Trial Outcomes & Findings for Surgeon Infiltration QL Block Comparison (NCT NCT03496610)
NCT ID: NCT03496610
Last Updated: 2024-03-05
Results Overview
COMPLETED
PHASE4
44 participants
24 hours postoperatively
2024-03-05
Participant Flow
Participant milestones
| Measure |
Quadratus Lumborum (QL) Block
Patients will receive a bilateral ultrasound guided QL block by the anesthesia team.
QL Block: Patient will receive ultrasound guided QL Block
|
Surgical Wound Infiltration
Patients will receive 266 mg of liposomal bupivacaine mixed with 50 mg non-liposomal bupivacaine infiltrated into the wound by the surgeon.
Liposomal Bupivicaine: Patient will receive liposomal bupivicaine mixed with non-liposomal bupivicaine directly to wound
|
|---|---|---|
|
Overall Study
STARTED
|
24
|
20
|
|
Overall Study
COMPLETED
|
19
|
18
|
|
Overall Study
NOT COMPLETED
|
5
|
2
|
Reasons for withdrawal
| Measure |
Quadratus Lumborum (QL) Block
Patients will receive a bilateral ultrasound guided QL block by the anesthesia team.
QL Block: Patient will receive ultrasound guided QL Block
|
Surgical Wound Infiltration
Patients will receive 266 mg of liposomal bupivacaine mixed with 50 mg non-liposomal bupivacaine infiltrated into the wound by the surgeon.
Liposomal Bupivicaine: Patient will receive liposomal bupivicaine mixed with non-liposomal bupivicaine directly to wound
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
3
|
2
|
|
Overall Study
Physician Decision
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
Surgeon Infiltration QL Block Comparison
Baseline characteristics by cohort
| Measure |
Quadratus Lumborum (QL) Block
n=22 Participants
Patients will receive a bilateral ultrasound guided QL block by the anesthesia team.
QL Block: Patient will receive ultrasound guided QL Block
|
Surgical Wound Infiltration
n=20 Participants
Patients will receive 266 mg of liposomal bupivacaine mixed with 50 mg non-liposomal bupivacaine infiltrated into the wound by the surgeon.
Liposomal Bupivicaine: Patient will receive liposomal bupivicaine mixed with non-liposomal bupivicaine directly to wound
|
Total
n=42 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
42.59 years
STANDARD_DEVIATION 14.41 • n=5 Participants
|
47.90 years
STANDARD_DEVIATION 12.51 • n=7 Participants
|
45.25 years
STANDARD_DEVIATION 13.46 • n=5 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
22 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
16 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
32 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
22 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 24 hours postoperativelyPopulation: This analysis excludes two subjects who were originally enrolled in the QL group--one subject who voluntarily withdrew and one who was withdrawn by the PI for a surgical site infection.
Outcome measures
| Measure |
Quadratus Lumborum (QL) Block
n=22 Participants
Patients will receive a bilateral ultrasound guided QL block by the anesthesia team.
QL Block: Patient will receive ultrasound guided QL Block
|
Surgical Wound Infiltration
n=20 Participants
Patients will receive 266 mg of liposomal bupivacaine mixed with 50 mg non-liposomal bupivacaine infiltrated into the wound by the surgeon.
Liposomal Bupivicaine: Patient will receive liposomal bupivicaine mixed with non-liposomal bupivicaine directly to wound
|
|---|---|---|
|
Opioid Consumption in Oral Morphine Milliequivalents for the First 24 Hours After Surgery (Defined as 24 Hours After the Anesthesia End Time)
|
17.50 oral morphine equivalents in milligrams
Interval 6.88 to 33.88
|
21.25 oral morphine equivalents in milligrams
Interval 7.5 to 46.88
|
SECONDARY outcome
Timeframe: Postoperative day 7Population: This analysis excludes two subjects who were originally enrolled in the QL group--one subject who voluntarily withdrew and one who was withdrawn by the PI for a surgical site infection. Five subjects (3 in the QL group and 2 in the infiltration group) were not reachable by phone on postoperative day 7 and were therefore excluded from this analysis.
Pain was measured on a self-reported scale of 0-10, where 0=no pain and 10=worst imaginable pain. Scores were gathered by phone on postoperative day 7.
Outcome measures
| Measure |
Quadratus Lumborum (QL) Block
n=19 Participants
Patients will receive a bilateral ultrasound guided QL block by the anesthesia team.
QL Block: Patient will receive ultrasound guided QL Block
|
Surgical Wound Infiltration
n=18 Participants
Patients will receive 266 mg of liposomal bupivacaine mixed with 50 mg non-liposomal bupivacaine infiltrated into the wound by the surgeon.
Liposomal Bupivicaine: Patient will receive liposomal bupivicaine mixed with non-liposomal bupivicaine directly to wound
|
|---|---|---|
|
Self-reported Numeric Pain Scores on Postoperative Day Seven
|
2 score on a scale
Interval 1.0 to 3.0
|
1 score on a scale
Interval 1.0 to 2.0
|
SECONDARY outcome
Timeframe: First seven days postoperativelyPopulation: This analysis excludes two subjects who were originally enrolled in the QL group--one subject who voluntarily withdrew and one who was withdrawn by the PI for a surgical site infection. Five subjects (3 in the QL group and 2 in the infiltration group) were not reachable by phone and were therefore excluded from this analysis.
Bloating severity scores were gathered daily by phone interview for the first week postoperatively. Bloating severity was assessed on a scale of 1-5, where 1= not at all severe and 5=very much. The highest severity score reported during the week was collected for this outcome measure.
Outcome measures
| Measure |
Quadratus Lumborum (QL) Block
n=19 Participants
Patients will receive a bilateral ultrasound guided QL block by the anesthesia team.
QL Block: Patient will receive ultrasound guided QL Block
|
Surgical Wound Infiltration
n=18 Participants
Patients will receive 266 mg of liposomal bupivacaine mixed with 50 mg non-liposomal bupivacaine infiltrated into the wound by the surgeon.
Liposomal Bupivicaine: Patient will receive liposomal bupivicaine mixed with non-liposomal bupivicaine directly to wound
|
|---|---|---|
|
Worst Bloating Severity in the First Postoperative Week
|
4 score on a scale
Interval 3.0 to 5.0
|
4 score on a scale
Interval 2.75 to 5.0
|
SECONDARY outcome
Timeframe: First seven days postoperativelyPopulation: This analysis excludes two subjects who were originally enrolled in the QL group--one subject who voluntarily withdrew and one who was withdrawn by the PI for a surgical site infection. Five subjects (3 in the QL group and 2 in the infiltration group) were not reachable by phone and were therefore excluded from this analysis.
Physical function was assessed by daily phone interview during the first postoperative week. Subjects were asked to assess their ability to go for a walk of at least 15 minute on a scale of 1-5 with 1=unable to do and 5= able to do without any difficulty. For this outcome, the number of subjects who reported being able to go for a walk of at least 15 minutes "without any difficulty" at any time during the first postoperative week is reported.
Outcome measures
| Measure |
Quadratus Lumborum (QL) Block
n=19 Participants
Patients will receive a bilateral ultrasound guided QL block by the anesthesia team.
QL Block: Patient will receive ultrasound guided QL Block
|
Surgical Wound Infiltration
n=18 Participants
Patients will receive 266 mg of liposomal bupivacaine mixed with 50 mg non-liposomal bupivacaine infiltrated into the wound by the surgeon.
Liposomal Bupivicaine: Patient will receive liposomal bupivicaine mixed with non-liposomal bupivicaine directly to wound
|
|---|---|---|
|
Self-reported Ability to Walk for 15 Minutes Without Any Difficulty Within the First Postoperative Week
|
10 Participants
|
12 Participants
|
Adverse Events
Quadratus Lumborum (QL) Block
Surgical Wound Infiltration
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