Trial Outcomes & Findings for Dose Response Study of Dexamethasone in Combination With Bupivacaine 0.25% (NCT NCT01690663)
NCT ID: NCT01690663
Last Updated: 2017-05-04
Results Overview
This is defined as time from the completion of the block to the initiation of supplemental analgesia medications after hospital discharge. The patients were evaluated on different days to capture the exact end time, which was the initiation of supplemental analgesia medication. We intentionally contacted patients several times to capture the time as early as possible to minimize recall bias.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
89 participants
Primary outcome timeframe
days 1, 2, and day 7
Results posted on
2017-05-04
Participant Flow
Participant milestones
| Measure |
Bupivacaine 0.25% Mixed With 1ml Normal Saline
Bupivacaine 0.25% mixed with 1ml normal saline (placebo/control group)
Bupivacaine 0.25%
normal saline: placebo
|
Bupivacaine 0.25% With 1mg Dexamethasone (1ml)
Bupivacaine 0.25% mixed with 1mg preservative free dexamethasone (1ml)
Bupivacaine 0.25%
Dexamethasone
|
Bupivacaine 0.25% Mixed With 2mg Dexamethasone
Bupivacaine 0.25% mixed with 2mg preservative free dexamethasone (1ml)
Bupivacaine 0.25%
Dexamethasone
|
Bupivacaine 0.25% Mixed With 4mg Dexamethasone (1ml
Bupivacaine 0.25% mixed with 4mg preservative free dexamethasone (1ml
Bupivacaine 0.25%
Dexamethasone
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
23
|
20
|
22
|
24
|
|
Overall Study
COMPLETED
|
20
|
17
|
19
|
20
|
|
Overall Study
NOT COMPLETED
|
3
|
3
|
3
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Dose Response Study of Dexamethasone in Combination With Bupivacaine 0.25%
Baseline characteristics by cohort
| Measure |
Bupivacaine 0.25% Mixed With 1ml Normal Saline
n=23 Participants
Bupivacaine 0.25% mixed with 1ml normal saline (placebo/control group)
Bupivacaine 0.25%
normal saline: placebo
|
Bupivacaine 0.25% With 1mg Dexamethasone (1ml)
n=20 Participants
Bupivacaine 0.25% mixed with 1mg preservative free dexamethasone (1ml)
Bupivacaine 0.25%
Dexamethasone
|
Bupivacaine 0.25% Mixed With 2mg Dexamethasone
n=22 Participants
Bupivacaine 0.25% mixed with 2mg preservative free dexamethasone (1ml)
Bupivacaine 0.25%
Dexamethasone
|
Bupivacaine 0.25% Mixed With 4mg Dexamethasone (1ml
n=24 Participants
Bupivacaine 0.25% mixed with 4mg preservative free dexamethasone (1ml
Bupivacaine 0.25%
Dexamethasone
|
Total
n=89 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
23 Participants
n=99 Participants
|
20 Participants
n=107 Participants
|
22 Participants
n=206 Participants
|
24 Participants
n=7 Participants
|
89 Participants
n=31 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Age, Continuous
|
47.1 years
STANDARD_DEVIATION 11.3 • n=99 Participants
|
46.2 years
STANDARD_DEVIATION 11.8 • n=107 Participants
|
48.8 years
STANDARD_DEVIATION 14.1 • n=206 Participants
|
53.0 years
STANDARD_DEVIATION 12.5 • n=7 Participants
|
48.4 years
STANDARD_DEVIATION 12.4 • n=31 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
5 Participants
n=7 Participants
|
22 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
19 Participants
n=7 Participants
|
67 Participants
n=31 Participants
|
|
Region of Enrollment
United States
|
23 participants
n=99 Participants
|
20 participants
n=107 Participants
|
22 participants
n=206 Participants
|
24 participants
n=7 Participants
|
89 participants
n=31 Participants
|
|
BMI
|
30.4 kg/m2
STANDARD_DEVIATION 6.6 • n=99 Participants
|
29.4 kg/m2
STANDARD_DEVIATION 4.0 • n=107 Participants
|
28.9 kg/m2
STANDARD_DEVIATION 4.4 • n=206 Participants
|
31.0 kg/m2
STANDARD_DEVIATION 6.3 • n=7 Participants
|
30.3 kg/m2
STANDARD_DEVIATION 5.7 • n=31 Participants
|
PRIMARY outcome
Timeframe: days 1, 2, and day 7This is defined as time from the completion of the block to the initiation of supplemental analgesia medications after hospital discharge. The patients were evaluated on different days to capture the exact end time, which was the initiation of supplemental analgesia medication. We intentionally contacted patients several times to capture the time as early as possible to minimize recall bias.
Outcome measures
| Measure |
Bupivacaine 0.25% Mixed With 1ml Normal Saline
n=20 Participants
Bupivacaine 0.25% mixed with 1ml normal saline (placebo/control group)
Bupivacaine 0.25%
normal saline: placebo
|
Bupivacaine 0.25% With 1mg Dexamethasone (1ml)
n=17 Participants
Bupivacaine 0.25% mixed with 1mg preservative free dexamethasone (1ml)
Bupivacaine 0.25%
Dexamethasone
|
Bupivacaine 0.25% Mixed With 2mg Dexamethasone
n=19 Participants
Bupivacaine 0.25% mixed with 2mg preservative free dexamethasone (1ml)
Bupivacaine 0.25%
Dexamethasone
|
Bupivacaine 0.25% Mixed With 4mg Dexamethasone (1ml
n=20 Participants
Bupivacaine 0.25% mixed with 4mg preservative free dexamethasone (1ml
Bupivacaine 0.25%
Dexamethasone
|
|---|---|---|---|---|
|
Primary Outcome Variable is Post Operative Sensory Block Duration
|
12.1 hours
Interval 9.8 to 20.9
|
22.3 hours
Interval 19.0 to 24.9
|
23.3 hours
Interval 19.5 to 26.8
|
21.2 hours
Interval 16.8 to 23.9
|
SECONDARY outcome
Timeframe: days 1, 2, and day 7This is defined as time from the completion of the block to the time when patient is able to move his or her forearm and/or hands. The patients were evaluated on different days to capture the exact end time, which was the initiation of supplemental analgesia medication. We intentionally contacted patients several times to capture the time as early as possible to minimize recall bias.
Outcome measures
| Measure |
Bupivacaine 0.25% Mixed With 1ml Normal Saline
n=20 Participants
Bupivacaine 0.25% mixed with 1ml normal saline (placebo/control group)
Bupivacaine 0.25%
normal saline: placebo
|
Bupivacaine 0.25% With 1mg Dexamethasone (1ml)
n=17 Participants
Bupivacaine 0.25% mixed with 1mg preservative free dexamethasone (1ml)
Bupivacaine 0.25%
Dexamethasone
|
Bupivacaine 0.25% Mixed With 2mg Dexamethasone
n=19 Participants
Bupivacaine 0.25% mixed with 2mg preservative free dexamethasone (1ml)
Bupivacaine 0.25%
Dexamethasone
|
Bupivacaine 0.25% Mixed With 4mg Dexamethasone (1ml
n=20 Participants
Bupivacaine 0.25% mixed with 4mg preservative free dexamethasone (1ml
Bupivacaine 0.25%
Dexamethasone
|
|---|---|---|---|---|
|
The Secondary Outcome Variable is Post Operative Motor Block Duration
|
12.1 hours
Interval 8.9 to 19.4
|
21 hours
Interval 16.8 to 22.7
|
20.9 hours
Interval 16.1 to 23.7
|
19.4 hours
Interval 14.9 to 23.2
|
Adverse Events
Bupivacaine 0.25% Mixed With 1ml Normal Saline
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Bupivacaine 0.25% With 1mg Dexamethasone (1ml)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Bupivacaine 0.25% Mixed With 2mg Dexamethasone
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Bupivacaine 0.25% Mixed With 4mg Dexamethasone (1ml
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