Exparel for Craniofacial Pain

Recruiting at 1 trial location

Overseen By Peter Hwang, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Stanford University

Disqualifiers: Age <18 or >80, Pregnancy, Allergy to bupivacaine, others

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 3 weeks

15 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a treatment called Exparel to determine its effectiveness for craniofacial pain, including migraines and cluster headaches. Exparel is known to provide pain relief for up to 72 hours when used at surgical sites. The trial compares Exparel injections to saline (a saltwater solution) to evaluate which is more effective. Individuals who often find relief from lidocaine, a common pain reliever used before ENT procedures, might be suitable candidates. Those visiting the Stanford Pain & ENT clinic for craniofacial pain may qualify for this study. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to significant medical advancements.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

In a previous study, Exparel (a form of Bupivacaine) showed no immediate or delayed adverse reactions, suggesting it is generally well-tolerated. Another study found common side effects such as increased blood pressure, fever, joint pain, and muscle spasms when used to block nerve pain. However, these side effects were not serious for most individuals. Exparel is already approved for post-surgical pain relief, indicating its safety for this use. Overall, research indicates that Exparel is a relatively safe option, though mild side effects may occur. ^{1 2 3 4 5}

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

Exparel is unique because it utilizes bupivacaine in a liposome formulation, providing prolonged pain relief compared to traditional anesthetics. Unlike other treatments for craniofacial pain, which often require multiple doses or have a shorter duration of action, Exparel's extended-release mechanism allows for a single injection to manage pain over several days. This innovative delivery method reduces the need for ongoing medication, potentially minimizing side effects and improving patient comfort. Researchers are excited about Exparel because it could simplify pain management in craniofacial procedures, offering a more efficient and convenient option for patients and healthcare providers.

What evidence suggests that Exparel might be an effective treatment for craniofacial pain?

Research has shown that Exparel, which contains Bupivacaine, can relieve pain for up to 72 hours after a single dose at surgery sites. Studies have found that patients using Exparel report significantly lower pain levels after their procedures. Exparel is already used safely in surgeries like cleft lip and palate repairs to manage pain effectively. It works by gradually releasing the pain-relieving medicine, helping to control pain for several days. In this trial, participants will receive either an endoscopically guided injection of Exparel or a saline placebo to evaluate its effectiveness in treating pain in the face and head area. These findings suggest that Exparel could be a promising option for managing craniofacial pain. ^{1 2 6 7 8}

Who Is on the Research Team?

Peter Hwang, MD

Principal Investigator

Stanford University

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

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

Exclusion Criteria

You are allergic to bupivacaine.

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

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive an endoscopically guided injection of Exparel (Bupivacaine) or saline for the treatment of craniofacial pain

3 weeks

1 visit (in-person)

Follow-up

Participants are monitored for changes in pain score and associated symptoms

3 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Exparel (Bupivacaine Liposome)

Trial Overview 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.

How Is the Trial Designed?

Group I: Exparel Active Control 1 Intervention

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

Group II: Saline Placebo Group 1 Intervention

Patients receive an endoscopically guided injection of saline

Exparel (Bupivacaine Liposome) is already approved in United States, European Union for the following indications:

Approved in United States as Exparel for:

• Postoperative pain
• Pain relief

Approved in European Union as Exparel for:

• Postoperative pain
• Pain relief

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

Published Research Related to This Trial

Parotid duct injuries can lead to serious complications due to the complex anatomy of the buccal region, often requiring surgical intervention for proper management.

In a unique case, an epidural catheter was successfully used to treat a parotid duct injury, suggesting an alternative approach to traditional methods like microsurgical anastomosis or salivary flow diversion.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Parotid duct repair using an epidural catheter. Sujeeth, S., Dindawar, S.[2011]

In two case reports, botulinum toxin was successfully used to treat traumatic salivary gland fistulas, demonstrating its efficacy in promoting faster closure compared to spontaneous healing.

The use of botulinum toxin is highlighted as a minimally invasive and well-tolerated treatment option, suggesting it may be preferable to traditional surgical repair for managing salivary gland injuries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Botulinum toxin A as a treatment of traumatic salivary gland fistulas]. Breuer, T., Ferrazzini, A., Grossenbacher, R.[2018]

In a study involving 59 patients undergoing total knee arthroplasty, liposomal bupivacaine did not show a significant clinical advantage over standard bupivacaine in terms of postoperative recovery, as measured by the number of physical therapy sessions needed for discharge.

The use of liposomal bupivacaine was associated with higher medication charges, raising concerns about its cost-effectiveness compared to standard care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Liposomal Bupivacaine Versus Standard Periarticular Injection in Total Knee Arthroplasty With Regional Anesthesia: A Prospective Randomized Controlled Trial. Hyland, SJ., Deliberato, DG., Fada, RA., et al.[2019]

In a study of 352 patients undergoing shoulder surgery with an Exparel interscalene block, 16.5% experienced postoperative complications, with 6.0% leading to emergency department visits, highlighting the need for careful patient selection.

The American Society of Anesthesiologists (ASA) score was identified as a significant risk factor for both minor and major complications, suggesting that patients with higher ASA scores may be at greater risk when receiving this type of anesthesia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Risk factors for complications and return to the emergency department after interscalene block using liposomal bupivacaine for shoulder surgery. Malige, A., Yeazell, S., Ng-Pellegrino, A., et al.[2021]

Buccal fat pad (BFP) excision surgery is effective for reducing lower facial volume and improving facial contour, with significant changes observed in facial measurements 12 months post-surgery.

The study involved patients averaging 54 years old, and the surgery took about 60 minutes, demonstrating that BFP excision can lead to noticeable facial slimming and address sagging in middle-aged individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Aesthetic Values of the Buccal Fat Pad Excision in Middle-Aged Patients. Kubo, T.[2022]

The buccal fat pad (BFP) can effectively reconstruct various ventral skull base defects after expanded endonasal approaches (EEA), as demonstrated in a cadaveric study involving 10 BFPs from 5 specimens.

The study confirmed that the BFP has adequate vascular supply for use in endoscopic procedures, making it a viable option for flap reconstruction in select cases following EEA.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The endonasal endoscopic harvest and anatomy of the buccal fat pad flap for closure of skull base defects. Markey, J., Benet, A., El-Sayed, IH.[2015]

EXPAREL® (bupivacaine liposome injectable suspension) is an effective extended-release local anesthetic that can significantly improve postoperative pain management in orthopedic trauma surgery, as demonstrated in two case studies.

Both patients treated with EXPAREL® experienced good control of postsurgical pain, highlighting its safety and efficacy as part of a multimodal analgesia approach in reducing the risk of chronic pain after surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Local infiltration of liposome bupivacaine in orthopedic trauma patients: case-based reviews. Hutchinson, HL.[2022]

In a study involving 98 mice, liposomal bupivacaine (Exparel®) provided a longer duration of pain relief compared to standard bupivacaine, with motor block lasting up to 180 minutes and thermoalgesic block lasting up to 420 minutes.

The addition of dexamethasone, either perineurally or systemically, significantly reduced neural inflammation caused by bupivacaine, and perineural dexamethasone also helped reduce inflammation from Exparel®, suggesting a protective effect against nerve damage.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perineural dexamethasone attenuates liposomal bupivacaine-induced delayed neural inflammation in mice in vivo. Ferré, F., Krin, A., Sanchez, M., et al.[2020]

DepoFoam bupivacaine, an extended-release formulation of the local anesthetic bupivacaine, provides effective pain relief for 3-4 days after a single administration at the surgical site, reducing the need for opioid pain relief.

The safety profile of DepoFoam bupivacaine is comparable to traditional bupivacaine HCl, with adverse events being dose-related, indicating it is a safe option for managing postsurgical pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of DepoFoam(®) bupivacaine for the treatment of postsurgical pain. Bergese, SD., Onel, E., Portillo, J.[2014]

In a retrospective analysis of 575 subjects across 6 clinical trials, liposome bupivacaine showed a similar safety profile to both bupivacaine HCl and normal saline, with 76% of liposome bupivacaine recipients experiencing adverse events (AEs).

The most common AEs for liposome bupivacaine included nausea and hypesthesia, and serious AEs occurred in 8% of subjects, indicating that the side effects are likely related to the surgical procedure rather than the medication itself.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and Side Effect Profile of Liposome Bupivacaine (Exparel) in Peripheral Nerve Blocks. Ilfeld, BM., Viscusi, ER., Hadzic, A., et al.[2022]

Exparel™ (DepoFoam bupivacaine) provides a longer-lasting nerve blockade (240 minutes) compared to standard bupivacaine solutions, which lasted 120 minutes and 210 minutes, indicating its potential for improved pain management.

While Exparel™ showed slightly higher inflammation scores than standard bupivacaine solutions shortly after injection, it had similar myotoxicity levels and no neurotoxicity, suggesting it may be a safe option for local anesthesia, though monitoring for tissue reactions is recommended.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multivesicular liposomal bupivacaine at the sciatic nerve. McAlvin, JB., Padera, RF., Shankarappa, SA., et al.[2022]

Botulinum toxin type A injections successfully treated a chronic salivary fistula in a 58-year-old woman after two unsuccessful surgeries, providing relief for 11 months without any adverse effects.

The treatment also significantly reduced facial synkinesis for 4 months, demonstrating the efficacy of botulinum toxin A in addressing both salivary discharge and facial muscle coordination issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of postparotidectomy salivary fistula with botulinum toxin. Guntinas-Lichius, O., Sittel, C.[2017]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04930887

Study Details | NCT04930887 | Clinical Trial of ... The study aims to evaluate the effectiveness of endoscopically-guided injection of Exparel (Bupivacaine) for the treatment of craniofacial pain.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04930887?cond=%22Paroxysmal%20Hemicrania%22&viewType=Table&rank=1

Clinical Trial of Endoscopically Guided Injection of Exparel ... The study aims to evaluate the effectiveness of endoscopically-guided injection of Exparel (Bupivacaine) for the treatment of craniofacial pain.

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40966057/

Safety and Efficacy of Liposomal Bupivacaine (ExparelⓇ) ... Conclusions: Lipsomal bupivacaine appears to be a safe adjunct for postoperative pain management in cleft lip and palate surgery for pediatric ...

4. centerwatch.com centerwatch.com/clinical-trials/listings/NCT04930887/clinical-trial-of-endoscopically-guided-injection-of-exparel-bupivacaine-for-the-treatment-of-craniofacial-pain

Clinical Trial of Endoscopically Guided Injection of Exparel ... Exparel has a proven efficacy in providing pain relief for up to 72 hours with a single-dose administration at surgical sites.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11614469/

Examining Liposomal Bupivacaine's Use in Dentistry - PMC Data from the reprinted study found later in this issue suggest that patients who received Exparel had significantly decreased postoperative pain scores up to ...

6. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/nda/2024/22496Orig1s037.pdf

CENTER FOR DRUG EVALUATION AND RESEARCH EXPAREL administration as a nerve block were increased BP, pyrexia, arthralgia, insomnia, muscle spasms, asthenia, increased systolic BP, ...

7. investor.pacira.com investor.pacira.com/news-releases/news-release-details/new-retrospective-analysis-shows-exparel-associated

New Retrospective Analysis Shows EXPAREL Associated ... EXPAREL (bupivacaine liposome injectable suspension) is indicated for single-dose infiltration in adults to produce postsurgical local analgesia and as an ...

8. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/29762332/

Extended Release Liposomal Bupivacaine Injection ... The authors demonstrate the safe use of LB in pediatric patients with improved pain control following palatoplasty. Materials and methods: Retrospective patient ...