Trial Outcomes & Findings for Liposomal Bupivacaine Interscalene Nerve Block in Shoulder Arthroplasty (NCT NCT03663283)
NCT ID: NCT03663283
Last Updated: 2021-02-21
Results Overview
Patient pain scores over the first 72 hours post-operatively as measured by the Visual Analogue Scale where Zero represents no pain and ten represents severe pain.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
104 participants
Primary outcome timeframe
72 hours post-operatively
Results posted on
2021-02-21
Participant Flow
Participant milestones
| Measure |
Liposomal Bupivacaine
Administered utilizing ultrasound guidance by an anesthesiologist. Study patients received 10ml (133 mg) of liposomal bupivacaine mixed with 7.5ml of 0.5% plain bupivacaine and 7.5ml of 0.25% bupivacaine. Further, 8 mg (2 ml) IV dexamethasone was administered concomitantly at the time of the block.
Liposomal Bupivacaine: Interscalene Nerve Blocks
|
Plain Bupivacaine
Peripheral nerve blocks were performed with ultrasound guidance by an anesthesiologist. Standard bupivacaine hydrochloride was utilized. 25 ml of 0.5% bupivacaine for peripheral nerve block was utilized. Further, 8 mg (2 ml) IV dexamethasone was administered concomitantly at the time of the block.
Bupivacaine Hydrochloride: Interscalene Nerve Blocks
|
|---|---|---|
|
Overall Study
STARTED
|
52
|
52
|
|
Overall Study
COMPLETED
|
52
|
52
|
|
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
n=52 Participants
Administered utilizing ultrasound guidance by an anesthesiologist. Study patients received 10ml (133 mg) of liposomal bupivacaine mixed with 7.5ml of 0.5% plain bupivacaine and 7.5ml of 0.25% bupivacaine. Further, 8 mg (2 ml) IV dexamethasone was administered concomitantly at the time of the block.
Liposomal Bupivacaine: Interscalene Nerve Blocks
|
Plain Bupivacaine
n=52 Participants
Peripheral nerve blocks were performed with ultrasound guidance by an anesthesiologist. Standard bupivacaine hydrochloride was utilized. 25 ml of 0.5% bupivacaine for peripheral nerve block was utilized. Further, 8 mg (2 ml) IV dexamethasone was administered concomitantly at the time of the block.
Bupivacaine Hydrochloride: Interscalene Nerve Blocks
|
Total
n=104 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
70.0 years
STANDARD_DEVIATION 6.84 • n=52 Participants
|
69.2 years
STANDARD_DEVIATION 10.15 • n=52 Participants
|
69.6 years
STANDARD_DEVIATION 8.62 • n=104 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=52 Participants
|
24 Participants
n=52 Participants
|
46 Participants
n=104 Participants
|
|
Sex: Female, Male
Male
|
30 Participants
n=52 Participants
|
28 Participants
n=52 Participants
|
58 Participants
n=104 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
52 participants
n=52 Participants
|
52 participants
n=52 Participants
|
104 participants
n=104 Participants
|
PRIMARY outcome
Timeframe: 72 hours post-operativelyPatient pain scores over the first 72 hours post-operatively as measured by the Visual Analogue Scale where Zero represents no pain and ten represents severe pain.
Outcome measures
| Measure |
Liposomal Bupivacaine
n=52 Participants
Administered utilizing ultrasound guidance by an anesthesiologist. Study patients received 10ml (133 mg) of liposomal bupivacaine mixed with 7.5ml of 0.5% plain bupivacaine and 7.5ml of 0.25% bupivacaine. Further, 8 mg (2 ml) IV dexamethasone was administered concomitantly at the time of the block.
Liposomal Bupivacaine: Interscalene Nerve Blocks
|
Plain Bupivacaine
n=52 Participants
Peripheral nerve blocks were performed with ultrasound guidance by an anesthesiologist. Standard bupivacaine hydrochloride was utilized. 25 ml of 0.5% bupivacaine for peripheral nerve block was utilized. Further, 8 mg (2 ml) IV dexamethasone was administered concomitantly at the time of the block.
Bupivacaine Hydrochloride: Interscalene Nerve Blocks
|
|---|---|---|
|
Patient Pain Scores
|
4.0 score on a scale
Standard Deviation 2.57
|
2.8 score on a scale
Standard Deviation 1.88
|
SECONDARY outcome
Timeframe: Measured at 72 hours and at 3 weeks post-operativelyTotal opioid consumption as measured by morphine milligram equivalent (MME) in first 72 hours and at 3 weeks
Outcome measures
| Measure |
Liposomal Bupivacaine
n=52 Participants
Administered utilizing ultrasound guidance by an anesthesiologist. Study patients received 10ml (133 mg) of liposomal bupivacaine mixed with 7.5ml of 0.5% plain bupivacaine and 7.5ml of 0.25% bupivacaine. Further, 8 mg (2 ml) IV dexamethasone was administered concomitantly at the time of the block.
Liposomal Bupivacaine: Interscalene Nerve Blocks
|
Plain Bupivacaine
n=52 Participants
Peripheral nerve blocks were performed with ultrasound guidance by an anesthesiologist. Standard bupivacaine hydrochloride was utilized. 25 ml of 0.5% bupivacaine for peripheral nerve block was utilized. Further, 8 mg (2 ml) IV dexamethasone was administered concomitantly at the time of the block.
Bupivacaine Hydrochloride: Interscalene Nerve Blocks
|
|---|---|---|
|
Opioid Consumption
72 hours
|
45.6 morphine milligram equivalent (MME)
Standard Deviation 37.55
|
56.2 morphine milligram equivalent (MME)
Standard Deviation 35.43
|
|
Opioid Consumption
3 weeks
|
133.9 morphine milligram equivalent (MME)
Standard Deviation 110.52
|
150.9 morphine milligram equivalent (MME)
Standard Deviation 138.4
|
SECONDARY outcome
Timeframe: 4, 8, 12, 16, 20, 24, and 28 hours post-operativelyMeasured by the number of subjects who reported cessation of nerve blockade as the first reported postoperative pain score of 3 or greater at the surgical site.
Outcome measures
| Measure |
Liposomal Bupivacaine
n=47 Participants
Administered utilizing ultrasound guidance by an anesthesiologist. Study patients received 10ml (133 mg) of liposomal bupivacaine mixed with 7.5ml of 0.5% plain bupivacaine and 7.5ml of 0.25% bupivacaine. Further, 8 mg (2 ml) IV dexamethasone was administered concomitantly at the time of the block.
Liposomal Bupivacaine: Interscalene Nerve Blocks
|
Plain Bupivacaine
n=45 Participants
Peripheral nerve blocks were performed with ultrasound guidance by an anesthesiologist. Standard bupivacaine hydrochloride was utilized. 25 ml of 0.5% bupivacaine for peripheral nerve block was utilized. Further, 8 mg (2 ml) IV dexamethasone was administered concomitantly at the time of the block.
Bupivacaine Hydrochloride: Interscalene Nerve Blocks
|
|---|---|---|
|
Time to Cessation of Nerve Blockade
16 hours
|
43 Participants
|
35 Participants
|
|
Time to Cessation of Nerve Blockade
20 hours
|
43 Participants
|
41 Participants
|
|
Time to Cessation of Nerve Blockade
24 hours
|
46 Participants
|
44 Participants
|
|
Time to Cessation of Nerve Blockade
4 hours
|
16 Participants
|
12 Participants
|
|
Time to Cessation of Nerve Blockade
8 hours
|
31 Participants
|
19 Participants
|
|
Time to Cessation of Nerve Blockade
12 hours
|
38 Participants
|
28 Participants
|
|
Time to Cessation of Nerve Blockade
28 hours
|
47 Participants
|
45 Participants
|
SECONDARY outcome
Timeframe: Measured at 72 hours and at three weeks post-operativelyPatient satisfaction with pain control at 72 hours post-operatively and three weeks post operatively using Patient Satisfaction with Pain Management Pain Scale where Zero represents unsatisfactory pain management and ten represents perfect pain management.
Outcome measures
| Measure |
Liposomal Bupivacaine
n=52 Participants
Administered utilizing ultrasound guidance by an anesthesiologist. Study patients received 10ml (133 mg) of liposomal bupivacaine mixed with 7.5ml of 0.5% plain bupivacaine and 7.5ml of 0.25% bupivacaine. Further, 8 mg (2 ml) IV dexamethasone was administered concomitantly at the time of the block.
Liposomal Bupivacaine: Interscalene Nerve Blocks
|
Plain Bupivacaine
n=52 Participants
Peripheral nerve blocks were performed with ultrasound guidance by an anesthesiologist. Standard bupivacaine hydrochloride was utilized. 25 ml of 0.5% bupivacaine for peripheral nerve block was utilized. Further, 8 mg (2 ml) IV dexamethasone was administered concomitantly at the time of the block.
Bupivacaine Hydrochloride: Interscalene Nerve Blocks
|
|---|---|---|
|
Satisfaction With Pain Control Using Satisfaction Scale
72 hours
|
6.6 units on a scale
Standard Deviation 2.74
|
6.9 units on a scale
Standard Deviation 2.64
|
|
Satisfaction With Pain Control Using Satisfaction Scale
3 weeks
|
7.5 units on a scale
Standard Deviation 2.52
|
7.8 units on a scale
Standard Deviation 2.23
|
Adverse Events
Liposomal Bupivacaine
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Plain 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