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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lidocaine | Drug | 6 mL of 1% lidocaine |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to Return to Baseline Pain After Injection. | Time (hours) until pain returns to baseline number. | up to 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Intensity in Follow-Up | 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. | 8 hours |
| Quality of Life, Physical Health |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tigran Kesayan, MD | Vanderbilt University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vanderbilt University Medical Center | Nashville | Tennessee | 37203 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40326696 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. Lidocaine: 6 mL of 1% lidocaine Guanfacine: 250 mcg |
| FG001 | 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. Lidocaine: 6 mL of 1% lidocaine Guanfacine: 250 mcg |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention (14 Days) |
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| Washout Period (14 Days) |
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| Second Intervention (14 Days) |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. Lidocaine: 6 mL of 1% lidocaine Guanfacine: 250 mcg |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Time to Return to Baseline Pain After Injection. | Time (hours) until pain returns to baseline number. | Posted | Median | Inter-Quartile Range | hours | up to 2 weeks |
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Up to 2 weeks after injection
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Lidocaine Alone | Data from injection where participants received an injection of lidocaine ALONE. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypertension | Vascular disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Shelby Meier, PhD - Senior Scientific Project Manager | Vanderbilt University Medical Center | 6159369228 | shelby.meier@vumc.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 7, 2022 | Sep 13, 2024 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Nov 20, 2023 | Nov 22, 2023 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D014277 | Trigeminal Neuralgia |
| ID | Term |
|---|---|
| D020433 | Trigeminal Nerve Diseases |
| D005156 | Facial Neuralgia |
| D005155 | Facial Nerve Diseases |
| D009059 | Mouth Diseases |
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| ID | Term |
|---|---|
| D008012 | Lidocaine |
| D016316 | Guanfacine |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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| Guanfacine | Drug | 250 mcg |
|
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.
| 14 days |
| Quality of Life, Mental Health | 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. | 14 days |
| Frequency of Nerve Pain Attacks | 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. | 14 days |
| Rescue Medication Use | Number of participants using rescue medication during the 8-hour follow-up period | 8 hours |
| Time to First Rescue Medication | Time, in hours, to use of first rescue medication in the follow-up period following the injection. | 14 days |
| NOT COMPLETED |
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| NOT COMPLETED |
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| 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. Lidocaine: 6 mL of 1% lidocaine Guanfacine: 250 mcg |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Participants |
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| Secondary | Pain Intensity in Follow-Up | 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. | The overall number of participants analyzed corresponds with how many participants were injected; however, not every participant responded at every timepoint. Therefore, only recorded responses at each timeline were analyzed. | Posted | Mean | Standard Deviation | score on a scale | 8 hours |
|
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| Secondary | Quality of Life, Physical Health | 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. | The overall number of participants analyzed corresponds with how many participants were injected; however, not every participant responded at every timepoint. Therefore, only recorded responses at each timeline were analyzed. | Posted | Mean | Standard Deviation | T-score | 14 days |
|
|
|
|
| Secondary | Quality of Life, Mental Health | 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. | The overall number of participants analyzed corresponds with how many participants were injected; however, not every participant responded at every timepoint. Therefore, only recorded responses at each timeline were analyzed. | Posted | Mean | Standard Deviation | T-score | 14 days |
|
|
|
|
| Secondary | Frequency of Nerve Pain Attacks | 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. | The overall number of participants analyzed corresponds with how many participants were injected; however, not every participant responded at every timepoint. Therefore, only recorded responses at each timeline were analyzed. | Posted | Mean | Standard Deviation | units on a scale | 14 days |
|
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|
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| Secondary | Rescue Medication Use | Number of participants using rescue medication during the 8-hour follow-up period | The overall number of participants analyzed corresponds with how many participants were injected; however, not every participant responded at every timepoint. Therefore, only recorded responses at each timeline were analyzed. | Posted | Count of Participants | Participants | 8 hours |
|
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| Secondary | Time to First Rescue Medication | Time, in hours, to use of first rescue medication in the follow-up period following the injection. | Not all participants reported using rescue medication, so this analysis only includes participants that reported rescue medication use. | Posted | Mean | Standard Deviation | hours | 14 days |
|
|
|
| 0 |
| 36 |
| 0 |
| 36 |
| 2 |
| 36 |
| EG001 | Lidocaine + Guanfacine | Data from injection where participants received lidocaine + guanfacine. | 0 | 28 | 0 | 28 | 1 | 28 |
| Left ear pressure after procedure | Ear and labyrinth disorders | Systematic Assessment |
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| Facial brusing and sensitivity | Injury, poisoning and procedural complications | Systematic Assessment |
|
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| D009057 |
| Stomatognathic Diseases |
| D003389 | Cranial Nerve Diseases |
| D009422 | Nervous System Diseases |
| Aniline Compounds |
| D000588 | Amines |
| D006146 | Guanidines |
| D000578 | Amidines |
| D010648 | Phenylacetates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| 0.5 hours |
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| 1 hour |
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| 1.5 hours |
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| 2 hours |
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| 2.5 hours |
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| 3 hours |
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| 3.5 hours |
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| 4 hours |
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| 4.5 hours |
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| 5 hours |
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| 5.5 hours |
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| 6 hours |
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| 6.5 hours |
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| 7 hours |
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| 7.5 hours |
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| 8 hours |
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| Day 7 |
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| Day 14 |
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| Day 7 |
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| Day 14 |
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| Day 14 |
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| 0.5 hours |
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| 1 hour |
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| 1.5 hours |
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| 2 hours |
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| 2.5 hours |
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| 3 hours |
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| 3.5 hours |
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| 4 hours |
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| 4.5 hours |
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| 5 hours |
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| 5.5 hours |
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| 6 hours |
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| 6.5 hours |
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| 7 hours |
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| 7.5 hours |
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| 8 hours |
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