Trial Outcomes & Findings for Efficacy of Guanfacine and Lidocaine Combination in Trigeminal Nerve Block for Pain Management in Trigeminal Neuropathy (NCT NCT03865940)
NCT ID: NCT03865940
Last Updated: 2025-03-30
Results Overview
Time (hours) until pain returns to baseline number.
COMPLETED
PHASE2
37 participants
up to 2 weeks
2025-03-30
Participant Flow
Participant milestones
| Measure |
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
|
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
|
|---|---|---|
|
First Intervention (14 Days)
STARTED
|
18
|
19
|
|
First Intervention (14 Days)
COMPLETED
|
18
|
19
|
|
First Intervention (14 Days)
NOT COMPLETED
|
0
|
0
|
|
Washout Period (14 Days)
STARTED
|
18
|
19
|
|
Washout Period (14 Days)
COMPLETED
|
18
|
19
|
|
Washout Period (14 Days)
NOT COMPLETED
|
0
|
0
|
|
Second Intervention (14 Days)
STARTED
|
18
|
19
|
|
Second Intervention (14 Days)
COMPLETED
|
10
|
18
|
|
Second Intervention (14 Days)
NOT COMPLETED
|
8
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Efficacy of Guanfacine and Lidocaine Combination in Trigeminal Nerve Block for Pain Management in Trigeminal Neuropathy
Baseline characteristics by cohort
| Measure |
Lidocaine Then Lidocaine + Guanfacine
n=18 Participants
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
|
Lidocaine + Guanfacine Then Lidocaine
n=19 Participants
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
|
Total
n=37 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
51.5 years
n=93 Participants
|
60.1 years
n=4 Participants
|
60.0 years
n=27 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=93 Participants
|
16 Participants
n=4 Participants
|
32 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
16 Participants
n=93 Participants
|
19 Participants
n=4 Participants
|
35 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
17 Participants
n=93 Participants
|
18 Participants
n=4 Participants
|
35 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
18 participants
n=93 Participants
|
19 participants
n=4 Participants
|
37 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: up to 2 weeksTime (hours) until pain returns to baseline number.
Outcome measures
| Measure |
Lidocaine Alone
n=36 Participants
Data from injection where participants received an injection of lidocaine ALONE.
|
Lidocaine + Guanfacine
n=28 Participants
Data from injection where participants received lidocaine + guanfacine.
|
|---|---|---|
|
Time to Return to Baseline Pain After Injection.
|
8 hours
Interval 4.0 to 120.0
|
5 hours
Interval 5.0 to 168.0
|
SECONDARY outcome
Timeframe: 8 hoursPopulation: 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.
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.
Outcome measures
| Measure |
Lidocaine Alone
n=36 Participants
Data from injection where participants received an injection of lidocaine ALONE.
|
Lidocaine + Guanfacine
n=28 Participants
Data from injection where participants received lidocaine + guanfacine.
|
|---|---|---|
|
Pain Intensity in Follow-Up
6.5 hours
|
3.42 score on a scale
Standard Deviation 2.17
|
2.81 score on a scale
Standard Deviation 2.23
|
|
Pain Intensity in Follow-Up
0 hours
|
6.75 score on a scale
Standard Deviation 1.56
|
6.63 score on a scale
Standard Deviation 1.43
|
|
Pain Intensity in Follow-Up
0.5 hours
|
1.91 score on a scale
Standard Deviation 2.31
|
1.88 score on a scale
Standard Deviation 2.72
|
|
Pain Intensity in Follow-Up
1 hour
|
2.24 score on a scale
Standard Deviation 2.2
|
1.54 score on a scale
Standard Deviation 2.25
|
|
Pain Intensity in Follow-Up
1.5 hours
|
2.83 score on a scale
Standard Deviation 2.6
|
1.42 score on a scale
Standard Deviation 1.98
|
|
Pain Intensity in Follow-Up
2 hours
|
2.47 score on a scale
Standard Deviation 2.26
|
1.81 score on a scale
Standard Deviation 2.11
|
|
Pain Intensity in Follow-Up
2.5 hours
|
2.7 score on a scale
Standard Deviation 2.53
|
2.21 score on a scale
Standard Deviation 2.45
|
|
Pain Intensity in Follow-Up
3 hours
|
2.84 score on a scale
Standard Deviation 2.38
|
2.4 score on a scale
Standard Deviation 2.61
|
|
Pain Intensity in Follow-Up
3.5 hours
|
3.03 score on a scale
Standard Deviation 2.37
|
2.38 score on a scale
Standard Deviation 2.45
|
|
Pain Intensity in Follow-Up
4 hours
|
2.74 score on a scale
Standard Deviation 2.18
|
2.04 score on a scale
Standard Deviation 2.49
|
|
Pain Intensity in Follow-Up
4.5 hours
|
2.79 score on a scale
Standard Deviation 2.18
|
2.29 score on a scale
Standard Deviation 2.41
|
|
Pain Intensity in Follow-Up
5 hours
|
3.65 score on a scale
Standard Deviation 2.12
|
2.58 score on a scale
Standard Deviation 2.44
|
|
Pain Intensity in Follow-Up
5.5 hours
|
3.69 score on a scale
Standard Deviation 2.14
|
3.0 score on a scale
Standard Deviation 2.81
|
|
Pain Intensity in Follow-Up
6 hours
|
3.31 score on a scale
Standard Deviation 2.24
|
2.67 score on a scale
Standard Deviation 2.45
|
|
Pain Intensity in Follow-Up
7 hours
|
3.76 score on a scale
Standard Deviation 2.4
|
2.79 score on a scale
Standard Deviation 2.17
|
|
Pain Intensity in Follow-Up
7.5 hours
|
3.52 score on a scale
Standard Deviation 2.65
|
2.85 score on a scale
Standard Deviation 2.19
|
|
Pain Intensity in Follow-Up
8 hours
|
3.56 score on a scale
Standard Deviation 2.53
|
2.68 score on a scale
Standard Deviation 2.25
|
SECONDARY outcome
Timeframe: 14 daysPopulation: 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.
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.
Outcome measures
| Measure |
Lidocaine Alone
n=36 Participants
Data from injection where participants received an injection of lidocaine ALONE.
|
Lidocaine + Guanfacine
n=28 Participants
Data from injection where participants received lidocaine + guanfacine.
|
|---|---|---|
|
Quality of Life, Physical Health
Day 0
|
40.35 T-score
Standard Deviation 6.66
|
39.86 T-score
Standard Deviation 6.07
|
|
Quality of Life, Physical Health
Day 7
|
42.88 T-score
Standard Deviation 6.47
|
43.2 T-score
Standard Deviation 6.3
|
|
Quality of Life, Physical Health
Day 14
|
42.83 T-score
Standard Deviation 7.89
|
41.67 T-score
Standard Deviation 7.16
|
SECONDARY outcome
Timeframe: 14 daysPopulation: 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.
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.
Outcome measures
| Measure |
Lidocaine Alone
n=36 Participants
Data from injection where participants received an injection of lidocaine ALONE.
|
Lidocaine + Guanfacine
n=28 Participants
Data from injection where participants received lidocaine + guanfacine.
|
|---|---|---|
|
Quality of Life, Mental Health
Day 0
|
44.98 T-score
Standard Deviation 10.47
|
44.4 T-score
Standard Deviation 8.93
|
|
Quality of Life, Mental Health
Day 7
|
44.34 T-score
Standard Deviation 8.42
|
46.07 T-score
Standard Deviation 8.42
|
|
Quality of Life, Mental Health
Day 14
|
43.78 T-score
Standard Deviation 7.91
|
45.72 T-score
Standard Deviation 9.91
|
SECONDARY outcome
Timeframe: 14 daysPopulation: 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.
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.
Outcome measures
| Measure |
Lidocaine Alone
n=36 Participants
Data from injection where participants received an injection of lidocaine ALONE.
|
Lidocaine + Guanfacine
n=28 Participants
Data from injection where participants received lidocaine + guanfacine.
|
|---|---|---|
|
Frequency of Nerve Pain Attacks
Day 7
|
3.64 units on a scale
Standard Deviation 1.11
|
3.70 units on a scale
Standard Deviation 1.17
|
|
Frequency of Nerve Pain Attacks
Day 14
|
3.61 units on a scale
Standard Deviation 1.15
|
3.81 units on a scale
Standard Deviation 0.83
|
SECONDARY outcome
Timeframe: 8 hoursPopulation: 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.
Number of participants using rescue medication during the 8-hour follow-up period
Outcome measures
| Measure |
Lidocaine Alone
n=36 Participants
Data from injection where participants received an injection of lidocaine ALONE.
|
Lidocaine + Guanfacine
n=28 Participants
Data from injection where participants received lidocaine + guanfacine.
|
|---|---|---|
|
Rescue Medication Use
2.5 hours
|
1 Participants
|
2 Participants
|
|
Rescue Medication Use
0 hours
|
16 Participants
|
12 Participants
|
|
Rescue Medication Use
0.5 hours
|
2 Participants
|
0 Participants
|
|
Rescue Medication Use
1 hour
|
0 Participants
|
1 Participants
|
|
Rescue Medication Use
1.5 hours
|
3 Participants
|
1 Participants
|
|
Rescue Medication Use
2 hours
|
3 Participants
|
0 Participants
|
|
Rescue Medication Use
3 hours
|
4 Participants
|
3 Participants
|
|
Rescue Medication Use
3.5 hours
|
1 Participants
|
1 Participants
|
|
Rescue Medication Use
4 hours
|
1 Participants
|
1 Participants
|
|
Rescue Medication Use
4.5 hours
|
3 Participants
|
2 Participants
|
|
Rescue Medication Use
5 hours
|
3 Participants
|
2 Participants
|
|
Rescue Medication Use
5.5 hours
|
2 Participants
|
1 Participants
|
|
Rescue Medication Use
6 hours
|
2 Participants
|
1 Participants
|
|
Rescue Medication Use
6.5 hours
|
1 Participants
|
3 Participants
|
|
Rescue Medication Use
7 hours
|
3 Participants
|
2 Participants
|
|
Rescue Medication Use
7.5 hours
|
5 Participants
|
2 Participants
|
|
Rescue Medication Use
8 hours
|
7 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 14 daysPopulation: Not all participants reported using rescue medication, so this analysis only includes participants that reported rescue medication use.
Time, in hours, to use of first rescue medication in the follow-up period following the injection.
Outcome measures
| Measure |
Lidocaine Alone
n=30 Participants
Data from injection where participants received an injection of lidocaine ALONE.
|
Lidocaine + Guanfacine
n=23 Participants
Data from injection where participants received lidocaine + guanfacine.
|
|---|---|---|
|
Time to First Rescue Medication
|
10.28 hours
Standard Deviation 23.54
|
23.76 hours
Standard Deviation 60.89
|
Adverse Events
Lidocaine Alone
Lidocaine + Guanfacine
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Lidocaine Alone
n=36 participants at risk
Data from injection where participants received an injection of lidocaine ALONE.
|
Lidocaine + Guanfacine
n=28 participants at risk
Data from injection where participants received lidocaine + guanfacine.
|
|---|---|---|
|
Vascular disorders
Hypertension
|
0.00%
0/36 • Up to 2 weeks after injection
|
3.6%
1/28 • Number of events 1 • Up to 2 weeks after injection
|
|
Ear and labyrinth disorders
Left ear pressure after procedure
|
2.8%
1/36 • Number of events 1 • Up to 2 weeks after injection
|
0.00%
0/28 • Up to 2 weeks after injection
|
|
Injury, poisoning and procedural complications
Facial brusing and sensitivity
|
2.8%
1/36 • Number of events 1 • Up to 2 weeks after injection
|
0.00%
0/28 • Up to 2 weeks after injection
|
Additional Information
Shelby Meier, PhD - Senior Scientific Project Manager
Vanderbilt University Medical Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place