Craniofacial PainPhase 2NCT04930887
Clinical Trial of Endoscopically Guided Injection of Exparel (Bupivacaine) for the Treatment of Craniofacial Pain
A Phase 2 study testing Exparel (Bupivacaine Liposome) and Saline in people with Craniofacial Pain and Migraine, run by Stanford University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Craniofacial Pain, Migraine, Cluster Headache
- What is being tested?
- Exparel (Bupivacaine Liposome) and Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2023to Jun 2030
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Peter H Hwang
Stanford, California, 94304
Peter H Hwang, 6503809590, hwangph@stanford.edu
About this study
Official title: Prospective, Randomized, Double-blinded, Placebo-controlled, Cross-over Trial of Endoscopically Guided Injection of Exparel (Bupivacaine) Towards the Ipsilateral Pterygopalatine Fossa for the Treatment of Craniofacial Pain
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).
- Conditions
- Craniofacial Pain, Migraine, Cluster Headache, Trigeminal Autonomic Cephalgia, Sphenopalatine Ganglion Neuralgia, Paroxysmal Hemicrania
- Being tested
- Exparel (Bupivacaine Liposome), Saline
- Medical subject headings
- Facial Pain, Migraine Disorders, Cluster Headache, Trigeminal Autonomic Cephalalgias, Facial Neuralgia, Paroxysmal Hemicrania
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exparel (Bupivacaine Liposome)Drug
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
SalineDrug
Prescription medicine used for fluid and electrolyte replenishment for intravenous administration; Exparel-matched Placebo treatment
| Study group | Role | What they receive |
|---|---|---|
| Exparel | Active comparator | Patients receive an endoscopically guided injection of Exparel (Bupivacaine). Receives: Drug: Exparel (Bupivacaine Liposome) |
| Saline | Placebo comparator | Patients receive an endoscopically guided injection of saline Receives: Drug: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Pain Score
Scores range from 0-10 (0=no pain, 10=worst pain)
Measured: 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
Measured: Baseline to day 21
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2021
- Study start1 Feb 2023
- Primary completionJun 2028 (estimated)
- Study completionJun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Craniofacial PainStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peter Hwang, Stanford University
- Investigators
- Peter Hwang, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04930887
- Sponsor's protocol ID
- 60832
- Status last verified
- Apr 2026
- First submitted
- 11 Jun 2021
- Last updated
- 27 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will be kept confidential and private and won't be used for any other studies or shared with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Randomized, Double-blinded, Placebo-controlled, Cross-over Trial of Endoscopically Guided Injection of Exparel (Bupivacaine) Towards the Ipsilateral Pterygopalatine Fossa for the Treatment of Craniofacial Pain
- ClinicalTrials.gov ID
- NCT04930887
- Acronym / sponsor ID
- 60832
- Conditions
- Craniofacial Pain, Migraine, Cluster Headache, Trigeminal Autonomic Cephalgia, Sphenopalatine Ganglion Neuralgia, Paroxysmal Hemicrania
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Jun 2030 (estimated)
- First posted
- 18 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exparel | Active comparator | Drug: Exparel (Bupivacaine Liposome)Patients receive an endoscopically guided injection of Exparel (Bupivacaine). |
| Saline | Placebo comparator | Drug: SalinePatients receive an endoscopically guided injection of saline |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Exparel |
| SalinePrescription medicine used for fluid and electrolyte replenishment for intravenous administration; Exparel-matched Placebo treatment | Drug | Saline |
Primary outcome
Change of Pain Score
Time frame: Baseline to day 21
Scores range from 0-10 (0=no pain, 10=worst pain)
1 secondary outcome
Change of Associated Symptoms
Time frame: Baseline to day 21
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2026.
- Individual participant dataSharing planned: No. IPD will be kept confidential and private and won't be used for any other studies or shared with other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Peter Hwang, MD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Exparel (Bupivacaine Liposome) and Saline in people with Craniofacial Pain and Migraine, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Peter Hwang, MD ((650) 723-5281, hwangph@stanford.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of Pain Score (time frame: Baseline to day 21). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2026.