Trial Outcomes & Findings for Efficacy of Liposomal Bupivacaine Versus 0.25% Bupivacaine for Laparoscopic Urologic Surgery (NCT NCT02222129)
NCT ID: NCT02222129
Last Updated: 2015-04-16
Results Overview
Total opioid consumption measured in intravenous morphine equivalents during the postoperative hospital stay
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
206 participants
Primary outcome timeframe
All data was recorded during the patient's hospital stay, typically less than 5 days. All data was tabulated from the electronic medical record, typically within 30 days of discharge from hospital.
Results posted on
2015-04-16
Participant Flow
Participant milestones
| Measure |
Bupivacaine
Surgical site infiltration of 0.25% bupivacaine.
Bupivacaine
|
Liposomal Bupivacaine
Surgical site infiltration of liposomal bupivacaine.
liposomal bupivacaine
|
|---|---|---|
|
Overall Study
STARTED
|
100
|
106
|
|
Overall Study
COMPLETED
|
100
|
106
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Efficacy of Liposomal Bupivacaine Versus 0.25% Bupivacaine for Laparoscopic Urologic Surgery
Baseline characteristics by cohort
| Measure |
Bupivacaine
n=94 Participants
Surgical site infiltration of 0.25% bupivacaine.
Bupivacaine
|
Liposomal Bupivacaine
n=97 Participants
Surgical site infiltration of liposomal bupivacaine.
liposomal bupivacaine
|
Total
n=191 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Age
|
63 years
n=5 Participants
|
62 years
n=7 Participants
|
63 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
37 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
71 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
57 Participants
n=5 Participants
|
63 Participants
n=7 Participants
|
120 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
45 participants
n=5 Participants
|
55 participants
n=7 Participants
|
100 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
41 participants
n=5 Participants
|
32 participants
n=7 Participants
|
73 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African American
|
5 participants
n=5 Participants
|
6 participants
n=7 Participants
|
11 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian/Pacific Islander
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
3 participants
n=5 Participants
|
3 participants
n=7 Participants
|
6 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
94 participants
n=5 Participants
|
97 participants
n=7 Participants
|
191 participants
n=5 Participants
|
|
BMI
|
28.9 kg/m2
n=5 Participants
|
28.2 kg/m2
n=7 Participants
|
28.7 kg/m2
n=5 Participants
|
PRIMARY outcome
Timeframe: All data was recorded during the patient's hospital stay, typically less than 5 days. All data was tabulated from the electronic medical record, typically within 30 days of discharge from hospital.Total opioid consumption measured in intravenous morphine equivalents during the postoperative hospital stay
Outcome measures
| Measure |
Bupivacaine
n=94 Participants
Surgical site infiltration of 0.25% bupivacaine.
Bupivacaine
|
Liposomal Bupivacaine
n=97 Participants
Surgical site infiltration of liposomal bupivacaine.
liposomal bupivacaine
|
|---|---|---|
|
Total Opioid Consumption Measured in Intravenous Morphine Equivalents During the Postoperative Hospital Stay
|
17.3 mg (morphine equivalents)
Interval 8.3 to 30.5
|
15 mg (morphine equivalents)
Interval 6.7 to 27.0
|
SECONDARY outcome
Timeframe: All data was recorded during the patient's hospital stay, typically less than 5 days. All data was tabulated from the electronic medical record, typically within 30 days of discharge from hospital.Visual analog pain scores.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: All data was recorded during the patient's hospital stay, typically less than 5 days. All data was tabulated from the electronic medical record, typically within 30 days of discharge from hospital.Length of hospital stay.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: All data was recorded during the patient's hospital stay, typically less than 5 days. All data was tabulated from the electronic medical record, typically within 30 days of discharge from hospital.Time to first opioid use.
Outcome measures
Outcome data not reported
Adverse Events
Bupivacaine
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