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

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

90 participants

Primary outcome timeframe

Pain scores will be measured 1 hour after surgery

Results posted on

2023-05-17

Participant Flow

Participant milestones

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

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

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 surgery

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

Outcome measures

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 surgery

The 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

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 surgery

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

Outcome measures

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 surgery

The 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

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 surgery

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

Outcome measures

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 surgery

The 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

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 surgery

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

Outcome measures

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 surgery

The 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

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 recorded

Opioid consumption will be collected by a study team member post operatively for 3 days per protocol time requirements

Outcome measures

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 recorded

Opioid consumption will be collected by a study team member post operatively for 3 days per protocol time requirements

Outcome measures

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 recorded

Opioid consumption will be collected by a study team member post operatively for 3 days per protocol time requirements

Outcome measures

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 recorded

Opioid consumption will be collected by a study team member post operatively for 3 days per protocol time requirements

Outcome measures

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Standard Bupivacaine

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Yar Luan Yeap

Indiana University

Phone: 317-274-0275

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place