Trial Outcomes & Findings for Comparing Liposomal Bupivacaine Versus Standard Bupivacaine in Colorectal Surgery (NCT NCT03702621)
NCT ID: NCT03702621
Last Updated: 2023-05-17
Results Overview
The VAS score at rest will be measured by a study team investigator using Visual Analog Scale (VAS). Using a scale of 1-10 for documentation with 10 being the worst pain and 0 being no pain
COMPLETED
PHASE3
90 participants
Pain scores will be measured 1 hour after surgery
2023-05-17
Participant Flow
Participant milestones
| Measure |
Liposomal Bupivacaine
LB (Liposomal Bupivacaine) group - This group will be receiving 20ml EXPAREL (266mg) and 40ml of 0.125% bupivacaine in total, 30ml on each side.
For the QL block, Shamrock sign consistent of the quadratus lumborum muscle, psoas major muscle, erector spinae muscles and the L4 transverse process will be identified. Under ultrasound guidance with an in-plane technique, the needle will be advanced into the fascial plane between the quadratus lumborum and psoas major muscles. Local anesthetic will be injected into the plane.
liposomal Bupivacaine: 20mL liposomal bupivacaine are injected into the liposomal bupivacaine group
|
Standard Bupivacaine
SB (Standard Bupivacaine) group - This group will be receiving 60ml of 0.25% bupivacaine in total, 30ml on each side.
For the QL block, Shamrock sign consistent of the quadratus lumborum muscle, psoas major muscle, erector spinae muscles and the L4 transverse process will be identified. Under ultrasound guidance with an in-plane technique, the needle will be advanced into the fascial plane between the quadratus lumborum and psoas major muscles. Local anesthetic will be injected into the plane.
Bupivacaine Hydrochloride: 40ml of 0.125% bupivacaine hydrochloride are injected into the liposomal bupivacaine group.
60mL of 0.25% bupivacaine hydrochloride are injected into the standard bupivacaine group
|
|---|---|---|
|
Overall Study
STARTED
|
44
|
46
|
|
Overall Study
COMPLETED
|
38
|
40
|
|
Overall Study
NOT COMPLETED
|
6
|
6
|
Reasons for withdrawal
| Measure |
Liposomal Bupivacaine
LB (Liposomal Bupivacaine) group - This group will be receiving 20ml EXPAREL (266mg) and 40ml of 0.125% bupivacaine in total, 30ml on each side.
For the QL block, Shamrock sign consistent of the quadratus lumborum muscle, psoas major muscle, erector spinae muscles and the L4 transverse process will be identified. Under ultrasound guidance with an in-plane technique, the needle will be advanced into the fascial plane between the quadratus lumborum and psoas major muscles. Local anesthetic will be injected into the plane.
liposomal Bupivacaine: 20mL liposomal bupivacaine are injected into the liposomal bupivacaine group
|
Standard Bupivacaine
SB (Standard Bupivacaine) group - This group will be receiving 60ml of 0.25% bupivacaine in total, 30ml on each side.
For the QL block, Shamrock sign consistent of the quadratus lumborum muscle, psoas major muscle, erector spinae muscles and the L4 transverse process will be identified. Under ultrasound guidance with an in-plane technique, the needle will be advanced into the fascial plane between the quadratus lumborum and psoas major muscles. Local anesthetic will be injected into the plane.
Bupivacaine Hydrochloride: 40ml of 0.125% bupivacaine hydrochloride are injected into the liposomal bupivacaine group.
60mL of 0.25% bupivacaine hydrochloride are injected into the standard bupivacaine group
|
|---|---|---|
|
Overall Study
Physician Decision
|
6
|
6
|
Baseline Characteristics
Comparing Liposomal Bupivacaine Versus Standard Bupivacaine in Colorectal Surgery
Baseline characteristics by cohort
| Measure |
Liposomal Bupivacaine
n=38 Participants
LB (Liposomal Bupivacaine) group - This group will be receiving 20 mL EXPAREL (266mg) and 40 mL of 0.125% bupivacaine in total, 30 mL on each side.
For the quadratus lumborum (QL) block, Shamrock sign consistent of the quadratus lumborum muscle, psoas major muscle, erector spinae muscles and the L4 transverse process will be identified. Under ultrasound guidance with an in-plane technique, the needle will be advanced into the fascial plane between the quadratus lumborum and psoas major muscles. Local anesthetic will be injected into the plane.
liposomal Bupivacaine: 20 mL liposomal bupivacaine are injected into the liposomal bupivacaine group
|
Standard Bupivacaine
n=40 Participants
SB (Standard Bupivacaine) group - This group will be receiving 60 mL of 0.25% bupivacaine in total, 30 mL on each side.
For the QL block, Shamrock sign consistent of the quadratus lumborum muscle, psoas major muscle, erector spinae muscles and the L4 transverse process will be identified. Under ultrasound guidance with an in-plane technique, the needle will be advanced into the fascial plane between the quadratus lumborum and psoas major muscles. Local anesthetic will be injected into the plane.
Bupivacaine Hydrochloride: 40 mL of 0.125% bupivacaine hydrochloride are injected into the liposomal bupivacaine group.
60mL of 0.25% bupivacaine hydrochloride are injected into the standard bupivacaine group
|
Total
n=78 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
59 years
n=5 Participants
|
62 years
n=7 Participants
|
61.5 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 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
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
36 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
72 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Body Mass Index
|
25.8 kg/square meter
n=5 Participants
|
28.7 kg/square meter
n=7 Participants
|
26.9 kg/square meter
n=5 Participants
|
|
No Known Allergies
|
17 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Height
|
172.7 cm
n=5 Participants
|
167.3 cm
n=7 Participants
|
170.2 cm
n=5 Participants
|
|
Weight
|
76.8 kg
n=5 Participants
|
77.5 kg
n=7 Participants
|
77.1 kg
n=5 Participants
|
PRIMARY outcome
Timeframe: Pain scores will be measured 1 hour after surgeryThe VAS score at rest will be measured by a study team investigator using Visual Analog Scale (VAS). Using a scale of 1-10 for documentation with 10 being the worst pain and 0 being no pain
Outcome measures
| Measure |
Liposomal Bupivacaine
n=38 Participants
LB (Liposomal Bupivacaine) group - This group will be receiving 20ml EXPAREL (266mg) and 40ml of 0.125% bupivacaine in total, 30ml on each side.
For the QL block, Shamrock sign consistent of the quadratus lumborum muscle, psoas major muscle, erector spinae muscles and the L4 transverse process will be identified. Under ultrasound guidance with an in-plane technique, the needle will be advanced into the fascial plane between the quadratus lumborum and psoas major muscles. Local anesthetic will be injected into the plane.
liposomal Bupivacaine: 20mL liposomal bupivacaine are injected into the liposomal bupivacaine group
|
Standard Bupivacaine
n=40 Participants
SB (Standard Bupivacaine) group - This group will be receiving 60ml of 0.25% bupivacaine in total, 30ml on each side.
For the QL block, Shamrock sign consistent of the quadratus lumborum muscle, psoas major muscle, erector spinae muscles and the L4 transverse process will be identified. Under ultrasound guidance with an in-plane technique, the needle will be advanced into the fascial plane between the quadratus lumborum and psoas major muscles. Local anesthetic will be injected into the plane.
Bupivacaine Hydrochloride: 40ml of 0.125% bupivacaine hydrochloride are injected into the liposomal bupivacaine group.
60mL of 0.25% bupivacaine hydrochloride are injected into the standard bupivacaine group
|
|---|---|---|
|
VAS Score at 1 Hour at Rest
|
5.0 score on a scale
Interval 0.0 to 7.0
|
3.0 score on a scale
Interval 0.0 to 6.0
|
PRIMARY outcome
Timeframe: Pain scores will be measured 1 hour after surgeryThe VAS score with movement (knee flexion) will be measured by a study team investigator using Visual Analog Scale (VAS). Using a scale of 1-10 for documentation with 10 being the worst pain and 0 being no pain
Outcome measures
| Measure |
Liposomal Bupivacaine
n=38 Participants
LB (Liposomal Bupivacaine) group - This group will be receiving 20ml EXPAREL (266mg) and 40ml of 0.125% bupivacaine in total, 30ml on each side.
For the QL block, Shamrock sign consistent of the quadratus lumborum muscle, psoas major muscle, erector spinae muscles and the L4 transverse process will be identified. Under ultrasound guidance with an in-plane technique, the needle will be advanced into the fascial plane between the quadratus lumborum and psoas major muscles. Local anesthetic will be injected into the plane.
liposomal Bupivacaine: 20mL liposomal bupivacaine are injected into the liposomal bupivacaine group
|
Standard Bupivacaine
n=40 Participants
SB (Standard Bupivacaine) group - This group will be receiving 60ml of 0.25% bupivacaine in total, 30ml on each side.
For the QL block, Shamrock sign consistent of the quadratus lumborum muscle, psoas major muscle, erector spinae muscles and the L4 transverse process will be identified. Under ultrasound guidance with an in-plane technique, the needle will be advanced into the fascial plane between the quadratus lumborum and psoas major muscles. Local anesthetic will be injected into the plane.
Bupivacaine Hydrochloride: 40ml of 0.125% bupivacaine hydrochloride are injected into the liposomal bupivacaine group.
60mL of 0.25% bupivacaine hydrochloride are injected into the standard bupivacaine group
|
|---|---|---|
|
VAS Score at 1 Hour With Movement
|
5.0 score on a scale
Interval 0.0 to 8.0
|
3.0 score on a scale
Interval 0.0 to 6.0
|
PRIMARY outcome
Timeframe: Pain scores will be measured 24 hours after surgeryThe VAS score at rest will be measured by a study team investigator using Visual Analog Scale (VAS). Using a scale of 1-10 for documentation with 10 being the worst pain and 0 being no pain
Outcome measures
| Measure |
Liposomal Bupivacaine
n=38 Participants
LB (Liposomal Bupivacaine) group - This group will be receiving 20ml EXPAREL (266mg) and 40ml of 0.125% bupivacaine in total, 30ml on each side.
For the QL block, Shamrock sign consistent of the quadratus lumborum muscle, psoas major muscle, erector spinae muscles and the L4 transverse process will be identified. Under ultrasound guidance with an in-plane technique, the needle will be advanced into the fascial plane between the quadratus lumborum and psoas major muscles. Local anesthetic will be injected into the plane.
liposomal Bupivacaine: 20mL liposomal bupivacaine are injected into the liposomal bupivacaine group
|
Standard Bupivacaine
n=40 Participants
SB (Standard Bupivacaine) group - This group will be receiving 60ml of 0.25% bupivacaine in total, 30ml on each side.
For the QL block, Shamrock sign consistent of the quadratus lumborum muscle, psoas major muscle, erector spinae muscles and the L4 transverse process will be identified. Under ultrasound guidance with an in-plane technique, the needle will be advanced into the fascial plane between the quadratus lumborum and psoas major muscles. Local anesthetic will be injected into the plane.
Bupivacaine Hydrochloride: 40ml of 0.125% bupivacaine hydrochloride are injected into the liposomal bupivacaine group.
60mL of 0.25% bupivacaine hydrochloride are injected into the standard bupivacaine group
|
|---|---|---|
|
VAS Score at 24 Hours at Rest
|
4.0 score on a scale
Interval 2.0 to 6.0
|
3.0 score on a scale
Interval 2.0 to 5.5
|
PRIMARY outcome
Timeframe: Pain scores will be measured 24 hours after surgeryThe VAS score with movement (knee flexion) will be measured by a study team investigator using Visual Analog Scale (VAS). Using a scale of 1-10 for documentation with 10 being the worst pain and 0 being no pain
Outcome measures
| Measure |
Liposomal Bupivacaine
n=38 Participants
LB (Liposomal Bupivacaine) group - This group will be receiving 20ml EXPAREL (266mg) and 40ml of 0.125% bupivacaine in total, 30ml on each side.
For the QL block, Shamrock sign consistent of the quadratus lumborum muscle, psoas major muscle, erector spinae muscles and the L4 transverse process will be identified. Under ultrasound guidance with an in-plane technique, the needle will be advanced into the fascial plane between the quadratus lumborum and psoas major muscles. Local anesthetic will be injected into the plane.
liposomal Bupivacaine: 20mL liposomal bupivacaine are injected into the liposomal bupivacaine group
|
Standard Bupivacaine
n=40 Participants
SB (Standard Bupivacaine) group - This group will be receiving 60ml of 0.25% bupivacaine in total, 30ml on each side.
For the QL block, Shamrock sign consistent of the quadratus lumborum muscle, psoas major muscle, erector spinae muscles and the L4 transverse process will be identified. Under ultrasound guidance with an in-plane technique, the needle will be advanced into the fascial plane between the quadratus lumborum and psoas major muscles. Local anesthetic will be injected into the plane.
Bupivacaine Hydrochloride: 40ml of 0.125% bupivacaine hydrochloride are injected into the liposomal bupivacaine group.
60mL of 0.25% bupivacaine hydrochloride are injected into the standard bupivacaine group
|
|---|---|---|
|
VAS Score at 24 Hours With Movement
|
7.0 score on a scale
Interval 4.0 to 9.0
|
6.0 score on a scale
Interval 3.0 to 8.0
|
PRIMARY outcome
Timeframe: Pain scores will be measured 48 hours after surgeryThe VAS score at rest will be measured by a study team investigator using Visual Analog Scale (VAS). Using a scale of 1-10 for documentation with 10 being the worst pain and 0 being no pain
Outcome measures
| Measure |
Liposomal Bupivacaine
n=38 Participants
LB (Liposomal Bupivacaine) group - This group will be receiving 20ml EXPAREL (266mg) and 40ml of 0.125% bupivacaine in total, 30ml on each side.
For the QL block, Shamrock sign consistent of the quadratus lumborum muscle, psoas major muscle, erector spinae muscles and the L4 transverse process will be identified. Under ultrasound guidance with an in-plane technique, the needle will be advanced into the fascial plane between the quadratus lumborum and psoas major muscles. Local anesthetic will be injected into the plane.
liposomal Bupivacaine: 20mL liposomal bupivacaine are injected into the liposomal bupivacaine group
|
Standard Bupivacaine
n=40 Participants
SB (Standard Bupivacaine) group - This group will be receiving 60ml of 0.25% bupivacaine in total, 30ml on each side.
For the QL block, Shamrock sign consistent of the quadratus lumborum muscle, psoas major muscle, erector spinae muscles and the L4 transverse process will be identified. Under ultrasound guidance with an in-plane technique, the needle will be advanced into the fascial plane between the quadratus lumborum and psoas major muscles. Local anesthetic will be injected into the plane.
Bupivacaine Hydrochloride: 40ml of 0.125% bupivacaine hydrochloride are injected into the liposomal bupivacaine group.
60mL of 0.25% bupivacaine hydrochloride are injected into the standard bupivacaine group
|
|---|---|---|
|
VAS Score at 48 Hours at Rest
|
3.0 score on a scale
Interval 1.0 to 6.0
|
2.5 score on a scale
Interval 1.0 to 5.0
|
PRIMARY outcome
Timeframe: Pain scores will be measured 48 hours after surgeryThe VAS score with movement (knee flexion) will be measured by a study team investigator using Visual Analog Scale (VAS). Using a scale of 1-10 for documentation with 10 being the worst pain and 0 being no pain
Outcome measures
| Measure |
Liposomal Bupivacaine
n=38 Participants
LB (Liposomal Bupivacaine) group - This group will be receiving 20ml EXPAREL (266mg) and 40ml of 0.125% bupivacaine in total, 30ml on each side.
For the QL block, Shamrock sign consistent of the quadratus lumborum muscle, psoas major muscle, erector spinae muscles and the L4 transverse process will be identified. Under ultrasound guidance with an in-plane technique, the needle will be advanced into the fascial plane between the quadratus lumborum and psoas major muscles. Local anesthetic will be injected into the plane.
liposomal Bupivacaine: 20mL liposomal bupivacaine are injected into the liposomal bupivacaine group
|
Standard Bupivacaine
n=40 Participants
SB (Standard Bupivacaine) group - This group will be receiving 60ml of 0.25% bupivacaine in total, 30ml on each side.
For the QL block, Shamrock sign consistent of the quadratus lumborum muscle, psoas major muscle, erector spinae muscles and the L4 transverse process will be identified. Under ultrasound guidance with an in-plane technique, the needle will be advanced into the fascial plane between the quadratus lumborum and psoas major muscles. Local anesthetic will be injected into the plane.
Bupivacaine Hydrochloride: 40ml of 0.125% bupivacaine hydrochloride are injected into the liposomal bupivacaine group.
60mL of 0.25% bupivacaine hydrochloride are injected into the standard bupivacaine group
|
|---|---|---|
|
VAS Score at 48 Hours With Movement
|
5.0 score on a scale
Interval 3.0 to 7.0
|
5.0 score on a scale
Interval 3.0 to 6.0
|
PRIMARY outcome
Timeframe: Pain scores will be measured 72 hours after surgeryThe VAS score at rest will be measured by a study team investigator using Visual Analog Scale (VAS). Using a scale of 1-10 for documentation with 10 being the worst pain and 0 being no pain
Outcome measures
| Measure |
Liposomal Bupivacaine
n=38 Participants
LB (Liposomal Bupivacaine) group - This group will be receiving 20ml EXPAREL (266mg) and 40ml of 0.125% bupivacaine in total, 30ml on each side.
For the QL block, Shamrock sign consistent of the quadratus lumborum muscle, psoas major muscle, erector spinae muscles and the L4 transverse process will be identified. Under ultrasound guidance with an in-plane technique, the needle will be advanced into the fascial plane between the quadratus lumborum and psoas major muscles. Local anesthetic will be injected into the plane.
liposomal Bupivacaine: 20mL liposomal bupivacaine are injected into the liposomal bupivacaine group
|
Standard Bupivacaine
n=40 Participants
SB (Standard Bupivacaine) group - This group will be receiving 60ml of 0.25% bupivacaine in total, 30ml on each side.
For the QL block, Shamrock sign consistent of the quadratus lumborum muscle, psoas major muscle, erector spinae muscles and the L4 transverse process will be identified. Under ultrasound guidance with an in-plane technique, the needle will be advanced into the fascial plane between the quadratus lumborum and psoas major muscles. Local anesthetic will be injected into the plane.
Bupivacaine Hydrochloride: 40ml of 0.125% bupivacaine hydrochloride are injected into the liposomal bupivacaine group.
60mL of 0.25% bupivacaine hydrochloride are injected into the standard bupivacaine group
|
|---|---|---|
|
VAS Score at 72 Hours at Rest
|
2.0 score on a scale
Interval 0.0 to 4.0
|
2.0 score on a scale
Interval 0.5 to 4.0
|
PRIMARY outcome
Timeframe: Pain scores will be measured 72 hours after surgeryThe VAS score with movement (knee flexion) will be measured by a study team investigator using Visual Analog Scale (VAS). Using a scale of 1-10 for documentation with 10 being the worst pain and 0 being no pain
Outcome measures
| Measure |
Liposomal Bupivacaine
n=38 Participants
LB (Liposomal Bupivacaine) group - This group will be receiving 20ml EXPAREL (266mg) and 40ml of 0.125% bupivacaine in total, 30ml on each side.
For the QL block, Shamrock sign consistent of the quadratus lumborum muscle, psoas major muscle, erector spinae muscles and the L4 transverse process will be identified. Under ultrasound guidance with an in-plane technique, the needle will be advanced into the fascial plane between the quadratus lumborum and psoas major muscles. Local anesthetic will be injected into the plane.
liposomal Bupivacaine: 20mL liposomal bupivacaine are injected into the liposomal bupivacaine group
|
Standard Bupivacaine
n=40 Participants
SB (Standard Bupivacaine) group - This group will be receiving 60ml of 0.25% bupivacaine in total, 30ml on each side.
For the QL block, Shamrock sign consistent of the quadratus lumborum muscle, psoas major muscle, erector spinae muscles and the L4 transverse process will be identified. Under ultrasound guidance with an in-plane technique, the needle will be advanced into the fascial plane between the quadratus lumborum and psoas major muscles. Local anesthetic will be injected into the plane.
Bupivacaine Hydrochloride: 40ml of 0.125% bupivacaine hydrochloride are injected into the liposomal bupivacaine group.
60mL of 0.25% bupivacaine hydrochloride are injected into the standard bupivacaine group
|
|---|---|---|
|
VAS Score at 72 Hours With Movement
|
4.0 score on a scale
Interval 2.0 to 6.0
|
3.0 score on a scale
Interval 2.0 to 5.0
|
SECONDARY outcome
Timeframe: Opioid consumption will be measured at 1 hour post op. The total amount will be recordedOpioid consumption will be collected by a study team member post operatively for 3 days per protocol time requirements
Outcome measures
| Measure |
Liposomal Bupivacaine
n=38 Participants
LB (Liposomal Bupivacaine) group - This group will be receiving 20ml EXPAREL (266mg) and 40ml of 0.125% bupivacaine in total, 30ml on each side.
For the QL block, Shamrock sign consistent of the quadratus lumborum muscle, psoas major muscle, erector spinae muscles and the L4 transverse process will be identified. Under ultrasound guidance with an in-plane technique, the needle will be advanced into the fascial plane between the quadratus lumborum and psoas major muscles. Local anesthetic will be injected into the plane.
liposomal Bupivacaine: 20mL liposomal bupivacaine are injected into the liposomal bupivacaine group
|
Standard Bupivacaine
n=40 Participants
SB (Standard Bupivacaine) group - This group will be receiving 60ml of 0.25% bupivacaine in total, 30ml on each side.
For the QL block, Shamrock sign consistent of the quadratus lumborum muscle, psoas major muscle, erector spinae muscles and the L4 transverse process will be identified. Under ultrasound guidance with an in-plane technique, the needle will be advanced into the fascial plane between the quadratus lumborum and psoas major muscles. Local anesthetic will be injected into the plane.
Bupivacaine Hydrochloride: 40ml of 0.125% bupivacaine hydrochloride are injected into the liposomal bupivacaine group.
60mL of 0.25% bupivacaine hydrochloride are injected into the standard bupivacaine group
|
|---|---|---|
|
Total Opioid Consumption at 1 Hour
|
8.0 morphine equivalent units
Interval 0.0 to 16.0
|
2.0 morphine equivalent units
Interval 0.0 to 15.0
|
SECONDARY outcome
Timeframe: Opioid consumption will be measured at 24 hour post op. The total amount will be recordedOpioid consumption will be collected by a study team member post operatively for 3 days per protocol time requirements
Outcome measures
| Measure |
Liposomal Bupivacaine
n=38 Participants
LB (Liposomal Bupivacaine) group - This group will be receiving 20ml EXPAREL (266mg) and 40ml of 0.125% bupivacaine in total, 30ml on each side.
For the QL block, Shamrock sign consistent of the quadratus lumborum muscle, psoas major muscle, erector spinae muscles and the L4 transverse process will be identified. Under ultrasound guidance with an in-plane technique, the needle will be advanced into the fascial plane between the quadratus lumborum and psoas major muscles. Local anesthetic will be injected into the plane.
liposomal Bupivacaine: 20mL liposomal bupivacaine are injected into the liposomal bupivacaine group
|
Standard Bupivacaine
n=40 Participants
SB (Standard Bupivacaine) group - This group will be receiving 60ml of 0.25% bupivacaine in total, 30ml on each side.
For the QL block, Shamrock sign consistent of the quadratus lumborum muscle, psoas major muscle, erector spinae muscles and the L4 transverse process will be identified. Under ultrasound guidance with an in-plane technique, the needle will be advanced into the fascial plane between the quadratus lumborum and psoas major muscles. Local anesthetic will be injected into the plane.
Bupivacaine Hydrochloride: 40ml of 0.125% bupivacaine hydrochloride are injected into the liposomal bupivacaine group.
60mL of 0.25% bupivacaine hydrochloride are injected into the standard bupivacaine group
|
|---|---|---|
|
Total Opioid Consumption at 24 Hour
|
54.0 morphine equivalent units
Interval 23.0 to 98.5
|
30.0 morphine equivalent units
Interval 5.0 to 62.0
|
SECONDARY outcome
Timeframe: Opioid consumption will be measured at 48 hour post op. The total amount will be recordedOpioid consumption will be collected by a study team member post operatively for 3 days per protocol time requirements
Outcome measures
| Measure |
Liposomal Bupivacaine
n=38 Participants
LB (Liposomal Bupivacaine) group - This group will be receiving 20ml EXPAREL (266mg) and 40ml of 0.125% bupivacaine in total, 30ml on each side.
For the QL block, Shamrock sign consistent of the quadratus lumborum muscle, psoas major muscle, erector spinae muscles and the L4 transverse process will be identified. Under ultrasound guidance with an in-plane technique, the needle will be advanced into the fascial plane between the quadratus lumborum and psoas major muscles. Local anesthetic will be injected into the plane.
liposomal Bupivacaine: 20mL liposomal bupivacaine are injected into the liposomal bupivacaine group
|
Standard Bupivacaine
n=40 Participants
SB (Standard Bupivacaine) group - This group will be receiving 60ml of 0.25% bupivacaine in total, 30ml on each side.
For the QL block, Shamrock sign consistent of the quadratus lumborum muscle, psoas major muscle, erector spinae muscles and the L4 transverse process will be identified. Under ultrasound guidance with an in-plane technique, the needle will be advanced into the fascial plane between the quadratus lumborum and psoas major muscles. Local anesthetic will be injected into the plane.
Bupivacaine Hydrochloride: 40ml of 0.125% bupivacaine hydrochloride are injected into the liposomal bupivacaine group.
60mL of 0.25% bupivacaine hydrochloride are injected into the standard bupivacaine group
|
|---|---|---|
|
Total Opioid Consumption at 48 Hour
|
43.8 morphine equivalent units
Interval 7.5 to 90.0
|
15.0 morphine equivalent units
Interval 5.5 to 45.0
|
SECONDARY outcome
Timeframe: Opioid consumption will be measured at 72 hour post op. The total amount will be recordedOpioid consumption will be collected by a study team member post operatively for 3 days per protocol time requirements
Outcome measures
| Measure |
Liposomal Bupivacaine
n=38 Participants
LB (Liposomal Bupivacaine) group - This group will be receiving 20ml EXPAREL (266mg) and 40ml of 0.125% bupivacaine in total, 30ml on each side.
For the QL block, Shamrock sign consistent of the quadratus lumborum muscle, psoas major muscle, erector spinae muscles and the L4 transverse process will be identified. Under ultrasound guidance with an in-plane technique, the needle will be advanced into the fascial plane between the quadratus lumborum and psoas major muscles. Local anesthetic will be injected into the plane.
liposomal Bupivacaine: 20mL liposomal bupivacaine are injected into the liposomal bupivacaine group
|
Standard Bupivacaine
n=40 Participants
SB (Standard Bupivacaine) group - This group will be receiving 60ml of 0.25% bupivacaine in total, 30ml on each side.
For the QL block, Shamrock sign consistent of the quadratus lumborum muscle, psoas major muscle, erector spinae muscles and the L4 transverse process will be identified. Under ultrasound guidance with an in-plane technique, the needle will be advanced into the fascial plane between the quadratus lumborum and psoas major muscles. Local anesthetic will be injected into the plane.
Bupivacaine Hydrochloride: 40ml of 0.125% bupivacaine hydrochloride are injected into the liposomal bupivacaine group.
60mL of 0.25% bupivacaine hydrochloride are injected into the standard bupivacaine group
|
|---|---|---|
|
Total Opioid Consumption at 72 Hour
|
17.5 morphine equivalent units
Interval 0.0 to 60.0
|
15.0 morphine equivalent units
Interval 0.0 to 38.8
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Nausea scores will be measured at 1 hour post-op.Nausea scores will be collected by a study team member post operatively up to 3 days per protocol. Nausea will be recorded as none, mild, moderate, or severe
Outcome measures
| Measure |
Liposomal Bupivacaine
n=38 Participants
LB (Liposomal Bupivacaine) group - This group will be receiving 20ml EXPAREL (266mg) and 40ml of 0.125% bupivacaine in total, 30ml on each side.
For the QL block, Shamrock sign consistent of the quadratus lumborum muscle, psoas major muscle, erector spinae muscles and the L4 transverse process will be identified. Under ultrasound guidance with an in-plane technique, the needle will be advanced into the fascial plane between the quadratus lumborum and psoas major muscles. Local anesthetic will be injected into the plane.
liposomal Bupivacaine: 20mL liposomal bupivacaine are injected into the liposomal bupivacaine group
|
Standard Bupivacaine
n=40 Participants
SB (Standard Bupivacaine) group - This group will be receiving 60ml of 0.25% bupivacaine in total, 30ml on each side.
For the QL block, Shamrock sign consistent of the quadratus lumborum muscle, psoas major muscle, erector spinae muscles and the L4 transverse process will be identified. Under ultrasound guidance with an in-plane technique, the needle will be advanced into the fascial plane between the quadratus lumborum and psoas major muscles. Local anesthetic will be injected into the plane.
Bupivacaine Hydrochloride: 40ml of 0.125% bupivacaine hydrochloride are injected into the liposomal bupivacaine group.
60mL of 0.25% bupivacaine hydrochloride are injected into the standard bupivacaine group
|
|---|---|---|
|
Nausea Scores (None) at 1 Hour
|
34 Participants
|
38 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Nausea scores will be measured at 1 hour post-op.Nausea scores will be collected by a study team member post operatively up to 3 days per protocol. Nausea will be recorded as none, mild, moderate, or severe
Outcome measures
| Measure |
Liposomal Bupivacaine
n=38 Participants
LB (Liposomal Bupivacaine) group - This group will be receiving 20ml EXPAREL (266mg) and 40ml of 0.125% bupivacaine in total, 30ml on each side.
For the QL block, Shamrock sign consistent of the quadratus lumborum muscle, psoas major muscle, erector spinae muscles and the L4 transverse process will be identified. Under ultrasound guidance with an in-plane technique, the needle will be advanced into the fascial plane between the quadratus lumborum and psoas major muscles. Local anesthetic will be injected into the plane.
liposomal Bupivacaine: 20mL liposomal bupivacaine are injected into the liposomal bupivacaine group
|
Standard Bupivacaine
n=40 Participants
SB (Standard Bupivacaine) group - This group will be receiving 60ml of 0.25% bupivacaine in total, 30ml on each side.
For the QL block, Shamrock sign consistent of the quadratus lumborum muscle, psoas major muscle, erector spinae muscles and the L4 transverse process will be identified. Under ultrasound guidance with an in-plane technique, the needle will be advanced into the fascial plane between the quadratus lumborum and psoas major muscles. Local anesthetic will be injected into the plane.
Bupivacaine Hydrochloride: 40ml of 0.125% bupivacaine hydrochloride are injected into the liposomal bupivacaine group.
60mL of 0.25% bupivacaine hydrochloride are injected into the standard bupivacaine group
|
|---|---|---|
|
Nausea Scores (Mild) at 1 Hour
|
4 Participants
|
1 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Nausea scores will be measured at 1 hour post-op.Nausea scores will be collected by a study team member post operatively up to 3 days per protocol. Nausea will be recorded as none, mild, moderate, or severe
Outcome measures
| Measure |
Liposomal Bupivacaine
n=38 Participants
LB (Liposomal Bupivacaine) group - This group will be receiving 20ml EXPAREL (266mg) and 40ml of 0.125% bupivacaine in total, 30ml on each side.
For the QL block, Shamrock sign consistent of the quadratus lumborum muscle, psoas major muscle, erector spinae muscles and the L4 transverse process will be identified. Under ultrasound guidance with an in-plane technique, the needle will be advanced into the fascial plane between the quadratus lumborum and psoas major muscles. Local anesthetic will be injected into the plane.
liposomal Bupivacaine: 20mL liposomal bupivacaine are injected into the liposomal bupivacaine group
|
Standard Bupivacaine
n=40 Participants
SB (Standard Bupivacaine) group - This group will be receiving 60ml of 0.25% bupivacaine in total, 30ml on each side.
For the QL block, Shamrock sign consistent of the quadratus lumborum muscle, psoas major muscle, erector spinae muscles and the L4 transverse process will be identified. Under ultrasound guidance with an in-plane technique, the needle will be advanced into the fascial plane between the quadratus lumborum and psoas major muscles. Local anesthetic will be injected into the plane.
Bupivacaine Hydrochloride: 40ml of 0.125% bupivacaine hydrochloride are injected into the liposomal bupivacaine group.
60mL of 0.25% bupivacaine hydrochloride are injected into the standard bupivacaine group
|
|---|---|---|
|
Nausea Scores (Moderate) at 1 Hour
|
0 Participants
|
1 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Nausea scores will be measured at 1 hour post-op.Nausea scores will be collected by a study team member post operatively up to 3 days per protocol. Nausea will be recorded as none, mild, moderate, or severe
Outcome measures
| Measure |
Liposomal Bupivacaine
n=38 Participants
LB (Liposomal Bupivacaine) group - This group will be receiving 20ml EXPAREL (266mg) and 40ml of 0.125% bupivacaine in total, 30ml on each side.
For the QL block, Shamrock sign consistent of the quadratus lumborum muscle, psoas major muscle, erector spinae muscles and the L4 transverse process will be identified. Under ultrasound guidance with an in-plane technique, the needle will be advanced into the fascial plane between the quadratus lumborum and psoas major muscles. Local anesthetic will be injected into the plane.
liposomal Bupivacaine: 20mL liposomal bupivacaine are injected into the liposomal bupivacaine group
|
Standard Bupivacaine
n=40 Participants
SB (Standard Bupivacaine) group - This group will be receiving 60ml of 0.25% bupivacaine in total, 30ml on each side.
For the QL block, Shamrock sign consistent of the quadratus lumborum muscle, psoas major muscle, erector spinae muscles and the L4 transverse process will be identified. Under ultrasound guidance with an in-plane technique, the needle will be advanced into the fascial plane between the quadratus lumborum and psoas major muscles. Local anesthetic will be injected into the plane.
Bupivacaine Hydrochloride: 40ml of 0.125% bupivacaine hydrochloride are injected into the liposomal bupivacaine group.
60mL of 0.25% bupivacaine hydrochloride are injected into the standard bupivacaine group
|
|---|---|---|
|
Nausea Scores (Severe) at 1 Hour
|
0 Participants
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Nausea scores will be measured at 24 hours post-op.Nausea scores will be collected by a study team member post operatively up to 3 days per protocol. Nausea will be recorded as none, mild, moderate, or severe
Outcome measures
| Measure |
Liposomal Bupivacaine
n=38 Participants
LB (Liposomal Bupivacaine) group - This group will be receiving 20ml EXPAREL (266mg) and 40ml of 0.125% bupivacaine in total, 30ml on each side.
For the QL block, Shamrock sign consistent of the quadratus lumborum muscle, psoas major muscle, erector spinae muscles and the L4 transverse process will be identified. Under ultrasound guidance with an in-plane technique, the needle will be advanced into the fascial plane between the quadratus lumborum and psoas major muscles. Local anesthetic will be injected into the plane.
liposomal Bupivacaine: 20mL liposomal bupivacaine are injected into the liposomal bupivacaine group
|
Standard Bupivacaine
n=40 Participants
SB (Standard Bupivacaine) group - This group will be receiving 60ml of 0.25% bupivacaine in total, 30ml on each side.
For the QL block, Shamrock sign consistent of the quadratus lumborum muscle, psoas major muscle, erector spinae muscles and the L4 transverse process will be identified. Under ultrasound guidance with an in-plane technique, the needle will be advanced into the fascial plane between the quadratus lumborum and psoas major muscles. Local anesthetic will be injected into the plane.
Bupivacaine Hydrochloride: 40ml of 0.125% bupivacaine hydrochloride are injected into the liposomal bupivacaine group.
60mL of 0.25% bupivacaine hydrochloride are injected into the standard bupivacaine group
|
|---|---|---|
|
Nausea Scores (None) at 24 Hours
|
26 Participants
|
27 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Nausea scores will be measured at 24 hours post-op.Nausea scores will be collected by a study team member post operatively up to 3 days per protocol. Nausea will be recorded as none, mild, moderate, or severe
Outcome measures
| Measure |
Liposomal Bupivacaine
n=38 Participants
LB (Liposomal Bupivacaine) group - This group will be receiving 20ml EXPAREL (266mg) and 40ml of 0.125% bupivacaine in total, 30ml on each side.
For the QL block, Shamrock sign consistent of the quadratus lumborum muscle, psoas major muscle, erector spinae muscles and the L4 transverse process will be identified. Under ultrasound guidance with an in-plane technique, the needle will be advanced into the fascial plane between the quadratus lumborum and psoas major muscles. Local anesthetic will be injected into the plane.
liposomal Bupivacaine: 20mL liposomal bupivacaine are injected into the liposomal bupivacaine group
|
Standard Bupivacaine
n=40 Participants
SB (Standard Bupivacaine) group - This group will be receiving 60ml of 0.25% bupivacaine in total, 30ml on each side.
For the QL block, Shamrock sign consistent of the quadratus lumborum muscle, psoas major muscle, erector spinae muscles and the L4 transverse process will be identified. Under ultrasound guidance with an in-plane technique, the needle will be advanced into the fascial plane between the quadratus lumborum and psoas major muscles. Local anesthetic will be injected into the plane.
Bupivacaine Hydrochloride: 40ml of 0.125% bupivacaine hydrochloride are injected into the liposomal bupivacaine group.
60mL of 0.25% bupivacaine hydrochloride are injected into the standard bupivacaine group
|
|---|---|---|
|
Nausea Scores (Mild) at 24 Hours
|
5 Participants
|
9 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Nausea scores will be measured at 24 hours post-op.Nausea scores will be collected by a study team member post operatively up to 3 days per protocol. Nausea will be recorded as none, mild, moderate, or severe
Outcome measures
| Measure |
Liposomal Bupivacaine
n=38 Participants
LB (Liposomal Bupivacaine) group - This group will be receiving 20ml EXPAREL (266mg) and 40ml of 0.125% bupivacaine in total, 30ml on each side.
For the QL block, Shamrock sign consistent of the quadratus lumborum muscle, psoas major muscle, erector spinae muscles and the L4 transverse process will be identified. Under ultrasound guidance with an in-plane technique, the needle will be advanced into the fascial plane between the quadratus lumborum and psoas major muscles. Local anesthetic will be injected into the plane.
liposomal Bupivacaine: 20mL liposomal bupivacaine are injected into the liposomal bupivacaine group
|
Standard Bupivacaine
n=40 Participants
SB (Standard Bupivacaine) group - This group will be receiving 60ml of 0.25% bupivacaine in total, 30ml on each side.
For the QL block, Shamrock sign consistent of the quadratus lumborum muscle, psoas major muscle, erector spinae muscles and the L4 transverse process will be identified. Under ultrasound guidance with an in-plane technique, the needle will be advanced into the fascial plane between the quadratus lumborum and psoas major muscles. Local anesthetic will be injected into the plane.
Bupivacaine Hydrochloride: 40ml of 0.125% bupivacaine hydrochloride are injected into the liposomal bupivacaine group.
60mL of 0.25% bupivacaine hydrochloride are injected into the standard bupivacaine group
|
|---|---|---|
|
Nausea Scores (Moderate) at 24 Hours
|
2 Participants
|
3 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Nausea scores will be measured at 24 hours post-op.Nausea scores will be collected by a study team member post operatively up to 3 days per protocol. Nausea will be recorded as none, mild, moderate, or severe
Outcome measures
| Measure |
Liposomal Bupivacaine
n=38 Participants
LB (Liposomal Bupivacaine) group - This group will be receiving 20ml EXPAREL (266mg) and 40ml of 0.125% bupivacaine in total, 30ml on each side.
For the QL block, Shamrock sign consistent of the quadratus lumborum muscle, psoas major muscle, erector spinae muscles and the L4 transverse process will be identified. Under ultrasound guidance with an in-plane technique, the needle will be advanced into the fascial plane between the quadratus lumborum and psoas major muscles. Local anesthetic will be injected into the plane.
liposomal Bupivacaine: 20mL liposomal bupivacaine are injected into the liposomal bupivacaine group
|
Standard Bupivacaine
n=40 Participants
SB (Standard Bupivacaine) group - This group will be receiving 60ml of 0.25% bupivacaine in total, 30ml on each side.
For the QL block, Shamrock sign consistent of the quadratus lumborum muscle, psoas major muscle, erector spinae muscles and the L4 transverse process will be identified. Under ultrasound guidance with an in-plane technique, the needle will be advanced into the fascial plane between the quadratus lumborum and psoas major muscles. Local anesthetic will be injected into the plane.
Bupivacaine Hydrochloride: 40ml of 0.125% bupivacaine hydrochloride are injected into the liposomal bupivacaine group.
60mL of 0.25% bupivacaine hydrochloride are injected into the standard bupivacaine group
|
|---|---|---|
|
Nausea Scores (Severe) at 24 Hours
|
2 Participants
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Nausea scores will be measured at 48 hours post-op.Nausea scores will be collected by a study team member post operatively up to 3 days per protocol. Nausea will be recorded as none, mild, moderate, or severe
Outcome measures
| Measure |
Liposomal Bupivacaine
n=38 Participants
LB (Liposomal Bupivacaine) group - This group will be receiving 20ml EXPAREL (266mg) and 40ml of 0.125% bupivacaine in total, 30ml on each side.
For the QL block, Shamrock sign consistent of the quadratus lumborum muscle, psoas major muscle, erector spinae muscles and the L4 transverse process will be identified. Under ultrasound guidance with an in-plane technique, the needle will be advanced into the fascial plane between the quadratus lumborum and psoas major muscles. Local anesthetic will be injected into the plane.
liposomal Bupivacaine: 20mL liposomal bupivacaine are injected into the liposomal bupivacaine group
|
Standard Bupivacaine
n=40 Participants
SB (Standard Bupivacaine) group - This group will be receiving 60ml of 0.25% bupivacaine in total, 30ml on each side.
For the QL block, Shamrock sign consistent of the quadratus lumborum muscle, psoas major muscle, erector spinae muscles and the L4 transverse process will be identified. Under ultrasound guidance with an in-plane technique, the needle will be advanced into the fascial plane between the quadratus lumborum and psoas major muscles. Local anesthetic will be injected into the plane.
Bupivacaine Hydrochloride: 40ml of 0.125% bupivacaine hydrochloride are injected into the liposomal bupivacaine group.
60mL of 0.25% bupivacaine hydrochloride are injected into the standard bupivacaine group
|
|---|---|---|
|
Nausea Scores (None) at 48 Hours
|
25 Participants
|
28 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Nausea scores will be measured at 48 hours post-op.Nausea scores will be collected by a study team member post operatively up to 3 days per protocol. Nausea will be recorded as none, mild, moderate, or severe
Outcome measures
| Measure |
Liposomal Bupivacaine
n=38 Participants
LB (Liposomal Bupivacaine) group - This group will be receiving 20ml EXPAREL (266mg) and 40ml of 0.125% bupivacaine in total, 30ml on each side.
For the QL block, Shamrock sign consistent of the quadratus lumborum muscle, psoas major muscle, erector spinae muscles and the L4 transverse process will be identified. Under ultrasound guidance with an in-plane technique, the needle will be advanced into the fascial plane between the quadratus lumborum and psoas major muscles. Local anesthetic will be injected into the plane.
liposomal Bupivacaine: 20mL liposomal bupivacaine are injected into the liposomal bupivacaine group
|
Standard Bupivacaine
n=40 Participants
SB (Standard Bupivacaine) group - This group will be receiving 60ml of 0.25% bupivacaine in total, 30ml on each side.
For the QL block, Shamrock sign consistent of the quadratus lumborum muscle, psoas major muscle, erector spinae muscles and the L4 transverse process will be identified. Under ultrasound guidance with an in-plane technique, the needle will be advanced into the fascial plane between the quadratus lumborum and psoas major muscles. Local anesthetic will be injected into the plane.
Bupivacaine Hydrochloride: 40ml of 0.125% bupivacaine hydrochloride are injected into the liposomal bupivacaine group.
60mL of 0.25% bupivacaine hydrochloride are injected into the standard bupivacaine group
|
|---|---|---|
|
Nausea Scores (Mild) at 48 Hours
|
5 Participants
|
9 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Nausea scores will be measured at 48 hours post-op.Nausea scores will be collected by a study team member post operatively up to 3 days per protocol. Nausea will be recorded as none, mild, moderate, or severe
Outcome measures
| Measure |
Liposomal Bupivacaine
n=38 Participants
LB (Liposomal Bupivacaine) group - This group will be receiving 20ml EXPAREL (266mg) and 40ml of 0.125% bupivacaine in total, 30ml on each side.
For the QL block, Shamrock sign consistent of the quadratus lumborum muscle, psoas major muscle, erector spinae muscles and the L4 transverse process will be identified. Under ultrasound guidance with an in-plane technique, the needle will be advanced into the fascial plane between the quadratus lumborum and psoas major muscles. Local anesthetic will be injected into the plane.
liposomal Bupivacaine: 20mL liposomal bupivacaine are injected into the liposomal bupivacaine group
|
Standard Bupivacaine
n=40 Participants
SB (Standard Bupivacaine) group - This group will be receiving 60ml of 0.25% bupivacaine in total, 30ml on each side.
For the QL block, Shamrock sign consistent of the quadratus lumborum muscle, psoas major muscle, erector spinae muscles and the L4 transverse process will be identified. Under ultrasound guidance with an in-plane technique, the needle will be advanced into the fascial plane between the quadratus lumborum and psoas major muscles. Local anesthetic will be injected into the plane.
Bupivacaine Hydrochloride: 40ml of 0.125% bupivacaine hydrochloride are injected into the liposomal bupivacaine group.
60mL of 0.25% bupivacaine hydrochloride are injected into the standard bupivacaine group
|
|---|---|---|
|
Nausea Scores (Moderate) at 48 Hours
|
2 Participants
|
3 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Nausea scores will be measured at 48 hours post-op.Nausea scores will be collected by a study team member post operatively up to 3 days per protocol. Nausea will be recorded as none, mild, moderate, or severe
Outcome measures
| Measure |
Liposomal Bupivacaine
n=38 Participants
LB (Liposomal Bupivacaine) group - This group will be receiving 20ml EXPAREL (266mg) and 40ml of 0.125% bupivacaine in total, 30ml on each side.
For the QL block, Shamrock sign consistent of the quadratus lumborum muscle, psoas major muscle, erector spinae muscles and the L4 transverse process will be identified. Under ultrasound guidance with an in-plane technique, the needle will be advanced into the fascial plane between the quadratus lumborum and psoas major muscles. Local anesthetic will be injected into the plane.
liposomal Bupivacaine: 20mL liposomal bupivacaine are injected into the liposomal bupivacaine group
|
Standard Bupivacaine
n=40 Participants
SB (Standard Bupivacaine) group - This group will be receiving 60ml of 0.25% bupivacaine in total, 30ml on each side.
For the QL block, Shamrock sign consistent of the quadratus lumborum muscle, psoas major muscle, erector spinae muscles and the L4 transverse process will be identified. Under ultrasound guidance with an in-plane technique, the needle will be advanced into the fascial plane between the quadratus lumborum and psoas major muscles. Local anesthetic will be injected into the plane.
Bupivacaine Hydrochloride: 40ml of 0.125% bupivacaine hydrochloride are injected into the liposomal bupivacaine group.
60mL of 0.25% bupivacaine hydrochloride are injected into the standard bupivacaine group
|
|---|---|---|
|
Nausea Scores (Severe) at 48 Hours
|
6 Participants
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Nausea scores will be measured at 72 hours post-op.Nausea scores will be collected by a study team member post operatively up to 3 days per protocol. Nausea will be recorded as none, mild, moderate, or severe
Outcome measures
| Measure |
Liposomal Bupivacaine
n=38 Participants
LB (Liposomal Bupivacaine) group - This group will be receiving 20ml EXPAREL (266mg) and 40ml of 0.125% bupivacaine in total, 30ml on each side.
For the QL block, Shamrock sign consistent of the quadratus lumborum muscle, psoas major muscle, erector spinae muscles and the L4 transverse process will be identified. Under ultrasound guidance with an in-plane technique, the needle will be advanced into the fascial plane between the quadratus lumborum and psoas major muscles. Local anesthetic will be injected into the plane.
liposomal Bupivacaine: 20mL liposomal bupivacaine are injected into the liposomal bupivacaine group
|
Standard Bupivacaine
n=40 Participants
SB (Standard Bupivacaine) group - This group will be receiving 60ml of 0.25% bupivacaine in total, 30ml on each side.
For the QL block, Shamrock sign consistent of the quadratus lumborum muscle, psoas major muscle, erector spinae muscles and the L4 transverse process will be identified. Under ultrasound guidance with an in-plane technique, the needle will be advanced into the fascial plane between the quadratus lumborum and psoas major muscles. Local anesthetic will be injected into the plane.
Bupivacaine Hydrochloride: 40ml of 0.125% bupivacaine hydrochloride are injected into the liposomal bupivacaine group.
60mL of 0.25% bupivacaine hydrochloride are injected into the standard bupivacaine group
|
|---|---|---|
|
Nausea Scores (None) at 72 Hours
|
26 Participants
|
29 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Nausea scores will be measured at 72 hours post-op.Nausea scores will be collected by a study team member post operatively up to 3 days per protocol. Nausea will be recorded as none, mild, moderate, or severe
Outcome measures
| Measure |
Liposomal Bupivacaine
n=38 Participants
LB (Liposomal Bupivacaine) group - This group will be receiving 20ml EXPAREL (266mg) and 40ml of 0.125% bupivacaine in total, 30ml on each side.
For the QL block, Shamrock sign consistent of the quadratus lumborum muscle, psoas major muscle, erector spinae muscles and the L4 transverse process will be identified. Under ultrasound guidance with an in-plane technique, the needle will be advanced into the fascial plane between the quadratus lumborum and psoas major muscles. Local anesthetic will be injected into the plane.
liposomal Bupivacaine: 20mL liposomal bupivacaine are injected into the liposomal bupivacaine group
|
Standard Bupivacaine
n=40 Participants
SB (Standard Bupivacaine) group - This group will be receiving 60ml of 0.25% bupivacaine in total, 30ml on each side.
For the QL block, Shamrock sign consistent of the quadratus lumborum muscle, psoas major muscle, erector spinae muscles and the L4 transverse process will be identified. Under ultrasound guidance with an in-plane technique, the needle will be advanced into the fascial plane between the quadratus lumborum and psoas major muscles. Local anesthetic will be injected into the plane.
Bupivacaine Hydrochloride: 40ml of 0.125% bupivacaine hydrochloride are injected into the liposomal bupivacaine group.
60mL of 0.25% bupivacaine hydrochloride are injected into the standard bupivacaine group
|
|---|---|---|
|
Nausea Scores (Mild) at 72 Hours
|
7 Participants
|
8 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Nausea scores will be measured at 72 hours post-op.Nausea scores will be collected by a study team member post operatively up to 3 days per protocol. Nausea will be recorded as none, mild, moderate, or severe
Outcome measures
| Measure |
Liposomal Bupivacaine
n=38 Participants
LB (Liposomal Bupivacaine) group - This group will be receiving 20ml EXPAREL (266mg) and 40ml of 0.125% bupivacaine in total, 30ml on each side.
For the QL block, Shamrock sign consistent of the quadratus lumborum muscle, psoas major muscle, erector spinae muscles and the L4 transverse process will be identified. Under ultrasound guidance with an in-plane technique, the needle will be advanced into the fascial plane between the quadratus lumborum and psoas major muscles. Local anesthetic will be injected into the plane.
liposomal Bupivacaine: 20mL liposomal bupivacaine are injected into the liposomal bupivacaine group
|
Standard Bupivacaine
n=40 Participants
SB (Standard Bupivacaine) group - This group will be receiving 60ml of 0.25% bupivacaine in total, 30ml on each side.
For the QL block, Shamrock sign consistent of the quadratus lumborum muscle, psoas major muscle, erector spinae muscles and the L4 transverse process will be identified. Under ultrasound guidance with an in-plane technique, the needle will be advanced into the fascial plane between the quadratus lumborum and psoas major muscles. Local anesthetic will be injected into the plane.
Bupivacaine Hydrochloride: 40ml of 0.125% bupivacaine hydrochloride are injected into the liposomal bupivacaine group.
60mL of 0.25% bupivacaine hydrochloride are injected into the standard bupivacaine group
|
|---|---|---|
|
Nausea Scores (Moderate) at 72 Hours
|
4 Participants
|
3 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Nausea scores will be measured at 72 hours post-op.Nausea scores will be collected by a study team member post operatively up to 3 days per protocol. Nausea will be recorded as none, mild, moderate, or severe
Outcome measures
| Measure |
Liposomal Bupivacaine
n=38 Participants
LB (Liposomal Bupivacaine) group - This group will be receiving 20ml EXPAREL (266mg) and 40ml of 0.125% bupivacaine in total, 30ml on each side.
For the QL block, Shamrock sign consistent of the quadratus lumborum muscle, psoas major muscle, erector spinae muscles and the L4 transverse process will be identified. Under ultrasound guidance with an in-plane technique, the needle will be advanced into the fascial plane between the quadratus lumborum and psoas major muscles. Local anesthetic will be injected into the plane.
liposomal Bupivacaine: 20mL liposomal bupivacaine are injected into the liposomal bupivacaine group
|
Standard Bupivacaine
n=40 Participants
SB (Standard Bupivacaine) group - This group will be receiving 60ml of 0.25% bupivacaine in total, 30ml on each side.
For the QL block, Shamrock sign consistent of the quadratus lumborum muscle, psoas major muscle, erector spinae muscles and the L4 transverse process will be identified. Under ultrasound guidance with an in-plane technique, the needle will be advanced into the fascial plane between the quadratus lumborum and psoas major muscles. Local anesthetic will be injected into the plane.
Bupivacaine Hydrochloride: 40ml of 0.125% bupivacaine hydrochloride are injected into the liposomal bupivacaine group.
60mL of 0.25% bupivacaine hydrochloride are injected into the standard bupivacaine group
|
|---|---|---|
|
Nausea Scores (Severe) at 72 Hours
|
1 Participants
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Sedation scores will be documented at 1 hour post-op.Sedation scores will be collected by a study team member post operatively up to 3 days per protocol requirements. Determining if patient is awake, alert, quietly awake, asleep and arousable, or deep sleep.
Outcome measures
| Measure |
Liposomal Bupivacaine
n=38 Participants
LB (Liposomal Bupivacaine) group - This group will be receiving 20ml EXPAREL (266mg) and 40ml of 0.125% bupivacaine in total, 30ml on each side.
For the QL block, Shamrock sign consistent of the quadratus lumborum muscle, psoas major muscle, erector spinae muscles and the L4 transverse process will be identified. Under ultrasound guidance with an in-plane technique, the needle will be advanced into the fascial plane between the quadratus lumborum and psoas major muscles. Local anesthetic will be injected into the plane.
liposomal Bupivacaine: 20mL liposomal bupivacaine are injected into the liposomal bupivacaine group
|
Standard Bupivacaine
n=40 Participants
SB (Standard Bupivacaine) group - This group will be receiving 60ml of 0.25% bupivacaine in total, 30ml on each side.
For the QL block, Shamrock sign consistent of the quadratus lumborum muscle, psoas major muscle, erector spinae muscles and the L4 transverse process will be identified. Under ultrasound guidance with an in-plane technique, the needle will be advanced into the fascial plane between the quadratus lumborum and psoas major muscles. Local anesthetic will be injected into the plane.
Bupivacaine Hydrochloride: 40ml of 0.125% bupivacaine hydrochloride are injected into the liposomal bupivacaine group.
60mL of 0.25% bupivacaine hydrochloride are injected into the standard bupivacaine group
|
|---|---|---|
|
Sedation Scores (Awake/Alert) at 1 Hour
|
6 Participants
|
8 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Sedation scores will be documented at 1 hour post-op.Sedation scores will be collected by a study team member post operatively up to 3 days per protocol requirements. Determining if patient is awake, alert, quietly awake, asleep and arousable, or deep sleep.
Outcome measures
| Measure |
Liposomal Bupivacaine
n=38 Participants
LB (Liposomal Bupivacaine) group - This group will be receiving 20ml EXPAREL (266mg) and 40ml of 0.125% bupivacaine in total, 30ml on each side.
For the QL block, Shamrock sign consistent of the quadratus lumborum muscle, psoas major muscle, erector spinae muscles and the L4 transverse process will be identified. Under ultrasound guidance with an in-plane technique, the needle will be advanced into the fascial plane between the quadratus lumborum and psoas major muscles. Local anesthetic will be injected into the plane.
liposomal Bupivacaine: 20mL liposomal bupivacaine are injected into the liposomal bupivacaine group
|
Standard Bupivacaine
n=40 Participants
SB (Standard Bupivacaine) group - This group will be receiving 60ml of 0.25% bupivacaine in total, 30ml on each side.
For the QL block, Shamrock sign consistent of the quadratus lumborum muscle, psoas major muscle, erector spinae muscles and the L4 transverse process will be identified. Under ultrasound guidance with an in-plane technique, the needle will be advanced into the fascial plane between the quadratus lumborum and psoas major muscles. Local anesthetic will be injected into the plane.
Bupivacaine Hydrochloride: 40ml of 0.125% bupivacaine hydrochloride are injected into the liposomal bupivacaine group.
60mL of 0.25% bupivacaine hydrochloride are injected into the standard bupivacaine group
|
|---|---|---|
|
Sedation Scores (Quietly Awake) at 1 Hour
|
26 Participants
|
15 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Sedation scores will be documented at 1 hour post-op.Sedation scores will be collected by a study team member post operatively up to 3 days per protocol requirements. Determining if patient is awake, alert, quietly awake, asleep and arousable, or deep sleep.
Outcome measures
| Measure |
Liposomal Bupivacaine
n=38 Participants
LB (Liposomal Bupivacaine) group - This group will be receiving 20ml EXPAREL (266mg) and 40ml of 0.125% bupivacaine in total, 30ml on each side.
For the QL block, Shamrock sign consistent of the quadratus lumborum muscle, psoas major muscle, erector spinae muscles and the L4 transverse process will be identified. Under ultrasound guidance with an in-plane technique, the needle will be advanced into the fascial plane between the quadratus lumborum and psoas major muscles. Local anesthetic will be injected into the plane.
liposomal Bupivacaine: 20mL liposomal bupivacaine are injected into the liposomal bupivacaine group
|
Standard Bupivacaine
n=40 Participants
SB (Standard Bupivacaine) group - This group will be receiving 60ml of 0.25% bupivacaine in total, 30ml on each side.
For the QL block, Shamrock sign consistent of the quadratus lumborum muscle, psoas major muscle, erector spinae muscles and the L4 transverse process will be identified. Under ultrasound guidance with an in-plane technique, the needle will be advanced into the fascial plane between the quadratus lumborum and psoas major muscles. Local anesthetic will be injected into the plane.
Bupivacaine Hydrochloride: 40ml of 0.125% bupivacaine hydrochloride are injected into the liposomal bupivacaine group.
60mL of 0.25% bupivacaine hydrochloride are injected into the standard bupivacaine group
|
|---|---|---|
|
Sedation Scores (Asleep/Arousable) at 1 Hour
|
19 Participants
|
22 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Sedation scores will be documented at 1 hour post-op.Sedation scores will be collected by a study team member post operatively up to 3 days per protocol requirements. Determining if patient is awake, alert, quietly awake, asleep and arousable, or deep sleep.
Outcome measures
| Measure |
Liposomal Bupivacaine
n=38 Participants
LB (Liposomal Bupivacaine) group - This group will be receiving 20ml EXPAREL (266mg) and 40ml of 0.125% bupivacaine in total, 30ml on each side.
For the QL block, Shamrock sign consistent of the quadratus lumborum muscle, psoas major muscle, erector spinae muscles and the L4 transverse process will be identified. Under ultrasound guidance with an in-plane technique, the needle will be advanced into the fascial plane between the quadratus lumborum and psoas major muscles. Local anesthetic will be injected into the plane.
liposomal Bupivacaine: 20mL liposomal bupivacaine are injected into the liposomal bupivacaine group
|
Standard Bupivacaine
n=40 Participants
SB (Standard Bupivacaine) group - This group will be receiving 60ml of 0.25% bupivacaine in total, 30ml on each side.
For the QL block, Shamrock sign consistent of the quadratus lumborum muscle, psoas major muscle, erector spinae muscles and the L4 transverse process will be identified. Under ultrasound guidance with an in-plane technique, the needle will be advanced into the fascial plane between the quadratus lumborum and psoas major muscles. Local anesthetic will be injected into the plane.
Bupivacaine Hydrochloride: 40ml of 0.125% bupivacaine hydrochloride are injected into the liposomal bupivacaine group.
60mL of 0.25% bupivacaine hydrochloride are injected into the standard bupivacaine group
|
|---|---|---|
|
Sedation Scores (Deep Sleep) at 1 Hour
|
3 Participants
|
4 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Sedation scores will be documented at 24 hours post-op.Sedation scores will be collected by a study team member post operatively up to 3 days per protocol requirements. Determining if patient is awake, alert, quietly awake, asleep and arousable, or deep sleep.
Outcome measures
| Measure |
Liposomal Bupivacaine
n=38 Participants
LB (Liposomal Bupivacaine) group - This group will be receiving 20ml EXPAREL (266mg) and 40ml of 0.125% bupivacaine in total, 30ml on each side.
For the QL block, Shamrock sign consistent of the quadratus lumborum muscle, psoas major muscle, erector spinae muscles and the L4 transverse process will be identified. Under ultrasound guidance with an in-plane technique, the needle will be advanced into the fascial plane between the quadratus lumborum and psoas major muscles. Local anesthetic will be injected into the plane.
liposomal Bupivacaine: 20mL liposomal bupivacaine are injected into the liposomal bupivacaine group
|
Standard Bupivacaine
n=40 Participants
SB (Standard Bupivacaine) group - This group will be receiving 60ml of 0.25% bupivacaine in total, 30ml on each side.
For the QL block, Shamrock sign consistent of the quadratus lumborum muscle, psoas major muscle, erector spinae muscles and the L4 transverse process will be identified. Under ultrasound guidance with an in-plane technique, the needle will be advanced into the fascial plane between the quadratus lumborum and psoas major muscles. Local anesthetic will be injected into the plane.
Bupivacaine Hydrochloride: 40ml of 0.125% bupivacaine hydrochloride are injected into the liposomal bupivacaine group.
60mL of 0.25% bupivacaine hydrochloride are injected into the standard bupivacaine group
|
|---|---|---|
|
Sedation Scores (Awake/Alert) at 24 Hours
|
36 Participants
|
36 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Sedation scores will be documented at 48 hours post-op.Sedation scores will be collected by a study team member post operatively up to 3 days per protocol requirements. Determining if patient is awake, alert, quietly awake, asleep and arousable, or deep sleep.
Outcome measures
| Measure |
Liposomal Bupivacaine
n=38 Participants
LB (Liposomal Bupivacaine) group - This group will be receiving 20ml EXPAREL (266mg) and 40ml of 0.125% bupivacaine in total, 30ml on each side.
For the QL block, Shamrock sign consistent of the quadratus lumborum muscle, psoas major muscle, erector spinae muscles and the L4 transverse process will be identified. Under ultrasound guidance with an in-plane technique, the needle will be advanced into the fascial plane between the quadratus lumborum and psoas major muscles. Local anesthetic will be injected into the plane.
liposomal Bupivacaine: 20mL liposomal bupivacaine are injected into the liposomal bupivacaine group
|
Standard Bupivacaine
n=40 Participants
SB (Standard Bupivacaine) group - This group will be receiving 60ml of 0.25% bupivacaine in total, 30ml on each side.
For the QL block, Shamrock sign consistent of the quadratus lumborum muscle, psoas major muscle, erector spinae muscles and the L4 transverse process will be identified. Under ultrasound guidance with an in-plane technique, the needle will be advanced into the fascial plane between the quadratus lumborum and psoas major muscles. Local anesthetic will be injected into the plane.
Bupivacaine Hydrochloride: 40ml of 0.125% bupivacaine hydrochloride are injected into the liposomal bupivacaine group.
60mL of 0.25% bupivacaine hydrochloride are injected into the standard bupivacaine group
|
|---|---|---|
|
Sedation Scores (Awake/Alert) at 48 Hours
|
35 Participants
|
38 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Sedation scores will be documented at 72 hours post-op.Sedation scores will be collected by a study team member post operatively up to 3 days per protocol requirements. Determining if patient is awake, alert, quietly awake, asleep and arousable, or deep sleep.
Outcome measures
| Measure |
Liposomal Bupivacaine
n=38 Participants
LB (Liposomal Bupivacaine) group - This group will be receiving 20ml EXPAREL (266mg) and 40ml of 0.125% bupivacaine in total, 30ml on each side.
For the QL block, Shamrock sign consistent of the quadratus lumborum muscle, psoas major muscle, erector spinae muscles and the L4 transverse process will be identified. Under ultrasound guidance with an in-plane technique, the needle will be advanced into the fascial plane between the quadratus lumborum and psoas major muscles. Local anesthetic will be injected into the plane.
liposomal Bupivacaine: 20mL liposomal bupivacaine are injected into the liposomal bupivacaine group
|
Standard Bupivacaine
n=40 Participants
SB (Standard Bupivacaine) group - This group will be receiving 60ml of 0.25% bupivacaine in total, 30ml on each side.
For the QL block, Shamrock sign consistent of the quadratus lumborum muscle, psoas major muscle, erector spinae muscles and the L4 transverse process will be identified. Under ultrasound guidance with an in-plane technique, the needle will be advanced into the fascial plane between the quadratus lumborum and psoas major muscles. Local anesthetic will be injected into the plane.
Bupivacaine Hydrochloride: 40ml of 0.125% bupivacaine hydrochloride are injected into the liposomal bupivacaine group.
60mL of 0.25% bupivacaine hydrochloride are injected into the standard bupivacaine group
|
|---|---|---|
|
Sedation Scores (Awake/Alert) at 72 Hours
|
36 Participants
|
37 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Duration of Surgery from surgery start time to surgery stop time (usually within 6 hours)Duration of surgery will be collected per MR of surgeon documentation.
Outcome measures
| Measure |
Liposomal Bupivacaine
n=38 Participants
LB (Liposomal Bupivacaine) group - This group will be receiving 20ml EXPAREL (266mg) and 40ml of 0.125% bupivacaine in total, 30ml on each side.
For the QL block, Shamrock sign consistent of the quadratus lumborum muscle, psoas major muscle, erector spinae muscles and the L4 transverse process will be identified. Under ultrasound guidance with an in-plane technique, the needle will be advanced into the fascial plane between the quadratus lumborum and psoas major muscles. Local anesthetic will be injected into the plane.
liposomal Bupivacaine: 20mL liposomal bupivacaine are injected into the liposomal bupivacaine group
|
Standard Bupivacaine
n=40 Participants
SB (Standard Bupivacaine) group - This group will be receiving 60ml of 0.25% bupivacaine in total, 30ml on each side.
For the QL block, Shamrock sign consistent of the quadratus lumborum muscle, psoas major muscle, erector spinae muscles and the L4 transverse process will be identified. Under ultrasound guidance with an in-plane technique, the needle will be advanced into the fascial plane between the quadratus lumborum and psoas major muscles. Local anesthetic will be injected into the plane.
Bupivacaine Hydrochloride: 40ml of 0.125% bupivacaine hydrochloride are injected into the liposomal bupivacaine group.
60mL of 0.25% bupivacaine hydrochloride are injected into the standard bupivacaine group
|
|---|---|---|
|
Surgery Duration
|
222.5 minutes
Interval 157.0 to 285.0
|
222.5 minutes
Interval 154.0 to 266.5
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Time Frame for Admission to Discharge (usually within 3-7 days)Admission date until Admission Discharge
Outcome measures
| Measure |
Liposomal Bupivacaine
n=38 Participants
LB (Liposomal Bupivacaine) group - This group will be receiving 20ml EXPAREL (266mg) and 40ml of 0.125% bupivacaine in total, 30ml on each side.
For the QL block, Shamrock sign consistent of the quadratus lumborum muscle, psoas major muscle, erector spinae muscles and the L4 transverse process will be identified. Under ultrasound guidance with an in-plane technique, the needle will be advanced into the fascial plane between the quadratus lumborum and psoas major muscles. Local anesthetic will be injected into the plane.
liposomal Bupivacaine: 20mL liposomal bupivacaine are injected into the liposomal bupivacaine group
|
Standard Bupivacaine
n=40 Participants
SB (Standard Bupivacaine) group - This group will be receiving 60ml of 0.25% bupivacaine in total, 30ml on each side.
For the QL block, Shamrock sign consistent of the quadratus lumborum muscle, psoas major muscle, erector spinae muscles and the L4 transverse process will be identified. Under ultrasound guidance with an in-plane technique, the needle will be advanced into the fascial plane between the quadratus lumborum and psoas major muscles. Local anesthetic will be injected into the plane.
Bupivacaine Hydrochloride: 40ml of 0.125% bupivacaine hydrochloride are injected into the liposomal bupivacaine group.
60mL of 0.25% bupivacaine hydrochloride are injected into the standard bupivacaine group
|
|---|---|---|
|
Length of Stay
|
3.5 days
Interval 2.9 to 4.3
|
3.1 days
Interval 2.3 to 5.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: End of Surgery until first reported Flatus (usually within 3 to 5 days)Hours for End of Surgery to first reported hour of Flatus
Outcome measures
| Measure |
Liposomal Bupivacaine
n=38 Participants
LB (Liposomal Bupivacaine) group - This group will be receiving 20ml EXPAREL (266mg) and 40ml of 0.125% bupivacaine in total, 30ml on each side.
For the QL block, Shamrock sign consistent of the quadratus lumborum muscle, psoas major muscle, erector spinae muscles and the L4 transverse process will be identified. Under ultrasound guidance with an in-plane technique, the needle will be advanced into the fascial plane between the quadratus lumborum and psoas major muscles. Local anesthetic will be injected into the plane.
liposomal Bupivacaine: 20mL liposomal bupivacaine are injected into the liposomal bupivacaine group
|
Standard Bupivacaine
n=40 Participants
SB (Standard Bupivacaine) group - This group will be receiving 60ml of 0.25% bupivacaine in total, 30ml on each side.
For the QL block, Shamrock sign consistent of the quadratus lumborum muscle, psoas major muscle, erector spinae muscles and the L4 transverse process will be identified. Under ultrasound guidance with an in-plane technique, the needle will be advanced into the fascial plane between the quadratus lumborum and psoas major muscles. Local anesthetic will be injected into the plane.
Bupivacaine Hydrochloride: 40ml of 0.125% bupivacaine hydrochloride are injected into the liposomal bupivacaine group.
60mL of 0.25% bupivacaine hydrochloride are injected into the standard bupivacaine group
|
|---|---|---|
|
Time to Flatus
|
20.1 hours
Interval 14.3 to 34.7
|
21.5 hours
Interval 15.9 to 37.2
|
OTHER_PRE_SPECIFIED outcome
Timeframe: End of Surgery until first reported Bowel movement per MR or patient reported (usually 3 to 5 days)Hours for End of Surgery to first reported hour of bowel movement
Outcome measures
| Measure |
Liposomal Bupivacaine
n=38 Participants
LB (Liposomal Bupivacaine) group - This group will be receiving 20ml EXPAREL (266mg) and 40ml of 0.125% bupivacaine in total, 30ml on each side.
For the QL block, Shamrock sign consistent of the quadratus lumborum muscle, psoas major muscle, erector spinae muscles and the L4 transverse process will be identified. Under ultrasound guidance with an in-plane technique, the needle will be advanced into the fascial plane between the quadratus lumborum and psoas major muscles. Local anesthetic will be injected into the plane.
liposomal Bupivacaine: 20mL liposomal bupivacaine are injected into the liposomal bupivacaine group
|
Standard Bupivacaine
n=40 Participants
SB (Standard Bupivacaine) group - This group will be receiving 60ml of 0.25% bupivacaine in total, 30ml on each side.
For the QL block, Shamrock sign consistent of the quadratus lumborum muscle, psoas major muscle, erector spinae muscles and the L4 transverse process will be identified. Under ultrasound guidance with an in-plane technique, the needle will be advanced into the fascial plane between the quadratus lumborum and psoas major muscles. Local anesthetic will be injected into the plane.
Bupivacaine Hydrochloride: 40ml of 0.125% bupivacaine hydrochloride are injected into the liposomal bupivacaine group.
60mL of 0.25% bupivacaine hydrochloride are injected into the standard bupivacaine group
|
|---|---|---|
|
Time to Bowel Movement
|
33.0 hours
Interval 17.5 to 61.5
|
26.4 hours
Interval 18.5 to 53.2
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Time from end of surgery to time of Os (usually 4-16 hours)Reported time after surgery to time of Os per MR or patient
Outcome measures
| Measure |
Liposomal Bupivacaine
n=38 Participants
LB (Liposomal Bupivacaine) group - This group will be receiving 20ml EXPAREL (266mg) and 40ml of 0.125% bupivacaine in total, 30ml on each side.
For the QL block, Shamrock sign consistent of the quadratus lumborum muscle, psoas major muscle, erector spinae muscles and the L4 transverse process will be identified. Under ultrasound guidance with an in-plane technique, the needle will be advanced into the fascial plane between the quadratus lumborum and psoas major muscles. Local anesthetic will be injected into the plane.
liposomal Bupivacaine: 20mL liposomal bupivacaine are injected into the liposomal bupivacaine group
|
Standard Bupivacaine
n=40 Participants
SB (Standard Bupivacaine) group - This group will be receiving 60ml of 0.25% bupivacaine in total, 30ml on each side.
For the QL block, Shamrock sign consistent of the quadratus lumborum muscle, psoas major muscle, erector spinae muscles and the L4 transverse process will be identified. Under ultrasound guidance with an in-plane technique, the needle will be advanced into the fascial plane between the quadratus lumborum and psoas major muscles. Local anesthetic will be injected into the plane.
Bupivacaine Hydrochloride: 40ml of 0.125% bupivacaine hydrochloride are injected into the liposomal bupivacaine group.
60mL of 0.25% bupivacaine hydrochloride are injected into the standard bupivacaine group
|
|---|---|---|
|
Time to Per Os
|
7.1 hours
Interval 4.4 to 14.2
|
6.6 hours
Interval 3.6 to 11.1
|
OTHER_PRE_SPECIFIED outcome
Timeframe: End of Surgery until first reported ambulated postoperatively per MR or patient reported (Usually within 24 hours postop)Number of patients who ambulated within 24 hours of end of surgery
Outcome measures
| Measure |
Liposomal Bupivacaine
n=38 Participants
LB (Liposomal Bupivacaine) group - This group will be receiving 20ml EXPAREL (266mg) and 40ml of 0.125% bupivacaine in total, 30ml on each side.
For the QL block, Shamrock sign consistent of the quadratus lumborum muscle, psoas major muscle, erector spinae muscles and the L4 transverse process will be identified. Under ultrasound guidance with an in-plane technique, the needle will be advanced into the fascial plane between the quadratus lumborum and psoas major muscles. Local anesthetic will be injected into the plane.
liposomal Bupivacaine: 20mL liposomal bupivacaine are injected into the liposomal bupivacaine group
|
Standard Bupivacaine
n=40 Participants
SB (Standard Bupivacaine) group - This group will be receiving 60ml of 0.25% bupivacaine in total, 30ml on each side.
For the QL block, Shamrock sign consistent of the quadratus lumborum muscle, psoas major muscle, erector spinae muscles and the L4 transverse process will be identified. Under ultrasound guidance with an in-plane technique, the needle will be advanced into the fascial plane between the quadratus lumborum and psoas major muscles. Local anesthetic will be injected into the plane.
Bupivacaine Hydrochloride: 40ml of 0.125% bupivacaine hydrochloride are injected into the liposomal bupivacaine group.
60mL of 0.25% bupivacaine hydrochloride are injected into the standard bupivacaine group
|
|---|---|---|
|
Ambulatory Postoperatively
|
35 Participants
|
40 Participants
|
Adverse Events
Liposomal Bupivacaine
Standard Bupivacaine
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