Atypical Facial Pain, Typical Facial Pain
Conditions
Brief summary
Trigeminal neuralgia is a craniofacial pain syndrome that is typically characterized by unilateral severe, recurrent, electrical pain in one or more distributions of the trigeminal nerve. Current treatment strategies include oral medications as first line therapy with surgical interventions reserved for those patients who are refractory to medications or unable to tolerate medication side effects. Despite these current treatment options, many patients continue to have symptoms. Ultrasound-guided trigeminal nerve block allows for fine adjustment of the needle tip and direct observation of the medicine. Local anesthetic and steroids have been successfully used for diagnostic and or therapeutic nerve pain with great success. Steroids can be short or long acting in duration with varying side effects. If there exists a difference in duration of action, using the longer acting drug will provide a greater period of symptom relief for the patient and may allow the patient to undergo fewer interventional procedures.
Interventions
DRUGBupivacaine
4 mL of 0.25% bupivacaine
DRUGTriamcinolone
40 mg of Triamcinolone
DRUGDexamethasone
4 mg of Dexamethasone
Sponsors
Northwestern University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* All patients presenting to the Northwestern Pain Center who are eligible and scheduled to receive a ultrasound-guided trigeminal nerve block.
Exclusion criteria
* Exclusion is the same for patients who are not eligible for ultrasound guided nerve blocks.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Proportion of Subjects Reporting at Least 50% Overall Pain Relief | 2 weeks | The number of subjects reporting a minimum of 50% pain relief after receiving the injection. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Group 2 4 mg of Dexamethasone and 4 mL of 0.25% bupivacaine
Bupivacaine: 4 mL of 0.25% bupivacaine
Dexamethasone: 4 mg of Dexamethasone | 30 |
| Group 1 40 mg of Triamcinolone and 4 mL of 0.25% bupivacaine
Bupivacaine: 4 mL of 0.25% bupivacaine
Triamcinolone: 40 mg of Triamcinolone | 30 |
| Total | 60 |
Baseline characteristics
| Characteristic | Group 2 | Group 1 | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 7 Participants | 13 Participants | 20 Participants |
| Age, Categorical Between 18 and 65 years | 23 Participants | 17 Participants | 40 Participants |
| Race/Ethnicity, Customized African American | 6 Participants | 2 Participants | 8 Participants |
| Race/Ethnicity, Customized Asian | 1 Participants | 1 Participants | 2 Participants |
| Race/Ethnicity, Customized Caucasian | 21 Participants | 26 Participants | 47 Participants |
| Race/Ethnicity, Customized Hispanic | 2 Participants | 1 Participants | 3 Participants |
| Sex: Female, Male Female | 19 Participants | 22 Participants | 41 Participants |
| Sex: Female, Male Male | 11 Participants | 8 Participants | 19 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 29 | 0 / 30 |
| other Total, other adverse events | 0 / 29 | 1 / 30 |
| serious Total, serious adverse events | 0 / 29 | 0 / 30 |
Outcome results
Primary
The Proportion of Subjects Reporting at Least 50% Overall Pain Relief
The number of subjects reporting a minimum of 50% pain relief after receiving the injection.
Time frame: 2 weeks
Population: Subjects reported percent relief at 2 weeks from receiving the ultrasound guided injection.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1 | The Proportion of Subjects Reporting at Least 50% Overall Pain Relief | Greater than 50% Pain Relief Reported | 19 Participants |
| Group 1 | The Proportion of Subjects Reporting at Least 50% Overall Pain Relief | Less than 50% Pain Relief Reported | 10 Participants |
| Group 2 | The Proportion of Subjects Reporting at Least 50% Overall Pain Relief | Greater than 50% Pain Relief Reported | 14 Participants |
| Group 2 | The Proportion of Subjects Reporting at Least 50% Overall Pain Relief | Less than 50% Pain Relief Reported | 16 Participants |
p-value: 0.19695% CI: [-45, 10]Chi-squared