Trial Outcomes & Findings for Analgesia After Total Shoulder Arthroplasty (NCT NCT01782872)
NCT ID: NCT01782872
Last Updated: 2016-05-18
Results Overview
Pain with movement at 24 hours from the nerve block (scale of 0-10; 0 = no pain, 10 = worst possible pain)
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
80 participants
Primary outcome timeframe
24 hours after the interscalene block is given
Results posted on
2016-05-18
Participant Flow
Participant milestones
| Measure |
High Dose
Interscalene Block (ISB) - 0.375% Ropivacaine + additives: Ultrasound-guided single-injection ISB: ropivacaine 0.375% + (clonidine \[100 mcg\] + dexamethasone \[4 mg\] + buprenorphine \[150 mcg\]); Intravenous (IV): saline
|
Medium Dose
Interscalene Block (ISB) - 0.2% Ropivacaine + additives: Ultrasound-guided single-injection ISB: ropivacaine 0.2% + (clonidine \[100 mcg\] + dexamethasone \[4 mg\] + buprenorphine \[150 mcg\]); Intravenous: saline
|
Low Dose
Interscalene Block (ISB) - 0.1% Ropivacaine + additives: Ultrasound-guided single-injection ISB: ropivacaine 0.1% + (clonidine \[100 mcg\] + dexamethasone \[4 mg\] + buprenorphine \[150 mcg\]); Intravenous: saline
|
Control
Interscalene Block (ISB) - Systemic Control: Ultrasound-guided single-injection ISB: ropivacaine 0.375%; Intravenous: clonidine (100 mcg) + dexamethasone (4 mg) + buprenorphine (150 mcg)
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
20
|
20
|
20
|
20
|
|
Overall Study
COMPLETED
|
20
|
19
|
20
|
19
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
0
|
1
|
Reasons for withdrawal
| Measure |
High Dose
Interscalene Block (ISB) - 0.375% Ropivacaine + additives: Ultrasound-guided single-injection ISB: ropivacaine 0.375% + (clonidine \[100 mcg\] + dexamethasone \[4 mg\] + buprenorphine \[150 mcg\]); Intravenous (IV): saline
|
Medium Dose
Interscalene Block (ISB) - 0.2% Ropivacaine + additives: Ultrasound-guided single-injection ISB: ropivacaine 0.2% + (clonidine \[100 mcg\] + dexamethasone \[4 mg\] + buprenorphine \[150 mcg\]); Intravenous: saline
|
Low Dose
Interscalene Block (ISB) - 0.1% Ropivacaine + additives: Ultrasound-guided single-injection ISB: ropivacaine 0.1% + (clonidine \[100 mcg\] + dexamethasone \[4 mg\] + buprenorphine \[150 mcg\]); Intravenous: saline
|
Control
Interscalene Block (ISB) - Systemic Control: Ultrasound-guided single-injection ISB: ropivacaine 0.375%; Intravenous: clonidine (100 mcg) + dexamethasone (4 mg) + buprenorphine (150 mcg)
|
|---|---|---|---|---|
|
Overall Study
Protocol Violation
|
0
|
0
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
0
|
0
|
Baseline Characteristics
Analgesia After Total Shoulder Arthroplasty
Baseline characteristics by cohort
| Measure |
High Dose
n=20 Participants
Interscalene Block (ISB) - 0.375% Ropivacaine + additives: Ultrasound-guided single-injection ISB: ropivacaine 0.375% + (clonidine \[100 mcg\] + dexamethasone \[4 mg\] + buprenorphine \[150 mcg\]); Intravenous (IV): saline
|
Medium Dose
n=20 Participants
Interscalene Block (ISB) - 0.2% Ropivacaine + additives: Ultrasound-guided single-injection ISB: ropivacaine 0.2% + (clonidine \[100 mcg\] + dexamethasone \[4 mg\] + buprenorphine \[150 mcg\]); Intravenous: saline
|
Low Dose
n=20 Participants
Interscalene Block (ISB) - 0.1% Ropivacaine + additives: Ultrasound-guided single-injection ISB: ropivacaine 0.1% + (clonidine \[100 mcg\] + dexamethasone \[4 mg\] + buprenorphine \[150 mcg\]); Intravenous: saline
|
Control
n=20 Participants
Interscalene Block (ISB) - Systemic Control: Ultrasound-guided single-injection ISB: ropivacaine 0.375%; Intravenous: clonidine (100 mcg) + dexamethasone (4 mg) + buprenorphine (150 mcg)
|
Total
n=80 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
66 years
STANDARD_DEVIATION 8 • n=5 Participants
|
64 years
STANDARD_DEVIATION 9 • n=7 Participants
|
69 years
STANDARD_DEVIATION 7 • n=5 Participants
|
68 years
STANDARD_DEVIATION 7 • n=4 Participants
|
67 years
STANDARD_DEVIATION 7 • n=21 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
47 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
33 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=5 Participants
|
20 participants
n=7 Participants
|
20 participants
n=5 Participants
|
20 participants
n=4 Participants
|
80 participants
n=21 Participants
|
|
BMI
|
28 kg/m^2
STANDARD_DEVIATION 4 • n=5 Participants
|
25 kg/m^2
STANDARD_DEVIATION 3 • n=7 Participants
|
27 kg/m^2
STANDARD_DEVIATION 4 • n=5 Participants
|
31 kg/m^2
STANDARD_DEVIATION 6 • n=4 Participants
|
28 kg/m^2
STANDARD_DEVIATION 5 • n=21 Participants
|
PRIMARY outcome
Timeframe: 24 hours after the interscalene block is givenPain with movement at 24 hours from the nerve block (scale of 0-10; 0 = no pain, 10 = worst possible pain)
Outcome measures
| Measure |
High Dose
n=20 Participants
Interscalene Block (ISB) - 0.375% Ropivacaine + additives: Ultrasound-guided single-injection ISB: ropivacaine 0.375% + (clonidine \[100 mcg\] + dexamethasone \[4 mg\] + buprenorphine \[150 mcg\]); Intravenous (IV): saline
|
Medium Dose
n=19 Participants
Interscalene Block (ISB) - 0.2% Ropivacaine + additives: Ultrasound-guided single-injection ISB: ropivacaine 0.2% + (clonidine \[100 mcg\] + dexamethasone \[4 mg\] + buprenorphine \[150 mcg\]); Intravenous: saline
|
Low Dose
n=20 Participants
Interscalene Block (ISB) - 0.1% Ropivacaine + additives: Ultrasound-guided single-injection ISB: ropivacaine 0.1% + (clonidine \[100 mcg\] + dexamethasone \[4 mg\] + buprenorphine \[150 mcg\]); Intravenous: saline
|
Control
n=19 Participants
Interscalene Block (ISB) - Systemic Control: Ultrasound-guided single-injection ISB: ropivacaine 0.375%; Intravenous: clonidine (100 mcg) + dexamethasone (4 mg) + buprenorphine (150 mcg)
|
|---|---|---|---|---|
|
Numeric Rating Scale (NRS) Pain Score With Movement
|
4.5 units on a scale
Standard Deviation 3.0
|
3.4 units on a scale
Standard Deviation 1.8
|
4.2 units on a scale
Standard Deviation 2.4
|
4.9 units on a scale
Standard Deviation 2.5
|
SECONDARY outcome
Timeframe: Postoperative day 1 at 8AM & 5PM, postoperative day 2 at 8AM & 5PMPopulation: Patients who were able to provide actual or estimates of time until they first needed to use pain medication were included in this analysis.
Median time until a patient needed to take opioid pain medication
Outcome measures
| Measure |
High Dose
n=16 Participants
Interscalene Block (ISB) - 0.375% Ropivacaine + additives: Ultrasound-guided single-injection ISB: ropivacaine 0.375% + (clonidine \[100 mcg\] + dexamethasone \[4 mg\] + buprenorphine \[150 mcg\]); Intravenous (IV): saline
|
Medium Dose
n=17 Participants
Interscalene Block (ISB) - 0.2% Ropivacaine + additives: Ultrasound-guided single-injection ISB: ropivacaine 0.2% + (clonidine \[100 mcg\] + dexamethasone \[4 mg\] + buprenorphine \[150 mcg\]); Intravenous: saline
|
Low Dose
n=17 Participants
Interscalene Block (ISB) - 0.1% Ropivacaine + additives: Ultrasound-guided single-injection ISB: ropivacaine 0.1% + (clonidine \[100 mcg\] + dexamethasone \[4 mg\] + buprenorphine \[150 mcg\]); Intravenous: saline
|
Control
n=20 Participants
Interscalene Block (ISB) - Systemic Control: Ultrasound-guided single-injection ISB: ropivacaine 0.375%; Intravenous: clonidine (100 mcg) + dexamethasone (4 mg) + buprenorphine (150 mcg)
|
|---|---|---|---|---|
|
Duration of Analgesia From Interscalene Nerve Block
|
21.3 hours
Standard Error 1.0
|
16.8 hours
Standard Error 1.6
|
18.2 hours
Standard Error 1.9
|
16.4 hours
Standard Error 1.4
|
SECONDARY outcome
Timeframe: PreopAssessment of NRS pain scores (scale of 0-10; 0 = no pain, 10 = worst possible pain) at rest
Outcome measures
| Measure |
High Dose
n=20 Participants
Interscalene Block (ISB) - 0.375% Ropivacaine + additives: Ultrasound-guided single-injection ISB: ropivacaine 0.375% + (clonidine \[100 mcg\] + dexamethasone \[4 mg\] + buprenorphine \[150 mcg\]); Intravenous (IV): saline
|
Medium Dose
n=19 Participants
Interscalene Block (ISB) - 0.2% Ropivacaine + additives: Ultrasound-guided single-injection ISB: ropivacaine 0.2% + (clonidine \[100 mcg\] + dexamethasone \[4 mg\] + buprenorphine \[150 mcg\]); Intravenous: saline
|
Low Dose
n=20 Participants
Interscalene Block (ISB) - 0.1% Ropivacaine + additives: Ultrasound-guided single-injection ISB: ropivacaine 0.1% + (clonidine \[100 mcg\] + dexamethasone \[4 mg\] + buprenorphine \[150 mcg\]); Intravenous: saline
|
Control
n=19 Participants
Interscalene Block (ISB) - Systemic Control: Ultrasound-guided single-injection ISB: ropivacaine 0.375%; Intravenous: clonidine (100 mcg) + dexamethasone (4 mg) + buprenorphine (150 mcg)
|
|---|---|---|---|---|
|
Numeric Rating Scale (NRS) Pain Scores at Rest
|
3.0 units on a scale
Interval 1.7 to 5.5
|
3.2 units on a scale
Interval 1.9 to 6.0
|
3.0 units on a scale
Interval 1.0 to 4.6
|
4.9 units on a scale
Interval 2.9 to 6.7
|
SECONDARY outcome
Timeframe: 24 hours after surgeryPopulation: Patients who agreed to the measurements were included in the analysis.
A physical assessment will be done to determine the strength of the middle deltoid muscle in the operative arm using a dynamometer
Outcome measures
| Measure |
High Dose
n=18 Participants
Interscalene Block (ISB) - 0.375% Ropivacaine + additives: Ultrasound-guided single-injection ISB: ropivacaine 0.375% + (clonidine \[100 mcg\] + dexamethasone \[4 mg\] + buprenorphine \[150 mcg\]); Intravenous (IV): saline
|
Medium Dose
n=17 Participants
Interscalene Block (ISB) - 0.2% Ropivacaine + additives: Ultrasound-guided single-injection ISB: ropivacaine 0.2% + (clonidine \[100 mcg\] + dexamethasone \[4 mg\] + buprenorphine \[150 mcg\]); Intravenous: saline
|
Low Dose
n=18 Participants
Interscalene Block (ISB) - 0.1% Ropivacaine + additives: Ultrasound-guided single-injection ISB: ropivacaine 0.1% + (clonidine \[100 mcg\] + dexamethasone \[4 mg\] + buprenorphine \[150 mcg\]); Intravenous: saline
|
Control
n=19 Participants
Interscalene Block (ISB) - Systemic Control: Ultrasound-guided single-injection ISB: ropivacaine 0.375%; Intravenous: clonidine (100 mcg) + dexamethasone (4 mg) + buprenorphine (150 mcg)
|
|---|---|---|---|---|
|
Middle Deltoid
|
2.8 kgf
Interval 1.7 to 4.2
|
1.5 kgf
Interval 1.3 to 2.2
|
2.2 kgf
Interval 2.0 to 3.2
|
1.8 kgf
Interval 1.4 to 2.2
|
Adverse Events
High Dose
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Medium Dose
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Low Dose
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control
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