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

Primary Purpose

Trigeminal Neuralgia

Status
Active
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Lidocaine
Guanfacine
Sponsored by
Vanderbilt University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Trigeminal Neuralgia

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Vanderbilt University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Lidocaine then Lidocaine + Guanfacine

Lidocaine + Guanfacine then Lidocaine

Arm 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.

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.

Outcomes

Primary Outcome Measures

Time to return to baseline pain after injection.
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

Pain intensity after treatment to be measured throughout follow-up
Pain will be measured on a visual analog scale 0-10 (0 = no pain, 10 = worst pain)
Quality of life after treatment
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.
Frequency of acute trigeminal nerve pain attacks during follow-up
Frequency of pain attacks
Time to first rescue medication during follow-up
Rescue medication (including opioid and non-opioid analgesics) use will be monitored once daily.
Total amount of rescue medications during follow-up
Rescue medication (including opioid and non-opioid analgesics) use will be monitored once daily.

Full Information

First Posted
March 1, 2019
Last Updated
October 11, 2023
Sponsor
Vanderbilt University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT03865940
Brief Title
Efficacy of Guanfacine and Lidocaine Combination in Trigeminal Nerve Block for Pain Management in Trigeminal Neuropathy
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 4, 2019 (Actual)
Primary Completion Date
October 4, 2023 (Actual)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt University Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Trigeminal Neuralgia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lidocaine then Lidocaine + Guanfacine
Arm Type
Experimental
Arm 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.
Arm Title
Lidocaine + Guanfacine then Lidocaine
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Lidocaine
Other Intervention Name(s)
Xylocaine
Intervention Description
6 mL of 1% lidocaine
Intervention Type
Drug
Intervention Name(s)
Guanfacine
Intervention Description
250 mcg
Primary Outcome Measure Information:
Title
Time to return to baseline pain after injection.
Description
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)
Time Frame
up to 2 weeks
Secondary Outcome Measure Information:
Title
Pain intensity after treatment to be measured throughout follow-up
Description
Pain will be measured on a visual analog scale 0-10 (0 = no pain, 10 = worst pain)
Time Frame
up to 2 weeks
Title
Quality of life after treatment
Description
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.
Time Frame
up to 2 weeks
Title
Frequency of acute trigeminal nerve pain attacks during follow-up
Description
Frequency of pain attacks
Time Frame
up to 2 weeks
Title
Time to first rescue medication during follow-up
Description
Rescue medication (including opioid and non-opioid analgesics) use will be monitored once daily.
Time Frame
up to 2 weeks
Title
Total amount of rescue medications during follow-up
Description
Rescue medication (including opioid and non-opioid analgesics) use will be monitored once daily.
Time Frame
up to 2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Edwards
Organizational Affiliation
Vanderbilt University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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