Trial Outcomes & Findings for Ultrasound Guided Trigeminal Nerve Block for Typical or Atypical Facial Pain (NCT NCT02024724)
NCT ID: NCT02024724
Last Updated: 2017-07-11
Results Overview
The number of subjects reporting a minimum of 50% pain relief after receiving the injection.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
60 participants
Primary outcome timeframe
2 weeks
Results posted on
2017-07-11
Participant Flow
Participant milestones
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
30
|
30
|
|
Overall Study
COMPLETED
|
29
|
30
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Ultrasound Guided Trigeminal Nerve Block for Typical or Atypical Facial Pain
Baseline characteristics by cohort
| Measure |
Group 2
n=30 Participants
4 mg of Dexamethasone and 4 mL of 0.25% bupivacaine
Bupivacaine: 4 mL of 0.25% bupivacaine
Dexamethasone: 4 mg of Dexamethasone
|
Group 1
n=30 Participants
40 mg of Triamcinolone and 4 mL of 0.25% bupivacaine
Bupivacaine: 4 mL of 0.25% bupivacaine
Triamcinolone: 40 mg of Triamcinolone
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
23 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
7 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
21 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African American
|
6 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 weeksPopulation: Subjects reported percent relief at 2 weeks from receiving the ultrasound guided injection.
The number of subjects reporting a minimum of 50% pain relief after receiving the injection.
Outcome measures
| Measure |
Group 1
n=29 Participants
4 mg of Dexamethasone and 4 mL of 0.25% bupivacaine
Bupivacaine: 4 mL of 0.25% bupivacaine
Dexamethasone: 4 mg of Dexamethasone
|
Group 2
n=30 Participants
40 mg of Triamcinolone and 4 mL of 0.25% bupivacaine
Bupivacaine: 4 mL of 0.25% bupivacaine
Triamcinolone: 40 mg of Triamcinolone
|
|---|---|---|
|
The Proportion of Subjects Reporting at Least 50% Overall Pain Relief
Greater than 50% Pain Relief Reported
|
19 Participants
|
14 Participants
|
|
The Proportion of Subjects Reporting at Least 50% Overall Pain Relief
Less than 50% Pain Relief Reported
|
10 Participants
|
16 Participants
|
Adverse Events
Group 1
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group 2
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Group 1
n=29 participants at risk
4 mg of Dexamethasone and 4 mL of 0.25% bupivacaine
Bupivacaine: 4 mL of 0.25% bupivacaine
Dexamethasone: 4 mg of Dexamethasone
|
Group 2
n=30 participants at risk
40 mg of Triamcinolone and 4 mL of 0.25% bupivacaine
Bupivacaine: 4 mL of 0.25% bupivacaine
Triamcinolone: 40 mg of Triamcinolone
|
|---|---|---|
|
Nervous system disorders
Transient numbing of the facial nerve
|
0.00%
0/29
|
3.3%
1/30 • Number of events 1
|
Additional Information
Antoun Nader, M.D.
Northwestern University, Feinberg School of Medicine
Phone: 312-695-4814
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place