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RecruitingPhase 2

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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 80 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Injections

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "The study aims to evaluate the effectiveness of endoscopically-guided injection of Exparel (Bupivacaine) for the treatment of craniofacial pain."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether Exparel (bupivacaine), a numbing drug, can ease head and face pain and improve daily function. The drug is injected into the side wall inside the nose using a thin viewing tool to guide it. The study is for people whose pain improves when lidocaine, another numbing drug, is applied inside the nose.

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).

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Your main health complaint is head or face pain, such as migraine, cluster headaches, or one of the other listed headache or nerve pain conditions.
  • You have a visit at the Stanford Pain & ENT clinic (ENT means ear, nose, and throat).

Who can't join

  • You are younger than 18 or older than 80.
  • You are pregnant.
  • You cannot afford the clinic visits or treatments.
  • You cannot make an informed decision about joining the study.
  • You are allergic to bupivacaine.
  • You are unable or unwilling to take part.
  • You plan to join another clinical study during this study.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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

Study sites (1)

CA