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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorStanford University

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

age <18 or >80

pregnant women

economically disadvantaged (not able to afford clinic visits/treatments)

decisionally impaired (unable to obtain informed consent)

Trial design

Design model

Crossover

Treatments tested in this trial

  • 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

Treatment groups

15 Participants
are divided into 2 treatment groups
Group A: ExparelActive comparator 1 intervention
Group B: SalinePlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change of Pain Score

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

Time frame
Baseline to day 21

Secondary outcomes

1

Change of Associated Symptoms

Changes of associated symptoms, including nausea, photophobia, use of rescue medication, relapse of headache, and/or change in headache disability scores

Time frame
Baseline to day 21

Other outcomes

Sponsors and contacts

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