Trial Outcomes & Findings for Perineural Steroids for Peripheral Nerve Blocks (NCT NCT02462148)
NCT ID: NCT02462148
Last Updated: 2018-09-24
Results Overview
The primary outcome will be time to resolution of the nerve block as assessed by pinprick over the saphenous nerve distribution. Testing will occur every two hours.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
85 participants
Primary outcome timeframe
12 to 48 hours
Results posted on
2018-09-24
Participant Flow
Participant milestones
| Measure |
4 mg Perineural Dexamethasone Group
4 mg of dexamethasone will be included in the saphenous nerve block mixture including 20 ml of 0.25% bupivacaine with 1:400,000 epinephrine. No systemic dexamethasone will be given.
Dexamethasone: Used in nerve block mixture
Bupivacaine: Used in nerve block mixture
Epinephrine: Used in nerve block mixture
Saphenous Peripheral Nerve Block: Peripheral nerve block.
|
1 mg Perineural Dexamethasone Group
1 mg of dexamethasone will be included in the saphenous nerve block mixture including 20 ml of 0.25% bupivacaine with 1:400,000 epinephrine. No systemic dexamethasone will be given.
Dexamethasone: Used in nerve block mixture
Bupivacaine: Used in nerve block mixture
Epinephrine: Used in nerve block mixture
Saphenous Peripheral Nerve Block: Peripheral nerve block.
|
Placebo Group
This group will receive only the saphenous nerve block mixture including 20 ml of 0.25% bupivacaine with 1:400,000 epinephrine. Dexamethasone will not be administered to this group systemically or perineural.
Bupivacaine: Used in nerve block mixture
Epinephrine: Used in nerve block mixture
Saphenous Peripheral Nerve Block: Peripheral nerve block.
|
|---|---|---|---|
|
Overall Study
STARTED
|
37
|
36
|
12
|
|
Overall Study
COMPLETED
|
36
|
36
|
12
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Perineural Steroids for Peripheral Nerve Blocks
Baseline characteristics by cohort
| Measure |
4 mg Perineural Dexamethasone Group
n=36 Participants
4 mg of dexamethasone will be included in the saphenous nerve block mixture including 20 ml of 0.25% bupivacaine with 1:400,000 epinephrine. No systemic dexamethasone will be given.
Dexamethasone: Used in nerve block mixture
Bupivacaine: Used in nerve block mixture
Epinephrine: Used in nerve block mixture
Saphenous Peripheral Nerve Block: Peripheral nerve block.
|
1 mg Perineural Dexamethasone Group
n=36 Participants
1 mg of dexamethasone will be included in the saphenous nerve block mixture including 20 ml of 0.25% bupivacaine with 1:400,000 epinephrine. No systemic dexamethasone will be given.
Dexamethasone: Used in nerve block mixture
Bupivacaine: Used in nerve block mixture
Epinephrine: Used in nerve block mixture
Saphenous Peripheral Nerve Block: Peripheral nerve block.
|
Placebo Group
n=12 Participants
This group will receive only the saphenous nerve block mixture including 20 ml of 0.25% bupivacaine with 1:400,000 epinephrine. Dexamethasone will not be administered to this group systemically or perineural.
Bupivacaine: Used in nerve block mixture
Epinephrine: Used in nerve block mixture
Saphenous Peripheral Nerve Block: Peripheral nerve block.
|
Total
n=84 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
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
23 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
52 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
13 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
32 Participants
n=4 Participants
|
|
Age, Continuous
|
62.8 years
STANDARD_DEVIATION 8.7 • n=5 Participants
|
63.3 years
STANDARD_DEVIATION 8.9 • n=7 Participants
|
59.2 years
STANDARD_DEVIATION 9.1 • n=5 Participants
|
62.7 years
STANDARD_DEVIATION 8.9 • n=4 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
41 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
43 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
36 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
84 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 12 to 48 hoursThe primary outcome will be time to resolution of the nerve block as assessed by pinprick over the saphenous nerve distribution. Testing will occur every two hours.
Outcome measures
| Measure |
4 mg Perineural Dexamethasone Group
n=36 Participants
4 mg of dexamethasone will be included in the saphenous nerve block mixture including 20 ml of 0.25% bupivacaine with 1:400,000 epinephrine. No systemic dexamethasone will be given.
Dexamethasone: Used in nerve block mixture
Bupivacaine: Used in nerve block mixture
Epinephrine: Used in nerve block mixture
Saphenous Peripheral Nerve Block: Peripheral nerve block.
|
1 mg Perineural Dexamethasone Group
n=36 Participants
1 mg of dexamethasone will be included in the saphenous nerve block mixture including 20 ml of 0.25% bupivacaine with 1:400,000 epinephrine. No systemic dexamethasone will be given.
Dexamethasone: Used in nerve block mixture
Bupivacaine: Used in nerve block mixture
Epinephrine: Used in nerve block mixture
Saphenous Peripheral Nerve Block: Peripheral nerve block.
|
Placebo Group
n=12 Participants
This group will receive only the saphenous nerve block mixture including 20 ml of 0.25% bupivacaine with 1:400,000 epinephrine. Dexamethasone will not be administered to this group systemically or perineural.
Bupivacaine: Used in nerve block mixture
Epinephrine: Used in nerve block mixture
Saphenous Peripheral Nerve Block: Peripheral nerve block.
|
|---|---|---|---|
|
Duration of Sensory Nerve Block
|
37.00 hours
Standard Deviation 11.18
|
31.75 hours
Standard Deviation 10.50
|
29.67 hours
Standard Deviation 6.76
|
SECONDARY outcome
Timeframe: 0 to 30 hoursVerbal Pain Scores will be compared between groups as obtained every six hours during hospitalization. Patients will be asked to provide verbal pain scores both at rest and with movement on a scale of 0-10 (0 being no pain and 10 being the worst pain). These scores will be taken at 0, 6, 12, 18, 24, and 30 hours.
Outcome measures
| Measure |
4 mg Perineural Dexamethasone Group
n=36 Participants
4 mg of dexamethasone will be included in the saphenous nerve block mixture including 20 ml of 0.25% bupivacaine with 1:400,000 epinephrine. No systemic dexamethasone will be given.
Dexamethasone: Used in nerve block mixture
Bupivacaine: Used in nerve block mixture
Epinephrine: Used in nerve block mixture
Saphenous Peripheral Nerve Block: Peripheral nerve block.
|
1 mg Perineural Dexamethasone Group
n=36 Participants
1 mg of dexamethasone will be included in the saphenous nerve block mixture including 20 ml of 0.25% bupivacaine with 1:400,000 epinephrine. No systemic dexamethasone will be given.
Dexamethasone: Used in nerve block mixture
Bupivacaine: Used in nerve block mixture
Epinephrine: Used in nerve block mixture
Saphenous Peripheral Nerve Block: Peripheral nerve block.
|
Placebo Group
n=12 Participants
This group will receive only the saphenous nerve block mixture including 20 ml of 0.25% bupivacaine with 1:400,000 epinephrine. Dexamethasone will not be administered to this group systemically or perineural.
Bupivacaine: Used in nerve block mixture
Epinephrine: Used in nerve block mixture
Saphenous Peripheral Nerve Block: Peripheral nerve block.
|
|---|---|---|---|
|
Verbal Pain Scores
0h
|
2.1 units on a scale
Standard Deviation 2.5
|
2.3 units on a scale
Standard Deviation 2.5
|
2.1 units on a scale
Standard Deviation 2.4
|
|
Verbal Pain Scores
6h
|
0.8 units on a scale
Standard Deviation 1.7
|
1.3 units on a scale
Standard Deviation 2.3
|
1.1 units on a scale
Standard Deviation 2.1
|
|
Verbal Pain Scores
12h
|
1.7 units on a scale
Standard Deviation 1.8
|
2.1 units on a scale
Standard Deviation 2.5
|
3.0 units on a scale
Standard Deviation 2.6
|
|
Verbal Pain Scores
18h
|
1.6 units on a scale
Standard Deviation 1.9
|
1.8 units on a scale
Standard Deviation 2.1
|
3.3 units on a scale
Standard Deviation 2.6
|
|
Verbal Pain Scores
24h
|
1.5 units on a scale
Standard Deviation 1.7
|
1.8 units on a scale
Standard Deviation 2.0
|
3.1 units on a scale
Standard Deviation 2.0
|
|
Verbal Pain Scores
30h
|
2.4 units on a scale
Standard Deviation 2.2
|
3.1 units on a scale
Standard Deviation 2.7
|
4.3 units on a scale
Standard Deviation 2.3
|
SECONDARY outcome
Timeframe: 0 to 30 hoursNumber of participants that experienced nausea and vomiting was recorded.
Outcome measures
| Measure |
4 mg Perineural Dexamethasone Group
n=36 Participants
4 mg of dexamethasone will be included in the saphenous nerve block mixture including 20 ml of 0.25% bupivacaine with 1:400,000 epinephrine. No systemic dexamethasone will be given.
Dexamethasone: Used in nerve block mixture
Bupivacaine: Used in nerve block mixture
Epinephrine: Used in nerve block mixture
Saphenous Peripheral Nerve Block: Peripheral nerve block.
|
1 mg Perineural Dexamethasone Group
n=36 Participants
1 mg of dexamethasone will be included in the saphenous nerve block mixture including 20 ml of 0.25% bupivacaine with 1:400,000 epinephrine. No systemic dexamethasone will be given.
Dexamethasone: Used in nerve block mixture
Bupivacaine: Used in nerve block mixture
Epinephrine: Used in nerve block mixture
Saphenous Peripheral Nerve Block: Peripheral nerve block.
|
Placebo Group
n=12 Participants
This group will receive only the saphenous nerve block mixture including 20 ml of 0.25% bupivacaine with 1:400,000 epinephrine. Dexamethasone will not be administered to this group systemically or perineural.
Bupivacaine: Used in nerve block mixture
Epinephrine: Used in nerve block mixture
Saphenous Peripheral Nerve Block: Peripheral nerve block.
|
|---|---|---|---|
|
Rate of Post Operative Nausea and Vomiting
|
5 Participants
|
14 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: throughout study completion, up to 48 hoursEach patient will be followed for neurologic complications (paresthesias, etc) if they should occur.
Outcome measures
| Measure |
4 mg Perineural Dexamethasone Group
n=36 Participants
4 mg of dexamethasone will be included in the saphenous nerve block mixture including 20 ml of 0.25% bupivacaine with 1:400,000 epinephrine. No systemic dexamethasone will be given.
Dexamethasone: Used in nerve block mixture
Bupivacaine: Used in nerve block mixture
Epinephrine: Used in nerve block mixture
Saphenous Peripheral Nerve Block: Peripheral nerve block.
|
1 mg Perineural Dexamethasone Group
n=36 Participants
1 mg of dexamethasone will be included in the saphenous nerve block mixture including 20 ml of 0.25% bupivacaine with 1:400,000 epinephrine. No systemic dexamethasone will be given.
Dexamethasone: Used in nerve block mixture
Bupivacaine: Used in nerve block mixture
Epinephrine: Used in nerve block mixture
Saphenous Peripheral Nerve Block: Peripheral nerve block.
|
Placebo Group
n=12 Participants
This group will receive only the saphenous nerve block mixture including 20 ml of 0.25% bupivacaine with 1:400,000 epinephrine. Dexamethasone will not be administered to this group systemically or perineural.
Bupivacaine: Used in nerve block mixture
Epinephrine: Used in nerve block mixture
Saphenous Peripheral Nerve Block: Peripheral nerve block.
|
|---|---|---|---|
|
Neurologic Complications
|
0 neurological complications
Standard Deviation 0
|
0 neurological complications
Standard Deviation 0
|
0 neurological complications
Standard Deviation 0
|
SECONDARY outcome
Timeframe: 0-30 hoursAmount of opioid use and consumption was recorded.
Outcome measures
| Measure |
4 mg Perineural Dexamethasone Group
n=36 Participants
4 mg of dexamethasone will be included in the saphenous nerve block mixture including 20 ml of 0.25% bupivacaine with 1:400,000 epinephrine. No systemic dexamethasone will be given.
Dexamethasone: Used in nerve block mixture
Bupivacaine: Used in nerve block mixture
Epinephrine: Used in nerve block mixture
Saphenous Peripheral Nerve Block: Peripheral nerve block.
|
1 mg Perineural Dexamethasone Group
n=36 Participants
1 mg of dexamethasone will be included in the saphenous nerve block mixture including 20 ml of 0.25% bupivacaine with 1:400,000 epinephrine. No systemic dexamethasone will be given.
Dexamethasone: Used in nerve block mixture
Bupivacaine: Used in nerve block mixture
Epinephrine: Used in nerve block mixture
Saphenous Peripheral Nerve Block: Peripheral nerve block.
|
Placebo Group
n=12 Participants
This group will receive only the saphenous nerve block mixture including 20 ml of 0.25% bupivacaine with 1:400,000 epinephrine. Dexamethasone will not be administered to this group systemically or perineural.
Bupivacaine: Used in nerve block mixture
Epinephrine: Used in nerve block mixture
Saphenous Peripheral Nerve Block: Peripheral nerve block.
|
|---|---|---|---|
|
Post Operative Opioid Use and Consumption
|
27.16 mg oxycodone equivalents
Standard Deviation 24.35
|
26.04 mg oxycodone equivalents
Standard Deviation 24.81
|
42.33 mg oxycodone equivalents
Standard Deviation 26.30
|
SECONDARY outcome
Timeframe: 0 to 36 hoursTime it took for the first opioid analgesic request was recorded.
Outcome measures
| Measure |
4 mg Perineural Dexamethasone Group
n=36 Participants
4 mg of dexamethasone will be included in the saphenous nerve block mixture including 20 ml of 0.25% bupivacaine with 1:400,000 epinephrine. No systemic dexamethasone will be given.
Dexamethasone: Used in nerve block mixture
Bupivacaine: Used in nerve block mixture
Epinephrine: Used in nerve block mixture
Saphenous Peripheral Nerve Block: Peripheral nerve block.
|
1 mg Perineural Dexamethasone Group
n=36 Participants
1 mg of dexamethasone will be included in the saphenous nerve block mixture including 20 ml of 0.25% bupivacaine with 1:400,000 epinephrine. No systemic dexamethasone will be given.
Dexamethasone: Used in nerve block mixture
Bupivacaine: Used in nerve block mixture
Epinephrine: Used in nerve block mixture
Saphenous Peripheral Nerve Block: Peripheral nerve block.
|
Placebo Group
n=12 Participants
This group will receive only the saphenous nerve block mixture including 20 ml of 0.25% bupivacaine with 1:400,000 epinephrine. Dexamethasone will not be administered to this group systemically or perineural.
Bupivacaine: Used in nerve block mixture
Epinephrine: Used in nerve block mixture
Saphenous Peripheral Nerve Block: Peripheral nerve block.
|
|---|---|---|---|
|
Time to First Opioid Analgesic Request
|
686.18 minutes
Standard Deviation 420.41
|
654.97 minutes
Standard Deviation 384.05
|
658.17 minutes
Standard Deviation 424.66
|
Adverse Events
4 mg Perineural Dexamethasone Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
1 mg Perineural Dexamethasone Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place