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

Migraine Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04930887
• Other study ID #: 60832
• Status: Recruiting
• Phase: Phase 2
• Start date: February 1, 2023
• Est. completion date: June 2030

Study information

• Verified date: April 2024
• Source: Stanford University
• Contact: Peter Hwang, MD
• Phone: (650) 723-5281
• Email: hwangph[@]stanford.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: June 2030
• Est. primary completion date: June 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Cluster Headache
• Facial Pain
• Headache
• Migraine
• Neuralgia
• Paroxysmal Hemicrania
• Trigeminal Autonomic Cephalgia

Intervention

Drug:
• Exparel (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
• Saline
Prescription medicine used for fluid and electrolyte replenishment for intravenous administration; Exparel-matched Placebo treatment

Locations

Country	Name	City	State
United States	Peter H Hwang	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of Pain Score	Scores range from 0-10 (0=no pain, 10=worst pain)	Baseline to day 21
Secondary	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	Baseline to day 21