Trial Outcomes & Findings for Intravenous Dexamethasone on Supraclavicular Brachial Plexus Block for Shoulder Arthroscopy (NCT NCT02688530)
NCT ID: NCT02688530
Last Updated: 2022-05-13
Results Overview
Defined as time from block placement until "pain relief from the block completely wears off" in the operative shoulder.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
140 participants
Primary outcome timeframe
Day of Surgery until Post-Operative Day 3 (if the block persists)
Results posted on
2022-05-13
Participant Flow
Participant milestones
| Measure |
0mg IV Dexamethasone
0mg IV Dexamethasone
IV Saline
|
4mg IV Dexamethasone
4mg IV Dexamethasone
IV Dexamethasone 4mg
|
6mg IV Dexamethasone
6mg IV Dexamethasone
IV Dexamethasone 6mg
|
8mg IV Dexamethasone
8mg IV Dexamethasone
IV Dexamethasone 8mg
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
35
|
35
|
35
|
35
|
|
Overall Study
COMPLETED
|
35
|
34
|
33
|
35
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
2
|
0
|
Reasons for withdrawal
| Measure |
0mg IV Dexamethasone
0mg IV Dexamethasone
IV Saline
|
4mg IV Dexamethasone
4mg IV Dexamethasone
IV Dexamethasone 4mg
|
6mg IV Dexamethasone
6mg IV Dexamethasone
IV Dexamethasone 6mg
|
8mg IV Dexamethasone
8mg IV Dexamethasone
IV Dexamethasone 8mg
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
2
|
0
|
Baseline Characteristics
Intravenous Dexamethasone on Supraclavicular Brachial Plexus Block for Shoulder Arthroscopy
Baseline characteristics by cohort
| Measure |
0mg IV Dexamethasone
n=35 Participants
0mg IV Dexamethasone
|
4mg IV Dexamethasone
n=34 Participants
4mg IV Dexamethasone
|
6mg IV Dexamethasone
n=33 Participants
6mg IV Dexamethasone
|
8mg IV Dexamethasone
n=35 Participants
8mg IV Dexamethasone
|
Total
n=137 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
28 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
32 Participants
n=4 Participants
|
112 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
25 Participants
n=21 Participants
|
|
Age, Continuous
|
49 years
STANDARD_DEVIATION 16 • n=5 Participants
|
50 years
STANDARD_DEVIATION 17 • n=7 Participants
|
52 years
STANDARD_DEVIATION 15 • n=5 Participants
|
49 years
STANDARD_DEVIATION 12 • n=4 Participants
|
50 years
STANDARD_DEVIATION 15 • n=21 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
42 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
25 Participants
n=4 Participants
|
95 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Race · Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Race · Black/African American
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
33 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
32 Participants
n=4 Participants
|
129 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Race · Unknown
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
35 participants
n=5 Participants
|
34 participants
n=7 Participants
|
33 participants
n=5 Participants
|
35 participants
n=4 Participants
|
137 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Day of Surgery until Post-Operative Day 3 (if the block persists)Defined as time from block placement until "pain relief from the block completely wears off" in the operative shoulder.
Outcome measures
| Measure |
0mg IV Dexamethasone
n=35 Participants
0mg IV Dexamethasone
|
4mg IV Dexamethasone
n=34 Participants
4mg IV Dexamethasone
|
6mg IV Dexamethasone
n=33 Participants
6mg IV Dexamethasone
|
8mg IV Dexamethasone
n=35 Participants
8mg IV Dexamethasone
|
|---|---|---|---|---|
|
Duration of Analgesia From a Supraclavicular Block Performed for Shoulder Arthroscopy
|
17.4 Hours
Interval 12.0 to 23.4
|
22.7 Hours
Interval 18.1 to 28.1
|
20.2 Hours
Interval 17.5 to 25.0
|
19.8 Hours
Interval 16.5 to 24.5
|
SECONDARY outcome
Timeframe: Day of Surgery until Post-Operative Day 3 (if the block persists)Population: shoulder arthroscopy
Defined as the time from block placement to restoration of normal strength at both the wrist and elbow.
Outcome measures
| Measure |
0mg IV Dexamethasone
n=35 Participants
0mg IV Dexamethasone
|
4mg IV Dexamethasone
n=34 Participants
4mg IV Dexamethasone
|
6mg IV Dexamethasone
n=33 Participants
6mg IV Dexamethasone
|
8mg IV Dexamethasone
n=35 Participants
8mg IV Dexamethasone
|
|---|---|---|---|---|
|
Duration of Motor Block From the Supraclavicular Block
|
10.5 Hours
Interval 8.3 to 14.9
|
19.7 Hours
Interval 14.8 to 21.9
|
18.3 Hours
Interval 15.0 to 21.4
|
14.7 Hours
Interval 12.7 to 18.7
|
SECONDARY outcome
Timeframe: Day of Surgery - before and 1-hour and 2-hours after IV Dexamethasone administrationPopulation: Prior to IV Dexamethasone, 1-hour and 2-hours after IV Dexamethasone administration
Fingerstick blood glucose test to be administered before and 1-hour and 2-hours after IV dexamethasone administration.
Outcome measures
| Measure |
0mg IV Dexamethasone
n=35 Participants
0mg IV Dexamethasone
|
4mg IV Dexamethasone
n=34 Participants
4mg IV Dexamethasone
|
6mg IV Dexamethasone
n=31 Participants
6mg IV Dexamethasone
|
8mg IV Dexamethasone
n=33 Participants
8mg IV Dexamethasone
|
|---|---|---|---|---|
|
Blood Glucose Levels
Prior to IV Dexamethasone
|
102 mg/dL
Standard Deviation 15
|
108 mg/dL
Standard Deviation 14
|
104 mg/dL
Standard Deviation 16
|
105 mg/dL
Standard Deviation 18
|
|
Blood Glucose Levels
1 hour after IV Dexamethasone
|
119 mg/dL
Standard Deviation 14
|
122 mg/dL
Standard Deviation 17
|
119 mg/dL
Standard Deviation 18
|
126 mg/dL
Standard Deviation 18
|
|
Blood Glucose Levels
2 hours after IV Dexamethasone
|
102 mg/dL
Standard Deviation 20
|
125 mg/dL
Standard Deviation 31
|
110 mg/dL
Standard Deviation 23
|
110 mg/dL
Standard Deviation 27
|
SECONDARY outcome
Timeframe: Post-Operative Day 21Documentation of any of these occurrences will be obtained from the surgeons and/or medical charts after the postoperative follow up visit.
Outcome measures
| Measure |
0mg IV Dexamethasone
n=28 Participants
0mg IV Dexamethasone
|
4mg IV Dexamethasone
n=29 Participants
4mg IV Dexamethasone
|
6mg IV Dexamethasone
n=27 Participants
6mg IV Dexamethasone
|
8mg IV Dexamethasone
n=28 Participants
8mg IV Dexamethasone
|
|---|---|---|---|---|
|
Occurrence of Postoperative Neuropraxia
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Post-Operative Day 21Documentation of any of these occurrences will be obtained from the surgeons and/or medical charts after the postoperative follow up visit.
Outcome measures
| Measure |
0mg IV Dexamethasone
n=28 Participants
0mg IV Dexamethasone
|
4mg IV Dexamethasone
n=29 Participants
4mg IV Dexamethasone
|
6mg IV Dexamethasone
n=27 Participants
6mg IV Dexamethasone
|
8mg IV Dexamethasone
n=28 Participants
8mg IV Dexamethasone
|
|---|---|---|---|---|
|
Occurrence of Postoperative Wound Infection
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day of Surgery until Post-Operative Day 3 (if the block persists)Population: Average daily pain scores Pre-Op to POD3 at rest and with movement.
Using the Numeric Rating Scale (NRS) Pain obtained by patient interview. Lower numbers represent less pain and better outcomes. The scale range is from 0 (no pain) to 10 (worst pain possible).
Outcome measures
| Measure |
0mg IV Dexamethasone
n=35 Participants
0mg IV Dexamethasone
|
4mg IV Dexamethasone
n=34 Participants
4mg IV Dexamethasone
|
6mg IV Dexamethasone
n=33 Participants
6mg IV Dexamethasone
|
8mg IV Dexamethasone
n=35 Participants
8mg IV Dexamethasone
|
|---|---|---|---|---|
|
Average Daily Pain Scores at Rest and With Movement
Pre-Op Average Pain Score at rest
|
2.6 score on a scale
Standard Deviation 1.9
|
3 score on a scale
Standard Deviation 2.5
|
2.4 score on a scale
Standard Deviation 2.4
|
2.5 score on a scale
Standard Deviation 2.5
|
|
Average Daily Pain Scores at Rest and With Movement
POD0 Average Pain Score at rest
|
0.4 score on a scale
Standard Deviation 1.1
|
0.2 score on a scale
Standard Deviation 0.7
|
0.4 score on a scale
Standard Deviation 0.9
|
0.5 score on a scale
Standard Deviation 1.6
|
|
Average Daily Pain Scores at Rest and With Movement
POD1 Average Pain Score at rest
|
4.1 score on a scale
Standard Deviation 2.5
|
3.2 score on a scale
Standard Deviation 2.1
|
3.1 score on a scale
Standard Deviation 2.8
|
3 score on a scale
Standard Deviation 2.5
|
|
Average Daily Pain Scores at Rest and With Movement
POD2 Average Pain Score at rest
|
2.9 score on a scale
Standard Deviation 2.1
|
3.7 score on a scale
Standard Deviation 1.8
|
3.3 score on a scale
Standard Deviation 2.7
|
3.1 score on a scale
Standard Deviation 2.4
|
|
Average Daily Pain Scores at Rest and With Movement
POD3 Average Pain Score at rest
|
0.5 score on a scale
Standard Deviation 0.7
|
4 score on a scale
Standard Deviation 1.7
|
3 score on a scale
Standard Deviation 0
|
2 score on a scale
Standard Deviation 2
|
|
Average Daily Pain Scores at Rest and With Movement
Pre-Op Average Pain Score with Movement
|
4.6 score on a scale
Standard Deviation 2.3
|
4.8 score on a scale
Standard Deviation 2.3
|
4.6 score on a scale
Standard Deviation 2.4
|
4.7 score on a scale
Standard Deviation 2.7
|
|
Average Daily Pain Scores at Rest and With Movement
POD0 Average Pain Score with Movement
|
0.5 score on a scale
Standard Deviation 1.4
|
0.3 score on a scale
Standard Deviation 0.8
|
0.2 score on a scale
Standard Deviation 0.5
|
0.4 score on a scale
Standard Deviation 1.7
|
|
Average Daily Pain Scores at Rest and With Movement
POD1 Average Pain Score with Movement
|
5.2 score on a scale
Standard Deviation 2.6
|
4.7 score on a scale
Standard Deviation 2.2
|
4.8 score on a scale
Standard Deviation 3.1
|
4.2 score on a scale
Standard Deviation 3.3
|
|
Average Daily Pain Scores at Rest and With Movement
POD2 Average Pain Score with Movement
|
4.6 score on a scale
Standard Deviation 2.6
|
5.1 score on a scale
Standard Deviation 2.3
|
5 score on a scale
Standard Deviation 2.3
|
4.8 score on a scale
Standard Deviation 2.3
|
|
Average Daily Pain Scores at Rest and With Movement
POD3 Average Pain Score with Movement
|
6 score on a scale
Standard Deviation 2.8
|
5 score on a scale
Standard Deviation 3
|
6 score on a scale
Standard Deviation 0
|
1.7 score on a scale
Standard Deviation 1.5
|
SECONDARY outcome
Timeframe: Day of Surgery until Post-Operative Day 3 (if the block persists)Population: Worst Daily Pain Scores at rest and with movement from Pre-Op to POD3
Using the numeric pain rating scale (NRS), will be obtained by patient interview. Lower numbers represent less pain and better outcomes. The scale range is from 0 (no pain) to 10 (worst pain possible).
Outcome measures
| Measure |
0mg IV Dexamethasone
n=35 Participants
0mg IV Dexamethasone
|
4mg IV Dexamethasone
n=34 Participants
4mg IV Dexamethasone
|
6mg IV Dexamethasone
n=33 Participants
6mg IV Dexamethasone
|
8mg IV Dexamethasone
n=35 Participants
8mg IV Dexamethasone
|
|---|---|---|---|---|
|
Worst Daily Pain Scores at Rest and With Movement
Pre-Op Worst Pain Score at rest
|
3.4 score on a scale
Standard Deviation 2.1
|
3.3 score on a scale
Standard Deviation 2.9
|
3.4 score on a scale
Standard Deviation 2.6
|
3.6 score on a scale
Standard Deviation 3.1
|
|
Worst Daily Pain Scores at Rest and With Movement
POD0 Worst Pain Score at rest
|
0.6 score on a scale
Standard Deviation 1.5
|
0.2 score on a scale
Standard Deviation 0.7
|
0.5 score on a scale
Standard Deviation 1.3
|
1.1 score on a scale
Standard Deviation 2.7
|
|
Worst Daily Pain Scores at Rest and With Movement
POD1 Worst Pain Score at rest
|
6.3 score on a scale
Standard Deviation 2.9
|
4.6 score on a scale
Standard Deviation 2.8
|
5.4 score on a scale
Standard Deviation 3.2
|
5.1 score on a scale
Standard Deviation 3.5
|
|
Worst Daily Pain Scores at Rest and With Movement
POD2 Worst Pain Score at rest
|
4.7 score on a scale
Standard Deviation 3
|
5.4 score on a scale
Standard Deviation 2.3
|
5.1 score on a scale
Standard Deviation 2.8
|
4.5 score on a scale
Standard Deviation 3.3
|
|
Worst Daily Pain Scores at Rest and With Movement
POD3 Worst Pain Score at rest
|
2 score on a scale
Standard Deviation 1.4
|
6.3 score on a scale
Standard Deviation 2.9
|
5 score on a scale
Standard Deviation 0
|
4.3 score on a scale
Standard Deviation 3.5
|
|
Worst Daily Pain Scores at Rest and With Movement
Pre-Op Worst Pain Score with Movement
|
6.1 score on a scale
Standard Deviation 2.7
|
6.5 score on a scale
Standard Deviation 2.4
|
6.4 score on a scale
Standard Deviation 2.5
|
6.9 score on a scale
Standard Deviation 2.7
|
|
Worst Daily Pain Scores at Rest and With Movement
POD0 Worst Pain Score with Movement
|
0.6 score on a scale
Standard Deviation 1.9
|
0.3 score on a scale
Standard Deviation 0.8
|
0.3 score on a scale
Standard Deviation 0.8
|
1.2 score on a scale
Standard Deviation 3.3
|
|
Worst Daily Pain Scores at Rest and With Movement
POD1 Worst Pain Score with Movement
|
7.3 score on a scale
Standard Deviation 2.6
|
5.9 score on a scale
Standard Deviation 2.7
|
6.5 score on a scale
Standard Deviation 3.1
|
5.7 score on a scale
Standard Deviation 3.4
|
|
Worst Daily Pain Scores at Rest and With Movement
POD2 Worst Pain Score with Movement
|
6.5 score on a scale
Standard Deviation 2.9
|
6.8 score on a scale
Standard Deviation 2.2
|
6.7 score on a scale
Standard Deviation 2.2
|
6.3 score on a scale
Standard Deviation 2.5
|
|
Worst Daily Pain Scores at Rest and With Movement
POD3 Worst Pain Score with Movement
|
7 score on a scale
Standard Deviation 1.4
|
6.7 score on a scale
Standard Deviation 3.2
|
7 score on a scale
Standard Deviation 0
|
3.7 score on a scale
Standard Deviation 3.2
|
SECONDARY outcome
Timeframe: Post-Operative Day 2 or Post-Operative Day 3 (if the block persists)Population: Patient Satisfaction with Post-Op Analgesia
Patient satisfaction with postoperative analgesia will be obtained by patient interview. Lower numbers represent worse outcomes. The scale range is from 0 (worst) to 10 (best).
Outcome measures
| Measure |
0mg IV Dexamethasone
n=28 Participants
0mg IV Dexamethasone
|
4mg IV Dexamethasone
n=29 Participants
4mg IV Dexamethasone
|
6mg IV Dexamethasone
n=27 Participants
6mg IV Dexamethasone
|
8mg IV Dexamethasone
n=28 Participants
8mg IV Dexamethasone
|
|---|---|---|---|---|
|
Patient Satisfaction With Postoperative Analgesia
|
9.1 score on a scale
Standard Deviation 1.2
|
8.9 score on a scale
Standard Deviation 1.6
|
9.2 score on a scale
Standard Deviation 1.2
|
8.7 score on a scale
Standard Deviation 1.7
|
SECONDARY outcome
Timeframe: Recovery Room until Post-Operative Day 3 (if block persists)Population: Cumulative Daily Opioid Usage
Dosages (reported in Morphine equivalent units) of opioid medication obtained by medical records and/or by patient interview.
Outcome measures
| Measure |
0mg IV Dexamethasone
n=35 Participants
0mg IV Dexamethasone
|
4mg IV Dexamethasone
n=34 Participants
4mg IV Dexamethasone
|
6mg IV Dexamethasone
n=33 Participants
6mg IV Dexamethasone
|
8mg IV Dexamethasone
n=35 Participants
8mg IV Dexamethasone
|
|---|---|---|---|---|
|
Cumulative Daily Opioid Usage
POD2 (24-48hrs)
|
22.3 oral morphine equivalent units (mg)
Standard Deviation 28.2
|
27.4 oral morphine equivalent units (mg)
Standard Deviation 41.4
|
32.6 oral morphine equivalent units (mg)
Standard Deviation 29.3
|
36.5 oral morphine equivalent units (mg)
Standard Deviation 47.5
|
|
Cumulative Daily Opioid Usage
POD 1 (0-24hrs)
|
31 oral morphine equivalent units (mg)
Standard Deviation 23.7
|
30.5 oral morphine equivalent units (mg)
Standard Deviation 29.3
|
30.7 oral morphine equivalent units (mg)
Standard Deviation 25.9
|
31.3 oral morphine equivalent units (mg)
Standard Deviation 34.1
|
Adverse Events
0mg IV Dexamethasone
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
4mg IV Dexamethasone
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
6mg IV Dexamethasone
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
8mg IV Dexamethasone
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
0mg IV Dexamethasone
n=35 participants at risk
0 mg IV Dexamethasone Adverse Event
|
4mg IV Dexamethasone
n=34 participants at risk
4 mg IV Dexamethasone Adverse Event
|
6mg IV Dexamethasone
n=33 participants at risk
6 mg IV Dexamethasone Adverse Event
|
8mg IV Dexamethasone
n=35 participants at risk
8 mg IV Dexamethasone Adverse Event
|
|---|---|---|---|---|
|
Surgical and medical procedures
Protocol Deviation
|
11.4%
4/35 • Number of events 4 • These protocol deviations were between 4/7/17-10/9/2017. Patients were followed for 3 days after surgery.
|
5.9%
2/34 • Number of events 2 • These protocol deviations were between 4/7/17-10/9/2017. Patients were followed for 3 days after surgery.
|
18.2%
6/33 • Number of events 6 • These protocol deviations were between 4/7/17-10/9/2017. Patients were followed for 3 days after surgery.
|
8.6%
3/35 • Number of events 3 • These protocol deviations were between 4/7/17-10/9/2017. Patients were followed for 3 days after surgery.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place