Trial Outcomes & Findings for Liposomal Bupivacaine for Pain Control After Total Shoulder Arthroplasty (NCT NCT02762071)
NCT ID: NCT02762071
Last Updated: 2020-03-30
Results Overview
The primary outcome was pain score on a visual analog scale (VAS) at 24 hours postoperatively. VAS pain scores range from 0 (no pain) to 10 (unbearable pain).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
108 participants
Primary outcome timeframe
At 24 hours after surgery
Results posted on
2020-03-30
Participant Flow
Participant milestones
| Measure |
Interscalene Nerve Block
Patients in this group will receive an interscalene nerve block containing the local anesthetic ropivacaine prior to surgery. The nerve block will be administered by a fellowship-trained anesthesiologist.
Interscalene Nerve Block: Patients in this group will receive an interscalene nerve block containing the local anesthetic ropivacaine prior to surgery. The nerve block will be administered by a fellowship-trained anesthesiologist.
|
Liposomal Bupivacaine
Patients in this group will receive a periarticular injection containing liposomal bupivacaine and with local bupivacaine during surgery. The injection will be administered by the surgeon.
|
|---|---|---|
|
Overall Study
STARTED
|
54
|
54
|
|
Overall Study
COMPLETED
|
54
|
54
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Liposomal Bupivacaine for Pain Control After Total Shoulder Arthroplasty
Baseline characteristics by cohort
| Measure |
Interscalene Nerve Block
n=54 Participants
Patients in this group will receive an interscalene nerve block containing the local anesthetic ropivacaine prior to surgery. The nerve block will be administered by a fellowship-trained anesthesiologist.
Interscalene Nerve Block: Patients in this group will receive an interscalene nerve block containing the local anesthetic ropivacaine prior to surgery. The nerve block will be administered by a fellowship-trained anesthesiologist.
|
Liposomal Bupivacaine
n=54 Participants
Patients in this group will receive a periarticular injection containing liposomal bupivacaine during surgery. The injection will be administered by the surgeon.
Liposomal bupivacaine: Patients in this group will receive a periarticular injection containing liposomal bupivacaine during surgery. The injection will be administered by the surgeon.
|
Total
n=108 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
17 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
37 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
67 Participants
n=5 Participants
|
|
Age, Continuous
|
68 years
STANDARD_DEVIATION 10 • n=5 Participants
|
65 years
STANDARD_DEVIATION 9 • n=7 Participants
|
67 years
STANDARD_DEVIATION 9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
30 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
61 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
49 Participants
n=5 Participants
|
52 Participants
n=7 Participants
|
101 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 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
|
8 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
46 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
86 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
54 Participants
n=5 Participants
|
54 Participants
n=7 Participants
|
108 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At 24 hours after surgeryThe primary outcome was pain score on a visual analog scale (VAS) at 24 hours postoperatively. VAS pain scores range from 0 (no pain) to 10 (unbearable pain).
Outcome measures
| Measure |
Interscalene Nerve Block
n=54 Participants
Patients in this group will receive an interscalene nerve block containing the local anesthetic ropivacaine prior to surgery. The nerve block will be administered by a fellowship-trained anesthesiologist.
Interscalene Nerve Block: Patients in this group will receive an interscalene nerve block containing the local anesthetic ropivacaine prior to surgery. The nerve block will be administered by a fellowship-trained anesthesiologist.
|
Liposomal Bupivacaine
n=54 Participants
Patients in this group will receive a periarticular injection containing liposomal bupivacaine during surgery. The injection will be administered by the surgeon.
Liposomal bupivacaine: Patients in this group will receive a periarticular injection containing liposomal bupivacaine during surgery. The injection will be administered by the surgeon.
|
|---|---|---|
|
Visual Analog Scale Pain Score at 24 Hours Postoperatively
|
5.0 score on a scale
Standard Deviation 3.0
|
4.9 score on a scale
Standard Deviation 2.7
|
SECONDARY outcome
Timeframe: Up to 4 days postoperativelyWe analyzed intraoperative opioid consumption; postoperative opioid consumption at days 1, 2, 3, and 4; total opioid consumption at day 1 (intraoperative + postoperative day 1). This was measured in morphine milligram equivalents.
Outcome measures
| Measure |
Interscalene Nerve Block
n=54 Participants
Patients in this group will receive an interscalene nerve block containing the local anesthetic ropivacaine prior to surgery. The nerve block will be administered by a fellowship-trained anesthesiologist.
Interscalene Nerve Block: Patients in this group will receive an interscalene nerve block containing the local anesthetic ropivacaine prior to surgery. The nerve block will be administered by a fellowship-trained anesthesiologist.
|
Liposomal Bupivacaine
n=54 Participants
Patients in this group will receive a periarticular injection containing liposomal bupivacaine during surgery. The injection will be administered by the surgeon.
Liposomal bupivacaine: Patients in this group will receive a periarticular injection containing liposomal bupivacaine during surgery. The injection will be administered by the surgeon.
|
|---|---|---|
|
Opioid Medication Consumption in Morphine Milligram Equivalents
Postoperative day 2
|
9 morphine milligram equivalents
Standard Deviation 10
|
7 morphine milligram equivalents
Standard Deviation 8
|
|
Opioid Medication Consumption in Morphine Milligram Equivalents
Total Intraoperative + Postoperative day 1
|
38 morphine milligram equivalents
Standard Deviation 14
|
60 morphine milligram equivalents
Standard Deviation 51
|
|
Opioid Medication Consumption in Morphine Milligram Equivalents
Intraoperative
|
21 morphine milligram equivalents
Standard Deviation 11
|
25 morphine milligram equivalents
Standard Deviation 14
|
|
Opioid Medication Consumption in Morphine Milligram Equivalents
Postoperative day 1
|
18 morphine milligram equivalents
Standard Deviation 12
|
36 morphine milligram equivalents
Standard Deviation 48
|
|
Opioid Medication Consumption in Morphine Milligram Equivalents
Postoperative day 3
|
3 morphine milligram equivalents
Standard Deviation 6
|
4 morphine milligram equivalents
Standard Deviation 8
|
|
Opioid Medication Consumption in Morphine Milligram Equivalents
Postoperative day 4
|
2 morphine milligram equivalents
Standard Deviation 6
|
2 morphine milligram equivalents
Standard Deviation 5
|
SECONDARY outcome
Timeframe: At the time of discharge from hospital, Up to 4 daysDuration of stay in hospital (hours) after shoulder replacement surgery.
Outcome measures
| Measure |
Interscalene Nerve Block
n=54 Participants
Patients in this group will receive an interscalene nerve block containing the local anesthetic ropivacaine prior to surgery. The nerve block will be administered by a fellowship-trained anesthesiologist.
Interscalene Nerve Block: Patients in this group will receive an interscalene nerve block containing the local anesthetic ropivacaine prior to surgery. The nerve block will be administered by a fellowship-trained anesthesiologist.
|
Liposomal Bupivacaine
n=54 Participants
Patients in this group will receive a periarticular injection containing liposomal bupivacaine during surgery. The injection will be administered by the surgeon.
Liposomal bupivacaine: Patients in this group will receive a periarticular injection containing liposomal bupivacaine during surgery. The injection will be administered by the surgeon.
|
|---|---|---|
|
Length of Hospital Stay
|
39 hours
Standard Deviation 20
|
36 hours
Standard Deviation 14
|
SECONDARY outcome
Timeframe: Up to first postoperative visit, maximum 30 daysWe analyzed postoperative VAS pain scores at 6, 12, 18, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96 hours and at the first postoperative visit. VAS pain scores range from 0 (no pain) to 10 (unbearable pain).
Outcome measures
| Measure |
Interscalene Nerve Block
n=54 Participants
Patients in this group will receive an interscalene nerve block containing the local anesthetic ropivacaine prior to surgery. The nerve block will be administered by a fellowship-trained anesthesiologist.
Interscalene Nerve Block: Patients in this group will receive an interscalene nerve block containing the local anesthetic ropivacaine prior to surgery. The nerve block will be administered by a fellowship-trained anesthesiologist.
|
Liposomal Bupivacaine
n=54 Participants
Patients in this group will receive a periarticular injection containing liposomal bupivacaine during surgery. The injection will be administered by the surgeon.
Liposomal bupivacaine: Patients in this group will receive a periarticular injection containing liposomal bupivacaine during surgery. The injection will be administered by the surgeon.
|
|---|---|---|
|
Postoperative Visual Analog Scale (VAS) Pain Scores
42 hours postoperative
|
4.0 score on a scale
Standard Deviation 2.8
|
4.6 score on a scale
Standard Deviation 2.8
|
|
Postoperative Visual Analog Scale (VAS) Pain Scores
48 hours postoperative
|
4.2 score on a scale
Standard Deviation 2.8
|
4.3 score on a scale
Standard Deviation 2.7
|
|
Postoperative Visual Analog Scale (VAS) Pain Scores
54 hours postoperative
|
4.2 score on a scale
Standard Deviation 2.7
|
4.4 score on a scale
Standard Deviation 2.5
|
|
Postoperative Visual Analog Scale (VAS) Pain Scores
96 hours postoperative
|
3.8 score on a scale
Standard Deviation 2.4
|
4.3 score on a scale
Standard Deviation 2.8
|
|
Postoperative Visual Analog Scale (VAS) Pain Scores
6 hours postoperative
|
2.9 score on a scale
Standard Deviation 3.1
|
5.1 score on a scale
Standard Deviation 2.9
|
|
Postoperative Visual Analog Scale (VAS) Pain Scores
12 hours postoperative
|
4.0 score on a scale
Standard Deviation 3.1
|
4.6 score on a scale
Standard Deviation 3.0
|
|
Postoperative Visual Analog Scale (VAS) Pain Scores
18 hours postoperative
|
5.2 score on a scale
Standard Deviation 3.4
|
4.6 score on a scale
Standard Deviation 3.1
|
|
Postoperative Visual Analog Scale (VAS) Pain Scores
30 hours postoperative
|
4.8 score on a scale
Standard Deviation 2.9
|
4.6 score on a scale
Standard Deviation 2.7
|
|
Postoperative Visual Analog Scale (VAS) Pain Scores
36 hours postoperative
|
4.1 score on a scale
Standard Deviation 2.9
|
5.1 score on a scale
Standard Deviation 2.2
|
|
Postoperative Visual Analog Scale (VAS) Pain Scores
60 hours postoperative
|
4.1 score on a scale
Standard Deviation 2.6
|
3.9 score on a scale
Standard Deviation 2.1
|
|
Postoperative Visual Analog Scale (VAS) Pain Scores
66 hours postoperative
|
3.8 score on a scale
Standard Deviation 2.6
|
3.6 score on a scale
Standard Deviation 2.2
|
|
Postoperative Visual Analog Scale (VAS) Pain Scores
72 hours postoperative
|
3.8 score on a scale
Standard Deviation 2.6
|
3.7 score on a scale
Standard Deviation 2.6
|
|
Postoperative Visual Analog Scale (VAS) Pain Scores
78 hours postoperative
|
4.0 score on a scale
Standard Deviation 2.4
|
4.2 score on a scale
Standard Deviation 2.6
|
|
Postoperative Visual Analog Scale (VAS) Pain Scores
84 hours postoperative
|
4.0 score on a scale
Standard Deviation 2.7
|
4.1 score on a scale
Standard Deviation 2.6
|
|
Postoperative Visual Analog Scale (VAS) Pain Scores
90 hours postoperative
|
3.9 score on a scale
Standard Deviation 2.5
|
4.1 score on a scale
Standard Deviation 2.5
|
|
Postoperative Visual Analog Scale (VAS) Pain Scores
1st postoperative visit
|
3.4 score on a scale
Standard Deviation 2.6
|
4.4 score on a scale
Standard Deviation 2.5
|
SECONDARY outcome
Timeframe: At first postoperative visit, up to 30 daysVisual Analog Scale (VAS) score for satisfaction with pain control in the hospital and at home. This was assessed at subjects' first postoperative visit.VAS satisfaction scores range from 0 (not satisfied) to 10 (completely satisfied).
Outcome measures
| Measure |
Interscalene Nerve Block
n=54 Participants
Patients in this group will receive an interscalene nerve block containing the local anesthetic ropivacaine prior to surgery. The nerve block will be administered by a fellowship-trained anesthesiologist.
Interscalene Nerve Block: Patients in this group will receive an interscalene nerve block containing the local anesthetic ropivacaine prior to surgery. The nerve block will be administered by a fellowship-trained anesthesiologist.
|
Liposomal Bupivacaine
n=54 Participants
Patients in this group will receive a periarticular injection containing liposomal bupivacaine during surgery. The injection will be administered by the surgeon.
Liposomal bupivacaine: Patients in this group will receive a periarticular injection containing liposomal bupivacaine during surgery. The injection will be administered by the surgeon.
|
|---|---|---|
|
Patient Satisfaction With Pain Management
Satisfaction with pain management in the hospital
|
8.4 score on a scale
Standard Deviation 2.6
|
7.8 score on a scale
Standard Deviation 3.1
|
|
Patient Satisfaction With Pain Management
Satisfaction with pain management at home
|
8.7 score on a scale
Standard Deviation 1.9
|
8.1 score on a scale
Standard Deviation 2.7
|
SECONDARY outcome
Timeframe: At the time of discharge from PACU, Up to 1 dayDuration of stay in the post-anesthesia care unit (minutes) after shoulder replacement surgery.
Outcome measures
| Measure |
Interscalene Nerve Block
n=54 Participants
Patients in this group will receive an interscalene nerve block containing the local anesthetic ropivacaine prior to surgery. The nerve block will be administered by a fellowship-trained anesthesiologist.
Interscalene Nerve Block: Patients in this group will receive an interscalene nerve block containing the local anesthetic ropivacaine prior to surgery. The nerve block will be administered by a fellowship-trained anesthesiologist.
|
Liposomal Bupivacaine
n=54 Participants
Patients in this group will receive a periarticular injection containing liposomal bupivacaine during surgery. The injection will be administered by the surgeon.
Liposomal bupivacaine: Patients in this group will receive a periarticular injection containing liposomal bupivacaine during surgery. The injection will be administered by the surgeon.
|
|---|---|---|
|
Length of Stay in the Post-anesthesia Care Unit (PACU)
|
102 minutes
Standard Deviation 53
|
139 minutes
Standard Deviation 77
|
Adverse Events
Interscalene Nerve Block
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
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