Trial Outcomes & Findings for The Effect of Dexamethasone on the Duration of Interscalene Nerve Blocks With Ropivacaine or Bupivacaine (NCT NCT00801138)
NCT ID: NCT00801138
Last Updated: 2017-05-01
Results Overview
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
218 participants
Primary outcome timeframe
Postoperative day 1, 2 and 3
Results posted on
2017-05-01
Participant Flow
Participant milestones
| Measure |
Group 1
Group 1 Ropivacaine: 30 ml 0.5% ropivacaine plus 2 ml 0.9% saline for interscalene block
Ropivacaine
Placebo: saline
|
Group 2
Group 2 Bupivacaine: 30 ml 0.5% bupivacaine plus 2 ml 0.9% saline
Bupivacaine
Placebo: saline
|
Group 3
Group 3 Ropivacaine and dexamethasone:
Ropivacaine plus dexamethasone
Ropivacaine
Dexamethasone: steroid
|
Group 4
Group 4 Bupivacaine and steroid:
Bupivacaine plus dexamethasone
Bupivacaine
Dexamethasone: steroid
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
54
|
56
|
54
|
54
|
|
Overall Study
COMPLETED
|
54
|
56
|
54
|
54
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Effect of Dexamethasone on the Duration of Interscalene Nerve Blocks With Ropivacaine or Bupivacaine
Baseline characteristics by cohort
| Measure |
Group 1
n=54 Participants
Group 1 Ropivacaine: 30 ml 0.5% ropivacaine plus 2 ml 0.9% saline for interscalene block
Ropivacaine
Placebo: saline
|
Group 2
n=56 Participants
Group 2 Bupivacaine: 30 ml 0.5% bupivacaine plus 2 ml 0.9% saline
Bupivacaine
Placebo: saline
|
Group 3
n=54 Participants
Group 3 Ropivacaine and dexamethasone:
Ropivacaine plus dexamethasone
Ropivacaine
Dexamethasone: steroid
|
Group 4
n=54 Participants
Group 4 Bupivacaine and steroid:
Bupivacaine plus dexamethasone
Bupivacaine
Dexamethasone: steroid
|
Total
n=218 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
55 years
n=5 Participants
|
60 years
n=7 Participants
|
59 years
n=5 Participants
|
58 years
n=4 Participants
|
58 years
n=21 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
83 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
33 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
32 Participants
n=4 Participants
|
135 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Postoperative day 1, 2 and 3Outcome measures
| Measure |
Group 1
n=54 Participants
Group 1 Ropivacaine: 30 ml 0.5% ropivacaine plus 2 ml 0.9% saline for interscalene block
Ropivacaine
Placebo: saline
|
Group 2
n=56 Participants
Group 2 Bupivacaine: 30 ml 0.5% bupivacaine plus 2 ml 0.9% saline
Bupivacaine
Placebo: saline
|
Group 3
n=54 Participants
Group 3 Ropivacaine and dexamethasone:
Ropivacaine plus dexamethasone
Ropivacaine
Dexamethasone: steroid
|
Group 4
n=54 Participants
Group 4 Bupivacaine and steroid:
Bupivacaine plus dexamethasone
Bupivacaine
Dexamethasone: steroid
|
|---|---|---|---|---|
|
The Duration of the Interscalene Nerve Block Which is Time to First Administration of Pain Medication After Block
|
11.8 hours
Interval 9.7 to 13.8
|
14.8 hours
Interval 11.8 to 18.1
|
22.2 hours
Interval 18.0 to 28.6
|
22.4 hours
Interval 20.5 to 29.3
|
SECONDARY outcome
Timeframe: Postoperative day 1, 2 and 3Outcome measures
| Measure |
Group 1
n=54 Participants
Group 1 Ropivacaine: 30 ml 0.5% ropivacaine plus 2 ml 0.9% saline for interscalene block
Ropivacaine
Placebo: saline
|
Group 2
n=56 Participants
Group 2 Bupivacaine: 30 ml 0.5% bupivacaine plus 2 ml 0.9% saline
Bupivacaine
Placebo: saline
|
Group 3
n=54 Participants
Group 3 Ropivacaine and dexamethasone:
Ropivacaine plus dexamethasone
Ropivacaine
Dexamethasone: steroid
|
Group 4
n=54 Participants
Group 4 Bupivacaine and steroid:
Bupivacaine plus dexamethasone
Bupivacaine
Dexamethasone: steroid
|
|---|---|---|---|---|
|
Time to First Report of Pain
|
11.9 hours
Interval 9.2 to 13.8
|
14.7 hours
Interval 13.4 to 17.9
|
22.3 hours
Interval 18.0 to 27.2
|
25.7 hours
Interval 21.7 to 29.2
|
SECONDARY outcome
Timeframe: Postoperative day 1, 2 and 3Visual Analogue Scale (VAS) pain scale is used to describe the severity or intensity of pain. It ranges from 0 to 10. Zero indicates"no pain at all" and ten indicates "worst pain imaginable." , The higher of the score, the worse of the pain.
Outcome measures
| Measure |
Group 1
n=54 Participants
Group 1 Ropivacaine: 30 ml 0.5% ropivacaine plus 2 ml 0.9% saline for interscalene block
Ropivacaine
Placebo: saline
|
Group 2
n=56 Participants
Group 2 Bupivacaine: 30 ml 0.5% bupivacaine plus 2 ml 0.9% saline
Bupivacaine
Placebo: saline
|
Group 3
n=54 Participants
Group 3 Ropivacaine and dexamethasone:
Ropivacaine plus dexamethasone
Ropivacaine
Dexamethasone: steroid
|
Group 4
n=54 Participants
Group 4 Bupivacaine and steroid:
Bupivacaine plus dexamethasone
Bupivacaine
Dexamethasone: steroid
|
|---|---|---|---|---|
|
Median Maximum VAS Pain Scores at Rest
|
5 units on a scale
Interval 3.0 to 7.0
|
5 units on a scale
Interval 3.0 to 7.0
|
4 units on a scale
Interval 2.0 to 6.0
|
3 units on a scale
Interval 0.0 to 5.0
|
SECONDARY outcome
Timeframe: Postoperative day 1, 2 and 3Outcome measures
| Measure |
Group 1
n=54 Participants
Group 1 Ropivacaine: 30 ml 0.5% ropivacaine plus 2 ml 0.9% saline for interscalene block
Ropivacaine
Placebo: saline
|
Group 2
n=56 Participants
Group 2 Bupivacaine: 30 ml 0.5% bupivacaine plus 2 ml 0.9% saline
Bupivacaine
Placebo: saline
|
Group 3
n=54 Participants
Group 3 Ropivacaine and dexamethasone:
Ropivacaine plus dexamethasone
Ropivacaine
Dexamethasone: steroid
|
Group 4
n=54 Participants
Group 4 Bupivacaine and steroid:
Bupivacaine plus dexamethasone
Bupivacaine
Dexamethasone: steroid
|
|---|---|---|---|---|
|
Total Three-day Opioid Consumption in Oral Oxycodone Equivalent
|
75 milligrams
Interval 45.0 to 153.0
|
85 milligrams
Interval 51.0 to 118.0
|
79 milligrams
Interval 45.0 to 153.0
|
60 milligrams
Interval 47.0 to 105.0
|
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: 0 other events
Deaths: 0 deaths
Group 3
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group 4
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