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NCT Number: NCT04930887

Clinical Trial of Endoscopically Guided Injection of Exparel (Bupivacaine) 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).

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Key information

Conditions

Craniofacial Pain Brain Diseases Central Nervous System Diseases Cluster Headache Cranial Nerve Diseases Facial Nerve Diseases Facial Neuralgia Facial Pain Headache Disorders Headache Disorders, Primary Migraine Migraine Disorders Mouth Diseases Nervous System Diseases Neurologic Manifestations Pain Paroxysmal Hemicrania Pathological Conditions, Signs and Symptoms Signs and Symptoms Sphenopalatine Ganglion Neuralgia Stomatognathic Diseases Trigeminal Autonomic Cephalalgias Trigeminal Autonomic Cephalgia

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Peter H Hwang

Stanford, California, 94304, United States

Location status: Recruiting

Location contact

Peter H Hwang

CONTACT

[email protected]

6503809590

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Saline

Drug

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

Primary outcomes

  1. Change of Pain Score

    Time frame: Baseline to day 21

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

Secondary outcomes

  1. Change of Associated Symptoms

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Peter Hwang, MD

CONTACT

[email protected]

(650) 723-5281

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2028
Study completion
2030
First posted
Jun 18, 2021
Registry last updated
Apr 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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