Trial Outcomes & Findings for Duration of Analgesia After Popliteal Fossa Nerve Blockade: Effects of Dexamethasone and Buprenorphine (NCT NCT01277159)
NCT ID: NCT01277159
Last Updated: 2022-04-14
Results Overview
Does adding dexamethasone and / or buprenorphine prolong the analgesia provided by a popliteal fossa nerve block?
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
108 participants
Primary outcome timeframe
up to 72 hours
Results posted on
2022-04-14
Participant Flow
Participant milestones
| Measure |
Control Nerve Block. IV Dexamethasone (4 mg).
Control Nerve Block. IV Dexamethasone (4 mg).
A. Control Nerve Block. IV Dexamethasone (4 mg).: A. Control Nerve Block. IV Dexamethasone (4 mg).
|
Nerve Block With Dexamethasone (4 mg). IV Saline.
B. Nerve Block with Dexamethasone (4 mg). IV saline.
B. Nerve Block with Dexamethasone (4 mg). IV saline.: B. Nerve Block with Dexamethasone (4 mg). IV saline.
|
Control Nerve Block. IV Dexamethasone (4 mg). IV Buprenorp
Control Nerve Block. IV Dexamethasone (4 mg). IV Buprenorphine (0.3 mg)
C. Control Nerve Block. IV Dexamethasone (4 mg). IV Buprenorphine (0.3 mg): C. Control Nerve Block. IV Dexamethasone (4 mg). IV Buprenorphine (0.3 mg)
|
Nerve Block With Buprenorphine (0.3 mg). IV Dexamethasone (
Nerve Block with Buprenorphine (0.3 mg). IV Dexamethasone (4 mg).
D. Nerve Block with Buprenorphine (0.3 mg). IV Dexamethasone (4 mg).: D. Nerve Block with Buprenorphine (0.3 mg). IV Dexamethasone (4 mg).
|
Nerve Block With Dexamethasone (4 mg) / Block Buprenorphine
Nerve Block with Dexamethasone (4 mg) / block Buprenorphine (0.3 mg). IV saline.
E. Nerve Block with Dexamethasone (4 mg) / block Buprenorphine (0.3 mg).: E. Nerve Block with Dexamethasone (4 mg) / block Buprenorphine (0.3 mg).
IV saline.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
21
|
22
|
22
|
22
|
21
|
|
Overall Study
COMPLETED
|
17
|
21
|
19
|
19
|
16
|
|
Overall Study
NOT COMPLETED
|
4
|
1
|
3
|
3
|
5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Control Nerve Block. IV Dexamethasone (4 mg).
n=17 Participants
Control Nerve Block. IV Dexamethasone (4 mg).
A. Control Nerve Block. IV Dexamethasone (4 mg).: A. Control Nerve Block. IV Dexamethasone (4 mg).
|
Nerve Block With Dexamethasone (4 mg). IV Saline.
n=21 Participants
B. Nerve Block with Dexamethasone (4 mg). IV saline.
B. Nerve Block with Dexamethasone (4 mg). IV saline.: B. Nerve Block with Dexamethasone (4 mg). IV saline.
|
Control Nerve Block. IV Dexamethasone (4 mg). IV Buprenorp
n=19 Participants
Control Nerve Block. IV Dexamethasone (4 mg). IV Buprenorphine (0.3 mg)
C. Control Nerve Block. IV Dexamethasone (4 mg). IV Buprenorphine (0.3 mg): C. Control Nerve Block. IV Dexamethasone (4 mg). IV Buprenorphine (0.3 mg)
|
Nerve Block With Buprenorphine (0.3 mg). IV Dexamethasone (
n=19 Participants
Nerve Block with Buprenorphine (0.3 mg). IV Dexamethasone (4 mg).
D. Nerve Block with Buprenorphine (0.3 mg). IV Dexamethasone (4 mg).: D. Nerve Block with Buprenorphine (0.3 mg). IV Dexamethasone (4 mg).
|
Nerve Block With Dexamethasone (4 mg) / Block Buprenorphine
n=16 Participants
Nerve Block with Dexamethasone (4 mg) / block Buprenorphine (0.3 mg). IV saline.
E. Nerve Block with Dexamethasone (4 mg) / block Buprenorphine (0.3 mg).: E. Nerve Block with Dexamethasone (4 mg) / block Buprenorphine (0.3 mg).
IV saline.
|
Total
n=92 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
51.29 years
STANDARD_DEVIATION 6.8 • n=17 Participants
|
47.81 years
STANDARD_DEVIATION 9.5 • n=21 Participants
|
46.26 years
STANDARD_DEVIATION 7.5 • n=19 Participants
|
47.95 years
STANDARD_DEVIATION 8.6 • n=19 Participants
|
52.19 years
STANDARD_DEVIATION 7.2 • n=16 Participants
|
49.1 years
STANDARD_DEVIATION 8.6 • n=92 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=17 Participants
|
13 Participants
n=21 Participants
|
10 Participants
n=19 Participants
|
14 Participants
n=19 Participants
|
13 Participants
n=16 Participants
|
61 Participants
n=92 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=17 Participants
|
8 Participants
n=21 Participants
|
9 Participants
n=19 Participants
|
5 Participants
n=19 Participants
|
3 Participants
n=16 Participants
|
31 Participants
n=92 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: up to 72 hoursDoes adding dexamethasone and / or buprenorphine prolong the analgesia provided by a popliteal fossa nerve block?
Outcome measures
| Measure |
Control Nerve Block. IV Dexamethasone (4 mg).
n=17 Participants
Control Nerve Block. IV Dexamethasone (4 mg).
A. Control Nerve Block. IV Dexamethasone (4 mg).: A. Control Nerve Block. IV Dexamethasone (4 mg).
|
Nerve Block With Dexamethasone (4 mg). IV Saline.
n=21 Participants
B. Nerve Block with Dexamethasone (4 mg). IV saline.
B. Nerve Block with Dexamethasone (4 mg). IV saline.: B. Nerve Block with Dexamethasone (4 mg). IV saline.
|
Control Nerve Block. IV Dexamethasone (4 mg). IV Buprenorp
n=19 Participants
Control Nerve Block. IV Dexamethasone (4 mg). IV Buprenorphine (0.3 mg)
C. Control Nerve Block. IV Dexamethasone (4 mg). IV Buprenorphine (0.3 mg): C. Control Nerve Block. IV Dexamethasone (4 mg). IV Buprenorphine (0.3 mg)
|
Nerve Block With Buprenorphine (0.3 mg). IV Dexamethasone (
n=19 Participants
Nerve Block with Buprenorphine (0.3 mg). IV Dexamethasone (4 mg).
D. Nerve Block with Buprenorphine (0.3 mg). IV Dexamethasone (4 mg).: D. Nerve Block with Buprenorphine (0.3 mg). IV Dexamethasone (4 mg).
|
Nerve Block With Dexamethasone (4 mg) / Block Buprenorphine
n=16 Participants
Nerve Block with Dexamethasone (4 mg) / block Buprenorphine (0.3 mg). IV saline.
E. Nerve Block with Dexamethasone (4 mg) / block Buprenorphine (0.3 mg).: E. Nerve Block with Dexamethasone (4 mg) / block Buprenorphine (0.3 mg).
IV saline.
|
|---|---|---|---|---|---|
|
Time it Takes for Nerve Block to Wear Off
|
30.4 hours
Standard Deviation 5.1
|
45.1 hours
Standard Deviation 5.2
|
32.2 hours
Standard Deviation 6.1
|
45.6 hours
Standard Deviation 5.6
|
45.6 hours
Standard Deviation 5.8
|
Adverse Events
Control Nerve Block. IV Dexamethasone (4 mg).
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Nerve Block With Dexamethasone (4 mg). IV Saline.
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control Nerve Block. IV Dexamethasone (4 mg). IV Buprenorp
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Nerve Block With Buprenorphine (0.3 mg). IV Dexamethasone (
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Nerve Block With Dexamethasone (4 mg) / Block Buprenorphine
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