Status:
COMPLETED
Efficacy of Guanfacine and Lidocaine Combination in Trigeminal Nerve Block for Pain Management in Trigeminal Neuropathy
Lead Sponsor:
Vanderbilt University Medical Center
Conditions:
Trigeminal Neuralgia
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
A phenome-wide association study (PheWAS) identified an association between a loss of function variant in the human alpha 2B adrenergic receptor gene and trigeminal nerve disorders. Guanfacine is the ...
Eligibility Criteria
Inclusion
- Ability to understand and read English
- History of painful trigeminal neuropathy with persistent background facial pain severity \> 5/10 on VAS
- Experience pain with a score of greater than 5 on a 0-10 scale (VAS) in the previous 24 hours before procedural treatment and at the time of procedural treatment.
- Eligible for trigeminal nerve block procedure and have not had a trigeminal nerve block procedure for pain management prior to the enrollment in the current study.
- Able to provide informed consent.
Exclusion
- Presence of a significant structural lesion (e.g., tumor) as the cause of pain as shown in at least one neuroimaging study.
- Current diagnosis of fibromyalgia, temporomandibular disorders (TMD), odontogenic pain or other orofacial pain deemed unrelated to the trigeminal nerve as the origin.
- Allergy or any other hypersensitivity reactions to guanfacine or lidocaine or local anesthetic of the amide type, or to both iodinated contrast and gadolinium contrast.
- Females who are pregnant or breastfeeding and/or plan to become pregnant or to breastfeed during study participation.
- Participation in another investigational drug study within 30 days before randomization.
- Inability to understand the requirements of the study, inability to abide by the study restrictions, inability to fill out the questionnaires, or inability to return for the required treatments.
- Any clinically significant medical or surgical condition that in the investigator's opinion could interfere with the administration of study drug, interpretation of study results, or compromise the safety or well-being of the subject (i.e. infection, unable to stop anticoagulants).
- No reliable access to telephone service to allow for contact with study personnel.
Key Trial Info
Start Date :
November 4 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 31 2024
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT03865940
Start Date
November 4 2019
End Date
January 31 2024
Last Update
March 30 2025
Active Locations (1)
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1
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37203