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

Part of paid clinical trials in Stanford, California.

Sponsor
Stanford University
Study ID
NCT04930887
Phase
PHASE2
Status
Recruiting
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Conditions

  • Cluster Headache
  • Craniofacial Pain
  • Migraine
  • Paroxysmal Hemicrania
  • Sphenopalatine Ganglion Neuralgia
  • Trigeminal Autonomic Cephalgia

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • 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

Study Details

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).

Key Dates

Start date
Feb 1, 2023
Status verified
Apr 2026
Primary completion
Jun 30, 2028
Completion
Jun 30, 2030

Study Design

Enrollment
15 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Active Comparator: Exparel
    Patients receive an endoscopically guided injection of Exparel (Bupivacaine).
  • Placebo Comparator: Saline
    Patients receive an endoscopically guided injection of saline

Primary Outcome Measure

Change of Pain Score [ Time Frame: Baseline to day 21 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Peter H HwangStanfordCalifornia94304
Peter H Hwang
[email protected]
6503809590

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Peter H Hwang· Stanford, CA

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