Trial Outcomes & Findings for Ropivacaine Block Alone or With Perineural or Systemic Dexamethasone for Pain in Shoulder Surgery (NCT NCT01450007)
NCT ID: NCT01450007
Last Updated: 2016-06-17
Results Overview
Duration from time of block until complete resolution of sensory blockade in the shoulder is recorded in minutes by patient report.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
130 participants
Primary outcome timeframe
Within 48 hours
Results posted on
2016-06-17
Participant Flow
Participants were recruited at Mayo Clinic in Arizona from June 2012 to September 2014.
238 patients were screened; of these 41 were excluded because they did not meet inclusion criteria, and 67 were excluded because they declined to be in the study.
Participant milestones
| Measure |
Dexamethasone Block
Blockade with 25 ml ropivacaine 0.5% mixed with 8 mg dexamethasone (0.8 ml), and 5 ml intravenous normal saline
|
Dexamethasone IV
Blockade with 25 ml ropivacaine 0.5% mixed with 0.8 ml normal saline, and intravenous 8 mg dexamethasone (0.8 ml dexamethasone, 4.2 ml saline) to total volume of 5 ml
|
Placebo
Blockade with 25 ml ropivacaine 0.5% mixed with 0.8 ml normal saline, and 5 ml intravenous normal saline
|
|---|---|---|---|
|
Overall Study
STARTED
|
44
|
42
|
44
|
|
Overall Study
COMPLETED
|
42
|
37
|
41
|
|
Overall Study
NOT COMPLETED
|
2
|
5
|
3
|
Reasons for withdrawal
| Measure |
Dexamethasone Block
Blockade with 25 ml ropivacaine 0.5% mixed with 8 mg dexamethasone (0.8 ml), and 5 ml intravenous normal saline
|
Dexamethasone IV
Blockade with 25 ml ropivacaine 0.5% mixed with 0.8 ml normal saline, and intravenous 8 mg dexamethasone (0.8 ml dexamethasone, 4.2 ml saline) to total volume of 5 ml
|
Placebo
Blockade with 25 ml ropivacaine 0.5% mixed with 0.8 ml normal saline, and 5 ml intravenous normal saline
|
|---|---|---|---|
|
Overall Study
Late exclusion before treatment
|
2
|
3
|
2
|
|
Overall Study
Protocol Violation
|
0
|
1
|
1
|
|
Overall Study
Adverse Event
|
0
|
1
|
0
|
Baseline Characteristics
Ropivacaine Block Alone or With Perineural or Systemic Dexamethasone for Pain in Shoulder Surgery
Baseline characteristics by cohort
| Measure |
Dexamethasone Block
n=42 Participants
Blockade with 25 ml ropivacaine 0.5% mixed with 8 mg dexamethasone (0.8 ml), and 5 ml intravenous normal saline
|
Dexamethasone IV
n=37 Participants
Blockade with 25 ml ropivacaine 0.5% mixed with 0.8 ml normal saline, and intravenous 8 mg dexamethasone (0.8 ml dexamethasone, 4.2 ml saline) to total volume of 5 ml
|
Placebo
n=41 Participants
Blockade with 25 ml ropivacaine 0.5% mixed with 0.8 ml normal saline, and 5 ml intravenous normal saline
|
Total
n=120 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
67.5 years
STANDARD_DEVIATION 12.7 • n=5 Participants
|
68.4 years
STANDARD_DEVIATION 7.7 • n=7 Participants
|
62.7 years
STANDARD_DEVIATION 11.3 • n=5 Participants
|
66.14 years
STANDARD_DEVIATION 10.7 • n=4 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
45 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
29 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
75 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
42 participants
n=5 Participants
|
37 participants
n=7 Participants
|
41 participants
n=5 Participants
|
120 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Within 48 hoursPopulation: Patients will be included in the primary analysis on the basis of intention to treat.
Duration from time of block until complete resolution of sensory blockade in the shoulder is recorded in minutes by patient report.
Outcome measures
| Measure |
Dexamethasone Block
n=42 Participants
Blockade with 25 ml ropivacaine 0.5% mixed with 8 mg dexamethasone (0.8 ml), and 5 ml intravenous normal saline
|
Dexamethasone IV
n=37 Participants
Blockade with 25 ml ropivacaine 0.5% mixed with 0.8 ml normal saline, and intravenous 8 mg dexamethasone (0.8 ml dexamethasone, 4.2 ml saline) to total volume of 5 ml
|
Placebo
n=41 Participants
Blockade with 25 ml ropivacaine 0.5% mixed with 0.8 ml normal saline, and 5 ml intravenous normal saline
|
|---|---|---|---|
|
Duration of Sensory Blockade
|
16.9 hours
Standard Deviation 5.2
|
18.2 hours
Standard Deviation 6.4
|
13.8 hours
Standard Deviation 3.8
|
SECONDARY outcome
Timeframe: approximately 24 hours after surgeryPopulation: The number of participants analyzed is different from the number of participants in each arm who completed the trial because data were not available for 1 participant in the Dexamethasone IV group and 1 participant in the placebo group.
Outcome measures
| Measure |
Dexamethasone Block
n=42 Participants
Blockade with 25 ml ropivacaine 0.5% mixed with 8 mg dexamethasone (0.8 ml), and 5 ml intravenous normal saline
|
Dexamethasone IV
n=36 Participants
Blockade with 25 ml ropivacaine 0.5% mixed with 0.8 ml normal saline, and intravenous 8 mg dexamethasone (0.8 ml dexamethasone, 4.2 ml saline) to total volume of 5 ml
|
Placebo
n=40 Participants
Blockade with 25 ml ropivacaine 0.5% mixed with 0.8 ml normal saline, and 5 ml intravenous normal saline
|
|---|---|---|---|
|
Post Operative Opioid Dose at 24 Hours
|
12.2 mg morphine equivalents
Standard Deviation 9.3
|
17.1 mg morphine equivalents
Standard Deviation 15.9
|
24.1 mg morphine equivalents
Standard Deviation 14.3
|
SECONDARY outcome
Timeframe: Approximately 10 hours after surgeryPopulation: The number of participants analyzed is different from the number of participants in each arm who completed the trial because data were not available for 1 participant in the Dexamethasone IV group and 1 participant in the placebo group.
Outcome measures
| Measure |
Dexamethasone Block
n=42 Participants
Blockade with 25 ml ropivacaine 0.5% mixed with 8 mg dexamethasone (0.8 ml), and 5 ml intravenous normal saline
|
Dexamethasone IV
n=36 Participants
Blockade with 25 ml ropivacaine 0.5% mixed with 0.8 ml normal saline, and intravenous 8 mg dexamethasone (0.8 ml dexamethasone, 4.2 ml saline) to total volume of 5 ml
|
Placebo
n=40 Participants
Blockade with 25 ml ropivacaine 0.5% mixed with 0.8 ml normal saline, and 5 ml intravenous normal saline
|
|---|---|---|---|
|
Time Until First Dose of Analgesic
|
8.4 hours
Standard Deviation 5.6
|
9.2 hours
Standard Deviation 5.6
|
8.4 hours
Standard Deviation 4.8
|
SECONDARY outcome
Timeframe: 24 hours, 48 hours, 1 weekPopulation: Patients analyzed for each category varied see explanations per row (time point): (n=dexamethasone block, dexamethasone IV, placebo).
Pain was rated on a visual analogue scale with 0 = no pain, 3=mild pain, 5=moderate pain, 7=moderate to severe pain, and 10=severe pain.
Outcome measures
| Measure |
Dexamethasone Block
n=42 Participants
Blockade with 25 ml ropivacaine 0.5% mixed with 8 mg dexamethasone (0.8 ml), and 5 ml intravenous normal saline
|
Dexamethasone IV
n=37 Participants
Blockade with 25 ml ropivacaine 0.5% mixed with 0.8 ml normal saline, and intravenous 8 mg dexamethasone (0.8 ml dexamethasone, 4.2 ml saline) to total volume of 5 ml
|
Placebo
n=41 Participants
Blockade with 25 ml ropivacaine 0.5% mixed with 0.8 ml normal saline, and 5 ml intravenous normal saline
|
|---|---|---|---|
|
Patient Satisfaction With Pain Control
24 hours (n=34, 28, 37)
|
7.8 units on a scale
Standard Deviation 2.7
|
7.9 units on a scale
Standard Deviation 2.6
|
7.3 units on a scale
Standard Deviation 2.8
|
|
Patient Satisfaction With Pain Control
48 hours (n=42, 37, 41)
|
8.4 units on a scale
Standard Deviation 2.2
|
8.7 units on a scale
Standard Deviation 2.0
|
7.6 units on a scale
Standard Deviation 2.9
|
|
Patient Satisfaction With Pain Control
1 week (n=42, 36, 41)
|
9.1 units on a scale
Standard Deviation 1.2
|
8.8 units on a scale
Standard Deviation 1.7
|
8.4 units on a scale
Standard Deviation 2.4
|
Adverse Events
Dexamethasone Block
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Dexamethasone IV
Serious events: 3 serious events
Other events: 2 other events
Deaths: 0 deaths
Placebo
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Dexamethasone Block
n=42 participants at risk
Blockade with 25 ml ropivacaine 0.5% mixed with 8 mg dexamethasone (0.8 ml), and 5 ml intravenous normal saline
|
Dexamethasone IV
n=37 participants at risk
Blockade with 25 ml ropivacaine 0.5% mixed with 0.8 ml normal saline, and intravenous 8 mg dexamethasone (0.8 ml dexamethasone, 4.2 ml saline) to total volume of 5 ml
|
Placebo
n=41 participants at risk
Blockade with 25 ml ropivacaine 0.5% mixed with 0.8 ml normal saline, and 5 ml intravenous normal saline
|
|---|---|---|---|
|
Injury, poisoning and procedural complications
Hospital admission for fall
|
0.00%
0/42 • One week
|
2.7%
1/37 • Number of events 1 • One week
|
0.00%
0/41 • One week
|
|
Infections and infestations
Hospital admission for bowel infection
|
0.00%
0/42 • One week
|
2.7%
1/37 • Number of events 1 • One week
|
0.00%
0/41 • One week
|
|
Injury, poisoning and procedural complications
Motor vehicle accident with fractured sternum
|
0.00%
0/42 • One week
|
2.7%
1/37 • Number of events 1 • One week
|
0.00%
0/41 • One week
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
0.00%
0/42 • One week
|
0.00%
0/37 • One week
|
2.4%
1/41 • Number of events 1 • One week
|
Other adverse events
| Measure |
Dexamethasone Block
n=42 participants at risk
Blockade with 25 ml ropivacaine 0.5% mixed with 8 mg dexamethasone (0.8 ml), and 5 ml intravenous normal saline
|
Dexamethasone IV
n=37 participants at risk
Blockade with 25 ml ropivacaine 0.5% mixed with 0.8 ml normal saline, and intravenous 8 mg dexamethasone (0.8 ml dexamethasone, 4.2 ml saline) to total volume of 5 ml
|
Placebo
n=41 participants at risk
Blockade with 25 ml ropivacaine 0.5% mixed with 0.8 ml normal saline, and 5 ml intravenous normal saline
|
|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Skin rash
|
4.8%
2/42 • Number of events 2 • One week
|
0.00%
0/37 • One week
|
0.00%
0/41 • One week
|
|
Skin and subcutaneous tissue disorders
Rash
|
2.4%
1/42 • Number of events 1 • One week
|
0.00%
0/37 • One week
|
2.4%
1/41 • Number of events 1 • One week
|
|
Blood and lymphatic system disorders
Syncope
|
2.4%
1/42 • Number of events 1 • One week
|
0.00%
0/37 • One week
|
2.4%
1/41 • Number of events 1 • One week
|
|
General disorders
10 lb fluid weight within 24 hours
|
2.4%
1/42 • Number of events 1 • One week
|
0.00%
0/37 • One week
|
0.00%
0/41 • One week
|
|
Gastrointestinal disorders
Diarrhea
|
2.4%
1/42 • Number of events 1 • One week
|
0.00%
0/37 • One week
|
0.00%
0/41 • One week
|
|
Gastrointestinal disorders
ER for nausea and vomiting
|
2.4%
1/42 • Number of events 1 • One week
|
0.00%
0/37 • One week
|
0.00%
0/41 • One week
|
|
Blood and lymphatic system disorders
Fainting
|
2.4%
1/42 • Number of events 1 • One week
|
0.00%
0/37 • One week
|
0.00%
0/41 • One week
|
|
Renal and urinary disorders
Frequent urination
|
2.4%
1/42 • Number of events 1 • One week
|
0.00%
0/37 • One week
|
0.00%
0/41 • One week
|
|
Nervous system disorders
Headache
|
2.4%
1/42 • Number of events 1 • One week
|
0.00%
0/37 • One week
|
0.00%
0/41 • One week
|
|
Respiratory, thoracic and mediastinal disorders
Hoarse
|
2.4%
1/42 • Number of events 1 • One week
|
0.00%
0/37 • One week
|
0.00%
0/41 • One week
|
|
Musculoskeletal and connective tissue disorders
Muscle soreness
|
2.4%
1/42 • Number of events 1 • One week
|
0.00%
0/37 • One week
|
0.00%
0/41 • One week
|
|
Nervous system disorders
Dizziness
|
0.00%
0/42 • One week
|
2.7%
1/37 • Number of events 1 • One week
|
0.00%
0/41 • One week
|
|
Musculoskeletal and connective tissue disorders
Wrist, hand, and finger pain
|
0.00%
0/42 • One week
|
2.7%
1/37 • Number of events 1 • One week
|
0.00%
0/41 • One week
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/42 • One week
|
0.00%
0/37 • One week
|
2.4%
1/41 • Number of events 1 • One week
|
|
Nervous system disorders
Cranial nerve XII motor tongue
|
0.00%
0/42 • One week
|
0.00%
0/37 • One week
|
2.4%
1/41 • Number of events 1 • One week
|
|
Respiratory, thoracic and mediastinal disorders
Difficulty breathing
|
0.00%
0/42 • One week
|
0.00%
0/37 • One week
|
2.4%
1/41 • Number of events 1 • One week
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place