SPG Block for Anxiety

Not yet 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a sphenopalatine ganglion (SPG) block can reduce anxiety at electronic dance music festivals. Participants will receive either a lidocaine-soaked cotton swab (SPG block) or a saline-soaked swab (placebo) in their nose for 10 minutes. The researchers seek to establish whether the lidocaine treatment is more effective than the placebo in easing anxiety. Individuals who frequently experience anxiety at festivals and have not taken other anti-anxiety medications during the event may be suitable candidates. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, allowing participants to contribute to early-stage findings.

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.

What prior data suggests that this SPG block is safe for reducing anxiety?

Research has shown that lidocaine, when used to numb an area, is usually well-tolerated. However, some people might experience side effects. Common side effects include dizziness, confusion, or headaches. These are not very serious but can be uncomfortable. More serious side effects, such as heart or nerve problems, are rare but can occur, especially if not used correctly.

In this trial, lidocaine is applied inside the nose with a cotton swab. This method differs from injections and might cause less irritation. The FDA has already approved lidocaine for other medical uses, indicating it is considered safe when used properly.

While specific research on using lidocaine in this exact manner is lacking, its overall safety record is reassuring. Prospective participants should discuss any concerns with the trial team before joining. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for anxiety?

Unlike standard treatments for anxiety, which often involve medications like SSRIs or benzodiazepines, the SPG block uses a localized approach. This method involves applying a 2% lidocaine solution to the sphenopalatine ganglion (SPG) through the nose. Researchers are excited because this technique targets a specific nerve cluster associated with anxiety, potentially providing rapid relief without the systemic side effects common with oral medications. Additionally, the direct delivery method could mean fewer interactions with other drugs, making it a promising option for individuals with complex medication regimens.

What evidence suggests that an SPG block might be an effective treatment for anxiety?

Research has shown that lidocaine, when applied to the skin, can reduce anxiety symptoms. Other studies have found lidocaine effective in managing pain, suggesting it might also have calming effects. In this trial, one group of participants will receive lidocaine applied inside the nose to target the sphenopalatine ganglion (SPG), believed to be involved in anxiety. Although lidocaine has primarily been used for pain relief, these findings suggest it might also help with anxiety. While specific data on anxiety is limited, the mechanism of lidocaine supports its potential calming effects. ^{6 7 8 9 10}

Who Is on the Research Team?

Anthony V Seto, MD

Principal Investigator

University of Calgary

Are You a Good Fit for This Trial?

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.

Exclusion Criteria

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

Inability to verbally report level of anxiety

Known allergy to lidocaine

Timeline for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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