SPG Block for Anxiety

Recruiting at 3 trial locations

Overseen By Anthony Seto

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: University of Calgary

Must not be taking: Anti-anxiety medications

Disqualifiers: Lidocaine allergy, Nasal obstruction, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 3

Duration: 1 day

70 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this clinical trial is to learn about the effect of a sphenopalatine ganglion (SPG) block in anxious patients at electronic dance music festivals. The main question is: - Is an SPG block useful in reducing anxiety, in comparison to placebo? Participants will have lidocaine-soaked cotton tip applicator placed inside each nare for 10-minutes, or have a saline-soaked cotton tip applicator placed inside each nare for 10-minutes. Researchers compare the lidocaine-soaked intervention (SPG block) with the saline-soaked intervention (placebo) to see if it reduces anxiety in patients presenting at electronic dance music festivals with anxiety.

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

The trial protocol does not specify whether you need to stop taking your current medications. However, if you have been given oral or intravenous anti-anxiety medication by festival medical staff, you cannot participate.

Is lidocaine safe for use in humans?

Lidocaine is generally safe for use in humans, but some people may experience allergic reactions, such as skin rashes or delayed hypersensitivity (allergic reaction that occurs some time after exposure). These reactions are rare, and testing can help identify individuals who might be allergic. ^{1 2 3 4 5}

How is the SPG block with Lidocaine 2% different from other anxiety treatments?

The SPG block with Lidocaine 2% is unique because it involves a local anesthetic delivered through the nose to target a specific nerve cluster (sphenopalatine ganglion) that may influence anxiety, unlike typical anxiety treatments that often involve oral medications affecting the whole body. ^{6 7 8 9 10}

Research Team

Anthony V Seto, MD

Principal Investigator

University of Calgary

Eligibility Criteria

This trial is for adults over 18 who are attending an electronic dance music festival and feel anxious, rating their anxiety at least a 1 out of 10. They shouldn't have taken any anti-anxiety meds since arriving at the festival or have issues that prevent cotton applicators from being placed in their nose, like a nosebleed or allergy to lidocaine.

Inclusion Criteria

I experience some level of anxiety.

I am 18 years old or older.

Exclusion Criteria

I haven't taken any anti-anxiety medication given by festival medical staff.

Known allergy to lidocaine

I cannot have anything inserted into my nose due to blockage or other issues.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1 day

1 visit (in-person)

Treatment

Participants receive either an SPG block with 2% lidocaine or a placebo with saline for 10 minutes

1 day

1 visit (in-person)

Follow-up

Participants are monitored for anxiety levels and use of rescue medication 10 minutes post-intervention

10 minutes

1 visit (in-person)

Treatment Details

Interventions

• Lidocaine 2% Injectable Solution
• Placebo

Trial Overview Researchers are testing if an SPG block with lidocaine can reduce anxiety compared to a placebo. Participants will get either lidocaine-soaked or saline-soaked cotton applicators in their nostrils for ten minutes to see which one better eases anxiety during the event.

Participant Groups

Group I: 2% Lidocaine Experimental Treatment 1 Intervention

1 cotton tip applicator, pre-soaked in 2% lidocaine, inserted into each nare, and left for 10 minutes

Group II: Placebo Placebo Group 1 Intervention

1 cotton tip applicator, pre-soaked in saline, inserted into each nare, and left for 10 minutes

Who Is Running the Clinical Trial?

University of Calgary

Lead Sponsor

Trials

827

Recruited

902,000+

Findings from Research

A retrospective study of 386 patients receiving intranasal sphenopalatine ganglion (SPG) blocks found that both lidocaine and bupivacaine were effective in reducing headache pain, with 90.2% of treatments resulting in decreased pain levels.

There was no statistically significant difference in efficacy between lidocaine and bupivacaine, suggesting that both anesthetics are viable options for SPG blocks, although the choice may depend on the specific delivery device used.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lidocaine Versus Bupivacaine in the Treatment of Headache with Intranasal Sphenopalatine Nerve Block. Kirkpatrick, DL., Townsend, T., Walter, C., et al.[2020]

The sphenopalatine ganglion (SPG) block is a quick and safe method for managing both acute and chronic pain, making it suitable for use in pain management offices.

This technique can be effectively taught to patients for at-home use, and it has shown efficacy in treating various pain conditions, including TMJ pain, cluster headaches, and trigeminal neuralgia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sphenopalatine ganglion block: a safe and easy method for the management of orofacial pain. Peterson, JN., Schames, J., Schames, M., et al.[2019]

References

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

Safety and Efficacy of Needle-free Powder Lidocaine Delivery System in Adult Patients Undergoing Venipuncture or Peripheral Venous Cannulation: A Randomized, Double-Blind, Placebo-controlled Trial. [2016]

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

Effects of lidocaine with epinephrine on fear related arousal among dental phobics. [2018]

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

Buffered versus plain lidocaine for digital nerve blocks. [2019]

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

Buffered lidocaine and bupivacaine mixture - the ideal local anesthetic solution? [2022]

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

Contact allergy to lidocaine: a report of sixteen cases. [2019]

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

A double-blind, placebo-controlled study of repetitive transnasal sphenopalatine ganglion blockade with tx360(®) as acute treatment for chronic migraine. [2022]

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

Lidocaine Versus Bupivacaine in the Treatment of Headache with Intranasal Sphenopalatine Nerve Block. [2020]

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

Bilateral Sphenopalatine Ganglion Block With Liposomal Bupivacaine Followed by Severe Hypertension: A Case Report. [2023]

9. England pubmed.ncbi.nlm.nih.gov

Sphenopalatine ganglion block: a safe and easy method for the management of orofacial pain. [2019]

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

Effect of a new local anesthetic buffering device on pain reduction during nerve block injections. [2022]