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Completed

NCT Number: NCT03865940

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

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.

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Key information

Conditions

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

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Vanderbilt University Medical Center

Nashville, Tennessee, 37203, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Lidocaine

Drug

6 mL of 1% lidocaine

Other names: Xylocaine

Guanfacine

Drug

250 mcg

Primary outcomes

  1. Time to Return to Baseline Pain After Injection.

    Time frame: up to 2 weeks

    Time (hours) until pain returns to baseline number.

Secondary outcomes

  1. Pain Intensity in Follow-Up

    Time frame: 8 hours

    Pain Intensity after treatment measured throughout the 8-hour follow-up period on a visual analog scale (VAS) from 0 to 10, where 0 is the least pain and 10 is the most pain.

  2. Quality of Life, Physical Health

    Time frame: 14 days

    Participant Quality of Life as measured by the PROMIS Global Health -10 SF during the 14-day follow-up. The scores reported are T-scores. The T-score rescales the raw sum score into a standardized score with a mean of 50 and a standard deviation (SD) of 10. Therefore a person with a T-score of 40 is one SD below the mean and a person with a T-score of 60 is one SD above the mean.

    For the Physical Health subscale, raw scores are converted into t-scores ranging from 16.2 to 67.7 and higher t-scores are indicative of better overall physical health.

  3. Quality of Life, Mental Health

    Time frame: 14 days

    Participant Quality of Life as measured by the PROMIS Global Health -10 SF during the 14-day follow-up. The scores reported are T-scores. The T-score rescales the raw sum score into a standardized score with a mean of 50 and a standard deviation (SD) of 10. Therefore a person with a T-score of 40 is one SD below the mean and a person with a T-score of 60 is one SD above the mean.

    In this Mental Health subscale, raw scores are converted into t-scores ranging from 21.2 to 67.6, where higher t-scores are indicative of better overall physical health.

  4. Frequency of Nerve Pain Attacks

    Time frame: 14 days

    Frequency of nerve pain attacks during the 14-day follow-up period. Pain frequency was recorded numerically as 0 - None (no pain), 1 - Weekly, 2 - Daily, 3 - Hourly, and 4 - Constant pain. Data was not collected at baseline, only at Day 7 and Day 14.

  5. Rescue Medication Use

    Time frame: 8 hours

    Number of participants using rescue medication during the 8-hour follow-up period

  6. Time to First Rescue Medication

    Time frame: 14 days

    Time, in hours, to use of first rescue medication in the follow-up period following the injection.

Sponsors and collaborators

Lead sponsor

Vanderbilt University Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2023
Study completion
2024
First posted
Mar 7, 2019
Registry last updated
Mar 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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