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

NCT ID: NCT03865940

Last Updated: 2025-03-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 37 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-04
• Study Completion Date: 2024-01-31

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.

Conditions

Trigeminal Neuralgia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Lidocaine then Lidocaine + Guanfacine

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.

Group Type: EXPERIMENTAL

Lidocaine

Intervention Type: DRUG

6 mL of 1% lidocaine

Guanfacine

Intervention Type: DRUG

250 mcg

Lidocaine + Guanfacine then Lidocaine

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.

Group Type: EXPERIMENTAL

Lidocaine

Intervention Type: DRUG

6 mL of 1% lidocaine

Guanfacine

Intervention Type: DRUG

250 mcg

Interventions

Lidocaine

6 mL of 1% lidocaine

Intervention Type: DRUG

Guanfacine

250 mcg

Intervention Type: DRUG

Other Intervention Names

Xylocaine

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vanderbilt University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Tigran Keseyan

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tigran Kesayan, MD

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University Medical Center

Locations

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Countries

United States

References

Meier SE, Orr MB, Shotwell MS, Jerome RN, Shirey-Rice JK, Pulley JM, Edwards DA, Toye AD, Mishra P, Kesayan T. Enhanced pain relief with guanfacine as an adjuvant for trigeminal nerve blocks: insights from a PheWAS-guided randomized controlled study. Pain Med. 2025 Oct 1;26(10):643-654. doi: 10.1093/pm/pnaf054.

Reference Type: DERIVED

PMID: 40326696 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

TN

Identifier Type: -

Identifier Source: org_study_id