Trial Outcomes & Findings for Comparison of Quadratus Lumborum Block Types (NCT NCT04588389)
NCT ID: NCT04588389
Last Updated: 2025-07-28
Results Overview
Dose of the opioids consumed
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
9 participants
Primary outcome timeframe
12 hours
Results posted on
2025-07-28
Participant Flow
Participant milestones
| Measure |
Group 1 Standard of Care
Group I will receive the standard of care multimodal pharmacological management.
Multimodal Pharmacological Management: standard of care multimodal pharmacological management
|
Group 2 Standard of Care + Quadratus Lumborum Block II
Group II will receive standard of care multimodal pharmacological management plus the Quadratus Lumborum II local anesthetic block.
Ropivacaine injection Location 1: Ropivacaine .5% and lidocaine 1% to the area behind the muscle Quadratus Lumborum location 1
Multimodal Pharmacological Management: standard of care multimodal pharmacological management
|
Group 3 Standard of Care + Quadratus Lumborum Block III
Group III will receive standard of care multimodal pharmacological management plus the Quadratus Lumborum III local anesthetic block. We will measure opioid use, pain, and side effects in each patient.
Ropivacaine injection Location 2: Ropivacaine .5% and lidocaine 1% to the area behind the muscle Quadratus Lumborum location 2
Multimodal Pharmacological Management: standard of care multimodal pharmacological management
|
|---|---|---|---|
|
Overall Study
STARTED
|
2
|
4
|
3
|
|
Overall Study
COMPLETED
|
0
|
4
|
3
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
0
|
Reasons for withdrawal
| Measure |
Group 1 Standard of Care
Group I will receive the standard of care multimodal pharmacological management.
Multimodal Pharmacological Management: standard of care multimodal pharmacological management
|
Group 2 Standard of Care + Quadratus Lumborum Block II
Group II will receive standard of care multimodal pharmacological management plus the Quadratus Lumborum II local anesthetic block.
Ropivacaine injection Location 1: Ropivacaine .5% and lidocaine 1% to the area behind the muscle Quadratus Lumborum location 1
Multimodal Pharmacological Management: standard of care multimodal pharmacological management
|
Group 3 Standard of Care + Quadratus Lumborum Block III
Group III will receive standard of care multimodal pharmacological management plus the Quadratus Lumborum III local anesthetic block. We will measure opioid use, pain, and side effects in each patient.
Ropivacaine injection Location 2: Ropivacaine .5% and lidocaine 1% to the area behind the muscle Quadratus Lumborum location 2
Multimodal Pharmacological Management: standard of care multimodal pharmacological management
|
|---|---|---|---|
|
Overall Study
Issues with anesthesia during surgery
|
2
|
0
|
0
|
Baseline Characteristics
Comparison of Quadratus Lumborum Block Types
Baseline characteristics by cohort
| Measure |
Group 1 Standard of Care
Group I will receive the standard of care multimodal pharmacological management.
Multimodal Pharmacological Management: standard of care multimodal pharmacological management
|
Group 2 Standard of Care + Quadratus Lumborum Block II
n=4 Participants
Group II will receive standard of care multimodal pharmacological management plus the Quadratus Lumborum II local anesthetic block.
Ropivacaine injection Location 1: Ropivacaine .5% and lidocaine 1% to the area behind the muscle Quadratus Lumborum location 1
Multimodal Pharmacological Management: standard of care multimodal pharmacological management
|
Group 3 Standard of Care + Quadratus Lumborum Block III
n=3 Participants
Group III will receive standard of care multimodal pharmacological management plus the Quadratus Lumborum III local anesthetic block. We will measure opioid use, pain, and side effects in each patient.
Ropivacaine injection Location 2: Ropivacaine .5% and lidocaine 1% to the area behind the muscle Quadratus Lumborum location 2
Multimodal Pharmacological Management: standard of care multimodal pharmacological management
|
Total
n=7 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Age, Continuous
|
—
|
63.75 years
n=7 Participants
|
73 years
n=5 Participants
|
67.71 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
—
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
—
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
—
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
—
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
—
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
—
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
—
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
—
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
—
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
0 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 12 hoursPopulation: No data was collected on Participants in Group 1 and were excluded from analysis population as there were issues with anesthesia. One participant received a large amount of local anesthetics by surgeon and the other received ketamine in anesthesia.
Dose of the opioids consumed
Outcome measures
| Measure |
Group 1 Standard of Care
Group I will receive the standard of care multimodal pharmacological management.
Multimodal Pharmacological Management: standard of care multimodal pharmacological management
|
Group 2 Standard of Care + Quadratus Lumborum Block II
n=4 Participants
Group II will receive standard of care multimodal pharmacological management plus the Quadratus Lumborum II local anesthetic block.
Ropivacaine injection Location 1: Ropivacaine .5% and lidocaine 1% to the area behind the muscle Quadratus Lumborum location 1
Multimodal Pharmacological Management: standard of care multimodal pharmacological management
|
Group 3 Standard of Care + Quadratus Lumborum Block III
n=3 Participants
Group III will receive standard of care multimodal pharmacological management plus the Quadratus Lumborum III local anesthetic block. We will measure opioid use, pain, and side effects in each patient.
Ropivacaine injection Location 2: Ropivacaine .5% and lidocaine 1% to the area behind the muscle Quadratus Lumborum location 2
Multimodal Pharmacological Management: standard of care multimodal pharmacological management
|
|---|---|---|---|
|
Opioid Consumption
|
—
|
30 morphine milligram equivalents
Interval 7.5 to 37.5
|
17.5 morphine milligram equivalents
Interval 7.5 to 22.5
|
PRIMARY outcome
Timeframe: 24 hoursPopulation: No data was collected on Participants in Group 1 and were excluded from analysis population as there were issues with anesthesia. One participant received a large amount of local anesthetics by surgeon and the other received ketamine in anesthesia.
Dose of the opioids consumed
Outcome measures
| Measure |
Group 1 Standard of Care
Group I will receive the standard of care multimodal pharmacological management.
Multimodal Pharmacological Management: standard of care multimodal pharmacological management
|
Group 2 Standard of Care + Quadratus Lumborum Block II
n=4 Participants
Group II will receive standard of care multimodal pharmacological management plus the Quadratus Lumborum II local anesthetic block.
Ropivacaine injection Location 1: Ropivacaine .5% and lidocaine 1% to the area behind the muscle Quadratus Lumborum location 1
Multimodal Pharmacological Management: standard of care multimodal pharmacological management
|
Group 3 Standard of Care + Quadratus Lumborum Block III
n=3 Participants
Group III will receive standard of care multimodal pharmacological management plus the Quadratus Lumborum III local anesthetic block. We will measure opioid use, pain, and side effects in each patient.
Ropivacaine injection Location 2: Ropivacaine .5% and lidocaine 1% to the area behind the muscle Quadratus Lumborum location 2
Multimodal Pharmacological Management: standard of care multimodal pharmacological management
|
|---|---|---|---|
|
Opioid Consumption
|
—
|
31 Morphine milligram equivalents
Interval 7.5 to 56.25
|
20 Morphine milligram equivalents
Interval 15.0 to 37.5
|
PRIMARY outcome
Timeframe: 36 hoursPopulation: No data was collected on Participants in Group 1 and were excluded from analysis population as there were issues with anesthesia. One participant received a large amount of local anesthetics by surgeon and the other received ketamine in anesthesia.
Dose of the opioids consumed
Outcome measures
| Measure |
Group 1 Standard of Care
Group I will receive the standard of care multimodal pharmacological management.
Multimodal Pharmacological Management: standard of care multimodal pharmacological management
|
Group 2 Standard of Care + Quadratus Lumborum Block II
n=4 Participants
Group II will receive standard of care multimodal pharmacological management plus the Quadratus Lumborum II local anesthetic block.
Ropivacaine injection Location 1: Ropivacaine .5% and lidocaine 1% to the area behind the muscle Quadratus Lumborum location 1
Multimodal Pharmacological Management: standard of care multimodal pharmacological management
|
Group 3 Standard of Care + Quadratus Lumborum Block III
n=3 Participants
Group III will receive standard of care multimodal pharmacological management plus the Quadratus Lumborum III local anesthetic block. We will measure opioid use, pain, and side effects in each patient.
Ropivacaine injection Location 2: Ropivacaine .5% and lidocaine 1% to the area behind the muscle Quadratus Lumborum location 2
Multimodal Pharmacological Management: standard of care multimodal pharmacological management
|
|---|---|---|---|
|
Opioid Consumption
|
—
|
35.625 Morphine milligram equivalents
Interval 15.0 to 52.5
|
20 Morphine milligram equivalents
Interval 7.5 to 30.0
|
PRIMARY outcome
Timeframe: 48 hoursPopulation: No data was collected on Participants in Group 1 and were excluded from analysis population as there were issues with anesthesia. One participant received a large amount of local anesthetics by surgeon and the other received ketamine in anesthesia.
Dose of the opioids consumed
Outcome measures
| Measure |
Group 1 Standard of Care
Group I will receive the standard of care multimodal pharmacological management.
Multimodal Pharmacological Management: standard of care multimodal pharmacological management
|
Group 2 Standard of Care + Quadratus Lumborum Block II
n=4 Participants
Group II will receive standard of care multimodal pharmacological management plus the Quadratus Lumborum II local anesthetic block.
Ropivacaine injection Location 1: Ropivacaine .5% and lidocaine 1% to the area behind the muscle Quadratus Lumborum location 1
Multimodal Pharmacological Management: standard of care multimodal pharmacological management
|
Group 3 Standard of Care + Quadratus Lumborum Block III
n=3 Participants
Group III will receive standard of care multimodal pharmacological management plus the Quadratus Lumborum III local anesthetic block. We will measure opioid use, pain, and side effects in each patient.
Ropivacaine injection Location 2: Ropivacaine .5% and lidocaine 1% to the area behind the muscle Quadratus Lumborum location 2
Multimodal Pharmacological Management: standard of care multimodal pharmacological management
|
|---|---|---|---|
|
Opioid Consumption
|
—
|
31.875 Morphine milligram equivalents
Interval 15.0 to 45.0
|
25 Morphine milligram equivalents
Interval 15.0 to 30.0
|
SECONDARY outcome
Timeframe: 0 HoursPopulation: No data was collected on Participants in Group 1 and were excluded from analysis population as there were issues with anesthesia. One participant received a large amount of local anesthetics by surgeon and the other received ketamine in anesthesia.
Numerical Pain Scale Rating, likert scale of 0-10 with a 0 indicating absence of pain and 10 indicating worst pain imaginable.
Outcome measures
| Measure |
Group 1 Standard of Care
Group I will receive the standard of care multimodal pharmacological management.
Multimodal Pharmacological Management: standard of care multimodal pharmacological management
|
Group 2 Standard of Care + Quadratus Lumborum Block II
n=4 Participants
Group II will receive standard of care multimodal pharmacological management plus the Quadratus Lumborum II local anesthetic block.
Ropivacaine injection Location 1: Ropivacaine .5% and lidocaine 1% to the area behind the muscle Quadratus Lumborum location 1
Multimodal Pharmacological Management: standard of care multimodal pharmacological management
|
Group 3 Standard of Care + Quadratus Lumborum Block III
n=3 Participants
Group III will receive standard of care multimodal pharmacological management plus the Quadratus Lumborum III local anesthetic block. We will measure opioid use, pain, and side effects in each patient.
Ropivacaine injection Location 2: Ropivacaine .5% and lidocaine 1% to the area behind the muscle Quadratus Lumborum location 2
Multimodal Pharmacological Management: standard of care multimodal pharmacological management
|
|---|---|---|---|
|
Pain Scale
|
—
|
8 score on a scale
Interval 5.0 to 10.0
|
3.67 score on a scale
Interval 0.0 to 7.0
|
SECONDARY outcome
Timeframe: 1 HourPopulation: No data was collected on Participants in Group 1 and were excluded from analysis population as there were issues with anesthesia. One participant received a large amount of local anesthetics by surgeon and the other received ketamine in anesthesia.
Numerical Pain Scale Rating of 0-10 with a 0 indicating absence of pain and 10 indicating worst pain imaginable.
Outcome measures
| Measure |
Group 1 Standard of Care
Group I will receive the standard of care multimodal pharmacological management.
Multimodal Pharmacological Management: standard of care multimodal pharmacological management
|
Group 2 Standard of Care + Quadratus Lumborum Block II
n=4 Participants
Group II will receive standard of care multimodal pharmacological management plus the Quadratus Lumborum II local anesthetic block.
Ropivacaine injection Location 1: Ropivacaine .5% and lidocaine 1% to the area behind the muscle Quadratus Lumborum location 1
Multimodal Pharmacological Management: standard of care multimodal pharmacological management
|
Group 3 Standard of Care + Quadratus Lumborum Block III
n=3 Participants
Group III will receive standard of care multimodal pharmacological management plus the Quadratus Lumborum III local anesthetic block. We will measure opioid use, pain, and side effects in each patient.
Ropivacaine injection Location 2: Ropivacaine .5% and lidocaine 1% to the area behind the muscle Quadratus Lumborum location 2
Multimodal Pharmacological Management: standard of care multimodal pharmacological management
|
|---|---|---|---|
|
Pain Scale
|
—
|
4.75 score on a scale
Interval 3.0 to 8.0
|
2 score on a scale
Interval 0.0 to 4.0
|
SECONDARY outcome
Timeframe: 6 HoursPopulation: No data was collected on Participants in Group 1 and were excluded from analysis population as there were issues with anesthesia. One participant received a large amount of local anesthetics by surgeon and the other received ketamine in anesthesia.
Numerical Pain Scale Rating, likert scale of 0-10 with a 0 indicating absence of pain and 10 indicating worst pain imaginable.
Outcome measures
| Measure |
Group 1 Standard of Care
Group I will receive the standard of care multimodal pharmacological management.
Multimodal Pharmacological Management: standard of care multimodal pharmacological management
|
Group 2 Standard of Care + Quadratus Lumborum Block II
n=4 Participants
Group II will receive standard of care multimodal pharmacological management plus the Quadratus Lumborum II local anesthetic block.
Ropivacaine injection Location 1: Ropivacaine .5% and lidocaine 1% to the area behind the muscle Quadratus Lumborum location 1
Multimodal Pharmacological Management: standard of care multimodal pharmacological management
|
Group 3 Standard of Care + Quadratus Lumborum Block III
n=3 Participants
Group III will receive standard of care multimodal pharmacological management plus the Quadratus Lumborum III local anesthetic block. We will measure opioid use, pain, and side effects in each patient.
Ropivacaine injection Location 2: Ropivacaine .5% and lidocaine 1% to the area behind the muscle Quadratus Lumborum location 2
Multimodal Pharmacological Management: standard of care multimodal pharmacological management
|
|---|---|---|---|
|
Pain Scale
|
—
|
5.25 score on a scale
Interval 3.0 to 8.0
|
2.33 score on a scale
Interval 0.0 to 4.0
|
SECONDARY outcome
Timeframe: 12 HoursPopulation: No data was collected on Participants in Group 1 and were excluded from analysis population as there were issues with anesthesia. One participant received a large amount of local anesthetics by surgeon and the other received ketamine in anesthesia.
Numerical Pain Scale Rating, likert scale of 0-10 with a 0 indicating absence of pain and 10 indicating worst pain imaginable.
Outcome measures
| Measure |
Group 1 Standard of Care
Group I will receive the standard of care multimodal pharmacological management.
Multimodal Pharmacological Management: standard of care multimodal pharmacological management
|
Group 2 Standard of Care + Quadratus Lumborum Block II
n=4 Participants
Group II will receive standard of care multimodal pharmacological management plus the Quadratus Lumborum II local anesthetic block.
Ropivacaine injection Location 1: Ropivacaine .5% and lidocaine 1% to the area behind the muscle Quadratus Lumborum location 1
Multimodal Pharmacological Management: standard of care multimodal pharmacological management
|
Group 3 Standard of Care + Quadratus Lumborum Block III
n=3 Participants
Group III will receive standard of care multimodal pharmacological management plus the Quadratus Lumborum III local anesthetic block. We will measure opioid use, pain, and side effects in each patient.
Ropivacaine injection Location 2: Ropivacaine .5% and lidocaine 1% to the area behind the muscle Quadratus Lumborum location 2
Multimodal Pharmacological Management: standard of care multimodal pharmacological management
|
|---|---|---|---|
|
Pain Scale
|
—
|
5.25 score on a scale
Interval 4.0 to 8.0
|
5.33 score on a scale
Interval 4.0 to 8.0
|
SECONDARY outcome
Timeframe: 18 HoursPopulation: No data was collected on Participants in Group 1 and were excluded from analysis population as there were issues with anesthesia. One participant received a large amount of local anesthetics by surgeon and the other received ketamine in anesthesia.
Numerical Pain Scale Rating, likert scale of 0-10 with a 0 indicating absence of pain and 10 indicating worst pain imaginable.
Outcome measures
| Measure |
Group 1 Standard of Care
Group I will receive the standard of care multimodal pharmacological management.
Multimodal Pharmacological Management: standard of care multimodal pharmacological management
|
Group 2 Standard of Care + Quadratus Lumborum Block II
n=4 Participants
Group II will receive standard of care multimodal pharmacological management plus the Quadratus Lumborum II local anesthetic block.
Ropivacaine injection Location 1: Ropivacaine .5% and lidocaine 1% to the area behind the muscle Quadratus Lumborum location 1
Multimodal Pharmacological Management: standard of care multimodal pharmacological management
|
Group 3 Standard of Care + Quadratus Lumborum Block III
n=3 Participants
Group III will receive standard of care multimodal pharmacological management plus the Quadratus Lumborum III local anesthetic block. We will measure opioid use, pain, and side effects in each patient.
Ropivacaine injection Location 2: Ropivacaine .5% and lidocaine 1% to the area behind the muscle Quadratus Lumborum location 2
Multimodal Pharmacological Management: standard of care multimodal pharmacological management
|
|---|---|---|---|
|
Pain Scale
|
—
|
6 score on a scale
Interval 4.0 to 9.0
|
5.33 score on a scale
Interval 3.0 to 8.0
|
SECONDARY outcome
Timeframe: 24 HoursPopulation: No data was collected on Participants in Group 1 and were excluded from analysis population as there were issues with anesthesia. One participant received a large amount of local anesthetics by surgeon and the other received ketamine in anesthesia.
Numerical Pain Scale Rating, likert scale of 0-10 with a 0 indicating absence of pain and 10 indicating worst pain imaginable.
Outcome measures
| Measure |
Group 1 Standard of Care
Group I will receive the standard of care multimodal pharmacological management.
Multimodal Pharmacological Management: standard of care multimodal pharmacological management
|
Group 2 Standard of Care + Quadratus Lumborum Block II
n=4 Participants
Group II will receive standard of care multimodal pharmacological management plus the Quadratus Lumborum II local anesthetic block.
Ropivacaine injection Location 1: Ropivacaine .5% and lidocaine 1% to the area behind the muscle Quadratus Lumborum location 1
Multimodal Pharmacological Management: standard of care multimodal pharmacological management
|
Group 3 Standard of Care + Quadratus Lumborum Block III
n=3 Participants
Group III will receive standard of care multimodal pharmacological management plus the Quadratus Lumborum III local anesthetic block. We will measure opioid use, pain, and side effects in each patient.
Ropivacaine injection Location 2: Ropivacaine .5% and lidocaine 1% to the area behind the muscle Quadratus Lumborum location 2
Multimodal Pharmacological Management: standard of care multimodal pharmacological management
|
|---|---|---|---|
|
Pain Scale
|
—
|
5.75 score on a scale
Interval 4.0 to 7.0
|
4.67 score on a scale
Interval 3.0 to 6.0
|
SECONDARY outcome
Timeframe: 30 HoursPopulation: No data was collected on Participants in Group 1 and were excluded from analysis population as there were issues with anesthesia. One participant received a large amount of local anesthetics by surgeon and the other received ketamine in anesthesia.
Numerical Pain Scale Rating, likert scale of 0-10 with a 0 indicating absence of pain and 10 indicating worst pain imaginable.
Outcome measures
| Measure |
Group 1 Standard of Care
Group I will receive the standard of care multimodal pharmacological management.
Multimodal Pharmacological Management: standard of care multimodal pharmacological management
|
Group 2 Standard of Care + Quadratus Lumborum Block II
n=4 Participants
Group II will receive standard of care multimodal pharmacological management plus the Quadratus Lumborum II local anesthetic block.
Ropivacaine injection Location 1: Ropivacaine .5% and lidocaine 1% to the area behind the muscle Quadratus Lumborum location 1
Multimodal Pharmacological Management: standard of care multimodal pharmacological management
|
Group 3 Standard of Care + Quadratus Lumborum Block III
n=3 Participants
Group III will receive standard of care multimodal pharmacological management plus the Quadratus Lumborum III local anesthetic block. We will measure opioid use, pain, and side effects in each patient.
Ropivacaine injection Location 2: Ropivacaine .5% and lidocaine 1% to the area behind the muscle Quadratus Lumborum location 2
Multimodal Pharmacological Management: standard of care multimodal pharmacological management
|
|---|---|---|---|
|
Pain Scale
|
—
|
4.75 score on a scale
Interval 0.0 to 8.0
|
2.3 score on a scale
Interval 0.0 to 5.0
|
SECONDARY outcome
Timeframe: 36 HoursPopulation: No data was collected on Participants in Group 1 and were excluded from analysis population as there were issues with anesthesia. One participant received a large amount of local anesthetics by surgeon and the other received ketamine in anesthesia.
Numerical Pain Scale Rating, likert scale of 0-10 with a 0 indicating absence of pain and 10 indicating worst pain imaginable.
Outcome measures
| Measure |
Group 1 Standard of Care
Group I will receive the standard of care multimodal pharmacological management.
Multimodal Pharmacological Management: standard of care multimodal pharmacological management
|
Group 2 Standard of Care + Quadratus Lumborum Block II
n=4 Participants
Group II will receive standard of care multimodal pharmacological management plus the Quadratus Lumborum II local anesthetic block.
Ropivacaine injection Location 1: Ropivacaine .5% and lidocaine 1% to the area behind the muscle Quadratus Lumborum location 1
Multimodal Pharmacological Management: standard of care multimodal pharmacological management
|
Group 3 Standard of Care + Quadratus Lumborum Block III
n=3 Participants
Group III will receive standard of care multimodal pharmacological management plus the Quadratus Lumborum III local anesthetic block. We will measure opioid use, pain, and side effects in each patient.
Ropivacaine injection Location 2: Ropivacaine .5% and lidocaine 1% to the area behind the muscle Quadratus Lumborum location 2
Multimodal Pharmacological Management: standard of care multimodal pharmacological management
|
|---|---|---|---|
|
Pain Scale
|
—
|
6.25 score on a scale
Interval 4.0 to 9.0
|
6.33 score on a scale
Interval 4.0 to 10.0
|
SECONDARY outcome
Timeframe: 42 HoursPopulation: No data was collected on Participants in Group 1 and were excluded from analysis population as there were issues with anesthesia. One participant received a large amount of local anesthetics by surgeon and the other received ketamine in anesthesia.
Numerical Pain Scale Rating, likert scale of 0-10 with a 0 indicating absence of pain and 10 indicating worst pain imaginable.
Outcome measures
| Measure |
Group 1 Standard of Care
Group I will receive the standard of care multimodal pharmacological management.
Multimodal Pharmacological Management: standard of care multimodal pharmacological management
|
Group 2 Standard of Care + Quadratus Lumborum Block II
n=4 Participants
Group II will receive standard of care multimodal pharmacological management plus the Quadratus Lumborum II local anesthetic block.
Ropivacaine injection Location 1: Ropivacaine .5% and lidocaine 1% to the area behind the muscle Quadratus Lumborum location 1
Multimodal Pharmacological Management: standard of care multimodal pharmacological management
|
Group 3 Standard of Care + Quadratus Lumborum Block III
n=3 Participants
Group III will receive standard of care multimodal pharmacological management plus the Quadratus Lumborum III local anesthetic block. We will measure opioid use, pain, and side effects in each patient.
Ropivacaine injection Location 2: Ropivacaine .5% and lidocaine 1% to the area behind the muscle Quadratus Lumborum location 2
Multimodal Pharmacological Management: standard of care multimodal pharmacological management
|
|---|---|---|---|
|
Pain Scale
|
—
|
5.25 score on a scale
Interval 4.0 to 7.0
|
2 score on a scale
Interval 0.0 to 6.0
|
SECONDARY outcome
Timeframe: 48 hoursPopulation: No data was collected on Participants in Group 1 and were excluded from analysis population as there were issues with anesthesia. One participant received a large amount of local anesthetics by surgeon and the other received ketamine in anesthesia. Not able to collect data on a Group 2 participant due to timing and discharge.
Numerical Pain Scale Rating, likert scale of 0-10 with a 0 indicating absence of pain and 10 indicating worst pain imaginable.
Outcome measures
| Measure |
Group 1 Standard of Care
Group I will receive the standard of care multimodal pharmacological management.
Multimodal Pharmacological Management: standard of care multimodal pharmacological management
|
Group 2 Standard of Care + Quadratus Lumborum Block II
n=3 Participants
Group II will receive standard of care multimodal pharmacological management plus the Quadratus Lumborum II local anesthetic block.
Ropivacaine injection Location 1: Ropivacaine .5% and lidocaine 1% to the area behind the muscle Quadratus Lumborum location 1
Multimodal Pharmacological Management: standard of care multimodal pharmacological management
|
Group 3 Standard of Care + Quadratus Lumborum Block III
n=3 Participants
Group III will receive standard of care multimodal pharmacological management plus the Quadratus Lumborum III local anesthetic block. We will measure opioid use, pain, and side effects in each patient.
Ropivacaine injection Location 2: Ropivacaine .5% and lidocaine 1% to the area behind the muscle Quadratus Lumborum location 2
Multimodal Pharmacological Management: standard of care multimodal pharmacological management
|
|---|---|---|---|
|
Pain Scale
|
—
|
6 score on a scale
Interval 4.0 to 8.0
|
3.667 score on a scale
Interval 3.0 to 4.0
|
SECONDARY outcome
Timeframe: 2 weeksPopulation: No data was collected on Participants in Group 1 and were excluded from analysis population as there were issues with anesthesia. One participant received a large amount of local anesthetics by surgeon and the other received ketamine in anesthesia.
The amount of left-over opioid pills at 2 weeks in the follow up visit.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 1 weekPopulation: No data was collected on Participants in Group 1 and were excluded from analysis population as there were issues with anesthesia. One participant received a large amount of local anesthetics by surgeon and the other received ketamine in anesthesia.
Number of Participants who experienced side effects.
Outcome measures
| Measure |
Group 1 Standard of Care
Group I will receive the standard of care multimodal pharmacological management.
Multimodal Pharmacological Management: standard of care multimodal pharmacological management
|
Group 2 Standard of Care + Quadratus Lumborum Block II
n=4 Participants
Group II will receive standard of care multimodal pharmacological management plus the Quadratus Lumborum II local anesthetic block.
Ropivacaine injection Location 1: Ropivacaine .5% and lidocaine 1% to the area behind the muscle Quadratus Lumborum location 1
Multimodal Pharmacological Management: standard of care multimodal pharmacological management
|
Group 3 Standard of Care + Quadratus Lumborum Block III
n=3 Participants
Group III will receive standard of care multimodal pharmacological management plus the Quadratus Lumborum III local anesthetic block. We will measure opioid use, pain, and side effects in each patient.
Ropivacaine injection Location 2: Ropivacaine .5% and lidocaine 1% to the area behind the muscle Quadratus Lumborum location 2
Multimodal Pharmacological Management: standard of care multimodal pharmacological management
|
|---|---|---|---|
|
Number of Participants Experiencing Side Effects
|
—
|
4 participants
|
3 participants
|
Adverse Events
Group 1 Standard of Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group 2 Standard of Care + Quadratus Lumborum Block II
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group 3 Standard of Care + Quadratus Lumborum Block III
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 Alexander Chan for Eman Nada, MD
UMass Chan Medical School
Phone: 7743030338
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place