Efficacy of Guanfacine and Lidocaine Combination in Trigeminal Nerve Block for Pain Management in Trigeminal Neuropathy

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

Sponsors

Lead Sponsor: Vanderbilt University Medical Center

Source Vanderbilt University Medical Center
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 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.

Overall Status Recruiting
Start Date 2019-11-04
Completion Date 2021-12-01
Primary Completion Date 2021-12-01
Phase Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
Time to return to baseline pain after injection. up to 2 weeks
Secondary Outcome
Measure Time Frame
Pain intensity after treatment to be measured throughout follow-up up to 2 weeks
Quality of life after treatment up to 2 weeks
Frequency of acute trigeminal nerve pain attacks during follow-up up to 2 weeks
Time to first rescue medication during follow-up up to 2 weeks
Total amount of rescue medications during follow-up up to 2 weeks
Enrollment 30
Condition
Intervention

Intervention Type: Drug

Intervention Name: Lidocaine

Description: 6 mL of 1% lidocaine

Other Name: Xylocaine

Intervention Type: Drug

Intervention Name: Guanfacine

Description: 250 mcg

Eligibility

Criteria:

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.

Gender:

All

Minimum Age:

18 Years

Maximum Age:

65 Years

Healthy Volunteers:

No

Overall Official
Last Name Role Affiliation
David Edwards Principal Investigator Vanderbilt University Medical Center
Overall Contact

Last Name: Patricia Hendricks

Phone: 615-936-2831

Email: [email protected]

Location
Facility: Status: Vanderbilt University Medical Center
Location Countries

United States

Verification Date

2021-01-01

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Vanderbilt University Medical Center

Investigator Full Name: David Edwards

Investigator Title: Assistant Professor

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Lidocaine then Lidocaine + Guanfacine

Type: Experimental

Description: Trigeminal nerve block will be performed with injection of 6 mL of 1% lidocaine (Day 1). Patient will return between Day 15-28 and trigeminal nerve block will be performed with injection of 6 mL of 1% lidocaine + 250 mcg guanfacine.

Label: Lidocaine + Guanfacine then Lidocaine

Type: Experimental

Description: Trigeminal nerve block will be performed with injection of 6 mL of 1% lidocaine + 250 mcg guanfacine (Day 1). Patient will return between Day 15-28 and trigeminal nerve block will be performed with injection of 6 mL of 1% lidocaine.

Patient Data No
Study Design Info

Allocation: Randomized

Intervention Model: Crossover Assignment

Primary Purpose: Treatment

Masking: Triple (Participant, Care Provider, Investigator)

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