Trial Outcomes & Findings for Liposomal Bupivacaine (Exparel ® ) Plus 0.5% Bupivacaine HCL Versus 0.5% Bupivacaine HCL for Interscalene Nerve Block (ISB) for Patients Undergoing Total Shoulder Arthroplasty(TSA) (NCT NCT03913091)
NCT ID: NCT03913091
Last Updated: 2022-02-01
Results Overview
Measure in morphine milligram equivalents \[MME\]
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
184 participants
Primary outcome timeframe
24-72 hour, Post-Operative Period
Results posted on
2022-02-01
Participant Flow
Participant milestones
| Measure |
20 mL 0.5% Bupivacaine HCL
0.5% Bupivacaine HCL: 0.5% Bupivacaine HCL for Interscalene Nerve Block (ISB)
|
Interscalene Nerve Block With Liposomal + Bupivacaine 0.5%
Administered in an Interscalene block for TSA
Liposomal Bupivacaine: Liposomal Bupivacaine Plus 0.5% Bupivacaine HCL
|
|---|---|---|
|
Overall Study
STARTED
|
92
|
92
|
|
Overall Study
COMPLETED
|
72
|
78
|
|
Overall Study
NOT COMPLETED
|
20
|
14
|
Reasons for withdrawal
| Measure |
20 mL 0.5% Bupivacaine HCL
0.5% Bupivacaine HCL: 0.5% Bupivacaine HCL for Interscalene Nerve Block (ISB)
|
Interscalene Nerve Block With Liposomal + Bupivacaine 0.5%
Administered in an Interscalene block for TSA
Liposomal Bupivacaine: Liposomal Bupivacaine Plus 0.5% Bupivacaine HCL
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
18
|
11
|
|
Overall Study
Required additional meds/surgery
|
1
|
2
|
|
Overall Study
Chronic pain/history of substance abuse
|
1
|
1
|
Baseline Characteristics
Liposomal Bupivacaine (Exparel ® ) Plus 0.5% Bupivacaine HCL Versus 0.5% Bupivacaine HCL for Interscalene Nerve Block (ISB) for Patients Undergoing Total Shoulder Arthroplasty(TSA)
Baseline characteristics by cohort
| Measure |
20 mL 0.5% Bupivacaine HCL
n=72 Participants
0.5% Bupivacaine HCL: 0.5% Bupivacaine HCL for Interscalene Nerve Block (ISB)
|
Interscalene Nerve Block With Liposomal + Bupivacaine 0.5%
n=78 Participants
Administered in an Interscalene block for TSA
Liposomal Bupivacaine: Liposomal Bupivacaine Plus 0.5% Bupivacaine HCL
|
Total
n=150 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
66.39 years
STANDARD_DEVIATION 8.77 • n=99 Participants
|
68.87 years
STANDARD_DEVIATION 8.83 • n=107 Participants
|
67.63 years
STANDARD_DEVIATION 8.8 • n=206 Participants
|
|
Sex: Female, Male
Female
|
30 Participants
n=99 Participants
|
39 Participants
n=107 Participants
|
69 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
42 Participants
n=99 Participants
|
39 Participants
n=107 Participants
|
81 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
7 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
65 Participants
n=99 Participants
|
69 Participants
n=107 Participants
|
134 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
60 Participants
n=99 Participants
|
61 Participants
n=107 Participants
|
121 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
72 participants
n=99 Participants
|
78 participants
n=107 Participants
|
150 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 24-72 hour, Post-Operative PeriodMeasure in morphine milligram equivalents \[MME\]
Outcome measures
| Measure |
20 mL 0.5% Bupivacaine HCL
n=72 Participants
0.5% Bupivacaine HCL: 0.5% Bupivacaine HCL for Interscalene Nerve Block (ISB)
|
Interscalene Nerve Block With Liposomal + Bupivacaine 0.5%
n=78 Participants
Administered in an Interscalene block for TSA
Liposomal Bupivacaine: Liposomal Bupivacaine Plus 0.5% Bupivacaine HCL
|
|---|---|---|
|
Opioid Utilization
|
54.79 Morphine Milligram Equivalents (MME)
Standard Deviation 15.26
|
30.38 Morphine Milligram Equivalents (MME)
Standard Deviation 11.62
|
SECONDARY outcome
Timeframe: Day 4-7, Post-Operative PeriodMeasure in morphine milligram equivalents \[MME\]
Outcome measures
| Measure |
20 mL 0.5% Bupivacaine HCL
n=72 Participants
0.5% Bupivacaine HCL: 0.5% Bupivacaine HCL for Interscalene Nerve Block (ISB)
|
Interscalene Nerve Block With Liposomal + Bupivacaine 0.5%
n=78 Participants
Administered in an Interscalene block for TSA
Liposomal Bupivacaine: Liposomal Bupivacaine Plus 0.5% Bupivacaine HCL
|
|---|---|---|
|
Opioid Utilization
|
36.44 Morphine Milligram Equivalents (MME)
Standard Deviation 11.13
|
18.73 Morphine Milligram Equivalents (MME)
Standard Deviation 7.55
|
SECONDARY outcome
Timeframe: Day 1-7, Post-Operative PeriodPopulation: The sample size is slightly smaller because this data was not collected at the beginning of the study.
PROMIS Pain Intensity surveys are made up of three pain intensity questions, on a scale of 1-5. 1. = No pain 2. = Mild 3. = Moderate 4. = Severe 5. = Very Severe
Outcome measures
| Measure |
20 mL 0.5% Bupivacaine HCL
n=67 Participants
0.5% Bupivacaine HCL: 0.5% Bupivacaine HCL for Interscalene Nerve Block (ISB)
|
Interscalene Nerve Block With Liposomal + Bupivacaine 0.5%
n=72 Participants
Administered in an Interscalene block for TSA
Liposomal Bupivacaine: Liposomal Bupivacaine Plus 0.5% Bupivacaine HCL
|
|---|---|---|
|
Score on Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Intensity Scale
"In the past 7 days, how intense was your pain at its worst?"
|
3.7 score on a scale
Standard Deviation 1.16
|
3.07 score on a scale
Standard Deviation 1.02
|
|
Score on Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Intensity Scale
"In the past 7 days, how intense was your average pain?"
|
2.81 score on a scale
Standard Deviation 1.2
|
2.39 score on a scale
Standard Deviation 1
|
|
Score on Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Intensity Scale
"What is your level of pain right now?"
|
2.22 score on a scale
Standard Deviation 1.16
|
1.83 score on a scale
Standard Deviation 1.02
|
SECONDARY outcome
Timeframe: Day 1-7, Post-Operative PeriodPopulation: The sample size is slightly smaller because this data was not collected at the beginning of the study.
PROMIS Pain Intensity surveys are made up of three pain questions, which generate T-scores. T-scores are standard scores with a mean of 50 and standard deviation of 10 in a reference population.
Outcome measures
| Measure |
20 mL 0.5% Bupivacaine HCL
n=67 Participants
0.5% Bupivacaine HCL: 0.5% Bupivacaine HCL for Interscalene Nerve Block (ISB)
|
Interscalene Nerve Block With Liposomal + Bupivacaine 0.5%
n=72 Participants
Administered in an Interscalene block for TSA
Liposomal Bupivacaine: Liposomal Bupivacaine Plus 0.5% Bupivacaine HCL
|
|---|---|---|
|
T-Scores, PROMIS Pain Intensity Scale
|
46.48 T-Score
Standard Deviation 7.6
|
50.8 T-Score
Standard Deviation 7.4
|
Adverse Events
20 mL 0.5% Bupivacaine HCL
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Interscalene Nerve Block With Liposomal + Bupivacaine 0.5%
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
20 mL 0.5% Bupivacaine HCL
n=72 participants at risk
0.5% Bupivacaine HCL: 0.5% Bupivacaine HCL for Interscalene Nerve Block (ISB)
|
Interscalene Nerve Block With Liposomal + Bupivacaine 0.5%
n=78 participants at risk
Administered in an Interscalene block for TSA
Liposomal Bupivacaine: Liposomal Bupivacaine Plus 0.5% Bupivacaine HCL
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Stress Fracture During Physical Therapy
|
0.00%
0/72 • 1 month
|
1.3%
1/78 • 1 month
|
|
Gastrointestinal disorders
ER visit due to bowel obstruction from opioids
|
1.4%
1/72 • 1 month
|
0.00%
0/78 • 1 month
|
|
Musculoskeletal and connective tissue disorders
Swelling on wrist/fingers 3 weeks post-op
|
0.00%
0/72 • 1 month
|
1.3%
1/78 • 1 month
|
|
Surgical and medical procedures
Revision surgery required 1 week post-op
|
1.4%
1/72 • 1 month
|
0.00%
0/78 • 1 month
|
|
Respiratory, thoracic and mediastinal disorders
Elevated hemi diaphragm from prolonged phrenic nerve block
|
0.00%
0/72 • 1 month
|
1.3%
1/78 • 1 month
|
|
Musculoskeletal and connective tissue disorders
Shoulder dislocation, required additional meds
|
0.00%
0/72 • 1 month
|
1.3%
1/78 • 1 month
|
|
Surgical and medical procedures
Intra-op fracture
|
0.00%
0/72 • 1 month
|
1.3%
1/78 • 1 month
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place