Trial Outcomes & Findings for Liposomal Bupivacaine in Total Shoulder Arthroplasty (NCT NCT02570022)
NCT ID: NCT02570022
Last Updated: 2016-10-13
Results Overview
Patients recorded pain levels every four hours using Visual analog scales for four days post operatively. Average daily pain was calculated for each patient. Range of the visual analog scale was 0-10, where 0 indicated a lower amount of pain and 10 indicated higher amount of pain.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
57 participants
Primary outcome timeframe
four days postoperatively
Results posted on
2016-10-13
Participant Flow
Participant milestones
| Measure |
Liposomal Bupivacaine
Patients in this group received local infiltration of Liposomal bupivacaine before the end of surgery.
Liposomal bupivacaine: Local infiltration of liposomal bupivacaine
|
Inter-scalene Nerve Block
Patients in this group received preoperative ultrasound guided inter-scalene nerve blocks by senior anesthesiologist using ropivicaine.
Inter-scalene nerve block: Pre-operative inter-scalene nerve block
Ropivacaine: Ropivicaine was used for the inter-scalene nerve block.
|
|---|---|---|
|
Overall Study
STARTED
|
26
|
31
|
|
Overall Study
COMPLETED
|
26
|
31
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Liposomal Bupivacaine in Total Shoulder Arthroplasty
Baseline characteristics by cohort
| Measure |
Liposomal Bupivacaine
n=26 Participants
Patients in this group received local infiltration of Liposomal bupivacaine before the end of surgery.
Liposomal bupivacaine: Local infiltration of liposomal bupivacaine
|
Inter-scalene Nerve Block
n=31 Participants
Patients in this group received preoperative ultrasound guided inter-scalene nerve blocks by senior anesthesiologist using ropivicaine.
Inter-scalene nerve block: Pre-operative inter-scalene nerve block
Ropivacaine: Ropivicaine was used for the inter-scalene nerve block.
|
Total
n=57 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
20 Participants
n=99 Participants
|
27 Participants
n=107 Participants
|
47 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
6 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Age, Continuous
|
69.4 years
n=99 Participants
|
67.1 years
n=107 Participants
|
67.8 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
29 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
28 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
26 participants
n=99 Participants
|
31 participants
n=107 Participants
|
57 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: four days postoperativelyPatients recorded pain levels every four hours using Visual analog scales for four days post operatively. Average daily pain was calculated for each patient. Range of the visual analog scale was 0-10, where 0 indicated a lower amount of pain and 10 indicated higher amount of pain.
Outcome measures
| Measure |
Liposomal Bupivacaine
n=26 Participants
Patients in this group received local infiltration of Liposomal bupivacaine before the end of surgery.
Liposomal bupivacaine: Local infiltration of liposomal bupivacaine
|
Inter-scalene Nerve Block
n=31 Participants
Patients in this group received preoperative ultrasound guided inter-scalene nerve blocks by senior anesthesiologist using ropivicaine.
Inter-scalene nerve block: Pre-operative inter-scalene nerve block
Ropivacaine: Ropivicaine was used for the inter-scalene nerve block.
|
|---|---|---|
|
Pain Levels
Mean Pain score Day 0
|
4.8 units on a scale
Standard Deviation 1.8
|
4.0 units on a scale
Standard Deviation 1.8
|
|
Pain Levels
Mean Pain score Day 1
|
4.7 units on a scale
Standard Deviation 2.3
|
4.0 units on a scale
Standard Deviation 1.7
|
|
Pain Levels
Mean Pain score Day 2
|
4.3 units on a scale
Standard Deviation 2.5
|
3.6 units on a scale
Standard Deviation 1.7
|
|
Pain Levels
Mean Pain score Day 3
|
4.1 units on a scale
Standard Deviation 2.0
|
4.3 units on a scale
Standard Deviation 2.1
|
SECONDARY outcome
Timeframe: four days postoperativelyPatients recorded opioid intake for four days postoperatively. Patients average daily morphine consumption was determined by averaging total patients daily morphine consumption by the number of patients.
Outcome measures
| Measure |
Liposomal Bupivacaine
n=26 Participants
Patients in this group received local infiltration of Liposomal bupivacaine before the end of surgery.
Liposomal bupivacaine: Local infiltration of liposomal bupivacaine
|
Inter-scalene Nerve Block
n=31 Participants
Patients in this group received preoperative ultrasound guided inter-scalene nerve blocks by senior anesthesiologist using ropivicaine.
Inter-scalene nerve block: Pre-operative inter-scalene nerve block
Ropivacaine: Ropivicaine was used for the inter-scalene nerve block.
|
|---|---|---|
|
Morphine Equivalents
Mean Morphine equivalents used Day 0
|
14.8 mg of morphine equivalent
Standard Deviation 9.2
|
21.4 mg of morphine equivalent
Standard Deviation 11.3
|
|
Morphine Equivalents
Mean Morphine equivalents used Day 1
|
8.9 mg of morphine equivalent
Standard Deviation 9.7
|
9.1 mg of morphine equivalent
Standard Deviation 11.4
|
|
Morphine Equivalents
Mean Morphine equivalents used Day 2
|
12.3 mg of morphine equivalent
Standard Deviation 16.9
|
5.2 mg of morphine equivalent
Standard Deviation 10.8
|
|
Morphine Equivalents
Mean Morphine equivalents used Day 3
|
2.8 mg of morphine equivalent
Standard Deviation 4.1
|
2.2 mg of morphine equivalent
Standard Deviation 6.1
|
Adverse Events
Liposomal Bupivacaine
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Inter-scalene Nerve Block
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Liposomal Bupivacaine
n=26 participants at risk
Patients in this group received local infiltration of Liposomal bupivacaine before the end of surgery.
Liposomal bupivacaine: Local infiltration of liposomal bupivacaine
|
Inter-scalene Nerve Block
n=31 participants at risk
Patients in this group received preoperative ultrasound guided inter-scalene nerve blocks by senior anesthesiologist using ropivicaine.
Inter-scalene nerve block: Pre-operative inter-scalene nerve block
Ropivacaine: Ropivicaine was used for the inter-scalene nerve block.
|
|---|---|---|
|
Nervous system disorders
Phrenic nerve palsy
|
0.00%
0/26
|
3.2%
1/31 • Number of events 1
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place