Trial Outcomes & Findings for Liposomal Bupivacaine vs Dexamethasone ISB (NCT NCT04047446)
NCT ID: NCT04047446
Last Updated: 2022-08-01
Results Overview
NRS pain at rest averaged over the first 72 hours. NRS pain is on a scale from 0 (no pain at all) to 10 (worst pain imaginable). Patient reported pain at 24, 48, and 72 hours are averaged to produce this number. Lower score is a better outcome.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
112 participants
Primary outcome timeframe
First 72 hours pain
Results posted on
2022-08-01
Participant Flow
Participant milestones
| Measure |
Liposomal Bupivacaine & Standard Bupivacaine
Exparel 133 MG Per 10 ML Injection: 10mL of 133mg liposomal bupivacaine with 5mL of 0.5% bupivacaine (15mL total)
|
Standard Bupivacaine & Dexamethasone
Dexamethasone: 15mL of 0.5% bupivacaine with 4mg of preservative-free dexamethasone will be injected
|
|---|---|---|
|
Overall Study
STARTED
|
56
|
56
|
|
Overall Study
COMPLETED
|
55
|
56
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Liposomal Bupivacaine & Standard Bupivacaine
Exparel 133 MG Per 10 ML Injection: 10mL of 133mg liposomal bupivacaine with 5mL of 0.5% bupivacaine (15mL total)
|
Standard Bupivacaine & Dexamethasone
Dexamethasone: 15mL of 0.5% bupivacaine with 4mg of preservative-free dexamethasone will be injected
|
|---|---|---|
|
Overall Study
Physician Decision
|
1
|
0
|
Baseline Characteristics
Liposomal Bupivacaine vs Dexamethasone ISB
Baseline characteristics by cohort
| Measure |
Liposomal Bupivacaine & Standard Bupivacaine
n=55 Participants
Exparel 133 MG Per 10 ML Injection: 10mL of 133mg liposomal bupivacaine with 5mL of 0.5% bupivacaine (15mL total)
|
Standard Bupivacaine & Dexamethasone
n=56 Participants
Dexamethasone: 15mL of 0.5% bupivacaine with 4mg of preservative-free dexamethasone will be injected
|
Total
n=111 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
55 year
n=5 Participants
|
49 year
n=7 Participants
|
53 year
n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
43 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
91 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
52 Participants
n=5 Participants
|
52 Participants
n=7 Participants
|
104 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
45 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
91 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
55 Participants
n=5 Participants
|
56 Participants
n=7 Participants
|
111 Participants
n=5 Participants
|
|
American Society of Anesthesiology Status
ASA Status I
|
10 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
American Society of Anesthesiology Status
ASA status II
|
45 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
89 Participants
n=5 Participants
|
|
Body Mass Index, kg/m^2
|
27.6 Kg/m^2
STANDARD_DEVIATION 4.1 • n=5 Participants
|
27.5 Kg/m^2
STANDARD_DEVIATION 4.1 • n=7 Participants
|
27.6 Kg/m^2
STANDARD_DEVIATION 4.1 • n=5 Participants
|
PRIMARY outcome
Timeframe: First 72 hours painNRS pain at rest averaged over the first 72 hours. NRS pain is on a scale from 0 (no pain at all) to 10 (worst pain imaginable). Patient reported pain at 24, 48, and 72 hours are averaged to produce this number. Lower score is a better outcome.
Outcome measures
| Measure |
Liposomal Bupivacaine & Standard Bupivacaine
n=55 Participants
Exparel 133 MG Per 10 ML Injection: 10mL of 133mg liposomal bupivacaine with 5mL of 0.5% bupivacaine (15mL total)
|
Standard Bupivacaine & Dexamethasone
n=56 Participants
Dexamethasone: 15mL of 0.5% bupivacaine with 4mg of preservative-free dexamethasone will be injected
|
|---|---|---|
|
Numerical Rating Scale (NRS) Pain at Rest Over 72 Hours
|
2.4 score on a scale
Standard Deviation 1.9
|
3.4 score on a scale
Standard Deviation 1.9
|
SECONDARY outcome
Timeframe: Postanesthesia care unit (up to 6 hours postoperative), postoperative day 1, postoperative day 2, postoperative day 3, postoperative day 4, postoperative day 7NRS pain is on a scale from 0 (no pain at all) to 10 (worst pain imaginable) and is patient reported for pain at rest. Lower score is a better outcome.
Outcome measures
| Measure |
Liposomal Bupivacaine & Standard Bupivacaine
n=55 Participants
Exparel 133 MG Per 10 ML Injection: 10mL of 133mg liposomal bupivacaine with 5mL of 0.5% bupivacaine (15mL total)
|
Standard Bupivacaine & Dexamethasone
n=56 Participants
Dexamethasone: 15mL of 0.5% bupivacaine with 4mg of preservative-free dexamethasone will be injected
|
|---|---|---|
|
Numerical Rating Scale (NRS) Pain at Rest
Postanesthesia care unit (0-6 hours postoperative)
|
1.3 score on a scale
Standard Deviation 1.9
|
0.9 score on a scale
Standard Deviation 1.8
|
|
Numerical Rating Scale (NRS) Pain at Rest
Postoperative day 1
|
2.1 score on a scale
Standard Deviation 2.6
|
3.0 score on a scale
Standard Deviation 2.5
|
|
Numerical Rating Scale (NRS) Pain at Rest
Postoperative day 2
|
2.5 score on a scale
Standard Deviation 2.3
|
4.1 score on a scale
Standard Deviation 2.7
|
|
Numerical Rating Scale (NRS) Pain at Rest
Postoperative day 3
|
2.4 score on a scale
Standard Deviation 2.2
|
3.3 score on a scale
Standard Deviation 2.4
|
|
Numerical Rating Scale (NRS) Pain at Rest
Postoperative day 4
|
2.5 score on a scale
Standard Deviation 2.0
|
3.0 score on a scale
Standard Deviation 2.2
|
|
Numerical Rating Scale (NRS) Pain at Rest
Postoperative day 7
|
1.7 score on a scale
Standard Deviation 2.0
|
2.3 score on a scale
Standard Deviation 2.2
|
SECONDARY outcome
Timeframe: Postanesthesia care unit (up to 6 hours postoperative), postoperative day 1, postoperative day 2, postoperative day 3, postoperative day 4, postoperative day 7NRS pain is on a scale from 0 (no pain at all) to 10 (worst pain imaginable) and is patient reported for pain with movement. Lower score means better outcome.
Outcome measures
| Measure |
Liposomal Bupivacaine & Standard Bupivacaine
n=55 Participants
Exparel 133 MG Per 10 ML Injection: 10mL of 133mg liposomal bupivacaine with 5mL of 0.5% bupivacaine (15mL total)
|
Standard Bupivacaine & Dexamethasone
n=56 Participants
Dexamethasone: 15mL of 0.5% bupivacaine with 4mg of preservative-free dexamethasone will be injected
|
|---|---|---|
|
Numerical Rating Scale (NRS) Pain With Movement
Postanesthesia care unit (0-6 hours postoperative)
|
8.9 score on a scale
Standard Deviation 4.3
|
9.98 score on a scale
Standard Deviation 3.2
|
|
Numerical Rating Scale (NRS) Pain With Movement
Postoperative day 1
|
4.0 score on a scale
Standard Deviation 3.1
|
4.3 score on a scale
Standard Deviation 3.1
|
|
Numerical Rating Scale (NRS) Pain With Movement
Postoperative day 2
|
4.1 score on a scale
Standard Deviation 2.9
|
5.6 score on a scale
Standard Deviation 3.1
|
|
Numerical Rating Scale (NRS) Pain With Movement
Postoperative day 3
|
4.0 score on a scale
Standard Deviation 2.7
|
5.3 score on a scale
Standard Deviation 2.3
|
|
Numerical Rating Scale (NRS) Pain With Movement
Postoperative day 4
|
4.0 score on a scale
Standard Deviation 2.8
|
4.9 score on a scale
Standard Deviation 2.4
|
|
Numerical Rating Scale (NRS) Pain With Movement
Postoperative day 7
|
3.9 score on a scale
Standard Deviation 2.6
|
4.7 score on a scale
Standard Deviation 2.5
|
SECONDARY outcome
Timeframe: Postanesthesia care unit (up to 6 hours postoperative), postoperative day 1, postoperative day 2, postoperative day 3, postoperative day 4, postoperative day 7Opioid consumption, measured in oral morphine equivalents
Outcome measures
| Measure |
Liposomal Bupivacaine & Standard Bupivacaine
n=55 Participants
Exparel 133 MG Per 10 ML Injection: 10mL of 133mg liposomal bupivacaine with 5mL of 0.5% bupivacaine (15mL total)
|
Standard Bupivacaine & Dexamethasone
n=56 Participants
Dexamethasone: 15mL of 0.5% bupivacaine with 4mg of preservative-free dexamethasone will be injected
|
|---|---|---|
|
Opioid Consumption
Postanesthesia care unit (0-6 hours postoperative)
|
1.8 Oral Morphine Equivalents (mg)
Standard Deviation 4.5
|
1.7 Oral Morphine Equivalents (mg)
Standard Deviation 4.6
|
|
Opioid Consumption
Postoperative day 1
|
4.8 Oral Morphine Equivalents (mg)
Standard Deviation 8.6
|
8.1 Oral Morphine Equivalents (mg)
Standard Deviation 10.4
|
|
Opioid Consumption
Postoperative day 2
|
12.3 Oral Morphine Equivalents (mg)
Standard Deviation 15.6
|
18.2 Oral Morphine Equivalents (mg)
Standard Deviation 20.8
|
|
Opioid Consumption
Postoperative day 3
|
8.9 Oral Morphine Equivalents (mg)
Standard Deviation 12.5
|
13.2 Oral Morphine Equivalents (mg)
Standard Deviation 14.0
|
|
Opioid Consumption
Postoperative day 4
|
6.9 Oral Morphine Equivalents (mg)
Standard Deviation 13.8
|
9.7 Oral Morphine Equivalents (mg)
Standard Deviation 15.5
|
|
Opioid Consumption
Postoperative day 7
|
3.7 Oral Morphine Equivalents (mg)
Standard Deviation 7.4
|
3.3 Oral Morphine Equivalents (mg)
Standard Deviation 7.2
|
SECONDARY outcome
Timeframe: Postanesthesia care unit (up to 6 hours postoperative), postoperative day 1, postoperative day 2, postoperative day 3, postoperative day 4, postoperative day 7Patient reported satisfaction on a scale of 0 (not satisfied) to 10 (complete satisfaction). This is patient opinionated and is reflective with patient contentedness with their pain management. Higher scores indicate greater satisfaction
Outcome measures
| Measure |
Liposomal Bupivacaine & Standard Bupivacaine
n=55 Participants
Exparel 133 MG Per 10 ML Injection: 10mL of 133mg liposomal bupivacaine with 5mL of 0.5% bupivacaine (15mL total)
|
Standard Bupivacaine & Dexamethasone
n=56 Participants
Dexamethasone: 15mL of 0.5% bupivacaine with 4mg of preservative-free dexamethasone will be injected
|
|---|---|---|
|
Patient Satisfaction With Pain Management: Scale
Postanesthesia care unit (0-6 hours postoperative)
|
9.4 score on a scale
Standard Deviation 1.3
|
9.8 score on a scale
Standard Deviation 0.5
|
|
Patient Satisfaction With Pain Management: Scale
Postoperative day 1
|
9.3 score on a scale
Standard Deviation 1.4
|
9.2 score on a scale
Standard Deviation 1.6
|
|
Patient Satisfaction With Pain Management: Scale
Postoperative day 2
|
8.9 score on a scale
Standard Deviation 2.1
|
8.6 score on a scale
Standard Deviation 1.8
|
|
Patient Satisfaction With Pain Management: Scale
Postoperative day 3
|
9.2 score on a scale
Standard Deviation 1.4
|
8.6 score on a scale
Standard Deviation 1.7
|
|
Patient Satisfaction With Pain Management: Scale
Postoperative day 4
|
9.1 score on a scale
Standard Deviation 1.2
|
8.5 score on a scale
Standard Deviation 1.7
|
|
Patient Satisfaction With Pain Management: Scale
Postoperative day 7
|
9.1 score on a scale
Standard Deviation 1.5
|
8.4 score on a scale
Standard Deviation 2.1
|
SECONDARY outcome
Timeframe: Postanesthesia care unit (up to 6 hours postoperative), postoperative day 1, postoperative day 2, postoperative day 3, postoperative day 4, postoperative day 7The Brief Pain Inventory (BPI) rapidly assesses the severity of pain and its impact on functioning. Higher scores indicate more pain. The minimum value is 0, the maximum value is 10. A lower score is a better outcome. This score is an average of the following measures on a 0-10 scale: General activity, Mood, Walking ability, Normal work, Relations to People, Sleep Quality, and Enjoyment of life.
Outcome measures
| Measure |
Liposomal Bupivacaine & Standard Bupivacaine
n=55 Participants
Exparel 133 MG Per 10 ML Injection: 10mL of 133mg liposomal bupivacaine with 5mL of 0.5% bupivacaine (15mL total)
|
Standard Bupivacaine & Dexamethasone
n=56 Participants
Dexamethasone: 15mL of 0.5% bupivacaine with 4mg of preservative-free dexamethasone will be injected
|
|---|---|---|
|
Brief Pain Inventory Short-form
Postanesthesia care unit (0-6 hours postoperative)
|
1.2 score on a scale
Standard Deviation 2.0
|
0.6 score on a scale
Standard Deviation 1.4
|
|
Brief Pain Inventory Short-form
Postoperative day 1
|
1.4 score on a scale
Standard Deviation 2.0
|
1.8 score on a scale
Standard Deviation 2.3
|
|
Brief Pain Inventory Short-form
Postoperative day 2
|
2.4 score on a scale
Standard Deviation 2.3
|
3.6 score on a scale
Standard Deviation 2.5
|
|
Brief Pain Inventory Short-form
Postoperative day 3
|
2.2 score on a scale
Standard Deviation 2.0
|
3.4 score on a scale
Standard Deviation 2.1
|
|
Brief Pain Inventory Short-form
Postoperative day 4
|
2.5 score on a scale
Standard Deviation 2.3
|
3.6 score on a scale
Standard Deviation 2.1
|
|
Brief Pain Inventory Short-form
Postoperative day 7
|
2.2 score on a scale
Standard Deviation 2.1
|
2.9 score on a scale
Standard Deviation 2.1
|
SECONDARY outcome
Timeframe: 24, 48, 72, 96 (if needed) hours postoperativelyPatients are contacted and asked questions regarding their motor strength and sensation in their shoulder. Patients are asked "When did your pain relief from the block completely wear off?" This indicates the block duration.
Outcome measures
| Measure |
Liposomal Bupivacaine & Standard Bupivacaine
n=55 Participants
Exparel 133 MG Per 10 ML Injection: 10mL of 133mg liposomal bupivacaine with 5mL of 0.5% bupivacaine (15mL total)
|
Standard Bupivacaine & Dexamethasone
n=56 Participants
Dexamethasone: 15mL of 0.5% bupivacaine with 4mg of preservative-free dexamethasone will be injected
|
|---|---|---|
|
Duration of Analgesic Block
|
26 Hours
Interval 20.0 to 42.0
|
27 Hours
Interval 20.0 to 39.0
|
SECONDARY outcome
Timeframe: 24, 48, 72, 96 (if needed) hours postoperativelyPatients are contacted and asked questions regarding their motor strength and sensation in their shoulder.
Outcome measures
| Measure |
Liposomal Bupivacaine & Standard Bupivacaine
n=55 Participants
Exparel 133 MG Per 10 ML Injection: 10mL of 133mg liposomal bupivacaine with 5mL of 0.5% bupivacaine (15mL total)
|
Standard Bupivacaine & Dexamethasone
n=56 Participants
Dexamethasone: 15mL of 0.5% bupivacaine with 4mg of preservative-free dexamethasone will be injected
|
|---|---|---|
|
Sensory Resolution
|
27 Hours
Interval 21.0 to 44.0
|
31 Hours
Interval 20.0 to 42.0
|
SECONDARY outcome
Timeframe: 24, 48, 72, 96 (if needed) hours postoperativelyPatients are contacted and asked questions regarding their motor strength and sensation in their shoulder.
Outcome measures
| Measure |
Liposomal Bupivacaine & Standard Bupivacaine
n=55 Participants
Exparel 133 MG Per 10 ML Injection: 10mL of 133mg liposomal bupivacaine with 5mL of 0.5% bupivacaine (15mL total)
|
Standard Bupivacaine & Dexamethasone
n=56 Participants
Dexamethasone: 15mL of 0.5% bupivacaine with 4mg of preservative-free dexamethasone will be injected
|
|---|---|---|
|
Motor Block Resolution
|
27 Hours
Interval 21.0 to 48.0
|
27 Hours
Interval 19.0 to 40.0
|
SECONDARY outcome
Timeframe: Postanesthesia care unit (0-6 hours postoperative)Time to readiness for PACU discharge was evaluated every 15min using the Post Anesthetic Discharge Scoring System.
Outcome measures
| Measure |
Liposomal Bupivacaine & Standard Bupivacaine
n=55 Participants
Exparel 133 MG Per 10 ML Injection: 10mL of 133mg liposomal bupivacaine with 5mL of 0.5% bupivacaine (15mL total)
|
Standard Bupivacaine & Dexamethasone
n=56 Participants
Dexamethasone: 15mL of 0.5% bupivacaine with 4mg of preservative-free dexamethasone will be injected
|
|---|---|---|
|
Time to Readiness for Discharge
|
90 minutes
Interval 60.0 to 119.0
|
90 minutes
Interval 75.0 to 119.0
|
SECONDARY outcome
Timeframe: Postanesthesia care unit (0-6 hours postoperative)Total length of PACU stay as defined by time of PACU admission to PACU discharge.
Outcome measures
| Measure |
Liposomal Bupivacaine & Standard Bupivacaine
n=55 Participants
Exparel 133 MG Per 10 ML Injection: 10mL of 133mg liposomal bupivacaine with 5mL of 0.5% bupivacaine (15mL total)
|
Standard Bupivacaine & Dexamethasone
n=56 Participants
Dexamethasone: 15mL of 0.5% bupivacaine with 4mg of preservative-free dexamethasone will be injected
|
|---|---|---|
|
Postanesthesia Care Unit Length of Stay
|
163.5 minutes
Interval 138.0 to 197.0
|
163 minutes
Interval 145.0 to 197.0
|
Adverse Events
Liposomal Bupivacaine & Standard Bupivacaine
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Standard Bupivacaine & 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 |
Liposomal Bupivacaine & Standard Bupivacaine
n=55 participants at risk
Exparel 133 MG Per 10 ML Injection: 10mL of 133mg liposomal bupivacaine with 5mL of 0.5% bupivacaine (15mL total)
|
Standard Bupivacaine & Dexamethasone
n=56 participants at risk
Dexamethasone: 15mL of 0.5% bupivacaine with 4mg of preservative-free dexamethasone will be injected
|
|---|---|---|
|
Nervous system disorders
Postoperative neurologic symptoms at 7 days after surgery
|
14.0%
6/43 • Up to 14 days following surgery
At Risk patients for the Liposomal Bupivacaine group were 55 in count. However, due to lost to follow up, 43 of the 55 patients were analyzed for POD7-POD 14. At Risk patients for the Dexamethasone ISB group were 56 in count. However, due to lost to follow up, only 42 patients were able to be analyzed for POD7-POD14.
|
7.1%
3/42 • Up to 14 days following surgery
At Risk patients for the Liposomal Bupivacaine group were 55 in count. However, due to lost to follow up, 43 of the 55 patients were analyzed for POD7-POD 14. At Risk patients for the Dexamethasone ISB group were 56 in count. However, due to lost to follow up, only 42 patients were able to be analyzed for POD7-POD14.
|
|
Nervous system disorders
Postoperative neurologic symptoms at 14 days after surgery
|
0.00%
0/43 • Up to 14 days following surgery
At Risk patients for the Liposomal Bupivacaine group were 55 in count. However, due to lost to follow up, 43 of the 55 patients were analyzed for POD7-POD 14. At Risk patients for the Dexamethasone ISB group were 56 in count. However, due to lost to follow up, only 42 patients were able to be analyzed for POD7-POD14.
|
0.00%
0/42 • Up to 14 days following surgery
At Risk patients for the Liposomal Bupivacaine group were 55 in count. However, due to lost to follow up, 43 of the 55 patients were analyzed for POD7-POD 14. At Risk patients for the Dexamethasone ISB group were 56 in count. However, due to lost to follow up, only 42 patients were able to be analyzed for POD7-POD14.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place