Exparel for Craniofacial Pain
Recruiting in Palo Alto (17 mi)
+1 other location
Overseen ByPeter Hwang, MD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: Stanford University
Disqualifiers: Age <18 or >80, Pregnancy, Allergy to bupivacaine, others
Prior Safety Data
Approved in 2 jurisdictions
Trial Summary
What is the purpose of this trial?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.
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.
What data supports the effectiveness of the drug Exparel (Bupivacaine Liposome) for craniofacial pain?
Exparel, a long-acting form of the local anesthetic bupivacaine, has been shown to effectively reduce postoperative pain and the need for opioid painkillers in various surgical procedures, such as orthopedic surgeries. This suggests it may also help manage craniofacial pain by providing extended pain relief.
12345Is Exparel (Bupivacaine Liposome) generally safe for use in humans?
Exparel (Bupivacaine Liposome) has a safety profile similar to regular bupivacaine, with some inflammation and muscle damage observed in animal studies, but no nerve damage was detected. In humans, adverse effects are dose-related, and it has been used safely in various surgical procedures, though monitoring for local tissue injury is important.
12367How is the drug Exparel different from other treatments for craniofacial pain?
Exparel is unique because it uses a liposome (tiny fat-like particles) to slowly release bupivacaine, a local anesthetic, over time, providing longer-lasting pain relief compared to traditional bupivacaine injections.
89101112Eligibility Criteria
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.
+3 more
Trial Timeline
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
Participant Groups
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.
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
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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Stanford UniversityStanford, CA
Peter H HwangStanford, CA
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Who Is Running the Clinical Trial?
Stanford UniversityLead Sponsor
References
Safety and Side Effect Profile of Liposome Bupivacaine (Exparel) in Peripheral Nerve Blocks. [2022]Liposome bupivacaine (Exparel) is a multivesicular liposomal formulation of bupivacaine currently approved in the United States for single-dose administration into the surgical site to provide postsurgical analgesia. This retrospective analysis examined safety data from clinical trials involving the off-label use of this formulation in peripheral nerve blocks.
Perineural dexamethasone attenuates liposomal bupivacaine-induced delayed neural inflammation in mice in vivo. [2020]Liposomal bupivacaine (Exparel®) is a sustained-release formulation of bupivacaine for use in surgical infiltration anaesthesia. We analysed the histological nerve toxicity and clinical effectiveness of perineural Exparel® alone or with added dexamethasone in a mouse model.
Evaluation of DepoFoam(®) bupivacaine for the treatment of postsurgical pain. [2014]SUMMARY An extended-release, multivesicular liposome-encapsulated form of the local anesthetic bupivacaine, DepoFoam(®) bupivacaine (proposed proprietary name EXPAREL™), is in development for use as part of a multimodal regimen for the treatment of postsurgical pain. Placebo- and active-controlled clinical trials in patients who have undergone either orthopedic or soft-tissue procedures indicate that a single local administration into the surgical site results in analgesic activity for up to 3-4 days and decreases the use of opioid rescue medication. The safety profile of DepoFoam bupivacaine appears to be similar to that of bupivacaine HCl, and adverse events are dose-related.
Local infiltration of liposome bupivacaine in orthopedic trauma patients: case-based reviews. [2022]Orthopedic trauma surgery is often associated with considerable postoperative pain, which can result in a cascade of direct and indirect clinical consequences. Patients undergoing orthopedic trauma surgery are at risk for the development of chronic postsurgical pain, which may persist for 2 years or longer. Effective approaches to reducing postoperative pain in orthopedic trauma surgery patients include the use of minimally invasive procedures and multimodal analgesia. Infiltration of the surgical site with EXPAREL® (bupivacaine liposome injectable suspension), an extended-release local anesthetic, represents an advance in the multimodal management of postoperative pain. As part of a multimodal regimen, EXPAREL® has been shown to provide effective, safe, and efficient analgesia across a range of surgical procedures. Two cases that illustrate the use of EXPAREL® in orthopedic trauma are described. The first case involves repair of a subtrochanteric nonunion in a 63-year-old woman with a history of bisphosphonate use and prior treatment with a cephalomedullary nail. The second case involves a young woman undergoing outpatient surgery for repair of a fractured clavicle. Both patients experienced good control of postsurgical pain, supporting the clinical utility of EXPAREL® in orthopedic trauma surgery.
Liposomal Bupivacaine Versus Standard Periarticular Injection in Total Knee Arthroplasty With Regional Anesthesia: A Prospective Randomized Controlled Trial. [2019]Liposomal bupivacaine (Exparel) is a long-acting local anesthetic preparation with demonstrated efficacy over placebo in reducing postoperative pain and opioid requirement. Limited comparative efficacy and cost-effectiveness data exist for its use in total knee arthroplasty (TKA) when used in a multimodal, opioid-sparing analgesic and anesthetic approach. We hypothesized that liposomal bupivacaine offers no clinical advantage over our standard of care but carries significant economic impact.
Multivesicular liposomal bupivacaine at the sciatic nerve. [2022]Clinical translation of sustained release formulations for local anesthetics has been limited by adverse tissue reaction. Exparel™ (DepoFoam bupivacaine) is a new liposomal local anesthetic formulation whose biocompatibility near nerve tissue is not well characterized. Exparel™ injection caused sciatic nerve blockade in rats lasting 240 min compared to 120 min for 0.5% (w/v) bupivacaine HCl and 210 min for 1.31% (w/v) bupivacaine HCl (same bupivacaine content as Exparel™). On histologic sections four days after injection, median inflammation scores in the Exparel™ group (2.5 of 4) were slightly higher than in groups treated with bupivacaine solutions (score 2). Myotoxicity scores in the Exparel™ group (2.5 of 6) were similar to in the 0.5% (w/v) bupivacaine HCl group (3), but significantly less than in the 1.31% (w/v) bupivacaine HCl group (5). After two weeks, inflammation from Exparel™ (score 2 of 6) was greater than from 0.5% (w/v) bupivacaine HCl (1) and similar to that from 1.31% (w/v) bupivacaine HCl (1). Myotoxicity in all three groups was not statistically significantly different. No neurotoxicity was detected in any group. Tissue reaction to Exparel™ was similar to that of 0.5% (w/v) bupivacaine HCl. Surveillance for local tissue injury will be important during future clinical evaluation.
Risk factors for complications and return to the emergency department after interscalene block using liposomal bupivacaine for shoulder surgery. [2021]Exparel (liposomal bupivacaine) has recently gained favor for use in interscalene regional blocks for shoulder surgery. While effective for pain relief, this does have adverse effects that can lead to postoperative emergency department (ED) visits. This study aimed to identify any patient risk factors that are associated with complications leading to ED return visits owing to interscalene blocks using Exparel before shoulder surgery.
Parotid duct repair using an epidural catheter. [2011]The anatomy of the buccal region of the face is complex and injuries in this region can lead to significant complications. Trauma in this region can easily injure the parotid duct and facial nerve. The management of parotid duct injuries is usually by microsurgical anastomosis, diversion of salivary flow by creating an oral fistula, or suppression of salivary gland function. The authors present a case of parotid duct injury treated by using an epidural catheter.
Aesthetic Values of the Buccal Fat Pad Excision in Middle-Aged Patients. [2022]Despite buccal fat pad (BFP) excision being an effective and established surgery for the reduction of lower facial volume, there are very few reports explaining a systematic and reliable method for this surgery. The author will demonstrate one method for BFP excision surgery with some important tips and information on the procedure.
Treatment of postparotidectomy salivary fistula with botulinum toxin. [2017]We report on the successful treatment with botulinum toxin type A local injections of a salivary fistula that occurred after superficial parotidectomy. In a 58-year-old woman, transcutaneous discharge of saliva in the preauricular region had persisted in spite of 2 surgical revisions. Moreover, facial weakness and synkinesis had developed as a result of an iatrogenic lesion that had occurred at the time of primary surgery and required immediate reanastomosis of the main nerve trunk. Botulinum toxin A was injected into the deep lobe of the remaining parotid gland under ultrasonographic guidance. Additionally, botulinum toxin A was injected into the left orbicularis oculi muscle in order to improve the synkinesis. No adverse effects were observed. The sialorrhea was stopped for 11 months, and the synkinesis of the facial muscles was reduced significantly for 4 months. We conclude that botulinum toxin A injection is a successful alternative for the treatment of chronic salivary fistula.
The endonasal endoscopic harvest and anatomy of the buccal fat pad flap for closure of skull base defects. [2015]Extirpation via expanded endonasal approaches (EEA) to the skull base can result in defects requiring vascularized rotational flap reconstruction. The buccal fat pad (BFP) is a vascularized graft described in open skull base resections, but its harvest and adequacy of vascular supply have not been examined for use with EEA.
[Botulinum toxin A as a treatment of traumatic salivary gland fistulas]. [2018]Injury of salivary gland tissue in the head and neck, as the result of extensive trauma, can often be overlooked on initial examination. In two case reports, the primary treatment and further follow-up of injuries of the head resulting in a parotid-maxillary sinus fistula as well as a fistula between the skin and sublingual gland are illustrated. The successful use of botulinum toxin in the treatment of traumatic salivary gland fistulas is documented in both cases. Alternative diagnostic and treatment measures of salivary gland fistulas are discussed. Surgical repair of salivary fistulas as primary treatment should be carefully considered. Treatment of a salivary fistula with the injection of botulinum toxin is possibly advantageous compared to spontaneous fistula closure. The injection of botulinum toxin shortens fistula closure time, is minimally invasive, effective and tolerable for the patient.