Trial Outcomes & Findings for Exparel for Postoperative Pain Management in Shoulder Surgery (NCT NCT02472314)
NCT ID: NCT02472314
Last Updated: 2023-12-29
Results Overview
Quality of analgesia as measured by numerical rating scores for pain (active and at rest) as (0=no pain, 10= worst pain) every two hours for the initial 36 hours, then on day2, day7 and day30 postoperatively
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
70 participants
Primary outcome timeframe
30 days
Results posted on
2023-12-29
Participant Flow
This prospective, randomized, controlled study included 70 consecutive shoulder arthroplasty patients from August 2015 through June 2016 during the period of 1 year at one location.
Participant milestones
| Measure |
Liposomal Bupivacaine A
One time injection of 1.3% Liposomal Bupivacaine during shoulder arthroplasty
1.3% Liposomal Bupivacaine: local tissue infiltration of Liposomal Bupivacaine during surgery
|
CISB Control for A
Peripheral nerve block (CISB) with 0.125% bupivacaine during shoulder arthroplasty .
0.125% Bupivacaine: Continues nerve block with Bupivacaine during surgery and postoperatively
|
|---|---|---|
|
Overall Study
STARTED
|
34
|
36
|
|
Overall Study
COMPLETED
|
34
|
36
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Liposomal Bupivacaine A
n=34 Participants
One time injection of 1.3% Liposomal Bupivacaine during shoulder arthroplasty
1.3% Liposomal Bupivacaine: local tissue infiltration of Liposomal Bupivacaine during surgery
|
CISB Control for A
n=36 Participants
Peripheral nerve block (CISB) with 0.125% bupivacaine during shoulder arthroplasty .
0.125% Bupivacaine: Continues nerve block with Bupivacaine during surgery and postoperatively
|
Total
n=70 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=34 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=70 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
34 Participants
n=34 Participants
|
36 Participants
n=36 Participants
|
70 Participants
n=70 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=34 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=70 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=34 Participants
|
17 Participants
n=36 Participants
|
26 Participants
n=70 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=34 Participants
|
19 Participants
n=36 Participants
|
44 Participants
n=70 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
34 participants
n=34 Participants
|
36 participants
n=36 Participants
|
70 participants
n=70 Participants
|
|
Surgical Side
Left
|
18 Participants
n=34 Participants
|
17 Participants
n=36 Participants
|
35 Participants
n=70 Participants
|
|
Surgical Side
Right
|
16 Participants
n=34 Participants
|
19 Participants
n=36 Participants
|
35 Participants
n=70 Participants
|
|
Arthroplasty type
Hemi
|
1 participants
n=34 Participants
|
1 participants
n=36 Participants
|
2 participants
n=70 Participants
|
|
Arthroplasty type
Reverse
|
16 participants
n=34 Participants
|
20 participants
n=36 Participants
|
36 participants
n=70 Participants
|
|
Arthroplasty type
Total
|
17 participants
n=34 Participants
|
15 participants
n=36 Participants
|
32 participants
n=70 Participants
|
PRIMARY outcome
Timeframe: 30 daysQuality of analgesia as measured by numerical rating scores for pain (active and at rest) as (0=no pain, 10= worst pain) every two hours for the initial 36 hours, then on day2, day7 and day30 postoperatively
Outcome measures
| Measure |
Liposomal Bupivacaine A
n=34 Participants
One time injection of 1.3% Liposomal Bupivacaine during shoulder arthroplasty
1.3% Liposomal Bupivacaine: local tissue infiltration of Liposomal Bupivacaine during surgery
|
CISB Control for A
n=36 Participants
Peripheral nerve block (CISB) with 0.125% bupivacaine during shoulder arthroplasty .
0.125% Bupivacaine: Continues nerve block with Bupivacaine during surgery and postoperatively
|
|---|---|---|
|
Quality of Analgesia
Day 2
|
4.1 score on a scale
Interval 0.0 to 10.0
|
4.0 score on a scale
Interval 0.0 to 10.0
|
|
Quality of Analgesia
At 24 to 48 hours
|
2.1 score on a scale
Interval 0.0 to 10.0
|
2.6 score on a scale
Interval 0.0 to 10.0
|
|
Quality of Analgesia
Day 7
|
3.4 score on a scale
Interval 0.0 to 10.0
|
2.6 score on a scale
Interval 0.0 to 10.0
|
|
Quality of Analgesia
Day 30
|
2.0 score on a scale
Interval 0.0 to 10.0
|
2.2 score on a scale
Interval 0.0 to 10.0
|
SECONDARY outcome
Timeframe: Preoperative, 6 weeks and last follow upAmerican Shoulder and Elbow Surgeons (ASES) score is an outcome reporting measure for assessments of shoulder function in patients with shoulder pathology and after shoulder arthroplasty surgery. ASES is a 100 points scale consisting of two measures: one pain scale (worth 50 points) and 10 activities of daily living(worth 50 points), the total score is the sum of both and the higher total score indicates better outcome.
Outcome measures
| Measure |
Liposomal Bupivacaine A
n=34 Participants
One time injection of 1.3% Liposomal Bupivacaine during shoulder arthroplasty
1.3% Liposomal Bupivacaine: local tissue infiltration of Liposomal Bupivacaine during surgery
|
CISB Control for A
n=36 Participants
Peripheral nerve block (CISB) with 0.125% bupivacaine during shoulder arthroplasty .
0.125% Bupivacaine: Continues nerve block with Bupivacaine during surgery and postoperatively
|
|---|---|---|
|
Post Operative American Shoulder and Elbow Surgeons (ASES)
Pre-operative
|
36.1 score on a scale
Standard Deviation 20.04
|
27.7 score on a scale
Standard Deviation 15.7
|
|
Post Operative American Shoulder and Elbow Surgeons (ASES)
6 Weeks after surgery
|
59.5 score on a scale
Standard Deviation 18.1
|
57.3 score on a scale
Standard Deviation 16.2
|
|
Post Operative American Shoulder and Elbow Surgeons (ASES)
Last Followup
|
74.5 score on a scale
Standard Deviation 22.7
|
59.7 score on a scale
Standard Deviation 20.5
|
SECONDARY outcome
Timeframe: Pre-operative, 6 weeks and last Follow upFunctional assessments after shoulder arthroplasty surgery. The SSV is defined as a patient's subjective shoulder assessment expressed as a percentage of an entirely normal shoulder, which would score 100%. The range is between 0% and 100%
Outcome measures
| Measure |
Liposomal Bupivacaine A
n=34 Participants
One time injection of 1.3% Liposomal Bupivacaine during shoulder arthroplasty
1.3% Liposomal Bupivacaine: local tissue infiltration of Liposomal Bupivacaine during surgery
|
CISB Control for A
n=36 Participants
Peripheral nerve block (CISB) with 0.125% bupivacaine during shoulder arthroplasty .
0.125% Bupivacaine: Continues nerve block with Bupivacaine during surgery and postoperatively
|
|---|---|---|
|
Subjective Shoulder Value (SSV)
Preoperative
|
30.7 score on a scale
Interval 0.0 to 100.0
|
24.3 score on a scale
Interval 0.0 to 100.0
|
|
Subjective Shoulder Value (SSV)
At last follow up
|
70.0 score on a scale
Interval 0.0 to 100.0
|
69.3 score on a scale
Interval 0.0 to 100.0
|
|
Subjective Shoulder Value (SSV)
at 6 weeks post-op
|
55.7 score on a scale
Interval 0.0 to 100.0
|
63.1 score on a scale
Interval 0.0 to 100.0
|
SECONDARY outcome
Timeframe: During hospital stay and at 2 weeks and 6 weeks post-operativelyNeuropraxia on the treatment side
Outcome measures
| Measure |
Liposomal Bupivacaine A
n=34 Participants
One time injection of 1.3% Liposomal Bupivacaine during shoulder arthroplasty
1.3% Liposomal Bupivacaine: local tissue infiltration of Liposomal Bupivacaine during surgery
|
CISB Control for A
n=36 Participants
Peripheral nerve block (CISB) with 0.125% bupivacaine during shoulder arthroplasty .
0.125% Bupivacaine: Continues nerve block with Bupivacaine during surgery and postoperatively
|
|---|---|---|
|
Incidence of Nerve Injury
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: During hospital stay up to 48 hours after surgeryCumulative amount of opioids administered during the time frame
Outcome measures
| Measure |
Liposomal Bupivacaine A
n=34 Participants
One time injection of 1.3% Liposomal Bupivacaine during shoulder arthroplasty
1.3% Liposomal Bupivacaine: local tissue infiltration of Liposomal Bupivacaine during surgery
|
CISB Control for A
n=36 Participants
Peripheral nerve block (CISB) with 0.125% bupivacaine during shoulder arthroplasty .
0.125% Bupivacaine: Continues nerve block with Bupivacaine during surgery and postoperatively
|
|---|---|---|
|
Post Operative Opioid Consumption
|
78.6 Total MME per Group
|
52.8 Total MME per Group
|
Adverse Events
Liposomal Bupivacaine A
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
CISB Control for A
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Liposomal Bupivacaine A
n=34 participants at risk
One time injection of 1.3% Liposomal Bupivacaine during shoulder arthroplasty
1.3% Liposomal Bupivacaine: local tissue infiltration of Liposomal Bupivacaine during surgery
|
CISB Control for A
n=36 participants at risk
Peripheral nerve block (CISB) with 0.125% bupivacaine during shoulder arthroplasty .
0.125% Bupivacaine: Continues nerve block with Bupivacaine during surgery and postoperatively
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
COPD
|
2.9%
1/34 • Three months
|
0.00%
0/36 • Three months
|
Other adverse events
| Measure |
Liposomal Bupivacaine A
n=34 participants at risk
One time injection of 1.3% Liposomal Bupivacaine during shoulder arthroplasty
1.3% Liposomal Bupivacaine: local tissue infiltration of Liposomal Bupivacaine during surgery
|
CISB Control for A
n=36 participants at risk
Peripheral nerve block (CISB) with 0.125% bupivacaine during shoulder arthroplasty .
0.125% Bupivacaine: Continues nerve block with Bupivacaine during surgery and postoperatively
|
|---|---|---|
|
Metabolism and nutrition disorders
hyperkalemia
|
2.9%
1/34 • Number of events 1 • Three months
|
0.00%
0/36 • Three months
|
|
Injury, poisoning and procedural complications
catheter malposition
|
0.00%
0/34 • Three months
|
5.6%
2/36 • Number of events 2 • Three months
|
|
Injury, poisoning and procedural complications
Catheter fall out
|
0.00%
0/34 • Three months
|
13.9%
5/36 • Number of events 5 • Three months
|
Additional Information
Vani J. Sabesan, MD
Wayne State University School of Medicine and Cleveland Clinic Florida
Phone: 131375138489
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place