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

Description

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

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Study Overview

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Study Details

Study overview

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).

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

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

Condition
Craniofacial Pain
Intervention / Treatment

-

Contacts and Locations

Stanford

Peter H Hwang, Stanford, California, United States, 94304

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to 80 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Stanford University,

Peter Hwang, MD, PRINCIPAL_INVESTIGATOR, Stanford University

Study Record Dates

2030-06