What side effects are associated with this type of intervention?

Common treatments for craniofacial pain that provide prolonged pain relief by blocking nerve signal transmission include local anesthetics like Bupivacaine. Known side effects of these treatments can include headache, scalp pain, feeling cold, neck pain, and heaviness of the head. Additionally, specific to Bupivacaine, there may be risks of local reactions at the injection site, systemic toxicity if absorbed in large amounts, and potential allergic reactions.

What prior FDA approvals exist?

Exparel (Bupivacaine) is an FDA-approved local anesthetic that provides prolonged pain relief by blocking nerve signal transmission at surgical sites. Similar treatments for craniofacial pain include other local anesthetics like lidocaine, which is commonly used for temporary pain relief in ENT procedures. Additionally, sphenopalatine ganglion blocks using bupivacaine have shown effectiveness in treating trigeminal neuralgia, a type of craniofacial pain. These treatments work by numbing the targeted nerves, thereby reducing pain for an extended period.

What other types of research exist?

Promising alternatives to Exparel (Bupivacaine) for craniofacial pain include: 1) Mandibular nerve block using an indwelling catheter with lidocaine or bupivacaine, which has been used for intractable cancer pain. 2) Ultrasound-guided trigeminal nerve block, which provides preemptive analgesia and reduces opioid consumption in faciomaxillary surgeries. These methods offer targeted, prolonged pain relief by blocking nerve signal transmission.

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Local Anesthetic

Exparel for Craniofacial Pain

Phase 2

Recruiting

Led By Peter Hwang, MD

Research Sponsored by Stanford University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients with a chief complaint of craniofacial pain (migraine, cluster headache, trigeminal autonomic cephalgia, sphenopalatine ganglioneuraligia, paroxysmal hemicrania) who has Stanford Pain & ENT clinic visit

Be older than 18 years old

Must not have

Decisionally impaired (unable to obtain informed consent)

Unable or unwilling to participate plans to participate in another clinical study at any time during this study

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to day 21

Summary

This trial tests if injecting Exparel into the nasal area can help people with craniofacial pain. Exparel is a long-lasting pain reliever, and the study focuses on those who usually get pain relief from Lidocaine during ENT procedures.

Who is the study for?

This trial is for adults aged 18-80 with craniofacial pain conditions like migraines and cluster headaches, who visit Stanford Pain & ENT clinic. It's not for pregnant women, those with bupivacaine allergies, or anyone unable to consent or afford treatment.

What is being tested?

The study tests Exparel (Bupivacaine) injections against saline (placebo) in managing craniofacial pain. It's a double-blind study where neither doctors nor patients know who gets the real drug versus placebo, ensuring unbiased results.

What are the potential side effects?

Exparel may cause side effects such as numbness at the injection site, nausea, headache, vomiting, fever or back pain. Serious allergic reactions are rare but possible in those sensitive to bupivacaine.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have severe head or facial pain and have seen a specialist at the Stanford Pain & ENT clinic.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am unable to understand and give consent for medical procedures.

Select...

I am not planning to join another clinical study while in this one.

Select...

I am younger than 18 or older than 80.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to day 21

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to day 21

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to day 21 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change of Pain Score

Secondary study objectives

Change of Associated Symptoms

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: ExparelActive Control1 Intervention

Patients receive an endoscopically guided injection of Exparel (Bupivacaine).

Group II: SalinePlacebo Group1 Intervention

Patients receive an endoscopically guided injection of saline

0 / 4Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for craniofacial pain, such as Exparel (Bupivacaine), work by blocking nerve signal transmission to provide prolonged pain relief. These treatments typically involve local anesthetics or nerve blocks that inhibit sodium channels in nerve cells, preventing the initiation and propagation of pain signals. This mechanism is important for craniofacial pain patients as it can significantly improve their quality of life by effectively managing pain, reducing the need for systemic medications, and minimizing associated side effects.

Ultrasound-Guided Pulsed Radiofrequency Application via the Pterygopalatine Fossa: A Practical Approach to Treat Refractory Trigeminal Neuralgia.