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

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

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04930887

Enrollment

Registered

2021-06-18

Start date

2023-02-01

Completion date

2030-06-01

Last updated

2026-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Brief 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).

Interventions

DRUGExparel (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

DRUGSaline

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

Study design

Allocation

NON_RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Change of Pain Score	Baseline to day 21	Scores range from 0-10 (0=no pain, 10=worst pain)

Secondary

Measure	Time frame	Description
Change of Associated Symptoms	Baseline to day 21	Changes of associated symptoms, including nausea, photophobia, use of rescue medication, relapse of headache, and/or change in headache disability scores

Countries

United States

Contacts

CONTACTPeter Hwang, MD

hwangph@stanford.edu(650) 723-5281

PRINCIPAL_INVESTIGATORPeter Hwang, MD

Stanford University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 28, 2026