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Local Anesthetic

Exparel for Craniofacial Pain

Phase 2
Recruiting
Led By Matt Lechner, MD, PhD
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to day 21
Awards & highlights

Study Summary

This trial will test whether a single dose of Exparel (a long-acting pain reliever) can provide pain relief for up to 72 hours after surgery, compared to a placebo. The study will be conducted in a prospective, randomized, double-blinded, placebo- controlled, and cross-over fashion.

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.Check my eligibility
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.See study design
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.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change of Pain Score
Secondary outcome measures
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

Find a Location

Who is running the clinical trial?

Stanford UniversityLead Sponsor
2,378 Previous Clinical Trials
17,333,344 Total Patients Enrolled
Matt Lechner, MD, PhDPrincipal InvestigatorStanford University
Peter Hwang, MDPrincipal InvestigatorStanford University

Media Library

Exparel (Bupivacaine Liposome) (Local Anesthetic) Clinical Trial Eligibility Overview. Trial Name: NCT04930887 — Phase 2
Craniofacial Pain Research Study Groups: Exparel, Saline
Craniofacial Pain Clinical Trial 2023: Exparel (Bupivacaine Liposome) Highlights & Side Effects. Trial Name: NCT04930887 — Phase 2
Exparel (Bupivacaine Liposome) (Local Anesthetic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04930887 — Phase 2
Craniofacial Pain Patient Testimony for trial: Trial Name: NCT04930887 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the odds of developing complications from Exparel (Bupivacaine Liposome)?

"While Phase 2 trials are not as well understood as Phase 3 trials, the available data suggests that Exparel (Bupivacaine Liposome) is safe."

Answered by AI

Does Exparel (Bupivacaine Liposome) have a history of being effective?

"There are 124 different clinical trials currently underway to test Exparel (Bupivacaine Liposome), 20 of which are in Phase 3. Exparel (Bupivacaine Liposome) is being studied at 170 different research centres, with several located in Philadelphia, Pennsylvania."

Answered by AI

Is this study seeking applicants who are under the age of 85?

"Eligible participants for this trial must be between 18-80 years old."

Answered by AI

Are people being recruited for this experiment as of now?

"The clinical trial in question was last updated on October 24th, 2022, over half a year ago. Since then, it appears that the study has stopped looking for new patients to enroll. There are, however, 529 other trials that are still recruiting patients."

Answered by AI

For what purpose is Exparel (Bupivacaine Liposome) most often employed?

"Exparel (Bupivacaine Liposome) provides an anesthetic solution for patients suffering from permphigus, acute nonspecific tenosynovitis, and general anesthesia."

Answered by AI

How many individuals are currently testing this medication?

"This specific trial is no longer recruiting patients. The first posting was on December 1st, 2022 and the most recent update was on October 24th, 2022. However, there are still many other ongoing trials searching for participants that suffer from migraines (405) or are testing Exparel (Bupivacaine Liposome) (124)."

Answered by AI

How can I sign-up to participate in this research project?

"This study is searching for 10 individuals who suffer from migraine and are between 18-80 years old. The most crucial qualifier for potential participants is that they must have Stanford Pain & ENT clinic visit related to craniofacial pain (migraine, cluster headache, trigeminal autonomic cephalgia, sphenopalatine ganglioneuraligia, paroxysmal hemicrania)."

Answered by AI

Who else is applying?

What state do they live in?
Texas
What site did they apply to?
Stanford University
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
3+

Why did patients apply to this trial?

I've had tn on the left side of my face for 8 years. It is now on my right side, too. I've tried various meds, nerve blocks, burning the nerve, etc. with little success.
PatientReceived 2+ prior treatments
~7 spots leftby Jun 2025