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

Last updated: April 16, 2024
Sponsor: Stanford University
Overall Status: Active - Recruiting

Phase

2

Condition

Migraine (Pediatric)

Pain

Trigeminal Neuralgia

Treatment

Exparel (Bupivacaine Liposome)

Saline

Clinical Study ID

NCT04930887
60832
  • Ages 18-80
  • All Genders

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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients with a chief complaint of craniofacial pain (migraine, cluster headache,trigeminal autonomic cephalgia, sphenopalatine ganglioneuraligia, paroxysmalhemicrania) who has Stanford Pain & ENT clinic visit

Exclusion

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 atany time during this study

Study Design

Total Participants: 15
Treatment Group(s): 2
Primary Treatment: Exparel (Bupivacaine Liposome)
Phase: 2
Study Start date:
February 01, 2023
Estimated Completion Date:
June 30, 2030

Connect with a study center

  • Peter H Hwang

    Stanford, California 94304
    United States

    Active - Recruiting

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