ClinicalTrials.gg
RecruitingNCT04930887Updated Apr 27, 2026

Clinical Trial of Endoscopically Guided Injection of Exparel (Bupivacaine) for the Treatment of Craniofacial Pain

A Phase 2 interventional study of Exparel (Bupivacaine Liposome) and Saline in Craniofacial Pain, Migraine and Cluster Headache, sponsored by Stanford University. Recruiting at 1 site in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-04-27.

Sponsored by Stanford University · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Started Feb 2023; still recruiting 3 years 9 months later.
Phase
Phase 2
Study type
Interventional
Enrollment
15
Allocation
Non-randomized
Ages
18 Years to 80 Years
Sex
All
01

Study summary

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).

02

Conditions studied

  • Craniofacial Pain
  • Migraine
  • Cluster Headache
  • Trigeminal Autonomic Cephalgia
  • Sphenopalatine Ganglion Neuralgia
  • Paroxysmal Hemicrania
03

In context

Facial Pain

182 studies on the registry are indexed under Facial Pain; 61 are open to participants now.

This study's planned enrollment of 15 is below the median of 50 across 132 interventional studies indexed under Facial Pain.

Browse Facial Pain studies →

Lead sponsor

Stanford University is the lead sponsor of 2,168 studies on the registry; 431 are open to participants now.

Of its 267 completed or terminated interventional studies of FDA-regulated products, 207 (78%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • age \<18 or >80
  • pregnant women
  • economically disadvantaged (not able to afford clinic visits/treatments)
  • decisionally impaired (unable to obtain )
  • has allergy to bupivacaine
  • unable or unwilling to participate plans to participate in another clinical study at any time during this study
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Crossover assignment
Masking
Single (Participant)
Enrollment
15 participants (estimated)

Study arms

  • Active comparator
    Exparel

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

    Drug: Exparel (Bupivacaine Liposome)

  • Placebo comparator
    Saline

    Patients receive an endoscopically guided injection of saline

    Drug: Saline

Interventions

  • 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

  • DrugSaline

    Prescription medicine used for fluid and electrolyte replenishment for intravenous administration; Exparel-matched Placebo treatment

06

What researchers measure

Primary outcomes

  1. Change of Pain Score

    Scores range from 0-10 (0=no pain, 10=worst pain)

    Time frame: Baseline to day 21

Secondary outcomes

  1. Change of Associated Symptoms

    Changes of associated symptoms, including nausea, photophobia, use of rescue medication, relapse of headache, and/or change in headache disability scores

    Time frame: Baseline to day 21

07

Study locations

1 of 1 sites recruiting
  • Peter H Hwang
    Stanford, California 94304, United States
    Recruiting
08

References and documents

Individual participant data

Plan to share: No — IPD will be kept confidential and private and won't be used for any other studies or shared with other researchers.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 27, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04930887
Responsible party
Peter Hwang (PROFESSOR OF OTOLARYNGOLOGY - HEAD & NECK SURGERY (OHNS) AND, BY COURTESY, OF NEUROSURGERY AT THE STANFORD UNIVERSITY MEDICAL CENTER, Stanford University) — Principal investigator
First posted
Jun 18, 2021
Start date
Feb 1, 2023
Primary completion
Jun 2028 (estimated)
Completion
Jun 2030 (estimated)
Last update
Apr 27, 2026

Study contacts

Peter Hwang, MD
Contact
hwangph@stanford.edu
(650) 723-5281
Peter Hwang, MD
principal investigator · Stanford University

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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