Trial Outcomes & Findings for Liposomal Bupivacaine in Bariatric Surgery (NCT NCT03373591)
NCT ID: NCT03373591
Last Updated: 2019-11-04
Results Overview
Fentanyl PCA (patient controlled analgesia) total microgram usage.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
219 participants
Primary outcome timeframe
24 hours post surgery.
Results posted on
2019-11-04
Participant Flow
Participant milestones
| Measure |
Liposomal Bupivacaine TAP Block
Patients were randomized to receive an intraoperative transverse abdominis peritoneal (TAP) block with liposomal bupivacaine (LB). The solution used to perform the TAP block with LB was composed of 20mL of liposomal bupivacaine solution, 30mL of 0.25% bupivacaine, and 100mL of normal saline.
Liposomal Bupivacaine TAP block: Infiltration of the transverse abdominis peritoneum by a local anesthetic under laparoscopic visualization.
|
Regular Bupivacaine TAP Block
Patients were randomized to receive an intraoperative transverse abdominis peritoneal (TAP) block with regular bupivacaine (RB).The solution used to perform the TAP block with RB was composed of 50mL of 0.25% bupivacaine and 100mL of normal saline.
Bupivacaine TAP block: Infiltration of the transverse abdominis peritoneum by a local anesthetic under laparoscopic visualization.
|
No TAP Block
Patients were randomized to receive no TAP block as a control group.
|
|---|---|---|---|
|
Overall Study
STARTED
|
75
|
71
|
73
|
|
Overall Study
COMPLETED
|
75
|
71
|
73
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Liposomal Bupivacaine in Bariatric Surgery
Baseline characteristics by cohort
| Measure |
Liposomal Bupivacaine TAP Block
n=75 Participants
Patients were randomized to receive an intraoperative transverse abdominis peritoneal (TAP) block with liposomal bupivacaine (LB). The solution used to perform the TAP block with LB was composed of 20mL of liposomal bupivacaine solution, 30mL of 0.25% bupivacaine, and 100mL of normal saline.
Liposomal Bupivacaine TAP block: Infiltration of the transverse abdominis peritoneum by a local anesthetic under laparoscopic visualization.
|
Regular Bupivacaine TAP Block
n=71 Participants
Patients were randomized to receive an intraoperative transverse abdominis peritoneal (TAP) block with regular bupivacaine (RB).The solution used to perform the TAP block with RB was composed of 50mL of 0.25% bupivacaine and 100mL of normal saline.
Bupivacaine TAP block: Infiltration of the transverse abdominis peritoneum by a local anesthetic under laparoscopic visualization.
|
No TAP Block
n=73 Participants
Patients were randomized to receive no TAP block as a control group.
|
Total
n=219 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
42.1 years
STANDARD_DEVIATION 9.8 • n=5 Participants
|
39.4 years
STANDARD_DEVIATION 10.9 • n=7 Participants
|
40.4 years
STANDARD_DEVIATION 11.0 • n=5 Participants
|
40.6 years
STANDARD_DEVIATION 10.6 • n=4 Participants
|
|
Sex: Female, Male
Female
|
60 Participants
n=5 Participants
|
55 Participants
n=7 Participants
|
66 Participants
n=5 Participants
|
181 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
38 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
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 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
|
25 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
76 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
16 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
27 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
34 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
113 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
75 participants
n=5 Participants
|
71 participants
n=7 Participants
|
73 participants
n=5 Participants
|
219 participants
n=4 Participants
|
|
Weight
|
119.5 Kilograms
STANDARD_DEVIATION 23.8 • n=5 Participants
|
121.7 Kilograms
STANDARD_DEVIATION 22.6 • n=7 Participants
|
116.6 Kilograms
STANDARD_DEVIATION 20.2 • n=5 Participants
|
119.3 Kilograms
STANDARD_DEVIATION 22.2 • n=4 Participants
|
|
BMI (Body Mass Index)
|
44.5 kg/m^2
STANDARD_DEVIATION 7.6 • n=5 Participants
|
44.8 kg/m^2
STANDARD_DEVIATION 5.5 • n=7 Participants
|
44.2 kg/m^2
STANDARD_DEVIATION 5.5 • n=5 Participants
|
44.5 kg/m^2
STANDARD_DEVIATION 6.2 • n=4 Participants
|
|
Procedure
Gastric Bypass
|
15 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
52 Participants
n=4 Participants
|
|
Procedure
Sleeve Gastrectomy
|
55 Participants
n=5 Participants
|
55 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
160 Participants
n=4 Participants
|
|
Procedure
Sleeve to Bypass Conversion
|
5 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 24 hours post surgery.Fentanyl PCA (patient controlled analgesia) total microgram usage.
Outcome measures
| Measure |
Liposomal Bupivacaine TAP Block
n=75 Participants
Patients were randomized to receive an intraoperative transverse abdominis peritoneal (TAP) block with liposomal bupivacaine (LB). The solution used to perform the TAP block with LB was composed of 20mL of liposomal bupivacaine solution, 30mL of 0.25% bupivacaine, and 100mL of normal saline.
Liposomal Bupivacaine TAP block: Infiltration of the transverse abdominis peritoneum by a local anesthetic under laparoscopic visualization.
|
Regular Bupivacaine TAP Block
n=71 Participants
Patients were randomized to receive an intraoperative transverse abdominis peritoneal (TAP) block with regular bupivacaine (RB).The solution used to perform the TAP block with RB was composed of 50mL of 0.25% bupivacaine and 100mL of normal saline.
Bupivacaine TAP block: Infiltration of the transverse abdominis peritoneum by a local anesthetic under laparoscopic visualization.
|
No TAP Block
n=73 Participants
Patients were randomized to receive no TAP block as a control group.
|
|---|---|---|---|
|
Fentanyl PCA mcg
|
351.4 Micrograms
Standard Deviation 209.4
|
360.7 Micrograms
Standard Deviation 223.5
|
353.9 Micrograms
Standard Deviation 231.0
|
PRIMARY outcome
Timeframe: During hospitalization, up to 7 days.Total fentanyl usage in micrograms, including both PCA and IV push administered medication.
Outcome measures
| Measure |
Liposomal Bupivacaine TAP Block
n=75 Participants
Patients were randomized to receive an intraoperative transverse abdominis peritoneal (TAP) block with liposomal bupivacaine (LB). The solution used to perform the TAP block with LB was composed of 20mL of liposomal bupivacaine solution, 30mL of 0.25% bupivacaine, and 100mL of normal saline.
Liposomal Bupivacaine TAP block: Infiltration of the transverse abdominis peritoneum by a local anesthetic under laparoscopic visualization.
|
Regular Bupivacaine TAP Block
n=71 Participants
Patients were randomized to receive an intraoperative transverse abdominis peritoneal (TAP) block with regular bupivacaine (RB).The solution used to perform the TAP block with RB was composed of 50mL of 0.25% bupivacaine and 100mL of normal saline.
Bupivacaine TAP block: Infiltration of the transverse abdominis peritoneum by a local anesthetic under laparoscopic visualization.
|
No TAP Block
n=73 Participants
Patients were randomized to receive no TAP block as a control group.
|
|---|---|---|---|
|
Total Fentanyl Usage
|
424.1 Micrograms
Standard Deviation 222.9
|
434.2 Micrograms
Standard Deviation 237.4
|
427.5 Micrograms
Standard Deviation 245.8
|
SECONDARY outcome
Timeframe: During hospitalization, up t 7 days.Total amount of acetaminophen used for analgesia.
Outcome measures
| Measure |
Liposomal Bupivacaine TAP Block
n=75 Participants
Patients were randomized to receive an intraoperative transverse abdominis peritoneal (TAP) block with liposomal bupivacaine (LB). The solution used to perform the TAP block with LB was composed of 20mL of liposomal bupivacaine solution, 30mL of 0.25% bupivacaine, and 100mL of normal saline.
Liposomal Bupivacaine TAP block: Infiltration of the transverse abdominis peritoneum by a local anesthetic under laparoscopic visualization.
|
Regular Bupivacaine TAP Block
n=71 Participants
Patients were randomized to receive an intraoperative transverse abdominis peritoneal (TAP) block with regular bupivacaine (RB).The solution used to perform the TAP block with RB was composed of 50mL of 0.25% bupivacaine and 100mL of normal saline.
Bupivacaine TAP block: Infiltration of the transverse abdominis peritoneum by a local anesthetic under laparoscopic visualization.
|
No TAP Block
n=73 Participants
Patients were randomized to receive no TAP block as a control group.
|
|---|---|---|---|
|
Acetaminophen Usage
|
486.4 Miligrams
Standard Deviation 553.1
|
501.0 Miligrams
Standard Deviation 456.0
|
353.4 Miligrams
Standard Deviation 486.9
|
SECONDARY outcome
Timeframe: During hospitalization, up to 7 days.Total amount of NSAID (ketorolac) use for analgesia.
Outcome measures
| Measure |
Liposomal Bupivacaine TAP Block
n=75 Participants
Patients were randomized to receive an intraoperative transverse abdominis peritoneal (TAP) block with liposomal bupivacaine (LB). The solution used to perform the TAP block with LB was composed of 20mL of liposomal bupivacaine solution, 30mL of 0.25% bupivacaine, and 100mL of normal saline.
Liposomal Bupivacaine TAP block: Infiltration of the transverse abdominis peritoneum by a local anesthetic under laparoscopic visualization.
|
Regular Bupivacaine TAP Block
n=71 Participants
Patients were randomized to receive an intraoperative transverse abdominis peritoneal (TAP) block with regular bupivacaine (RB).The solution used to perform the TAP block with RB was composed of 50mL of 0.25% bupivacaine and 100mL of normal saline.
Bupivacaine TAP block: Infiltration of the transverse abdominis peritoneum by a local anesthetic under laparoscopic visualization.
|
No TAP Block
n=73 Participants
Patients were randomized to receive no TAP block as a control group.
|
|---|---|---|---|
|
NSAID Usage
|
14.2 Miligrams
Standard Deviation 30.2
|
42.5 Miligrams
Standard Deviation 21.5
|
21.3 Miligrams
Standard Deviation 30.5
|
SECONDARY outcome
Timeframe: 24 hours post surgery.Patient reported composite measure pain score, with a total range of 0 to 10, with 0 being the absence of pain, 1 being the least amount of pain and 10 being the highest amount of pain.
Outcome measures
| Measure |
Liposomal Bupivacaine TAP Block
n=75 Participants
Patients were randomized to receive an intraoperative transverse abdominis peritoneal (TAP) block with liposomal bupivacaine (LB). The solution used to perform the TAP block with LB was composed of 20mL of liposomal bupivacaine solution, 30mL of 0.25% bupivacaine, and 100mL of normal saline.
Liposomal Bupivacaine TAP block: Infiltration of the transverse abdominis peritoneum by a local anesthetic under laparoscopic visualization.
|
Regular Bupivacaine TAP Block
n=71 Participants
Patients were randomized to receive an intraoperative transverse abdominis peritoneal (TAP) block with regular bupivacaine (RB).The solution used to perform the TAP block with RB was composed of 50mL of 0.25% bupivacaine and 100mL of normal saline.
Bupivacaine TAP block: Infiltration of the transverse abdominis peritoneum by a local anesthetic under laparoscopic visualization.
|
No TAP Block
n=73 Participants
Patients were randomized to receive no TAP block as a control group.
|
|---|---|---|---|
|
Pain Score
|
4.3 units on a scale
Standard Deviation 1.7
|
4.7 units on a scale
Standard Deviation 1.7
|
4.7 units on a scale
Standard Deviation 1.5
|
SECONDARY outcome
Timeframe: Assessed every 24 hours post surgery, up to 168 hour post-surgery.Hours of hospitalization post-surgery
Outcome measures
| Measure |
Liposomal Bupivacaine TAP Block
n=75 Participants
Patients were randomized to receive an intraoperative transverse abdominis peritoneal (TAP) block with liposomal bupivacaine (LB). The solution used to perform the TAP block with LB was composed of 20mL of liposomal bupivacaine solution, 30mL of 0.25% bupivacaine, and 100mL of normal saline.
Liposomal Bupivacaine TAP block: Infiltration of the transverse abdominis peritoneum by a local anesthetic under laparoscopic visualization.
|
Regular Bupivacaine TAP Block
n=71 Participants
Patients were randomized to receive an intraoperative transverse abdominis peritoneal (TAP) block with regular bupivacaine (RB).The solution used to perform the TAP block with RB was composed of 50mL of 0.25% bupivacaine and 100mL of normal saline.
Bupivacaine TAP block: Infiltration of the transverse abdominis peritoneum by a local anesthetic under laparoscopic visualization.
|
No TAP Block
n=73 Participants
Patients were randomized to receive no TAP block as a control group.
|
|---|---|---|---|
|
Length of Stay
24 hours
|
42 Participants
|
44 Participants
|
46 Participants
|
|
Length of Stay
48 hours
|
26 Participants
|
26 Participants
|
25 Participants
|
|
Length of Stay
72 hours
|
5 Participants
|
1 Participants
|
1 Participants
|
|
Length of Stay
96 hours
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Length of Stay
120 hours
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Length of Stay
168 hours
|
0 Participants
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 24 hours post surgery.Number of participants with presence or absence of nausea reported and recorded by the nurse.
Outcome measures
| Measure |
Liposomal Bupivacaine TAP Block
n=75 Participants
Patients were randomized to receive an intraoperative transverse abdominis peritoneal (TAP) block with liposomal bupivacaine (LB). The solution used to perform the TAP block with LB was composed of 20mL of liposomal bupivacaine solution, 30mL of 0.25% bupivacaine, and 100mL of normal saline.
Liposomal Bupivacaine TAP block: Infiltration of the transverse abdominis peritoneum by a local anesthetic under laparoscopic visualization.
|
Regular Bupivacaine TAP Block
n=71 Participants
Patients were randomized to receive an intraoperative transverse abdominis peritoneal (TAP) block with regular bupivacaine (RB).The solution used to perform the TAP block with RB was composed of 50mL of 0.25% bupivacaine and 100mL of normal saline.
Bupivacaine TAP block: Infiltration of the transverse abdominis peritoneum by a local anesthetic under laparoscopic visualization.
|
No TAP Block
n=73 Participants
Patients were randomized to receive no TAP block as a control group.
|
|---|---|---|---|
|
Nausea
|
27 Participants
|
41 Participants
|
34 Participants
|
SECONDARY outcome
Timeframe: Assessed every 24 hours post surgery, up to 168 hour post-surgery.Outcome measures
| Measure |
Liposomal Bupivacaine TAP Block
n=75 Participants
Patients were randomized to receive an intraoperative transverse abdominis peritoneal (TAP) block with liposomal bupivacaine (LB). The solution used to perform the TAP block with LB was composed of 20mL of liposomal bupivacaine solution, 30mL of 0.25% bupivacaine, and 100mL of normal saline.
Liposomal Bupivacaine TAP block: Infiltration of the transverse abdominis peritoneum by a local anesthetic under laparoscopic visualization.
|
Regular Bupivacaine TAP Block
n=71 Participants
Patients were randomized to receive an intraoperative transverse abdominis peritoneal (TAP) block with regular bupivacaine (RB).The solution used to perform the TAP block with RB was composed of 50mL of 0.25% bupivacaine and 100mL of normal saline.
Bupivacaine TAP block: Infiltration of the transverse abdominis peritoneum by a local anesthetic under laparoscopic visualization.
|
No TAP Block
n=73 Participants
Patients were randomized to receive no TAP block as a control group.
|
|---|---|---|---|
|
Time to Ambulation
|
51 Hours
Standard Deviation 1.7
|
60 Hours
Standard Deviation 1.6
|
59 Hours
Standard Deviation 2.0
|
Adverse Events
Liposomal Bupivacaine TAP Block
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Regular Bupivacaine TAP Block
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
No TAP Block
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