Efficacy of Guanfacine and Lidocaine Combination in Trigeminal Nerve Block for Pain Management in Trigeminal Neuropathy
| Status: | Not yet recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 3/9/2019 |
| Start Date: | April 2019 |
| End Date: | April 2020 |
| Contact: | Patricia Hendricks |
| Email: | patty.hendricks@vumc.org |
| Phone: | 615-936-2831 |
A Randomized, Double-Blind, 2-Way Crossover Trial to Assess the Efficacy of Guanfacine and Lidocaine Combination Versus Lidocaine Alone in Trigeminal Nerve Block for Pain Management in Painful Trigeminal Neuropathy Patients
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 oldest alpha-2 adrenergic agonist in clinical use and is
approved for hypertension and attention deficit hyperactivity disorder. We hypothesize that
guanfacine will be an effective adjunct to lidocaine for the treatment of neuropathic pain by
enhancing and prolonging pain relief due to its activation of alpha-2 adrenergic receptors.
The objectives of the study will be to evaluate the efficacy and safety of guanfacine in
combination with lidocaine for trigeminal nerve block procedures for pain management in
trigeminal neuralgia patients. This study will evaluate the efficacy of guanfacine in
reducing acute pain and extending duration of pain relief when delivered in combination with
lidocaine as a trigeminal nerve block, measured by Visual Analog Scale (VAS) data collected
at specific time points after each injection.
function variant in the human alpha 2B adrenergic receptor gene and trigeminal nerve
disorders. Guanfacine is the oldest alpha-2 adrenergic agonist in clinical use and is
approved for hypertension and attention deficit hyperactivity disorder. We hypothesize that
guanfacine will be an effective adjunct to lidocaine for the treatment of neuropathic pain by
enhancing and prolonging pain relief due to its activation of alpha-2 adrenergic receptors.
The objectives of the study will be to evaluate the efficacy and safety of guanfacine in
combination with lidocaine for trigeminal nerve block procedures for pain management in
trigeminal neuralgia patients. This study will evaluate the efficacy of guanfacine in
reducing acute pain and extending duration of pain relief when delivered in combination with
lidocaine as a trigeminal nerve block, measured by Visual Analog Scale (VAS) data collected
at specific time points after each injection.
Inclusion Criteria:
- 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 Criteria:
- 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.
We found this trial at
1
site
1211 Medical Center Dr
Nashville, Tennessee 37232
Nashville, Tennessee 37232
(615) 322-5000
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
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