Trial Outcomes & Findings for Liposomal Bupivacaine in Rotator Cuff Repair (NCT NCT03738696)
NCT ID: NCT03738696
Last Updated: 2024-05-16
Results Overview
Visual analog pain scores after operation \[0-10, with 10 being the worst pain\]
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
64 participants
Primary outcome timeframe
Up to 96 hrs postoperative
Results posted on
2024-05-16
Participant Flow
Participant milestones
| Measure |
Liposomal Bupivacaine Block
10 mL (133 mg) of liposomal bupivacaine mixed with 7 mL (35 mg) bolus of 0.5% bupivacaine
Exparel: A long-acting injectable sodium channel blocker bound to lipid that is indicated in controlling postoperative pain
|
Ropivacaine Interscalene Catheter
* bolus of 15-20 mL of 0.5% ropivacaine given through the needle prior to threading the catheter
* 0.2% ropivacaine started in the post-anesthesia care unit at 8 mL/hour for 48 hours
Ropivacaine: A short-acting injectable sodium channel blocker bound to lipid that is indicated in controlling postoperative pain
|
|---|---|---|
|
Overall Study
STARTED
|
28
|
36
|
|
Overall Study
COMPLETED
|
20
|
21
|
|
Overall Study
NOT COMPLETED
|
8
|
15
|
Reasons for withdrawal
| Measure |
Liposomal Bupivacaine Block
10 mL (133 mg) of liposomal bupivacaine mixed with 7 mL (35 mg) bolus of 0.5% bupivacaine
Exparel: A long-acting injectable sodium channel blocker bound to lipid that is indicated in controlling postoperative pain
|
Ropivacaine Interscalene Catheter
* bolus of 15-20 mL of 0.5% ropivacaine given through the needle prior to threading the catheter
* 0.2% ropivacaine started in the post-anesthesia care unit at 8 mL/hour for 48 hours
Ropivacaine: A short-acting injectable sodium channel blocker bound to lipid that is indicated in controlling postoperative pain
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
8
|
14
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Liposomal Bupivacaine Block
n=28 Participants
10 mL (133 mg) of liposomal bupivacaine mixed with 7 mL (35 mg) bolus of 0.5% bupivacaine
Exparel: A long-acting injectable sodium channel blocker bound to lipid that is indicated in controlling postoperative pain
|
Ropivacaine Interscalene Catheter
n=35 Participants
* bolus of 15-20 mL of 0.5% ropivacaine given through the needle prior to threading the catheter
* 0.2% ropivacaine started in the post-anesthesia care unit at 8 mL/hour for 48 hours
Ropivacaine: A short-acting injectable sodium channel blocker bound to lipid that is indicated in controlling postoperative pain
|
Total
n=63 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
56.5 years
STANDARD_DEVIATION 12.9 • n=28 Participants
|
54.2 years
STANDARD_DEVIATION 13.0 • n=35 Participants
|
55.2 years
STANDARD_DEVIATION 12.9 • n=63 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=28 Participants
|
14 Participants
n=35 Participants
|
25 Participants
n=63 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=28 Participants
|
21 Participants
n=35 Participants
|
38 Participants
n=63 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
28 participants
n=28 Participants
|
35 participants
n=35 Participants
|
63 participants
n=63 Participants
|
|
Body Mass Index
|
31.8 kg/m2
STANDARD_DEVIATION 6.8 • n=28 Participants
|
33.0 kg/m2
STANDARD_DEVIATION 5.8 • n=35 Participants
|
32.5 kg/m2
STANDARD_DEVIATION 6.2 • n=63 Participants
|
|
Tobacco Use
|
7 participants
n=28 Participants
|
9 participants
n=35 Participants
|
16 participants
n=63 Participants
|
PRIMARY outcome
Timeframe: Up to 96 hrs postoperativePopulation: In the 96 hour timeframe, only 33 of the 35 patients in the Ropivacaine Interscalene Catheter group filled out their surveys.
Visual analog pain scores after operation \[0-10, with 10 being the worst pain\]
Outcome measures
| Measure |
Liposomal Bupivacaine Block
n=28 Participants
10 mL (133 mg) of liposomal bupivacaine mixed with 7 mL (35 mg) bolus of 0.5% bupivacaine
Exparel: A long-acting injectable sodium channel blocker bound to lipid that is indicated in controlling postoperative pain
|
Ropivacaine Interscalene Catheter
n=33 Participants
* bolus of 15-20 mL of 0.5% ropivacaine given through the needle prior to threading the catheter
* 0.2% ropivacaine started in the post-anesthesia care unit at 8 mL/hour for 48 hours
Ropivacaine: A short-acting injectable sodium channel blocker bound to lipid that is indicated in controlling postoperative pain
|
|---|---|---|
|
Average Postoperative Pain Scores Over a 96 Hour Timeframe
|
3.0 score on a scale
Standard Deviation 2.7
|
3.5 score on a scale
Standard Deviation 3.0
|
SECONDARY outcome
Timeframe: Up to 96 hrsPopulation: In the 96 hour timeframe, only 33 of the 35 patients in the Ropivacaine Interscalene Catheter group filled out their surveys.
oral morphine equivalents of all opioid-containing medications received
Outcome measures
| Measure |
Liposomal Bupivacaine Block
n=28 Participants
10 mL (133 mg) of liposomal bupivacaine mixed with 7 mL (35 mg) bolus of 0.5% bupivacaine
Exparel: A long-acting injectable sodium channel blocker bound to lipid that is indicated in controlling postoperative pain
|
Ropivacaine Interscalene Catheter
n=33 Participants
* bolus of 15-20 mL of 0.5% ropivacaine given through the needle prior to threading the catheter
* 0.2% ropivacaine started in the post-anesthesia care unit at 8 mL/hour for 48 hours
Ropivacaine: A short-acting injectable sodium channel blocker bound to lipid that is indicated in controlling postoperative pain
|
|---|---|---|
|
Average Postoperative Oral Morphine Equivalents Over a 96 Hour Timeframe
|
56.4 morphine milligram equivalents
Standard Deviation 42.9
|
58.5 morphine milligram equivalents
Standard Deviation 40.8
|
SECONDARY outcome
Timeframe: Up to 96 hrsPopulation: In the 96 hour timeframe, only 33 of the 35 patients in the Ropivacaine Interscalene Catheter group filled out their surveys.
Likert scale of analgesia satisfaction \[0-5, with 5 being the most satisfied\]
Outcome measures
| Measure |
Liposomal Bupivacaine Block
n=28 Participants
10 mL (133 mg) of liposomal bupivacaine mixed with 7 mL (35 mg) bolus of 0.5% bupivacaine
Exparel: A long-acting injectable sodium channel blocker bound to lipid that is indicated in controlling postoperative pain
|
Ropivacaine Interscalene Catheter
n=33 Participants
* bolus of 15-20 mL of 0.5% ropivacaine given through the needle prior to threading the catheter
* 0.2% ropivacaine started in the post-anesthesia care unit at 8 mL/hour for 48 hours
Ropivacaine: A short-acting injectable sodium channel blocker bound to lipid that is indicated in controlling postoperative pain
|
|---|---|---|
|
Average Analgesia Satisfaction Over a 96 Hour Timeframe
|
4.4 score on a scale
Standard Deviation 0.9
|
4.4 score on a scale
Standard Deviation 0.8
|
SECONDARY outcome
Timeframe: Up to 96 hrsPopulation: In the 96 hour timeframe, only 33 of the 35 patients in the Ropivacaine Interscalene Catheter group filled out their surveys.
Complications resulting from the method of analgesia utilized
Outcome measures
| Measure |
Liposomal Bupivacaine Block
n=28 Participants
10 mL (133 mg) of liposomal bupivacaine mixed with 7 mL (35 mg) bolus of 0.5% bupivacaine
Exparel: A long-acting injectable sodium channel blocker bound to lipid that is indicated in controlling postoperative pain
|
Ropivacaine Interscalene Catheter
n=33 Participants
* bolus of 15-20 mL of 0.5% ropivacaine given through the needle prior to threading the catheter
* 0.2% ropivacaine started in the post-anesthesia care unit at 8 mL/hour for 48 hours
Ropivacaine: A short-acting injectable sodium channel blocker bound to lipid that is indicated in controlling postoperative pain
|
|---|---|---|
|
Percentage of Participants With Analgesia Complications
|
13.1 percentage of participants
|
29.8 percentage of participants
|
SECONDARY outcome
Timeframe: Up to 96 hrs postoperativePopulation: In the 96 hour timeframe, only 33 of the 35 patients in the Ropivacaine Interscalene Catheter group filled out their surveys.
Scale of sleep quality \[0-10, with 10 being the most satisfied\]
Outcome measures
| Measure |
Liposomal Bupivacaine Block
n=28 Participants
10 mL (133 mg) of liposomal bupivacaine mixed with 7 mL (35 mg) bolus of 0.5% bupivacaine
Exparel: A long-acting injectable sodium channel blocker bound to lipid that is indicated in controlling postoperative pain
|
Ropivacaine Interscalene Catheter
n=33 Participants
* bolus of 15-20 mL of 0.5% ropivacaine given through the needle prior to threading the catheter
* 0.2% ropivacaine started in the post-anesthesia care unit at 8 mL/hour for 48 hours
Ropivacaine: A short-acting injectable sodium channel blocker bound to lipid that is indicated in controlling postoperative pain
|
|---|---|---|
|
Average Sleep Quality Over a 96 Hour Timeframe
|
5.7 score on a scale
Standard Deviation 2.5
|
5.2 score on a scale
Standard Deviation 2.6
|
SECONDARY outcome
Timeframe: Up to 96 hrs postoperativePopulation: In the 96 hour timeframe, only 33 of the 35 patients in the Ropivacaine Interscalene Catheter group filled out their surveys.
Hours of sleep uninterrupted by pain \[numerical, hours\]
Outcome measures
| Measure |
Liposomal Bupivacaine Block
n=28 Participants
10 mL (133 mg) of liposomal bupivacaine mixed with 7 mL (35 mg) bolus of 0.5% bupivacaine
Exparel: A long-acting injectable sodium channel blocker bound to lipid that is indicated in controlling postoperative pain
|
Ropivacaine Interscalene Catheter
n=33 Participants
* bolus of 15-20 mL of 0.5% ropivacaine given through the needle prior to threading the catheter
* 0.2% ropivacaine started in the post-anesthesia care unit at 8 mL/hour for 48 hours
Ropivacaine: A short-acting injectable sodium channel blocker bound to lipid that is indicated in controlling postoperative pain
|
|---|---|---|
|
Average Hours of Painless Sleep
|
4.9 hours of uninterrupted sleep (longest)
Standard Deviation 2.5
|
4.4 hours of uninterrupted sleep (longest)
Standard Deviation 2.4
|
Adverse Events
Liposomal Bupivacaine Block
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Ropivacaine Interscalene Catheter
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Liposomal Bupivacaine Block
n=28 participants at risk
10 mL (133 mg) of liposomal bupivacaine mixed with 7 mL (35 mg) bolus of 0.5% bupivacaine
Exparel: A long-acting injectable sodium channel blocker bound to lipid that is indicated in controlling postoperative pain
|
Ropivacaine Interscalene Catheter
n=33 participants at risk
* bolus of 15-20 mL of 0.5% ropivacaine given through the needle prior to threading the catheter
* 0.2% ropivacaine started in the post-anesthesia care unit at 8 mL/hour for 48 hours
Ropivacaine: A short-acting injectable sodium channel blocker bound to lipid that is indicated in controlling postoperative pain
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
28.6%
8/28 • Number of events 8 • 12 weeks
|
36.4%
12/33 • Number of events 12 • 12 weeks
|
Additional Information
Dr. Amit Momaya
University of Alabama at Birmingham, Department of Orthopaedics
Phone: 205-930-8339
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place