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

Phase 2

Recruiting

• Conditions: Craniofacial Pain; Migraine; Trigeminal Autonomic Cephalgia; Paroxysmal Hemicrania; Cluster Headache; Sphenopalatine Ganglion Neuralgia
• Interventions: Drug: Exparel (Bupivacaine Liposome); Drug: Saline

• Registration Number: NCT04930887
• Lead Sponsor: Stanford University

Brief 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).

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2021-06-11
• Study First Submitted QC: 2021-06-11
• Study First Posted: 2021-06-18
• Study Start: 2023-02-01
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-16
• Last Update Posted: 2024-04-17
• Primary Completion: 2025-06
• Study Completion: 2030-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 15

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Exparel	Exparel (Bupivacaine Liposome)	Patients receive an endoscopically guided injection of Exparel (Bupivacaine).
Saline	Saline	Patients receive an endoscopically guided injection of saline

Primary Outcome Measures

Name	Time	Method
Change of Pain Score	Baseline to day 21	Scores range from 0-10 (0=no pain, 10=worst pain)

Secondary Outcome Measures

Name	Time	Method
Change of Associated Symptoms	Baseline to day 21	Changes of associated symptoms, including nausea, photophobia, use of rescue medication, relapse of headache, and/or change in headache disability scores

Trial Locations

Locations (1)

Peter H Hwang; 🇺🇸 Stanford, California, United States