Trial Outcomes & Findings for Interscalene Nerve Blocks With Ropivacaine Alone, With Dexamethasone, Plus Systemic Dexamethasone (NCT NCT00519584)
NCT ID: NCT00519584
Last Updated: 2017-07-21
Results Overview
the interval between the onset of sensory block and the initial PACU use of opioid analgesia for surgical site pain
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
218 participants
Primary outcome timeframe
surgical date to postoperative day 1 (pod 0 -1 day)
Results posted on
2017-07-21
Participant Flow
Participant milestones
| Measure |
Ropivacaine/Saline
Ropivacaine 30ml 0.5% ropivacaine plus 2 ml 0.9% saline (local placebo) for interscalene block and 0.9% saline 2 ml (systemic placebo) for intravenous injection with sedation for the block
Ropivacaine: 30 ml 0.5%
Saline: 0.9% saline; systemic and local
|
Ropivacaine/Dex
Ropivacaine and local steroid: 30 ml 0.5% ropivacaine plus dexamethasone 8 mg (2 ml) mixed with the local anesthetic and 0.9% saline 2ml (systemic placebo) for intravenous injection with sedation for the block;
Ropivacaine: 30 ml 0.5%
dex: 8 mg (2 ml)
|
Bupivacaine/Dex
bupivacaine and systemic steroid: 30 ml 0.5% ropivacaine plus 2 ml 0.9% saline (local placebo) for interscalene block plus dexamethasone 8 mg (2 ml) administered intravenously with sedation administered for the block.
dex: 8 mg (2 ml)
Bupivacaine: 30 ml 0.5%
|
Bupivacaine/Saline
bupivacaine 30ml 0.5% ropivacaine plus 2 ml 0.9% saline (local placebo) for interscalene block and 0.9% saline 2 ml (systemic placebo) for intravenous injection with sedation for the block
Bupivacaine: 30 ml 0.5%
Saline: 0.9% saline; systemic and local
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
54
|
54
|
54
|
56
|
|
Overall Study
COMPLETED
|
54
|
54
|
54
|
56
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Interscalene Nerve Blocks With Ropivacaine Alone, With Dexamethasone, Plus Systemic Dexamethasone
Baseline characteristics by cohort
| Measure |
Ropivacaine/Saline
n=54 Participants
Ropivacaine 30ml 0.5% ropivacaine plus 2 ml 0.9% saline (local placebo) for interscalene block and 0.9% saline 2 ml (systemic placebo) for intravenous injection with sedation for the block
Ropivacaine: 30 ml 0.5%
Saline: 0.9% saline; systemic and local
|
Ropivacaine/Dex
n=54 Participants
Ropivacaine and local steroid: 30 ml 0.5% ropivacaine plus dexamethasone 8 mg (2 ml) mixed with the local anesthetic and 0.9% saline 2ml (systemic placebo) for intravenous injection with sedation for the block;
Ropivacaine: 30 ml 0.5%
dex: 8 mg (2 ml)
|
Bupivacaine/Dex
n=54 Participants
bupivacaine and systemic steroid: 30 ml 0.5% ropivacaine plus 2 ml 0.9% saline (local placebo) for interscalene block plus dexamethasone 8 mg (2 ml) administered intravenously with sedation administered for the block.
dex: 8 mg (2 ml)
Bupivacaine: 30 ml 0.5%
|
Bupivacaine/Saline
n=56 Participants
bupivacaine 30ml 0.5% ropivacaine plus 2 ml 0.9% saline (local placebo) for interscalene block and 0.9% saline 2 ml (systemic placebo) for intravenous injection with sedation for the block
Bupivacaine: 30 ml 0.5%
Saline: 0.9% saline; systemic and local
|
Total
n=218 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
55 years
n=5 Participants
|
59 years
n=7 Participants
|
58 years
n=5 Participants
|
60 years
n=4 Participants
|
59 years
n=21 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
82 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
33 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
37 Participants
n=4 Participants
|
136 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: surgical date to postoperative day 1 (pod 0 -1 day)the interval between the onset of sensory block and the initial PACU use of opioid analgesia for surgical site pain
Outcome measures
| Measure |
Ropivacaine/Saline
n=54 Participants
Ropivacaine 30ml 0.5% ropivacaine plus 2 ml 0.9% saline (local placebo) for interscalene block and 0.9% saline 2 ml (systemic placebo) for intravenous injection with sedation for the block
Ropivacaine: 30 ml 0.5%
Saline: 0.9% saline; systemic and local
|
Ropivacaine/Dex
n=54 Participants
Ropivacaine and local steroid: 30 ml 0.5% ropivacaine plus dexamethasone 8 mg (2 ml) mixed with the local anesthetic and 0.9% saline 2ml (systemic placebo) for intravenous injection with sedation for the block;
Ropivacaine: 30 ml 0.5%
dex: 8 mg (2 ml)
|
Bupivacaine/Dex
n=54 Participants
bupivacaine and systemic steroid: 30 ml 0.5% ropivacaine plus 2 ml 0.9% saline (local placebo) for interscalene block plus dexamethasone 8 mg (2 ml) administered intravenously with sedation administered for the block.
dex: 8 mg (2 ml)
Bupivacaine: 30 ml 0.5%
|
Bupivacaine/Saline
n=56 Participants
bupivacaine 30ml 0.5% ropivacaine plus 2 ml 0.9% saline (local placebo) for interscalene block and 0.9% saline 2 ml (systemic placebo) for intravenous injection with sedation for the block
Bupivacaine: 30 ml 0.5%
Saline: 0.9% saline; systemic and local
|
|---|---|---|---|---|
|
the Duration of Analgesia
|
22.2 hours
Interval 18.0 to 28.6
|
11.8 hours
Interval 9.7 to 13.8
|
14.8 hours
Interval 11.8 to 18.1
|
22.4 hours
Interval 20.5 to 29.3
|
SECONDARY outcome
Timeframe: during postoperative day 1 to 3the length of time until the patients' first report of surgical site pain.
Outcome measures
| Measure |
Ropivacaine/Saline
n=54 Participants
Ropivacaine 30ml 0.5% ropivacaine plus 2 ml 0.9% saline (local placebo) for interscalene block and 0.9% saline 2 ml (systemic placebo) for intravenous injection with sedation for the block
Ropivacaine: 30 ml 0.5%
Saline: 0.9% saline; systemic and local
|
Ropivacaine/Dex
n=54 Participants
Ropivacaine and local steroid: 30 ml 0.5% ropivacaine plus dexamethasone 8 mg (2 ml) mixed with the local anesthetic and 0.9% saline 2ml (systemic placebo) for intravenous injection with sedation for the block;
Ropivacaine: 30 ml 0.5%
dex: 8 mg (2 ml)
|
Bupivacaine/Dex
n=54 Participants
bupivacaine and systemic steroid: 30 ml 0.5% ropivacaine plus 2 ml 0.9% saline (local placebo) for interscalene block plus dexamethasone 8 mg (2 ml) administered intravenously with sedation administered for the block.
dex: 8 mg (2 ml)
Bupivacaine: 30 ml 0.5%
|
Bupivacaine/Saline
n=56 Participants
bupivacaine 30ml 0.5% ropivacaine plus 2 ml 0.9% saline (local placebo) for interscalene block and 0.9% saline 2 ml (systemic placebo) for intravenous injection with sedation for the block
Bupivacaine: 30 ml 0.5%
Saline: 0.9% saline; systemic and local
|
|---|---|---|---|---|
|
Time to a Significant Increase in Shoulder Discomfort
|
22.3 hours
Interval 18.0 to 27.2
|
11.9 hours
Interval 9.2 to 13.8
|
14.7 hours
Interval 13.4 to 17.9
|
25.7 hours
Interval 21.7 to 29.2
|
SECONDARY outcome
Timeframe: postoperative day 1 day 2, day 3.Verbal rating scales (VRS): a list of adjectives describing different levels of pain intensity with 0 = no pian and 10 = extremely intense pain. An adequate VRS of pain intensity should include adjectives that reflect the extremes of this dimension; from 'no pain' to 'extremely intense pain'. Patients are asked to read over the list of adjectives and select the word or phrase that best describes their level of pain on the scale from 0 to 10.
Outcome measures
| Measure |
Ropivacaine/Saline
n=54 Participants
Ropivacaine 30ml 0.5% ropivacaine plus 2 ml 0.9% saline (local placebo) for interscalene block and 0.9% saline 2 ml (systemic placebo) for intravenous injection with sedation for the block
Ropivacaine: 30 ml 0.5%
Saline: 0.9% saline; systemic and local
|
Ropivacaine/Dex
n=54 Participants
Ropivacaine and local steroid: 30 ml 0.5% ropivacaine plus dexamethasone 8 mg (2 ml) mixed with the local anesthetic and 0.9% saline 2ml (systemic placebo) for intravenous injection with sedation for the block;
Ropivacaine: 30 ml 0.5%
dex: 8 mg (2 ml)
|
Bupivacaine/Dex
n=54 Participants
bupivacaine and systemic steroid: 30 ml 0.5% ropivacaine plus 2 ml 0.9% saline (local placebo) for interscalene block plus dexamethasone 8 mg (2 ml) administered intravenously with sedation administered for the block.
dex: 8 mg (2 ml)
Bupivacaine: 30 ml 0.5%
|
Bupivacaine/Saline
n=56 Participants
bupivacaine 30ml 0.5% ropivacaine plus 2 ml 0.9% saline (local placebo) for interscalene block and 0.9% saline 2 ml (systemic placebo) for intravenous injection with sedation for the block
Bupivacaine: 30 ml 0.5%
Saline: 0.9% saline; systemic and local
|
|---|---|---|---|---|
|
Maximum VRS Pain Scores at Rest
POD#1
|
5 units on a scale
Interval 3.0 to 6.8
|
3.9 units on a scale
Interval 2.0 to 5.9
|
3 units on a scale
Interval 0.0 to 4.9
|
4.9 units on a scale
Interval 3.0 to 7.4
|
|
Maximum VRS Pain Scores at Rest
POD#2
|
3 units on a scale
Interval 1.9 to 4.2
|
3 units on a scale
Interval 1.9 to 4.8
|
4.1 units on a scale
Interval 3.0 to 5.9
|
4.1 units on a scale
Interval 2.1 to 4.9
|
|
Maximum VRS Pain Scores at Rest
POD#3
|
1.9 units on a scale
Interval 0.8 to 3.8
|
2.9 units on a scale
Interval 1.8 to 4.9
|
4 units on a scale
Interval 1.9 to 4.9
|
1.8 units on a scale
Interval 1.1 to 3.8
|
SECONDARY outcome
Timeframe: during first 3 days after surgerycumulative opioid consumption in oral oxycodone equivalents (mg) during the first 3 days after surgery.
Outcome measures
| Measure |
Ropivacaine/Saline
n=54 Participants
Ropivacaine 30ml 0.5% ropivacaine plus 2 ml 0.9% saline (local placebo) for interscalene block and 0.9% saline 2 ml (systemic placebo) for intravenous injection with sedation for the block
Ropivacaine: 30 ml 0.5%
Saline: 0.9% saline; systemic and local
|
Ropivacaine/Dex
n=54 Participants
Ropivacaine and local steroid: 30 ml 0.5% ropivacaine plus dexamethasone 8 mg (2 ml) mixed with the local anesthetic and 0.9% saline 2ml (systemic placebo) for intravenous injection with sedation for the block;
Ropivacaine: 30 ml 0.5%
dex: 8 mg (2 ml)
|
Bupivacaine/Dex
n=54 Participants
bupivacaine and systemic steroid: 30 ml 0.5% ropivacaine plus 2 ml 0.9% saline (local placebo) for interscalene block plus dexamethasone 8 mg (2 ml) administered intravenously with sedation administered for the block.
dex: 8 mg (2 ml)
Bupivacaine: 30 ml 0.5%
|
Bupivacaine/Saline
n=56 Participants
bupivacaine 30ml 0.5% ropivacaine plus 2 ml 0.9% saline (local placebo) for interscalene block and 0.9% saline 2 ml (systemic placebo) for intravenous injection with sedation for the block
Bupivacaine: 30 ml 0.5%
Saline: 0.9% saline; systemic and local
|
|---|---|---|---|---|
|
Total Opioid Consumption
|
75 mg
Interval 45.2 to 152.5
|
79 mg
Interval 45.2 to 100.0
|
60 mg
Interval 46.7 to 105.2
|
85 mg
Interval 51.3 to 117.6
|
Adverse Events
Ropivacaine/Saline
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Ropivacaine/Dex
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Bupivacaine/Dex
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Bupivacaine/Saline
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