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

NCT04930887 | Recruiting Phase 2 FDA Drug

• 1 other identifier: 60832
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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

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

Outcome Measures

Primary Outcomes (1)

• Change of Pain Score

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

  Baseline to day 21

Secondary Outcomes (1)

• Change of Associated Symptoms

  Baseline to day 21

Study Arms (2)

Exparel

ACTIVE COMPARATOR

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

Drug: Exparel (Bupivacaine Liposome)

Saline

PLACEBO COMPARATOR

Patients receive an endoscopically guided injection of saline

Drug: Saline

Interventions

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

Exparel

Saline DRUG

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

Saline

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Peter H Hwang

Stanford, California, 94304, United States

RECRUITING

MeSH Terms

Conditions

Facial Pain; Migraine Disorders; Cluster Headache; Trigeminal Autonomic Cephalalgias; Facial Neuralgia; Paroxysmal Hemicrania

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Facial Nerve Diseases; Mouth Diseases; Stomatognathic Diseases; Cranial Nerve Diseases

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Peter Hwang, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Peter Hwang, MD

CONTACT

(650) 723-5281; hwangph@stanford.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PROFESSOR OF OTOLARYNGOLOGY - HEAD & NECK SURGERY (OHNS) AND, BY COURTESY, OF NEUROSURGERY AT THE STANFORD UNIVERSITY MEDICAL CENTER

Study Record Dates

• First Submitted: June 11, 2021
• First Posted: June 18, 2021
• Study Start: February 1, 2023
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2030
• Last Updated: April 27, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)