Stellate Ganglion Block for COVID-19-Induced Olfactory Dysfunction

Overseen By Nyssa F Farrell, MD

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Washington University School of Medicine

Must not be taking: Blood thinners, Antiplatelet agents

Disqualifiers: Chronic rhinosinusitis, Neurodegenerative disorders, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

Duration: 5-10 days

20 Participants Needed

Trial Summary

Do I need to stop my current medications for the trial?

The trial requires that you stop taking blood thinners or antiplatelet agents. Other medications are not specifically mentioned, so it's best to discuss with the trial team.

What data supports the effectiveness of the treatment Stellate Ganglion Block (SGB)?

Research shows that Stellate Ganglion Block (SGB) is effective in managing pain in conditions like Complex Regional Pain Syndrome (CRPS) and facial pain. It has also been explored for non-pain conditions, although the evidence is still being synthesized. ^{1 2 3 4 5}

Is Stellate Ganglion Block (SGB) generally safe for humans?

Stellate Ganglion Block (SGB) is generally considered a safe procedure, but in rare cases, it can lead to serious complications like retropharyngeal hematomas (a type of throat bleeding) and toxicity from the anesthetics used. These complications require specific management and preventive measures. ^{1 6 7 8 9}

How is Stellate Ganglion Block (SGB) treatment different from other treatments?

Stellate Ganglion Block (SGB) is unique because it blocks sympathetic nerve signals, which can help control conditions like refractory ventricular arrhythmias that don't respond to other treatments. Unlike many treatments that focus on pain relief, SGB is also being explored for various non-pain conditions, making it a versatile option. ^{1 6 9 10 11}

What is the purpose of this trial?

This trial is testing a treatment called stellate ganglion block, which involves numbing certain nerves in the neck. It aims to help people who have lost their sense of smell and have other long-term symptoms after COVID-19. The treatment works by calming overactive nerve signals to improve these persistent issues.

Eligibility Criteria

Inclusion Criteria

Adults age 18 to 70

Ability to read, write, and understand English

You have been diagnosed with COVID at least 12 months prior to study enrollment with self-reported olfactory dysfunction.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive sequential stellate ganglion blocks to treat COVID-19-induced olfactory dysfunction and other long COVID symptoms

5-10 days

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 month

2 visits (in-person)

Treatment Details

Interventions

• Stellate Ganglion Block

Participant Groups

Group I: Stellate Ganglion Block Experimental Treatment 1 Intervention

The ultrasound guided stellate ganglion blocks will be performed by a pain management specialist with extensive experience performing these blocks. The first SGB at the initial visit will be performed on the right side, and the second SGB will be on the left side 5-10 days after the first SGB, given that the patient tolerated the first SGB.

Stellate Ganglion Block is already approved in United States for the following indications:

Approved in United States as Stellate Ganglion Block for:

• Chronic pain management
• Posttraumatic stress disorder (PTSD) symptoms reduction

Who Is Running the Clinical Trial?

Washington University School of Medicine

Lead Sponsor

Trials

2,027

Recruited

2,353,000+

Findings from Research

Stellate ganglion block (SGB) has been found effective for non-pain indications such as reducing cardiovascular sympathetic stimulation and improving blood flow in limbs, with moderate to low certainty based on 24 studies including 19 randomized controlled trials.

SGB is also recommended for alleviating menopausal symptoms like hot flashes, particularly in cases where conventional treatments have failed, although evidence for other non-pain uses remains insufficient.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stellate ganglion block for non-pain indications: a scoping review. Feigin, G., Velasco Figueroa, S., Englesakis, MF., et al.[2023]

Stellate ganglion block (SGB) significantly reduced facial pain in patients, with a mean visual analog scale (VAS) score dropping from 8.89 to 0.2 after treatment, and this relief was maintained for at least 12 months.

In contrast, patients who received oral medications (tramadol and gabapentin) showed only a moderate reduction in pain, indicating that early administration of SGB is crucial for optimal efficacy in treating facial pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Facial pain: a possible therapy with stellate ganglion block. Salvaggio, I., Adducci, E., Dell'Aquila, L., et al.[2022]

Stellate Ganglion Block (SGB) is an effective treatment for upper extremity pain due to Chronic Regional Pain Syndrome (CRPS), and this study compared the effectiveness of ultrasound-guided SGB versus fluoroscopy-guided SGB in 14 patients.

The results indicated that ultrasound guidance for SGB is safer and leads to better improvements in patient disability indexes compared to fluoroscopic guidance, with significant reductions in pain intensity observed over six months.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of Stellate Ganglion Block Under Fuoroscopy or Ultrasound Guidance in Upper Extremity CRPS. Imani, F., Hemati, K., Rahimzadeh, P., et al.[2022]

In a study of 60 patients with complex regional pain syndrome type II undergoing surgery, stellate ganglion block (SGB) significantly reduced the need for intraoperative propofol and fentanyl, indicating its efficacy in managing acute pain during surgery.

Patients receiving SGB also experienced a longer time before needing their first analgesic and required less fentanyl in the 24 hours post-surgery, suggesting that SGB can effectively decrease opioid consumption after surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Stellate Ganglion Block on Intraoperative Propofol and Fentanyl Consumption in Patients with Complex Regional Pain Syndrome Undergoing Surgical Repair of Brachial Plexus Injury: A Randomized, Double-blind, Placebo-controlled Trial. Rajagopalan, V., Chouhan, RS., Pandia, MP., et al.[2022]

Ultrasonographic guidance for stellate ganglion block (SGB) resulted in a complete block in all patients, compared to 11 out of 12 with the blind technique, indicating improved efficacy.

The use of ultrasound significantly reduced complications, as no hematomas occurred with the imaging technique, while three patients experienced hematomas with the blind method, highlighting enhanced safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ultrasound imaging for stellate ganglion block: direct visualization of puncture site and local anesthetic spread. A pilot study. Kapral, S., Krafft, P., Gosch, M., et al.[2022]

A 59-year-old male with refractory ventricular tachycardia (VT) experienced immediate cessation of VT and maintained sinus rhythm after receiving a left stellate ganglion block (LSGB) using a lidocaine and bupivacaine solution.

The LSGB procedure appears to be a safe and effective method for controlling refractory VT, suggesting its potential as a rescue therapy before more invasive treatments like catheter ablation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Left stellate ganglion block, a rescue treatment for ventricular arrhythmia refractory to radiofrequency catheter ablation: A care-compliant case report. Yang, SC., Wu, CC., Hsieh, YJ.[2022]

Stellate ganglion block (SGB) is generally a safe procedure, but it can lead to serious complications like retropharyngeal hematomas (RPH) and local anesthetic toxicity in rare cases.

Management of these complications includes emergency airway management for RPH and the use of higher doses of intravenous lipid emulsions to improve outcomes in cases of local anesthetic toxicity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Complication and Anesthetics-induced Toxicity of Stellate Ganglion Block]. Okuda, Y., Suzuki, H., Saima, S.[2018]

This clinical trial aims to evaluate whether a single-shot stellate ganglion block (SGB) can reduce the incidence of myocardial injury after non-cardiac surgery (MINS) in high-risk patients undergoing laparoscopic colorectal cancer surgery, involving 950 participants aged over 45 with at least one risk factor for MINS.

The study will assess multiple outcomes, including pain levels, recovery quality, and serious cardiovascular complications, providing a comprehensive evaluation of SGB's efficacy and safety in improving postoperative recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Postoperative stellate ganglion block to reduce myocardial injury after laparoscopic radical resection for colorectal cancer: protocol for a randomised trial. Hu, Z., Li, W., Zhao, G., et al.[2023]

References

1. England pubmed.ncbi.nlm.nih.gov

Stellate ganglion block for non-pain indications: a scoping review. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Facial pain: a possible therapy with stellate ganglion block. [2022]

3. India pubmed.ncbi.nlm.nih.gov

Effectiveness of Stellate Ganglion Block Under Fuoroscopy or Ultrasound Guidance in Upper Extremity CRPS. [2022]

4. India pubmed.ncbi.nlm.nih.gov

Effect of Stellate Ganglion Block on Intraoperative Propofol and Fentanyl Consumption in Patients with Complex Regional Pain Syndrome Undergoing Surgical Repair of Brachial Plexus Injury: A Randomized, Double-blind, Placebo-controlled Trial. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Ultrasound imaging for stellate ganglion block: direct visualization of puncture site and local anesthetic spread. A pilot study. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Left stellate ganglion block, a rescue treatment for ventricular arrhythmia refractory to radiofrequency catheter ablation: A care-compliant case report. [2022]

7. Japan pubmed.ncbi.nlm.nih.gov

[Complication and Anesthetics-induced Toxicity of Stellate Ganglion Block]. [2018]

8. England pubmed.ncbi.nlm.nih.gov

Postoperative stellate ganglion block to reduce myocardial injury after laparoscopic radical resection for colorectal cancer: protocol for a randomised trial. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

A lateral percutaneous technique for stellate ganglion blockade in rats. [2017]

10. England pubmed.ncbi.nlm.nih.gov

Effectiveness of cervical sympathetic ganglia block on regeneration of the trigeminal nerve following transection in rats. [2019]

11. England pubmed.ncbi.nlm.nih.gov

Effects of Stellate Ganglion Block on Analgesia Produced by Cervical Paravertebral Block as Established by Quantitative Sensory Testing: A Randomized Controlled Trial. [2019]