Trial Outcomes & Findings for Interscalene Block With Low-dose IV vs. Perineural Dexamethasone for Shoulder Arthroscopy (NCT NCT02506660)
NCT ID: NCT02506660
Last Updated: 2018-08-29
Results Overview
Time at which the pain relief from the block has completely worn off
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
128 participants
Primary outcome timeframe
Postoperative day 2+
Results posted on
2018-08-29
Participant Flow
Participant milestones
| Measure |
Intravenous Dexamethasone
Patients will receive 1 cc (1 mg) dexamethasone intravenously and a block containing 15 cc bupivacaine 0.5% and 1 cc saline.
Bupivacaine
Intravenous dexamethasone
Perineural saline: Saline in nerve block
|
Perineural Dexamethasone
Patients will receive 1 cc saline intravenously and a block containing 15 cc bupivacaine 0.5% and 1 cc (1 mg) dexamethasone.
Bupivacaine
Perineural dexamethasone: Dexamethasone in nerve block
Intravenous saline
|
|---|---|---|
|
Overall Study
STARTED
|
64
|
64
|
|
Overall Study
COMPLETED
|
62
|
63
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Interscalene Block With Low-dose IV vs. Perineural Dexamethasone for Shoulder Arthroscopy
Baseline characteristics by cohort
| Measure |
Intravenous Dexamethasone
n=62 Participants
Patients will receive 1 cc (1 mg) dexamethasone intravenously and a block containing 15 cc bupivacaine 0.5% and 1 cc saline.
Bupivacaine
Intravenous dexamethasone
Perineural saline: Saline in nerve block
|
Perineural Dexamethasone
n=63 Participants
Patients will receive 1 cc saline intravenously and a block containing 15 cc bupivacaine 0.5% and 1 cc (1 mg) dexamethasone.
Bupivacaine
Perineural dexamethasone: Dexamethasone in nerve block
Intravenous saline
|
Total
n=125 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
46.7 years
STANDARD_DEVIATION 14.6 • n=5 Participants
|
49.9 years
STANDARD_DEVIATION 13.6 • n=7 Participants
|
48.3 years
STANDARD_DEVIATION 14.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
39 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
76 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
57 Participants
n=5 Participants
|
57 Participants
n=7 Participants
|
114 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Postoperative day 2+Time at which the pain relief from the block has completely worn off
Outcome measures
| Measure |
Intravenous Dexamethasone
n=62 Participants
Patients will receive 1 cc (1 mg) dexamethasone intravenously and a block containing 15 cc bupivacaine 0.5% and 1 cc saline.
Bupivacaine
Intravenous dexamethasone
Perineural saline: Saline in nerve block
|
Perineural Dexamethasone
n=63 Participants
Patients will receive 1 cc saline intravenously and a block containing 15 cc bupivacaine 0.5% and 1 cc (1 mg) dexamethasone.
Bupivacaine
Perineural dexamethasone: Dexamethasone in nerve block
Intravenous saline
|
|---|---|---|
|
Nerve Block Duration
|
22.2 Hours
Interval 19.5 to 26.0
|
25.7 Hours
Interval 22.2 to 31.5
|
SECONDARY outcome
Timeframe: Duration of stay in recovery room after surgery (average of 3 hours)The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable")
Outcome measures
| Measure |
Intravenous Dexamethasone
n=62 Participants
Patients will receive 1 cc (1 mg) dexamethasone intravenously and a block containing 15 cc bupivacaine 0.5% and 1 cc saline.
Bupivacaine
Intravenous dexamethasone
Perineural saline: Saline in nerve block
|
Perineural Dexamethasone
n=63 Participants
Patients will receive 1 cc saline intravenously and a block containing 15 cc bupivacaine 0.5% and 1 cc (1 mg) dexamethasone.
Bupivacaine
Perineural dexamethasone: Dexamethasone in nerve block
Intravenous saline
|
|---|---|---|
|
Numerical Rating Scale Pain Scores
|
0 Units on a Scale
Interval 0.0 to 2.0
|
0 Units on a Scale
Interval 0.0 to 2.0
|
SECONDARY outcome
Timeframe: Postoperative day 2, postoperative day 3Outcome measures
| Measure |
Intravenous Dexamethasone
n=62 Participants
Patients will receive 1 cc (1 mg) dexamethasone intravenously and a block containing 15 cc bupivacaine 0.5% and 1 cc saline.
Bupivacaine
Intravenous dexamethasone
Perineural saline: Saline in nerve block
|
Perineural Dexamethasone
n=63 Participants
Patients will receive 1 cc saline intravenously and a block containing 15 cc bupivacaine 0.5% and 1 cc (1 mg) dexamethasone.
Bupivacaine
Perineural dexamethasone: Dexamethasone in nerve block
Intravenous saline
|
|---|---|---|
|
Opioid Consumption
Postoperative day 2
|
67.3 mg
Standard Deviation 55.7
|
67.4 mg
Standard Deviation 51
|
|
Opioid Consumption
postoperative day 3
|
33 mg
Standard Deviation 48.6
|
39.7 mg
Standard Deviation 55.3
|
SECONDARY outcome
Timeframe: Postoperative day 2, postoperative day 3Opioid-related symptom distress scale is calculated using responses to the symptom severity questions only. For each symptom, severity is assessed by the question: "(If yes), how severe was it usually?" (In the past 24 hours) The responses to the severity questions are measured on a 5-point scale from 0-4 in ascending order as follows: Did not have symptom (0) Slight (1) Moderate (2) Severe (3) Very severe (4)
Outcome measures
| Measure |
Intravenous Dexamethasone
n=60 Participants
Patients will receive 1 cc (1 mg) dexamethasone intravenously and a block containing 15 cc bupivacaine 0.5% and 1 cc saline.
Bupivacaine
Intravenous dexamethasone
Perineural saline: Saline in nerve block
|
Perineural Dexamethasone
n=63 Participants
Patients will receive 1 cc saline intravenously and a block containing 15 cc bupivacaine 0.5% and 1 cc (1 mg) dexamethasone.
Bupivacaine
Perineural dexamethasone: Dexamethasone in nerve block
Intravenous saline
|
|---|---|---|
|
Side Effects
Postoperative day 2
|
0.5 units on a scale
Standard Deviation 0.5
|
0.6 units on a scale
Standard Deviation 0.5
|
|
Side Effects
postoperative day 3
|
0.4 units on a scale
Standard Deviation 0.4
|
0.4 units on a scale
Standard Deviation 0.4
|
SECONDARY outcome
Timeframe: Postoperative day 2, postoperative day 30-10 scale (0=not satisfied; 10=extremely satisfied)
Outcome measures
| Measure |
Intravenous Dexamethasone
n=58 Participants
Patients will receive 1 cc (1 mg) dexamethasone intravenously and a block containing 15 cc bupivacaine 0.5% and 1 cc saline.
Bupivacaine
Intravenous dexamethasone
Perineural saline: Saline in nerve block
|
Perineural Dexamethasone
n=61 Participants
Patients will receive 1 cc saline intravenously and a block containing 15 cc bupivacaine 0.5% and 1 cc (1 mg) dexamethasone.
Bupivacaine
Perineural dexamethasone: Dexamethasone in nerve block
Intravenous saline
|
|---|---|---|
|
Block Satisfaction
postoperative day 2
|
8.1 units on a scale
Standard Deviation 2.2
|
8.1 units on a scale
Standard Deviation 2.2
|
|
Block Satisfaction
postoperative day 3
|
8.0 units on a scale
Standard Deviation 2.1
|
7.5 units on a scale
Standard Deviation 2.5
|
SECONDARY outcome
Timeframe: Postoperative day 7-10Outcome measures
| Measure |
Intravenous Dexamethasone
n=62 Participants
Patients will receive 1 cc (1 mg) dexamethasone intravenously and a block containing 15 cc bupivacaine 0.5% and 1 cc saline.
Bupivacaine
Intravenous dexamethasone
Perineural saline: Saline in nerve block
|
Perineural Dexamethasone
n=63 Participants
Patients will receive 1 cc saline intravenously and a block containing 15 cc bupivacaine 0.5% and 1 cc (1 mg) dexamethasone.
Bupivacaine
Perineural dexamethasone: Dexamethasone in nerve block
Intravenous saline
|
|---|---|---|
|
Block-related Complications
|
0 patients with block complications
|
0 patients with block complications
|
SECONDARY outcome
Timeframe: Postoperative day 7-10Patients will be asked whether they believe they were in the IV dexamethasone or intravenous dexamethasone group
Outcome measures
| Measure |
Intravenous Dexamethasone
n=57 Participants
Patients will receive 1 cc (1 mg) dexamethasone intravenously and a block containing 15 cc bupivacaine 0.5% and 1 cc saline.
Bupivacaine
Intravenous dexamethasone
Perineural saline: Saline in nerve block
|
Perineural Dexamethasone
n=56 Participants
Patients will receive 1 cc saline intravenously and a block containing 15 cc bupivacaine 0.5% and 1 cc (1 mg) dexamethasone.
Bupivacaine
Perineural dexamethasone: Dexamethasone in nerve block
Intravenous saline
|
|---|---|---|
|
% of Participants Who Guessed the Correct Group
|
-7 % of participants
Interval -16.0 to 2.0
|
3.4 % of participants
Interval -6.3 to 13.2
|
Adverse Events
Intravenous Dexamethasone
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Perineural Dexamethasone
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