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

NCT04930887 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2026-04-27

No results posted yet for this 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).

Conditions

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

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

Sponsors & Collaborators

Principal Investigators

  • Peter Hwang, MD · Stanford University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-02-01
Primary Completion
2028-06-30
Completion
2030-06-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04930887 on ClinicalTrials.gov