Trial Outcomes & Findings for A Prospective Study to Compare Bupivacaine and Exparel Versus Bupivacaine or Exparel Alone for Postoperative Pain Relief (NCT NCT03514277)
NCT ID: NCT03514277
Last Updated: 2021-01-06
Results Overview
Wong-Baker pain faces scale of 0-no pain, to 10-extreme pain
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
19 participants
Primary outcome timeframe
last day of hospitalization, average of 3 days in hospital
Results posted on
2021-01-06
Participant Flow
Participant milestones
| Measure |
Local Infiltration of EXPAREL and Bupivacaine
Exparel: 1 level patients - 20 mL Exparel; 2 level patients - 20 mL Exparel diluted to 40 mL
Bupivacaine: 30 mL bupivacaine 0.5% w/v solution
|
Local Infiltration of Exparel
Exparel: 1 level patients - 20 mL Exparel; 2 level patients - 20 mL Exparel diluted to 40 mL
|
Local Infiltration of Bupivacaine
Bupivacaine: 30 mL bupivacaine 0.5% w/v solution
|
|---|---|---|---|
|
Overall Study
STARTED
|
11
|
4
|
4
|
|
Overall Study
COMPLETED
|
11
|
4
|
4
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Prospective Study to Compare Bupivacaine and Exparel Versus Bupivacaine or Exparel Alone for Postoperative Pain Relief
Baseline characteristics by cohort
| Measure |
Local Infiltration of EXPAREL and Bupivacaine
n=11 Participants
Exparel: 1 level patients - 20 mL Exparel; 2 level patients - 20 mL Exparel diluted to 40 mL
Bupivacaine: 30 mL bupivacaine 0.5% w/v solution
|
Local Infiltration of Exparel
n=4 Participants
Exparel: 1 level patients - 20 mL Exparel; 2 level patients - 20 mL Exparel diluted to 40 mL
|
Local Infiltration of Bupivacaine
n=4 Participants
Bupivacaine: 30 mL bupivacaine 0.5% w/v solution
|
Total
n=19 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
67.8 years
n=5 Participants
|
72.3 years
n=7 Participants
|
67.3 years
n=5 Participants
|
68.6 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 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
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: last day of hospitalization, average of 3 days in hospitalPopulation: Data is not collected for one patient in the Local infiltration of EXPAREL and Bupivacaine group
Wong-Baker pain faces scale of 0-no pain, to 10-extreme pain
Outcome measures
| Measure |
Local Infiltration of EXPAREL and Bupivacaine
n=10 Participants
Exparel: 1 level patients - 20 mL Exparel; 2 level patients - 20 mL Exparel diluted to 40 mL
Bupivacaine: 30 mL bupivacaine 0.5% w/v solution
|
Local Infiltration of Exparel
n=4 Participants
Exparel: 1 level patients - 20 mL Exparel; 2 level patients - 20 mL Exparel diluted to 40 mL
|
Local Infiltration of Bupivacaine
n=4 Participants
Bupivacaine: 30 mL bupivacaine 0.5% w/v solution
|
|---|---|---|---|
|
Mean Postoperative Pain Score
|
5.2 units on a scale
Interval 3.0 to 7.6
|
4.2 units on a scale
Interval 3.1 to 5.6
|
5.6 units on a scale
Interval 4.4 to 6.7
|
SECONDARY outcome
Timeframe: last day of hospitalization, average of 3 days in hospitalPopulation: Data is not collected for one patient in the Local infiltration of EXPAREL and Bupivacaine group
All opioid analgesics will be converted into oral mg morphine equivalent to determine the total dose of opioids
Outcome measures
| Measure |
Local Infiltration of EXPAREL and Bupivacaine
n=10 Participants
Exparel: 1 level patients - 20 mL Exparel; 2 level patients - 20 mL Exparel diluted to 40 mL
Bupivacaine: 30 mL bupivacaine 0.5% w/v solution
|
Local Infiltration of Exparel
n=4 Participants
Exparel: 1 level patients - 20 mL Exparel; 2 level patients - 20 mL Exparel diluted to 40 mL
|
Local Infiltration of Bupivacaine
n=4 Participants
Bupivacaine: 30 mL bupivacaine 0.5% w/v solution
|
|---|---|---|---|
|
Total Consumption of Opioids During Hospital Stay
|
106.1 milligram
Interval 0.0 to 300.0
|
87.3 milligram
Interval 4.0 to 202.5
|
46.1 milligram
Interval 13.5 to 81.0
|
SECONDARY outcome
Timeframe: last day of hospitalization, average of 3 days in hospitalPopulation: This data was not collected
Mean time to achieve physical therapy discharge criteria
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: last day of hospitalization, average of 3 days in hospitalNumber of Participants with Opioid Related Adverse Events
Outcome measures
| Measure |
Local Infiltration of EXPAREL and Bupivacaine
n=11 Participants
Exparel: 1 level patients - 20 mL Exparel; 2 level patients - 20 mL Exparel diluted to 40 mL
Bupivacaine: 30 mL bupivacaine 0.5% w/v solution
|
Local Infiltration of Exparel
n=4 Participants
Exparel: 1 level patients - 20 mL Exparel; 2 level patients - 20 mL Exparel diluted to 40 mL
|
Local Infiltration of Bupivacaine
n=4 Participants
Bupivacaine: 30 mL bupivacaine 0.5% w/v solution
|
|---|---|---|---|
|
Number of Participants With Opioid Related Adverse Events
|
1 Participants
|
0 Participants
|
1 Participants
|
Adverse Events
Local Infiltration of EXPAREL and Bupivacaine
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Local Infiltration of Exparel
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Local Infiltration of Bupivacaine
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Local Infiltration of EXPAREL and Bupivacaine
n=11 participants at risk
Exparel: 1 level patients - 20 mL Exparel; 2 level patients - 20 mL Exparel diluted to 40 mL
Bupivacaine: 30 mL bupivacaine 0.5% w/v solution
|
Local Infiltration of Exparel
n=4 participants at risk
Exparel: 1 level patients - 20 mL Exparel; 2 level patients - 20 mL Exparel diluted to 40 mL
|
Local Infiltration of Bupivacaine
n=4 participants at risk
Bupivacaine: 30 mL bupivacaine 0.5% w/v solution
|
|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
9.1%
1/11 • Number of events 1 • Duration of patient's hospital stay, an average of three days
|
0.00%
0/4 • Duration of patient's hospital stay, an average of three days
|
25.0%
1/4 • Number of events 1 • Duration of patient's hospital stay, an average of three days
|
|
Gastrointestinal disorders
Nausea
|
9.1%
1/11 • Number of events 1 • Duration of patient's hospital stay, an average of three days
|
0.00%
0/4 • Duration of patient's hospital stay, an average of three days
|
25.0%
1/4 • Number of events 1 • Duration of patient's hospital stay, an average of three days
|
|
General disorders
lethargy
|
9.1%
1/11 • Number of events 1 • Duration of patient's hospital stay, an average of three days
|
0.00%
0/4 • Duration of patient's hospital stay, an average of three days
|
0.00%
0/4 • Duration of patient's hospital stay, an average of three days
|
|
General disorders
Dehydration
|
9.1%
1/11 • Number of events 1 • Duration of patient's hospital stay, an average of three days
|
0.00%
0/4 • Duration of patient's hospital stay, an average of three days
|
0.00%
0/4 • Duration of patient's hospital stay, an average of three days
|
|
General disorders
Unsteadiness
|
9.1%
1/11 • Number of events 1 • Duration of patient's hospital stay, an average of three days
|
0.00%
0/4 • Duration of patient's hospital stay, an average of three days
|
0.00%
0/4 • Duration of patient's hospital stay, an average of three days
|
|
Renal and urinary disorders
Urinary retention
|
9.1%
1/11 • Number of events 1 • Duration of patient's hospital stay, an average of three days
|
0.00%
0/4 • Duration of patient's hospital stay, an average of three days
|
0.00%
0/4 • Duration of patient's hospital stay, an average of three days
|
|
Gastrointestinal disorders
Constitpation
|
9.1%
1/11 • Number of events 1 • Duration of patient's hospital stay, an average of three days
|
0.00%
0/4 • Duration of patient's hospital stay, an average of three days
|
0.00%
0/4 • Duration of patient's hospital stay, an average of three days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place