Trial · NCT03865940

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

NCT03865940, Phase 2, Completed, Vanderbilt University Medical Center; results first posted 2024-10-17

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Efficacy of Guanfacine and Lidocaine Combination in Trigeminal Nerve Block for Pain Management in Trigeminal Neuropathy. Trials, record NCT03865940. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03865940

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Efficacy of Guanfacine and Lidocaine Combination in Trigeminal Nerve Block for Pain Management in Trigeminal Neuropathy
NCT number: NCT03865940
Status: Completed
Phases: Phase 2
Enrollment: 37 participants, actual
Lead sponsor: Vanderbilt University Medical Center
Conditions: Trigeminal Neuralgia
Interventions: Lidocaine, Guanfacine
First posted: 2019-03-07
Last updated: 2025-03-30
Results first posted: 2024-10-17

Source ClinicalTrials.gov

Registered outcomes7

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Time to Return to Baseline Pain After Injection.	up to 2 weeks	Time (hours) until pain returns to baseline number.
Secondary	Pain Intensity in Follow-Up	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.
Secondary	Quality of Life, Physical Health	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.
Secondary	Quality of Life, Mental Health	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.
Secondary	Frequency of Nerve Pain Attacks	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.
Secondary	Rescue Medication Use	8 hours	Number of participants using rescue medication during the 8-hour follow-up period
Secondary	Time to First Rescue Medication	14 days	Time, in hours, to use of first rescue medication in the follow-up period following the injection.

Source ClinicalTrials.gov

Outcomes7

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Time to Return to Baseline Pain After Injection.	up to 2 weeks		hours	MEDIAN
SECONDARY	Pain Intensity in Follow-Up	8 hours	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.	score on a scale	MEAN
SECONDARY	Quality of Life, Physical Health	14 days	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.	T-score	MEAN
SECONDARY	Quality of Life, Mental Health	14 days	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.	T-score	MEAN
SECONDARY	Frequency of Nerve Pain Attacks	14 days	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.	units on a scale	MEAN
SECONDARY	Rescue Medication Use	8 hours	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.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Time to First Rescue Medication	14 days	Not all participants reported using rescue medication, so this analysis only includes participants that reported rescue medication use.	hours	MEAN

Source ClinicalTrials.gov

Results by group88

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Time to Return to Baseline Pain After Injection.	Lidocaine Alone		8	Inter-Quartile Range 4 to 120	hours
Time to Return to Baseline Pain After Injection.	Lidocaine + Guanfacine		5	Inter-Quartile Range 5 to 168	hours
Pain Intensity in Follow-Up	Lidocaine Alone	0 hours	6.75	Standard Deviation 1.56	score on a scale
Pain Intensity in Follow-Up	Lidocaine + Guanfacine	0 hours	6.63	Standard Deviation 1.43	score on a scale
Pain Intensity in Follow-Up	Lidocaine Alone	0.5 hours	1.91	Standard Deviation 2.31	score on a scale
Pain Intensity in Follow-Up	Lidocaine + Guanfacine	0.5 hours	1.88	Standard Deviation 2.72	score on a scale
Pain Intensity in Follow-Up	Lidocaine Alone	1 hour	2.24	Standard Deviation 2.2	score on a scale
Pain Intensity in Follow-Up	Lidocaine + Guanfacine	1 hour	1.54	Standard Deviation 2.25	score on a scale
Pain Intensity in Follow-Up	Lidocaine Alone	1.5 hours	2.83	Standard Deviation 2.6	score on a scale
Pain Intensity in Follow-Up	Lidocaine + Guanfacine	1.5 hours	1.42	Standard Deviation 1.98	score on a scale

1 to 10 of 88Source ClinicalTrials.gov

See all 88 results by group

Participant flow18

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
First Intervention (14 Days)	STARTED	Lidocaine Then Lidocaine + Guanfacine	18
First Intervention (14 Days)	STARTED	Lidocaine + Guanfacine Then Lidocaine	19
First Intervention (14 Days)	COMPLETED	Lidocaine Then Lidocaine + Guanfacine	18
First Intervention (14 Days)	COMPLETED	Lidocaine + Guanfacine Then Lidocaine	19
First Intervention (14 Days)	NOT COMPLETED	Lidocaine Then Lidocaine + Guanfacine	0
First Intervention (14 Days)	NOT COMPLETED	Lidocaine + Guanfacine Then Lidocaine	0
Washout Period (14 Days)	STARTED	Lidocaine Then Lidocaine + Guanfacine	18
Washout Period (14 Days)	STARTED	Lidocaine + Guanfacine Then Lidocaine	19
Washout Period (14 Days)	COMPLETED	Lidocaine Then Lidocaine + Guanfacine	18
Washout Period (14 Days)	COMPLETED	Lidocaine + Guanfacine Then Lidocaine	19

1 to 10 of 18Source ClinicalTrials.gov

See all 18 participant flow

Adverse events6

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Hypertension	Vascular disorders	Lidocaine Alone	0	36	0
other	Hypertension	Vascular disorders	Lidocaine + Guanfacine	1	28	1
other	Left ear pressure after procedure	Ear and labyrinth disorders	Lidocaine Alone	1	36	1
other	Left ear pressure after procedure	Ear and labyrinth disorders	Lidocaine + Guanfacine	0	28	0
other	Facial brusing and sensitivity	Injury, poisoning and procedural complications	Lidocaine Alone	1	36	1
other	Facial brusing and sensitivity	Injury, poisoning and procedural complications	Lidocaine + Guanfacine	0	28	0

Source ClinicalTrials.gov

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Lidocaine Alone	0	36
Total, all-cause mortality	Lidocaine + Guanfacine	0	28
Total, other adverse events	Lidocaine Alone	2	36
Total, other adverse events	Lidocaine + Guanfacine	1	28
Total, serious adverse events	Lidocaine Alone	0	36
Total, serious adverse events	Lidocaine + Guanfacine	0	28

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
40326696	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Lidocaine Alone vs Lidocaine + Guanfacine: deaths from any cause	Trial comparisons
Lidocaine Alone vs Lidocaine + Guanfacine: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT03865940

GET https://conductscience.org/api/trials/v1/NCT03865940/results?page=2

API reference For AI assistants