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Trial record 25 of 119 for:    "Neuromuscular Disease" | "Lidocaine"

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

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ClinicalTrials.gov Identifier: NCT03865940
Recruitment Status : Not yet recruiting
First Posted : March 7, 2019
Last Update Posted : May 16, 2019
Sponsor:
Information provided by (Responsible Party):
David Edwards, 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.

Condition or disease Intervention/treatment Phase
Trigeminal Neuralgia Drug: Lidocaine Drug: Guanfacine Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official 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
Estimated Study Start Date : July 2019
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : April 2020


Arm Intervention/treatment
Experimental: 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.

Drug: Lidocaine
6 mL of 1% lidocaine
Other Name: Xylocaine

Drug: Guanfacine
250 mcg

Experimental: 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.

Drug: Lidocaine
6 mL of 1% lidocaine
Other Name: Xylocaine

Drug: Guanfacine
250 mcg




Primary Outcome Measures :
  1. Time to return to baseline pain after injection. [ Time Frame: up to 2 weeks ]
    Time in (hours or days) until pain returns to baseline number. Pain will be measured on a visual analog scale 0-10 (0 = no pain, 10 = worst pain)


Secondary Outcome Measures :
  1. Pain intensity after treatment to be measured throughout follow-up [ Time Frame: up to 2 weeks ]
    Pain will be measured on a visual analog scale 0-10 (0 = no pain, 10 = worst pain)

  2. Quality of life after treatment [ Time Frame: up to 2 weeks ]
    Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health version 1.2 [health-related quality of life] includes 10 questions and measures assess an individual's physical, mental, and social health. The adult PROMIS Global Health measure produces two scores: Physical Health and Mental Health. All items, except for the rating of pain, use a 1-5 rating, with higher ratings corresponding with better outcomes. The pain item will be recoded from a 1-10 scale to convert to a 1-5 scale, with higher ratings corresponding to better outcomes. The remaining two items (general health and social roles) are not used to calculate summary scores; these two questions use a 1-5 rating, with higher ratings corresponding with better outcomes. The raw scores for Physical Health and Mental Health will comprise a sum of the numerical responses for the four questions in each group. T scores will be calculated, with higher T scores corresponding with better outcomes.

  3. Frequency of acute trigeminal nerve pain attacks during follow-up [ Time Frame: up to 2 weeks ]
    Frequency of pain attacks

  4. Time to first rescue medication during follow-up [ Time Frame: up to 2 weeks ]
    Rescue medication (including opioid and non-opioid analgesics) use will be monitored once daily.

  5. Total amount of rescue medications during follow-up [ Time Frame: up to 2 weeks ]
    Rescue medication (including opioid and non-opioid analgesics) use will be monitored once daily.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03865940


Contacts
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Contact: Patricia Hendricks 615-936-2831 patty.hendricks@vumc.org

Locations
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United States, Tennessee
Vanderbilt University Medical Center Not yet recruiting
Nashville, Tennessee, United States, 37203
Sponsors and Collaborators
Vanderbilt University Medical Center
Investigators
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Principal Investigator: David Edwards Vanderbilt University Medical Center

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Responsible Party: David Edwards, Assistant Professor, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT03865940     History of Changes
Other Study ID Numbers: TN
First Posted: March 7, 2019    Key Record Dates
Last Update Posted: May 16, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neuromuscular Diseases
Lidocaine
Trigeminal Neuralgia
Trigeminal Nerve Diseases
Neuralgia
Peripheral Nervous System Diseases
Nervous System Diseases
Pain
Neurologic Manifestations
Signs and Symptoms
Facial Neuralgia
Facial Nerve Diseases
Mouth Diseases
Stomatognathic Diseases
Cranial Nerve Diseases
Guanfacine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Antihypertensive Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists