Trial Outcomes & Findings for Comparison of Analgesic Efficacy Between of Interscalene Block With Liposomal Bupivacaine With Bupivacaine and Dexamethasone (NCT NCT03969875)
NCT ID: NCT03969875
Last Updated: 2024-05-07
Results Overview
Numerical rating score for pain is assessed from 0 to 10, with 0 being no pain and 10 being worst pain.
Recruitment status
COMPLETED
Target enrollment
90 participants
Primary outcome timeframe
at 6 hours, 12 hours, 18 hours, 24 hours, 36 hours, 48 hours
Results posted on
2024-05-07
Participant Flow
Recruitment from 2018 to 2022
There were 155 eligible participants and 90 were randomized.
Participant milestones
| Measure |
Interscalene Catheter
Interscalene catheter 0.5 % bupivacaine 15cc with rescue catheters attached to a PCA pump with bupivacaine infusion at 6cc /hour.
Interscalene catheter: rescue catheters attached to a PCA pump
Bupivacaine: 0.5% bupivacaine
|
Interscalene With Bupivacaine and Dexamethasone
Interscalene single shot with bupivacaine and dexamethasone as adjuvant 0.5% bupivacaine 14cc with 1 cc of 4mg dexamethasone, total 15cc with rescue catheter attached to a PCA pump with normal saline at 6cc/hour infusion.
Dexamethasone: 1 cc of 4mg
Bupivacaine: 0.5% bupivacaine
|
Interscalene Single Shot With Liposomal Bupivacaine
Liposomal bupivacaine 10cc of exparel with 0.5% bupivacaine 5cc, total 15cc with rescue catheter attached to a PCA pump with normal saline at 6cc/hour infusion.
Liposomal bupivacaine: 10 cc
|
|---|---|---|---|
|
Overall Study
STARTED
|
31
|
29
|
30
|
|
Overall Study
COMPLETED
|
24
|
24
|
24
|
|
Overall Study
NOT COMPLETED
|
7
|
5
|
6
|
Reasons for withdrawal
| Measure |
Interscalene Catheter
Interscalene catheter 0.5 % bupivacaine 15cc with rescue catheters attached to a PCA pump with bupivacaine infusion at 6cc /hour.
Interscalene catheter: rescue catheters attached to a PCA pump
Bupivacaine: 0.5% bupivacaine
|
Interscalene With Bupivacaine and Dexamethasone
Interscalene single shot with bupivacaine and dexamethasone as adjuvant 0.5% bupivacaine 14cc with 1 cc of 4mg dexamethasone, total 15cc with rescue catheter attached to a PCA pump with normal saline at 6cc/hour infusion.
Dexamethasone: 1 cc of 4mg
Bupivacaine: 0.5% bupivacaine
|
Interscalene Single Shot With Liposomal Bupivacaine
Liposomal bupivacaine 10cc of exparel with 0.5% bupivacaine 5cc, total 15cc with rescue catheter attached to a PCA pump with normal saline at 6cc/hour infusion.
Liposomal bupivacaine: 10 cc
|
|---|---|---|---|
|
Overall Study
did not receive allocated intervention
|
3
|
3
|
4
|
|
Overall Study
Protocol Violation
|
4
|
2
|
2
|
Baseline Characteristics
Comparison of Analgesic Efficacy Between of Interscalene Block With Liposomal Bupivacaine With Bupivacaine and Dexamethasone
Baseline characteristics by cohort
| Measure |
Interscalene Catheter
n=24 Participants
Interscalene catheter 0.5 % bupivacaine 15cc with rescue catheters attached to a PCA pump with bupivacaine infusion at 6cc /hour.
Interscalene catheter: rescue catheters attached to a PCA pump
Bupivacaine: 0.5% bupivacaine
|
Interscalene With Bupivacaine and Dexamethasone
n=24 Participants
Interscalene single shot with bupivacaine and dexamethasone as adjuvant 0.5% bupivacaine 14cc with 1 cc of 4mg dexamethasone, total 15cc with rescue catheter attached to a PCA pump with normal saline at 6cc/hour infusion.
Dexamethasone: 1 cc of 4mg
Bupivacaine: 0.5% bupivacaine
|
Interscalene Single Shot With Liposomal Bupivacaine
n=24 Participants
Liposomal bupivacaine 10cc of exparel with 0.5% bupivacaine 5cc, total 15cc with rescue catheter attached to a PCA pump with normal saline at 6cc/hour infusion.
Liposomal bupivacaine: 10 cc
|
Total
n=72 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
69.08 years
STANDARD_DEVIATION 6.23 • n=93 Participants
|
71.75 years
STANDARD_DEVIATION 6.58 • n=4 Participants
|
68 years
STANDARD_DEVIATION 8.50 • n=27 Participants
|
69.61 years
STANDARD_DEVIATION 7.25 • n=483 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=93 Participants
|
17 Participants
n=4 Participants
|
13 Participants
n=27 Participants
|
44 Participants
n=483 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
11 Participants
n=27 Participants
|
28 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
10 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
22 Participants
n=93 Participants
|
19 Participants
n=4 Participants
|
21 Participants
n=27 Participants
|
62 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
2 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
12 Participants
n=483 Participants
|
|
Race (NIH/OMB)
White
|
18 Participants
n=93 Participants
|
13 Participants
n=4 Participants
|
17 Participants
n=27 Participants
|
48 Participants
n=483 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
10 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Type of Shoulder Replacement
Anatomic
|
10 Participants
n=93 Participants
|
13 Participants
n=4 Participants
|
12 Participants
n=27 Participants
|
35 Participants
n=483 Participants
|
|
Type of Shoulder Replacement
Reverse
|
14 Participants
n=93 Participants
|
11 Participants
n=4 Participants
|
12 Participants
n=27 Participants
|
37 Participants
n=483 Participants
|
|
Side of Surgery
Right
|
12 Participants
n=93 Participants
|
13 Participants
n=4 Participants
|
15 Participants
n=27 Participants
|
40 Participants
n=483 Participants
|
|
Side of Surgery
Left
|
12 Participants
n=93 Participants
|
11 Participants
n=4 Participants
|
9 Participants
n=27 Participants
|
32 Participants
n=483 Participants
|
|
The American Society of Anesthesiologists (ASA) Physical Status Classification System
ASA I
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
|
The American Society of Anesthesiologists (ASA) Physical Status Classification System
ASA II
|
8 Participants
n=93 Participants
|
18 Participants
n=4 Participants
|
12 Participants
n=27 Participants
|
38 Participants
n=483 Participants
|
|
The American Society of Anesthesiologists (ASA) Physical Status Classification System
ASA III
|
15 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
12 Participants
n=27 Participants
|
33 Participants
n=483 Participants
|
|
Current Smoker
|
0 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
4 Participants
n=483 Participants
|
|
Level of Education
Under High School
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
3 Participants
n=483 Participants
|
|
Level of Education
High School
|
10 Participants
n=93 Participants
|
9 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
24 Participants
n=483 Participants
|
|
Level of Education
Bachelor
|
7 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
10 Participants
n=27 Participants
|
25 Participants
n=483 Participants
|
|
Level of Education
Graduate
|
6 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
8 Participants
n=27 Participants
|
20 Participants
n=483 Participants
|
|
Number of Participant Employed
|
13 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
8 Participants
n=27 Participants
|
24 Participants
n=483 Participants
|
PRIMARY outcome
Timeframe: at 6 hours, 12 hours, 18 hours, 24 hours, 36 hours, 48 hoursNumerical rating score for pain is assessed from 0 to 10, with 0 being no pain and 10 being worst pain.
Outcome measures
| Measure |
Interscalene Catheter
n=24 Participants
Interscalene catheter 0.5 % bupivacaine 15cc with rescue catheters attached to a PCA pump with bupivacaine infusion at 6cc /hour.
Interscalene catheter: rescue catheters attached to a PCA pump
Bupivacaine: 0.5% bupivacaine
|
Interscalene With Bupivacaine and Dexamethasone
n=24 Participants
Interscalene single shot with bupivacaine and dexamethasone as adjuvant 0.5% bupivacaine 14cc with 1 cc of 4mg dexamethasone, total 15cc with rescue catheter attached to a PCA pump with normal saline at 6cc/hour infusion.
Dexamethasone: 1 cc of 4mg Bupivacaine: 0.5% bupivacaine
|
Interscalene Single Shot With Liposomal Bupivacaine
n=24 Participants
Liposomal bupivacaine 10cc of exparel with 0.5% bupivacaine 5cc, total 15cc with rescue catheter attached to a PCA pump with normal saline at 6cc/hour infusion.
Liposomal bupivacaine: 10 cc
|
|---|---|---|---|
|
Numerical Rating Score for Pain
6 hours
|
0.00 score on a scale
Interval 0.0 to 2.25
|
0.00 score on a scale
Interval 0.0 to 3.0
|
0.00 score on a scale
Interval 0.0 to 1.0
|
|
Numerical Rating Score for Pain
12 hours
|
0.00 score on a scale
Interval 0.0 to 5.0
|
0.00 score on a scale
Interval 0.0 to 2.25
|
2.00 score on a scale
Interval 0.0 to 7.0
|
|
Numerical Rating Score for Pain
18 hours
|
2.00 score on a scale
Interval 0.0 to 4.25
|
5.50 score on a scale
Interval 0.0 to 7.0
|
0.50 score on a scale
Interval 0.0 to 2.5
|
|
Numerical Rating Score for Pain
24 hours
|
2.50 score on a scale
Interval 0.0 to 5.0
|
3.00 score on a scale
Interval 0.0 to 6.25
|
2.00 score on a scale
Interval 0.0 to 3.0
|
|
Numerical Rating Score for Pain
36 hours
|
3.00 score on a scale
Interval 0.0 to 5.0
|
2.00 score on a scale
Interval 0.75 to 5.25
|
2.00 score on a scale
Interval 1.0 to 5.0
|
|
Numerical Rating Score for Pain
48 hours
|
2.00 score on a scale
Interval 0.0 to 3.25
|
2.00 score on a scale
Interval 0.75 to 5.0
|
2.50 score on a scale
Interval 0.75 to 5.0
|
SECONDARY outcome
Timeframe: Day 1Time to first analgesic request on Day 1
Outcome measures
| Measure |
Interscalene Catheter
n=24 Participants
Interscalene catheter 0.5 % bupivacaine 15cc with rescue catheters attached to a PCA pump with bupivacaine infusion at 6cc /hour.
Interscalene catheter: rescue catheters attached to a PCA pump
Bupivacaine: 0.5% bupivacaine
|
Interscalene With Bupivacaine and Dexamethasone
n=24 Participants
Interscalene single shot with bupivacaine and dexamethasone as adjuvant 0.5% bupivacaine 14cc with 1 cc of 4mg dexamethasone, total 15cc with rescue catheter attached to a PCA pump with normal saline at 6cc/hour infusion.
Dexamethasone: 1 cc of 4mg Bupivacaine: 0.5% bupivacaine
|
Interscalene Single Shot With Liposomal Bupivacaine
n=24 Participants
Liposomal bupivacaine 10cc of exparel with 0.5% bupivacaine 5cc, total 15cc with rescue catheter attached to a PCA pump with normal saline at 6cc/hour infusion.
Liposomal bupivacaine: 10 cc
|
|---|---|---|---|
|
Time to First Analgesic Request
|
1.50 hours
Interval 0.16 to 18.0
|
3.50 hours
Interval 0.0 to 12.0
|
2.19 hours
Interval 0.15 to 9.0
|
SECONDARY outcome
Timeframe: hospital stay, up to 48 hoursTotal narcotic consumption in mg morphine equivalents (MME) during hospital stay
Outcome measures
| Measure |
Interscalene Catheter
n=24 Participants
Interscalene catheter 0.5 % bupivacaine 15cc with rescue catheters attached to a PCA pump with bupivacaine infusion at 6cc /hour.
Interscalene catheter: rescue catheters attached to a PCA pump
Bupivacaine: 0.5% bupivacaine
|
Interscalene With Bupivacaine and Dexamethasone
n=24 Participants
Interscalene single shot with bupivacaine and dexamethasone as adjuvant 0.5% bupivacaine 14cc with 1 cc of 4mg dexamethasone, total 15cc with rescue catheter attached to a PCA pump with normal saline at 6cc/hour infusion.
Dexamethasone: 1 cc of 4mg Bupivacaine: 0.5% bupivacaine
|
Interscalene Single Shot With Liposomal Bupivacaine
n=24 Participants
Liposomal bupivacaine 10cc of exparel with 0.5% bupivacaine 5cc, total 15cc with rescue catheter attached to a PCA pump with normal saline at 6cc/hour infusion.
Liposomal bupivacaine: 10 cc
|
|---|---|---|---|
|
Total Narcotic Consumption
|
30.00 MME
Interval 12.5 to 65.25
|
21.05 MME
Interval 5.62 to 57.45
|
13.25 MME
Interval 0.0 to 33.95
|
SECONDARY outcome
Timeframe: at 6 hours, 12 hours, 18 hours, 24 hours, 36 hoursArm weakness as assessed by flexion and extension at wrist -- total scale from 1 to 10, with 10 being most weakness
Outcome measures
| Measure |
Interscalene Catheter
n=24 Participants
Interscalene catheter 0.5 % bupivacaine 15cc with rescue catheters attached to a PCA pump with bupivacaine infusion at 6cc /hour.
Interscalene catheter: rescue catheters attached to a PCA pump
Bupivacaine: 0.5% bupivacaine
|
Interscalene With Bupivacaine and Dexamethasone
n=24 Participants
Interscalene single shot with bupivacaine and dexamethasone as adjuvant 0.5% bupivacaine 14cc with 1 cc of 4mg dexamethasone, total 15cc with rescue catheter attached to a PCA pump with normal saline at 6cc/hour infusion.
Dexamethasone: 1 cc of 4mg Bupivacaine: 0.5% bupivacaine
|
Interscalene Single Shot With Liposomal Bupivacaine
n=24 Participants
Liposomal bupivacaine 10cc of exparel with 0.5% bupivacaine 5cc, total 15cc with rescue catheter attached to a PCA pump with normal saline at 6cc/hour infusion.
Liposomal bupivacaine: 10 cc
|
|---|---|---|---|
|
Arm Weakness
6 hours
|
2.00 score on a scale
Interval 1.0 to 2.0
|
2.00 score on a scale
Interval 0.75 to 3.0
|
2.00 score on a scale
Interval 0.75 to 2.0
|
|
Arm Weakness
12 hours
|
2.00 score on a scale
Interval 1.75 to 3.25
|
3.00 score on a scale
Interval 2.0 to 4.0
|
4.00 score on a scale
Interval 2.0 to 4.0
|
|
Arm Weakness
18 hours
|
3.00 score on a scale
Interval 2.0 to 4.0
|
4.00 score on a scale
Interval 3.0 to 5.0
|
4.00 score on a scale
Interval 3.0 to 5.0
|
|
Arm Weakness
24 hours
|
4.00 score on a scale
Interval 3.0 to 5.0
|
5.00 score on a scale
Interval 4.75 to 5.0
|
5.00 score on a scale
Interval 4.0 to 5.0
|
|
Arm Weakness
36 hours
|
5.00 score on a scale
Interval 4.0 to 5.0
|
5.00 score on a scale
Interval 5.0 to 5.0
|
5.00 score on a scale
Interval 4.75 to 5.0
|
SECONDARY outcome
Timeframe: at 6 hours, 12 hours, 18 hours, 24 hours, 36 hoursArm numbness assessed by the sensation at deltoid area. Sensation total scale from 1 to 10, with higher number indicating most sensation.
Outcome measures
| Measure |
Interscalene Catheter
n=24 Participants
Interscalene catheter 0.5 % bupivacaine 15cc with rescue catheters attached to a PCA pump with bupivacaine infusion at 6cc /hour.
Interscalene catheter: rescue catheters attached to a PCA pump
Bupivacaine: 0.5% bupivacaine
|
Interscalene With Bupivacaine and Dexamethasone
n=24 Participants
Interscalene single shot with bupivacaine and dexamethasone as adjuvant 0.5% bupivacaine 14cc with 1 cc of 4mg dexamethasone, total 15cc with rescue catheter attached to a PCA pump with normal saline at 6cc/hour infusion.
Dexamethasone: 1 cc of 4mg Bupivacaine: 0.5% bupivacaine
|
Interscalene Single Shot With Liposomal Bupivacaine
n=24 Participants
Liposomal bupivacaine 10cc of exparel with 0.5% bupivacaine 5cc, total 15cc with rescue catheter attached to a PCA pump with normal saline at 6cc/hour infusion.
Liposomal bupivacaine: 10 cc
|
|---|---|---|---|
|
Arm Numbness
6 hours
|
1.00 score on a scale
Interval 1.0 to 1.0
|
1.00 score on a scale
Interval 1.0 to 1.0
|
1.00 score on a scale
Interval 1.0 to 2.0
|
|
Arm Numbness
12 hours
|
2.00 score on a scale
Interval 1.0 to 2.0
|
2.00 score on a scale
Interval 0.75 to 3.0
|
2.00 score on a scale
Interval 0.75 to 2.0
|
|
Arm Numbness
18 hours
|
2.00 score on a scale
Interval 1.0 to 2.0
|
2.00 score on a scale
Interval 2.0 to 2.0
|
2.00 score on a scale
Interval 2.0 to 2.0
|
|
Arm Numbness
24 hours
|
2.00 score on a scale
Interval 2.0 to 2.0
|
2.00 score on a scale
Interval 2.0 to 2.0
|
2.00 score on a scale
Interval 2.0 to 2.0
|
|
Arm Numbness
36 hours
|
2.00 score on a scale
Interval 2.0 to 4.0
|
3.00 score on a scale
Interval 2.0 to 4.0
|
2.00 score on a scale
Interval 2.0 to 4.0
|
SECONDARY outcome
Timeframe: Day 1The duration for which the patient has no pain on Day 1
Outcome measures
| Measure |
Interscalene Catheter
n=24 Participants
Interscalene catheter 0.5 % bupivacaine 15cc with rescue catheters attached to a PCA pump with bupivacaine infusion at 6cc /hour.
Interscalene catheter: rescue catheters attached to a PCA pump
Bupivacaine: 0.5% bupivacaine
|
Interscalene With Bupivacaine and Dexamethasone
n=24 Participants
Interscalene single shot with bupivacaine and dexamethasone as adjuvant 0.5% bupivacaine 14cc with 1 cc of 4mg dexamethasone, total 15cc with rescue catheter attached to a PCA pump with normal saline at 6cc/hour infusion.
Dexamethasone: 1 cc of 4mg Bupivacaine: 0.5% bupivacaine
|
Interscalene Single Shot With Liposomal Bupivacaine
n=24 Participants
Liposomal bupivacaine 10cc of exparel with 0.5% bupivacaine 5cc, total 15cc with rescue catheter attached to a PCA pump with normal saline at 6cc/hour infusion.
Liposomal bupivacaine: 10 cc
|
|---|---|---|---|
|
Time of Analgesia Duration
|
6.00 hours
Interval 1.5 to 17.0
|
11.00 hours
Interval 5.75 to 15.75
|
8.00 hours
Interval 5.0 to 16.5
|
SECONDARY outcome
Timeframe: Day 1Time of motor recovery on Day 1
Outcome measures
| Measure |
Interscalene Catheter
n=24 Participants
Interscalene catheter 0.5 % bupivacaine 15cc with rescue catheters attached to a PCA pump with bupivacaine infusion at 6cc /hour.
Interscalene catheter: rescue catheters attached to a PCA pump
Bupivacaine: 0.5% bupivacaine
|
Interscalene With Bupivacaine and Dexamethasone
n=24 Participants
Interscalene single shot with bupivacaine and dexamethasone as adjuvant 0.5% bupivacaine 14cc with 1 cc of 4mg dexamethasone, total 15cc with rescue catheter attached to a PCA pump with normal saline at 6cc/hour infusion.
Dexamethasone: 1 cc of 4mg Bupivacaine: 0.5% bupivacaine
|
Interscalene Single Shot With Liposomal Bupivacaine
n=24 Participants
Liposomal bupivacaine 10cc of exparel with 0.5% bupivacaine 5cc, total 15cc with rescue catheter attached to a PCA pump with normal saline at 6cc/hour infusion.
Liposomal bupivacaine: 10 cc
|
|---|---|---|---|
|
Time of Motor Recovery
|
12.00 hours
Interval 10.0 to 24.0
|
14.00 hours
Interval 10.0 to 18.0
|
12.00 hours
Interval 6.75 to 18.0
|
SECONDARY outcome
Timeframe: at 6 hours, 12 hours, 18 hours, 24 hours, 36 hoursSensory testing by using pinprick in the region of C5 dermatome. Scale from 1 to 10, with higher score indicating more sensation.
Outcome measures
| Measure |
Interscalene Catheter
n=24 Participants
Interscalene catheter 0.5 % bupivacaine 15cc with rescue catheters attached to a PCA pump with bupivacaine infusion at 6cc /hour.
Interscalene catheter: rescue catheters attached to a PCA pump
Bupivacaine: 0.5% bupivacaine
|
Interscalene With Bupivacaine and Dexamethasone
n=24 Participants
Interscalene single shot with bupivacaine and dexamethasone as adjuvant 0.5% bupivacaine 14cc with 1 cc of 4mg dexamethasone, total 15cc with rescue catheter attached to a PCA pump with normal saline at 6cc/hour infusion.
Dexamethasone: 1 cc of 4mg Bupivacaine: 0.5% bupivacaine
|
Interscalene Single Shot With Liposomal Bupivacaine
n=24 Participants
Liposomal bupivacaine 10cc of exparel with 0.5% bupivacaine 5cc, total 15cc with rescue catheter attached to a PCA pump with normal saline at 6cc/hour infusion.
Liposomal bupivacaine: 10 cc
|
|---|---|---|---|
|
Sensory Intact
6 hours
|
1.00 score on a scale
Interval 1.0 to 1.0
|
1.00 score on a scale
Interval 1.0 to 1.0
|
1.00 score on a scale
Interval 1.0 to 1.0
|
|
Sensory Intact
12 hours
|
2.00 score on a scale
Interval 1.0 to 2.0
|
2.00 score on a scale
Interval 1.0 to 2.0
|
2.00 score on a scale
Interval 1.0 to 2.0
|
|
Sensory Intact
18 hours
|
2.00 score on a scale
Interval 1.0 to 2.0
|
2.00 score on a scale
Interval 1.0 to 2.0
|
2.00 score on a scale
Interval 1.0 to 2.0
|
|
Sensory Intact
24 hours
|
2.00 score on a scale
Interval 2.0 to 2.0
|
2.00 score on a scale
Interval 2.0 to 2.0
|
2.00 score on a scale
Interval 2.0 to 2.0
|
|
Sensory Intact
36 hours
|
2.00 score on a scale
Interval 2.0 to 4.0
|
2.00 score on a scale
Interval 2.0 to 4.0
|
2.00 score on a scale
Interval 2.0 to 4.0
|
SECONDARY outcome
Timeframe: at 6 hours, 12 hours, 18 hours, 24 hours, 36 hoursHand strength assessed by using dynamometer, a device for measuring the amount of static force that can squeeze around a dynamometer, in kilograms.
Outcome measures
| Measure |
Interscalene Catheter
n=24 Participants
Interscalene catheter 0.5 % bupivacaine 15cc with rescue catheters attached to a PCA pump with bupivacaine infusion at 6cc /hour.
Interscalene catheter: rescue catheters attached to a PCA pump
Bupivacaine: 0.5% bupivacaine
|
Interscalene With Bupivacaine and Dexamethasone
n=24 Participants
Interscalene single shot with bupivacaine and dexamethasone as adjuvant 0.5% bupivacaine 14cc with 1 cc of 4mg dexamethasone, total 15cc with rescue catheter attached to a PCA pump with normal saline at 6cc/hour infusion.
Dexamethasone: 1 cc of 4mg Bupivacaine: 0.5% bupivacaine
|
Interscalene Single Shot With Liposomal Bupivacaine
n=24 Participants
Liposomal bupivacaine 10cc of exparel with 0.5% bupivacaine 5cc, total 15cc with rescue catheter attached to a PCA pump with normal saline at 6cc/hour infusion.
Liposomal bupivacaine: 10 cc
|
|---|---|---|---|
|
Hand Strength
6 hours - Left hand
|
16.90 kg
Interval 10.68 to 26.75
|
18.00 kg
Interval 12.0 to 20.8
|
16.35 kg
Interval 14.45 to 30.0
|
|
Hand Strength
12 hours - Left hand
|
13.50 kg
Interval 9.35 to 26.75
|
19.00 kg
Interval 12.0 to 21.0
|
16.85 kg
Interval 6.05 to 29.25
|
|
Hand Strength
18 hours Left hand
|
13.95 kg
Interval 9.17 to 26.55
|
16.50 kg
Interval 14.9 to 22.35
|
19.50 kg
Interval 8.45 to 31.25
|
|
Hand Strength
24 hours - Left hand
|
15.10 kg
Interval 10.0 to 26.75
|
19.00 kg
Interval 13.3 to 22.25
|
20.00 kg
Interval 9.75 to 35.25
|
|
Hand Strength
36 hours - Left hand
|
16.50 kg
Interval 9.8 to 26.5
|
20.00 kg
Interval 14.5 to 24.25
|
20.00 kg
Interval 11.5 to 35.25
|
|
Hand Strength
6 hours - Right hand
|
14.90 kg
Interval 8.75 to 23.95
|
13.50 kg
Interval 5.43 to 24.25
|
10.00 kg
Interval 2.0 to 22.7
|
|
Hand Strength
12 hours - Right hand
|
14.75 kg
Interval 9.0 to 22.0
|
14.50 kg
Interval 9.53 to 24.12
|
12.00 kg
Interval 4.57 to 22.65
|
|
Hand Strength
18 hours - Right hand
|
16.80 kg
Interval 9.9 to 22.75
|
16.35 kg
Interval 10.75 to 25.77
|
12.40 kg
Interval 7.35 to 21.83
|
|
Hand Strength
24 hours - Right hand
|
16.90 kg
Interval 10.68 to 26.75
|
19.30 kg
Interval 10.88 to 26.0
|
17.50 kg
Interval 8.75 to 25.25
|
|
Hand Strength
36 hours - Right hand
|
13.50 kg
Interval 9.35 to 26.75
|
20.50 kg
Interval 10.75 to 30.0
|
18.50 kg
Interval 10.0 to 25.75
|
SECONDARY outcome
Timeframe: Day 1Post-anesthesia Care Unit length of stay in hours on Day 1
Outcome measures
| Measure |
Interscalene Catheter
n=24 Participants
Interscalene catheter 0.5 % bupivacaine 15cc with rescue catheters attached to a PCA pump with bupivacaine infusion at 6cc /hour.
Interscalene catheter: rescue catheters attached to a PCA pump
Bupivacaine: 0.5% bupivacaine
|
Interscalene With Bupivacaine and Dexamethasone
n=24 Participants
Interscalene single shot with bupivacaine and dexamethasone as adjuvant 0.5% bupivacaine 14cc with 1 cc of 4mg dexamethasone, total 15cc with rescue catheter attached to a PCA pump with normal saline at 6cc/hour infusion.
Dexamethasone: 1 cc of 4mg Bupivacaine: 0.5% bupivacaine
|
Interscalene Single Shot With Liposomal Bupivacaine
n=24 Participants
Liposomal bupivacaine 10cc of exparel with 0.5% bupivacaine 5cc, total 15cc with rescue catheter attached to a PCA pump with normal saline at 6cc/hour infusion.
Liposomal bupivacaine: 10 cc
|
|---|---|---|---|
|
PACU Length of Stay
|
2.7 hours
Interval 2.11 to 3.0
|
2.44 hours
Interval 2.0 to 3.0
|
3 hours
Interval 2.0 to 3.26
|
SECONDARY outcome
Timeframe: up to 3 daysLength of stay for duration of hospital admission
Outcome measures
| Measure |
Interscalene Catheter
n=24 Participants
Interscalene catheter 0.5 % bupivacaine 15cc with rescue catheters attached to a PCA pump with bupivacaine infusion at 6cc /hour.
Interscalene catheter: rescue catheters attached to a PCA pump
Bupivacaine: 0.5% bupivacaine
|
Interscalene With Bupivacaine and Dexamethasone
n=24 Participants
Interscalene single shot with bupivacaine and dexamethasone as adjuvant 0.5% bupivacaine 14cc with 1 cc of 4mg dexamethasone, total 15cc with rescue catheter attached to a PCA pump with normal saline at 6cc/hour infusion.
Dexamethasone: 1 cc of 4mg Bupivacaine: 0.5% bupivacaine
|
Interscalene Single Shot With Liposomal Bupivacaine
n=24 Participants
Liposomal bupivacaine 10cc of exparel with 0.5% bupivacaine 5cc, total 15cc with rescue catheter attached to a PCA pump with normal saline at 6cc/hour infusion.
Liposomal bupivacaine: 10 cc
|
|---|---|---|---|
|
Hospital Length of Stay
|
2.75 days
Interval 1.0 to 3.0
|
2 days
Interval 1.0 to 2.5
|
1.75 days
Interval 1.0 to 3.0
|
SECONDARY outcome
Timeframe: up to 3 daysNumber of complications - any associated complications like nausea, vomiting, dizziness, horner's syndrome, hoarseness and dyspnea
Outcome measures
| Measure |
Interscalene Catheter
n=24 Participants
Interscalene catheter 0.5 % bupivacaine 15cc with rescue catheters attached to a PCA pump with bupivacaine infusion at 6cc /hour.
Interscalene catheter: rescue catheters attached to a PCA pump
Bupivacaine: 0.5% bupivacaine
|
Interscalene With Bupivacaine and Dexamethasone
n=24 Participants
Interscalene single shot with bupivacaine and dexamethasone as adjuvant 0.5% bupivacaine 14cc with 1 cc of 4mg dexamethasone, total 15cc with rescue catheter attached to a PCA pump with normal saline at 6cc/hour infusion.
Dexamethasone: 1 cc of 4mg Bupivacaine: 0.5% bupivacaine
|
Interscalene Single Shot With Liposomal Bupivacaine
n=24 Participants
Liposomal bupivacaine 10cc of exparel with 0.5% bupivacaine 5cc, total 15cc with rescue catheter attached to a PCA pump with normal saline at 6cc/hour infusion.
Liposomal bupivacaine: 10 cc
|
|---|---|---|---|
|
Number of Complication Events
Nausea
|
3 events
|
2 events
|
1 events
|
|
Number of Complication Events
Vomiting
|
0 events
|
0 events
|
0 events
|
|
Number of Complication Events
Dizziness
|
2 events
|
2 events
|
2 events
|
|
Number of Complication Events
Horners
|
2 events
|
0 events
|
0 events
|
|
Number of Complication Events
Hoarseness
|
1 events
|
3 events
|
0 events
|
|
Number of Complication Events
Dyspnea
|
0 events
|
0 events
|
0 events
|
SECONDARY outcome
Timeframe: average of 3 daysPatient to rate their quality of sleep as good, average, or bad
Outcome measures
| Measure |
Interscalene Catheter
n=24 Participants
Interscalene catheter 0.5 % bupivacaine 15cc with rescue catheters attached to a PCA pump with bupivacaine infusion at 6cc /hour.
Interscalene catheter: rescue catheters attached to a PCA pump
Bupivacaine: 0.5% bupivacaine
|
Interscalene With Bupivacaine and Dexamethasone
n=24 Participants
Interscalene single shot with bupivacaine and dexamethasone as adjuvant 0.5% bupivacaine 14cc with 1 cc of 4mg dexamethasone, total 15cc with rescue catheter attached to a PCA pump with normal saline at 6cc/hour infusion.
Dexamethasone: 1 cc of 4mg Bupivacaine: 0.5% bupivacaine
|
Interscalene Single Shot With Liposomal Bupivacaine
n=24 Participants
Liposomal bupivacaine 10cc of exparel with 0.5% bupivacaine 5cc, total 15cc with rescue catheter attached to a PCA pump with normal saline at 6cc/hour infusion.
Liposomal bupivacaine: 10 cc
|
|---|---|---|---|
|
Number of Participants With Quality of Sleep Rating
Good
|
12 Participants
|
9 Participants
|
7 Participants
|
|
Number of Participants With Quality of Sleep Rating
Average
|
5 Participants
|
6 Participants
|
7 Participants
|
|
Number of Participants With Quality of Sleep Rating
Bad
|
7 Participants
|
9 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: during the hospital stay, up to 3 daysNumber of Participants with Patient satisfaction. Patients were asked if they were satisfied.
Outcome measures
| Measure |
Interscalene Catheter
n=24 Participants
Interscalene catheter 0.5 % bupivacaine 15cc with rescue catheters attached to a PCA pump with bupivacaine infusion at 6cc /hour.
Interscalene catheter: rescue catheters attached to a PCA pump
Bupivacaine: 0.5% bupivacaine
|
Interscalene With Bupivacaine and Dexamethasone
n=24 Participants
Interscalene single shot with bupivacaine and dexamethasone as adjuvant 0.5% bupivacaine 14cc with 1 cc of 4mg dexamethasone, total 15cc with rescue catheter attached to a PCA pump with normal saline at 6cc/hour infusion.
Dexamethasone: 1 cc of 4mg Bupivacaine: 0.5% bupivacaine
|
Interscalene Single Shot With Liposomal Bupivacaine
n=24 Participants
Liposomal bupivacaine 10cc of exparel with 0.5% bupivacaine 5cc, total 15cc with rescue catheter attached to a PCA pump with normal saline at 6cc/hour infusion.
Liposomal bupivacaine: 10 cc
|
|---|---|---|---|
|
Number of Participants With Patient's Satisfaction
|
16 Participants
|
16 Participants
|
16 Participants
|
SECONDARY outcome
Timeframe: baseline and one week post-opPROMIS global assessment assesses physical and mental activities of daily living scored from 0 (poor) to 5 (excellent) at first post-operative visit as compared to baseline. Each scale from 0-100, higher score indicates better health outcomes.
Outcome measures
| Measure |
Interscalene Catheter
n=24 Participants
Interscalene catheter 0.5 % bupivacaine 15cc with rescue catheters attached to a PCA pump with bupivacaine infusion at 6cc /hour.
Interscalene catheter: rescue catheters attached to a PCA pump
Bupivacaine: 0.5% bupivacaine
|
Interscalene With Bupivacaine and Dexamethasone
n=24 Participants
Interscalene single shot with bupivacaine and dexamethasone as adjuvant 0.5% bupivacaine 14cc with 1 cc of 4mg dexamethasone, total 15cc with rescue catheter attached to a PCA pump with normal saline at 6cc/hour infusion.
Dexamethasone: 1 cc of 4mg Bupivacaine: 0.5% bupivacaine
|
Interscalene Single Shot With Liposomal Bupivacaine
n=24 Participants
Liposomal bupivacaine 10cc of exparel with 0.5% bupivacaine 5cc, total 15cc with rescue catheter attached to a PCA pump with normal saline at 6cc/hour infusion.
Liposomal bupivacaine: 10 cc
|
|---|---|---|---|
|
Change in Patient Reported Outcomes Measurement Information System (PROMIS)
Pre-Physical, baseline
|
41.98 score on a scale
Standard Deviation 9.88
|
42.42 score on a scale
Standard Deviation 8.83
|
42.19 score on a scale
Standard Deviation 9.26
|
|
Change in Patient Reported Outcomes Measurement Information System (PROMIS)
Post-Physical, one week post-op
|
44.44 score on a scale
Standard Deviation 9.57
|
43.55 score on a scale
Standard Deviation 9.52
|
45.15 score on a scale
Standard Deviation 8.89
|
|
Change in Patient Reported Outcomes Measurement Information System (PROMIS)
Pre-Mental, baseline
|
50.00 score on a scale
Standard Deviation 12.18
|
51.64 score on a scale
Standard Deviation 11.01
|
51.44 score on a scale
Standard Deviation 8.35
|
|
Change in Patient Reported Outcomes Measurement Information System (PROMIS)
Post-Mental, one week post-op
|
49.75 score on a scale
Standard Deviation 11.51
|
52.14 score on a scale
Standard Deviation 10.41
|
52.99 score on a scale
Standard Deviation 6.93
|
Adverse Events
Interscalene Catheter
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Interscalene With Bupivacaine and Dexamethasone
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Interscalene Single Shot With Liposomal Bupivacaine
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