Recruiting
Phase 2

Exparel

Sponsor:

Stanford University

Code:

NCT04930887

Conditions

Craniofacial Pain

Migraine

Cluster Headache

Trigeminal Autonomic Cephalgia

Sphenopalatine Ganglion Neuralgia

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Exparel (Bupivacaine Liposome)

Saline

Study Details

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).

Conditions

Craniofacial Pain

Migraine

Cluster Headache

Trigeminal Autonomic Cephalgia

Sphenopalatine Ganglion Neuralgia

Study ID

NCT04930887

Start date

Feb 1, 2023

Status verified date

Apr, 2026

Completion date

Jun, 2030

Anticipated

Primary completion date

Jun, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

15 participants

Anticipated

Allocation

Non randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Exparel

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

placebo comparator: Saline

Patients receive an endoscopically guided injection of saline

Interventions

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

Saline

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

Primary outcome measure

  • Change of Pain Score [ Time Frame: Baseline to day 21 ]

Central Contacts and Locations

Central contacts

Peter Hwang, MD

(650) 723-5281hwangph@stanford.edu

Locations

Peter H Hwang

Recruiting

Stanford, California, United States, 94304

Contacts

Peter H Hwang

6503809590hwangph@stanford.edu

More Information

Sponsor

Stanford University

Last update posted

Apr 27, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Stanford University on 2026-04-27.