Exparel (Bupivacaine Liposome) for Facial Pain
This study is evaluating whether a local injection of a painkiller can help relieve pain in people with craniofacial pain.
See full descriptionAbout the trial for Facial Pain
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.
About The Treatment
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.
Approximate Timelines
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.
Who is running the study
Principal InvestigatorPatient Q & A Section
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.