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

NCT03865940 | Completed Phase 2 Results FDA Drug

• 1 other identifier: TN
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Time to Return to Baseline Pain After Injection.

  Time (hours) until pain returns to baseline number.

  up to 2 weeks

Secondary Outcomes (6)

• Pain Intensity in Follow-Up

  8 hours

• Quality of Life, Physical Health

  14 days

• Quality of Life, Mental Health

  14 days

• Frequency of Nerve Pain Attacks

  14 days

• Rescue Medication Use

  8 hours

Study Arms (2)

Lidocaine then Lidocaine + Guanfacine

EXPERIMENTAL

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.

Drug: Lidocaine; Drug: Guanfacine

Lidocaine + Guanfacine then Lidocaine

EXPERIMENTAL

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.

Drug: Lidocaine; Drug: Guanfacine

Interventions

Lidocaine DRUG

6 mL of 1% lidocaine

Also known as: Xylocaine

Lidocaine + Guanfacine then Lidocaine; Lidocaine then Lidocaine + Guanfacine

Guanfacine DRUG

250 mcg

Lidocaine + Guanfacine then Lidocaine; Lidocaine then Lidocaine + Guanfacine

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37203, United States

Location

Related Publications (1)

• 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.

  PMID: 40326696 DERIVED

MeSH Terms

Conditions

Trigeminal Neuralgia

Interventions

Lidocaine; Guanfacine

Condition Hierarchy (Ancestors)

Trigeminal Nerve Diseases; Facial Neuralgia; Facial Nerve Diseases; Mouth Diseases; Stomatognathic Diseases; Cranial Nerve Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Guanidines; Amidines; Phenylacetates; Acids, Carbocyclic; Carboxylic Acids

Results Point of Contact

• Title: Shelby Meier, PhD - Senior Scientific Project Manager
• Organization: Vanderbilt University Medical Center

shelby.meier@vumc.org

6159369228

Study Officials

• Tigran Kesayan, MD

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 1, 2019
• First Posted: March 7, 2019
• Study Start: November 4, 2019
• Primary Completion: October 4, 2023
• Study Completion: January 31, 2024
• Last Updated: March 30, 2025
• Results First Posted: October 17, 2024

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)