. Results help identify symptoms such as dizziness, palpitations, or light-headedness related to positional changes. If a participant cannot complete 10 minutes, the test is still considered valid. | 4 weeks after the intervention |
| D007239 |
| Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D000094025 | Post-Infectious Disorders |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000588 |
| Amines |