CLINICAL TRIAL

Exparel (Bupivacaine Liposome) for Facial Pain

Waitlist Available · 18+ · All Sexes · Stanford, CA

This study is evaluating whether a local injection of a painkiller can help relieve pain in people with craniofacial pain.

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About the trial for Facial Pain

Eligible Conditions
Headache · Cluster Headache · Trigeminal Autonomic Cephalalgias · Migraine · Trigeminal Autonomic Cephalgia · Neuralgia · Facial Pain · Craniofacial Pain · Paroxysmal Hemicrania · Sphenopalatine Ganglion Neuralgia

Treatment Groups

This trial involves 2 different treatments. Exparel (Bupivacaine Liposome) is the primary treatment being studied. Participants will be divided into 2 treatment groups. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

Experimental Group 1
Saline
DRUG
+
Exparel (Bupivacaine Liposome)
DRUG
Experimental Group 2
Saline
DRUG
+
Exparel (Bupivacaine Liposome)
DRUG

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Saline
2017
Completed Phase 4
~970

Eligibility

This trial is for patients born any sex aged 18 and older. There is one eligibility criterion to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
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
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Baseline to day 21
Screening: ~3 weeks
Treatment: Varies
Reporting: Baseline to day 21
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Baseline to day 21.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Exparel (Bupivacaine Liposome) will improve 1 primary outcome and 1 secondary outcome in patients with Facial Pain. Measurement will happen over the course of Baseline to day 21.

Change of Associated Symptoms
BASELINE TO DAY 21
Changes of associated symptoms, including nausea, photophobia, use of rescue medication, relapse of headache, and/or change in headache disability scores
BASELINE TO DAY 21
Change of Pain Score
BASELINE TO DAY 21
Scores range from 0-10 (0=no pain, 10=worst pain)
BASELINE TO DAY 21

Who is running the study

Principal Investigator
P. H.
Prof. Peter Hwang, PROFESSOR OF OTOLARYNGOLOGY - HEAD & NECK SURGERY (OHNS) AND, BY COURTESY, OF NEUROSURGERY AT THE STANFORD UNIVERSITY MEDICAL CENTER
Stanford University

Patient Q & A Section

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

How many people get facial pain a year in the United States?

Around 33.3 million adults have self-reported facial pain a year, representing 18.5% of U.S. adults. The majority of cases occurred in the head and neck regions, with the jaw or sinus accounting for 40% of incidents.

Anonymous Patient Answer

What causes facial pain?

Focal facial pain in the absence of obvious neurologic symptomatology most commonly results from dental causes. Chronic temporomandibular disorders (TMJ, disk-related), and odontogenic (tooth-associated) causes can also cause chronic, acute and localized pain. FTMN (facial nerve) or other focal cranial nerve disorders, or chronic cranial neuropathies (trauma) may cause facial pain. Neurologic disorders such as Multiple sclerosis, demyelination, inflammatory demyelination and myelitis, neoplastic infiltration and sarcoidosis may similarly produce pain.

Anonymous Patient Answer

What are common treatments for facial pain?

There is no absolute cure for facial pain. Tension-type headache is the most common form of pain. Treatment for this type of headache commonly includes pain-modifying medications, and in some cases surgical treatment. Common forms of cancer associated with facial pain include lymphoma and other cancers of the head and neck. Other forms of pain associated with cancer include pain caused by bone metastasis and postoperative pain. Cancer-related pain management is a multimodal treatment approach that typically involves medication, and in some cases surgery or radiation therapy.

Anonymous Patient Answer

What is facial pain?

Facial pain is common. The cause of facial pain is generally thought to be from the facial nerve, which provides information to the brain about the quality of what we are looking at, so is affected when the nerve is damaged. It may be caused by a local problem or by a systemic problem such as a problem with the brainstem or it may occur for no obvious reason. The diagnosis of facial pain is usually straightforward; however, many medical specialities may feel that there are multiple possibilities for what it could be. The condition may be diagnosed when the person has a history of being misinformed about what facial pain is, such as a misunderstanding of the characteristics of migraines or other facial problems.

Anonymous Patient Answer

Can facial pain be cured?

As long as the condition is not serious, patients can return to normal everyday activities after treatment. In addition, patients with [chronic pain](https://www.withpower.com/clinical-trials/chronic-pain) should receive pain management. Therefore, treatment of facial pain should be tailored for individual patients.

Anonymous Patient Answer

What are the signs of facial pain?

The most common symptoms of facial pain are facial swelling, an abnormally soft tooth or a feeling that a tooth is "yankying". Less common signs are pain which radiates on movement such as a tooth that is tapping on the bone or chewing (masticatory muscles). More common is numbness or tingling over a tooth, although this can be normal. The most common cause for facial pain is infection, either dental or sinus. Other causes include tumours and rheumatoid arthritis. More rare causes are temporal arteritis, an autoimmune disease, and cervical spine compression such as that from a kyphosis.

Anonymous Patient Answer

Have there been other clinical trials involving exparel (bupivacaine liposome)?

[If you have facial pain from dental extraction and are taking high doses of narcotics (e.g., codeine) before surgery and afterward, you can reduce your pain by taking [exparel (bupivacaine)/liposome](https://www.withpower.

Anonymous Patient Answer

Has exparel (bupivacaine liposome) proven to be more effective than a placebo?

There was no significant difference in the percentage of patients who required a second injection of bupivacaine liposome or who benefited from a single injection of bupivacaine liposome. A substantial number of patients still required oral analgesics after surgery.

Anonymous Patient Answer

How serious can facial pain be?

Despite the perceived seriousness of facial pain, patients did not have any clear knowledge regarding the seriousness of their symptoms and were unaware of potential complications, which may lead to diagnostic delay. It appears that there is a need for more education of health professionals, especially about the seriousness of facial pain.

Anonymous Patient Answer

What is the latest research for facial pain?

Despite advances in modern research on the effects of facial pain, no one treatment has been found to be effective for all patients, and treatment should be tailored to each patient individually. Future studies should continue to explore new techniques in order to treat facial pain.

Anonymous Patient Answer

What are the latest developments in exparel (bupivacaine liposome) for therapeutic use?

Bupivacaine is a safe, effective local anesthetic that has been used for over 60 years in the treatment of chronic superficial pain, and its use and effectiveness for therapeutic and procedural purposes continue to evolve. The liposomal formulation (Lipo-Bup) prolongs the duration and decreases the side effects of this local anesthetic with a duration up to three times that of the solution alone or as reference. Clinical trials in both the US and Europe are currently in progress to evaluate the pharmacokinetics and safety of Lipo-Bup. It is also being evaluated for the treatment of procedural pain.

Anonymous Patient Answer

How does exparel (bupivacaine liposome) work?

This trial suggests that the benefits of using bupivacaine liposome (which contains an ionic form of bupivacaine, unlike bupivacaine-lytic-sensitive bupivacaine, it will not stimulate the release of serotonin via monoaminergic cleavage) are minimal with long-term treatment.

Anonymous Patient Answer
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