NCT04930887 · Stanford University
Clinical Trial of Endoscopically Guided Injection of Exparel (Bupivacaine) for the Treatment of Craniofacial Pain
What this study is about
Exparel has a proven effectiveness in providing pain relief for up to 72 hours with a single-dose administration at surgical sites. The study aims to evaluate the effectiveness of endoscopically-guided injection of Exparel (Bupivacaine) for the treatment of craniofacial pain.
View original scientific description
Exparel has a proven efficacy in providing pain relief for up to 72 hours with a single-dose administration at surgical sites. The study aims to evaluate the effectiveness of endoscopically-guided injection of Exparel (Bupivacaine) for the treatment of craniofacial pain. This study would be conducted in a prospective, randomized, double-blinded, placebo- controlled, and cross-over fashion. We aim to investigate whether the administration of Exparel (Bupivacaine) to the lateral nasal wall may positively impact craniofacial pain and functional outcomes, in patients who experience relief with the topical application of Lidocaine (routinely given prior to almost all ENT endoscopy).
Interventions
DRUG
Exparel (Bupivacaine Liposome)
Non-opioid postsurgical analgesic used in the management of postsurgical pain; 133 mg/10 mL (13.3 mg/mL) single-dose vial (per Pacira), study administers 3cc bilaterally
DRUG
Saline
Prescription medicine used for fluid and electrolyte replenishment for intravenous administration; Exparel-matched Placebo treatment
Primary outcome measures
Change of Pain Score
Time frame: Baseline to day 21
Scores range from 0-10 (0=no pain, 10=worst pain)
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
Exclusion criteria
- age \<18 or \>80
- pregnant women
- economically disadvantaged (not able to afford clinic visits/treatments)
- decisionally impaired (unable to obtain informed consent)
- has allergy to bupivacaine
- unable or unwilling to participate plans to participate in another clinical study at any time during this study
Where
- Stanford, California
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 27, 2026 · Source of record for eligibility and locations