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RecruitingNCT04930887

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

Status
Recruiting
Phase
Phase 2
Study type
Interventional
Enrollment
15 (estimated)
Sponsor
Stanford University · Academic / Other
Sex
All
Age
18 Years – 80 Years
Healthy volunteers
Not accepted

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).

Conditions

Interventions

TypeNameDescription
DRUGExparel (Bupivacaine Liposome)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
DRUGSalinePrescription medicine used for fluid and electrolyte replenishment for intravenous administration; Exparel-matched Placebo treatment

Timeline

Start date
2023-02-01
Primary completion
2025-06-01
Completion
2030-06-01
First posted
2021-06-18
Last updated
2024-04-17

Locations

1 site across 1 country: United States

Regulatory

Source: ClinicalTrials.gov record NCT04930887. Inclusion in this directory is not an endorsement.