Trial Outcomes & Findings for Impact of Quadratus Lumborum Block on Recovery Profile After Ventral Hernia Repair (NCT NCT03794882)

NCT ID: NCT03794882

Last Updated: 2022-09-21

Results Overview

Pain Score assessed on POD 1 using a Numerical Rating Scale (NRS) (0-10) where 0 represents no pain and 10 represents the worst pain imaginable.

• Recruitment status: TERMINATED
• Study phase: PHASE4
• Target enrollment: 14 participants
• Primary outcome timeframe: 24 hours
• Results posted on: 2022-09-21

Participant Flow

Participant milestones

Measure	QLB + Medical Management Subjects will undergo Intervention: Procedure/Surgery: Quadratus Lumborum Block and receive Intervention: Procedure: Standard Medical Management as needed. Quadratus Lumborum Block: 30 mL of .25% bupivacaine with 2.5mcg/mL epinephrine will ne injected on both sides of the mid-abdomen posterior to the mid-axillary line. Standard Medical Management: Standard medical management typically includes perioperative multimodal analgesia utilizing acetaminophen, opioids, non-steroidal anti-inflammatory drugs, and dexamethasone	Standard Medical Management Subjects will receive Intervention: Procedure: Standard Medical Management as needed. Standard Medical Management: Standard medical management typically includes perioperative multimodal analgesia utilizing acetaminophen, opioids, non-steroidal anti-inflammatory drugs, and dexamethasone
Overall Study STARTED	8	6
Overall Study COMPLETED	8	6
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Impact of Quadratus Lumborum Block on Recovery Profile After Ventral Hernia Repair

Baseline characteristics by cohort

Measure	QLB + Medical Management n=8 Participants Subjects will undergo Intervention: Procedure/Surgery: Quadratus Lumborum Block and receive Intervention: Procedure: Standard Medical Management as needed. Quadratus Lumborum Block: 30 mL of .25% bupivacaine with 2.5mcg/mL epinephrine will ne injected on both sides of the mid-abdomen posterior to the mid-axillary line. Standard Medical Management: Standard medical management typically includes perioperative multimodal analgesia utilizing acetaminophen, opioids, non-steroidal anti-inflammatory drugs, and dexamethasone	Standard Medical Management n=6 Participants Subjects will receive Intervention: Procedure: Standard Medical Management as needed. Standard Medical Management: Standard medical management typically includes perioperative multimodal analgesia utilizing acetaminophen, opioids, non-steroidal anti-inflammatory drugs, and dexamethasone	Total n=14 Participants Total of all reporting groups
Age, Continuous	49.38 years n=5 Participants	56.17 years n=7 Participants	54.69 years n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	3 Participants n=7 Participants	8 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	8 Participants n=5 Participants	6 Participants n=7 Participants	14 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	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 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	8 Participants n=5 Participants	6 Participants n=7 Participants	14 Participants n=5 Participants
Region of Enrollment United States	8 participants n=5 Participants	6 participants n=7 Participants	14 participants n=5 Participants

PRIMARY outcome

Timeframe: 24 hours

Population: Not all participants answered the survey.

Pain Score assessed on POD 1 using a Numerical Rating Scale (NRS) (0-10) where 0 represents no pain and 10 represents the worst pain imaginable.

Outcome measures

Measure	QLB + Medical Management n=8 Participants Subjects will undergo Intervention: Procedure/Surgery: Quadratus Lumborum Block and receive Intervention: Procedure: Standard Medical Management as needed. Quadratus Lumborum Block: 30 mL of .25% bupivacaine with 2.5mcg/mL epinephrine will ne injected on both sides of the mid-abdomen posterior to the mid-axillary line. Standard Medical Management: Standard medical management typically includes perioperative multimodal analgesia utilizing acetaminophen, opioids, non-steroidal anti-inflammatory drugs, and dexamethasone	Standard Medical Management n=5 Participants Subjects will receive Intervention: Procedure: Standard Medical Management as needed. Standard Medical Management: Standard medical management typically includes perioperative multimodal analgesia utilizing acetaminophen, opioids, non-steroidal anti-inflammatory drugs, and dexamethasone
Postoperative Day (POD) 1 Pain Score	3.7857 score on a scale Standard Deviation 1.643	4.015 score on a scale Standard Deviation 2.291

SECONDARY outcome

Timeframe: PACU, POD1, POD2, POD7

Population: Not all participants answered the survey.

Pain at rest in PACU, and on POD 1, 2, 7 using a Numerical Rating Scale (NRS) (0-10) where 0 represents no pain and 10 represents the worst pain imaginable.

Outcome measures

Measure	QLB + Medical Management n=8 Participants Subjects will undergo Intervention: Procedure/Surgery: Quadratus Lumborum Block and receive Intervention: Procedure: Standard Medical Management as needed. Quadratus Lumborum Block: 30 mL of .25% bupivacaine with 2.5mcg/mL epinephrine will ne injected on both sides of the mid-abdomen posterior to the mid-axillary line. Standard Medical Management: Standard medical management typically includes perioperative multimodal analgesia utilizing acetaminophen, opioids, non-steroidal anti-inflammatory drugs, and dexamethasone	Standard Medical Management n=6 Participants Subjects will receive Intervention: Procedure: Standard Medical Management as needed. Standard Medical Management: Standard medical management typically includes perioperative multimodal analgesia utilizing acetaminophen, opioids, non-steroidal anti-inflammatory drugs, and dexamethasone
Pain Score at Rest Pain Score at Rest PACU	7.5833 score on a scale Standard Deviation 2.224	7.12 score on a scale Standard Deviation 1.443
Pain Score at Rest Pain at Rest POD 1	3.88 score on a scale Standard Deviation 1.64	3.50 score on a scale Standard Deviation 2.25
Pain Score at Rest Pain at Rest POD 2	3.33 score on a scale Standard Deviation 0.96	3.00 score on a scale Standard Deviation 1.73
Pain Score at Rest Pain at Rest POD 7	1.43 score on a scale Standard Deviation 1.03	1.57 score on a scale Standard Deviation 1.34

SECONDARY outcome

Timeframe: PACU, POD1, POD2, POD7

Population: Not all participants answered survey questions.

Pain with activity in PACU and on POD 1, 2, 7 assessed using a Numerical Rating Scale (NRS) (0-10) where 0 represents no pain and 10 represents the worst pain imaginable.

Outcome measures

Measure	QLB + Medical Management n=8 Participants Subjects will undergo Intervention: Procedure/Surgery: Quadratus Lumborum Block and receive Intervention: Procedure: Standard Medical Management as needed. Quadratus Lumborum Block: 30 mL of .25% bupivacaine with 2.5mcg/mL epinephrine will ne injected on both sides of the mid-abdomen posterior to the mid-axillary line. Standard Medical Management: Standard medical management typically includes perioperative multimodal analgesia utilizing acetaminophen, opioids, non-steroidal anti-inflammatory drugs, and dexamethasone	Standard Medical Management n=6 Participants Subjects will receive Intervention: Procedure: Standard Medical Management as needed. Standard Medical Management: Standard medical management typically includes perioperative multimodal analgesia utilizing acetaminophen, opioids, non-steroidal anti-inflammatory drugs, and dexamethasone
Pain Score With Activity Pain Score with Activity POD 1	7.07 score on a scale Standard Deviation 2.20	6.75 score on a scale Standard Deviation 1.97
Pain Score With Activity Pain Score with Activity POD 2	7.00 score on a scale Standard Deviation 2.57	5.58 score on a scale Standard Deviation 1.41
Pain Score With Activity Pain Score with Activity POD 7	3.5712 score on a scale Standard Deviation 2.012	3.670 score on a scale Standard Deviation 1.155

SECONDARY outcome

Timeframe: PACU, POD1, POD2, POD7

Population: 3 participants from the QLB + Management Group did not respond to the 7 day OMME question.

Opioid Consumption in morphine equivalents in PACU and on POD, 1, 2, 7.

Outcome measures

Measure	QLB + Medical Management n=5 Participants Subjects will undergo Intervention: Procedure/Surgery: Quadratus Lumborum Block and receive Intervention: Procedure: Standard Medical Management as needed. Quadratus Lumborum Block: 30 mL of .25% bupivacaine with 2.5mcg/mL epinephrine will ne injected on both sides of the mid-abdomen posterior to the mid-axillary line. Standard Medical Management: Standard medical management typically includes perioperative multimodal analgesia utilizing acetaminophen, opioids, non-steroidal anti-inflammatory drugs, and dexamethasone	Standard Medical Management n=6 Participants Subjects will receive Intervention: Procedure: Standard Medical Management as needed. Standard Medical Management: Standard medical management typically includes perioperative multimodal analgesia utilizing acetaminophen, opioids, non-steroidal anti-inflammatory drugs, and dexamethasone
Opioid Consumption in Oral Morphine Milligram Equivalent (OMME) Opioid Consumption in PACU	28.93 OMME Standard Deviation 25.65	36.64 OMME Standard Deviation 16.70
Opioid Consumption in Oral Morphine Milligram Equivalent (OMME) Opioid Consumption POD 1	24.58 OMME Standard Deviation 15.31	19.50 OMME Standard Deviation 2.89
Opioid Consumption in Oral Morphine Milligram Equivalent (OMME) Opioid Consumption POD 2	27.50 OMME Standard Deviation 17.00	20.50 OMME Standard Deviation 5.77
Opioid Consumption in Oral Morphine Milligram Equivalent (OMME) Opioid Consumption POD 7	58 OMME Standard Deviation 79.88	66.5 OMME Standard Deviation 37.27

SECONDARY outcome

Timeframe: PACU, POD1, POD2, POD7

Population: Two subjects on the expermental protocol and one in the control group were unable to provide the answers to this secondary aim question when asked by the study team.

Location of most severe pain on assessed by questioning the patient in PACU and on POD 1, 2, 7.

Outcome measures

Measure	QLB + Medical Management n=8 Participants Subjects will undergo Intervention: Procedure/Surgery: Quadratus Lumborum Block and receive Intervention: Procedure: Standard Medical Management as needed. Quadratus Lumborum Block: 30 mL of .25% bupivacaine with 2.5mcg/mL epinephrine will ne injected on both sides of the mid-abdomen posterior to the mid-axillary line. Standard Medical Management: Standard medical management typically includes perioperative multimodal analgesia utilizing acetaminophen, opioids, non-steroidal anti-inflammatory drugs, and dexamethasone	Standard Medical Management n=6 Participants Subjects will receive Intervention: Procedure: Standard Medical Management as needed. Standard Medical Management: Standard medical management typically includes perioperative multimodal analgesia utilizing acetaminophen, opioids, non-steroidal anti-inflammatory drugs, and dexamethasone
Location of Most Severe Pain PACU · around navel	4 Participants	2 Participants
Location of Most Severe Pain PACU · incision area	2 Participants	2 Participants
Location of Most Severe Pain PACU · abdomen	0 Participants	0 Participants
Location of Most Severe Pain PACU · navel	0 Participants	1 Participants
Location of Most Severe Pain PACU · stomach area	0 Participants	0 Participants
Location of Most Severe Pain PACU · middle of abomen	0 Participants	0 Participants
Location of Most Severe Pain PACU · middle	0 Participants	0 Participants
Location of Most Severe Pain POD 1 · around navel	0 Participants	0 Participants
Location of Most Severe Pain POD 1 · incision area	2 Participants	2 Participants
Location of Most Severe Pain POD 1 · abdomen	2 Participants	2 Participants
Location of Most Severe Pain POD 1 · navel	0 Participants	0 Participants
Location of Most Severe Pain POD 1 · stomach area	1 Participants	0 Participants
Location of Most Severe Pain POD 1 · middle of abomen	1 Participants	0 Participants
Location of Most Severe Pain POD 1 · middle	1 Participants	0 Participants
Location of Most Severe Pain POD 2 · around navel	1 Participants	1 Participants
Location of Most Severe Pain POD 2 · incision area	3 Participants	2 Participants
Location of Most Severe Pain POD 2 · abdomen	1 Participants	2 Participants
Location of Most Severe Pain POD 2 · navel	0 Participants	0 Participants
Location of Most Severe Pain POD 2 · stomach area	0 Participants	1 Participants
Location of Most Severe Pain POD 2 · middle of abomen	2 Participants	0 Participants
Location of Most Severe Pain POD 2 · middle	0 Participants	0 Participants
Location of Most Severe Pain POD 7 · around navel	0 Participants	0 Participants
Location of Most Severe Pain POD 7 · incision area	3 Participants	2 Participants
Location of Most Severe Pain POD 7 · abdomen	0 Participants	2 Participants
Location of Most Severe Pain POD 7 · navel	0 Participants	1 Participants
Location of Most Severe Pain POD 7 · stomach area	2 Participants	0 Participants
Location of Most Severe Pain POD 7 · middle of abomen	0 Participants	0 Participants
Location of Most Severe Pain POD 7 · middle	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 48 hours

Duration of patients' time in PACU.

Outcome measures

Measure	QLB + Medical Management n=8 Participants Subjects will undergo Intervention: Procedure/Surgery: Quadratus Lumborum Block and receive Intervention: Procedure: Standard Medical Management as needed. Quadratus Lumborum Block: 30 mL of .25% bupivacaine with 2.5mcg/mL epinephrine will ne injected on both sides of the mid-abdomen posterior to the mid-axillary line. Standard Medical Management: Standard medical management typically includes perioperative multimodal analgesia utilizing acetaminophen, opioids, non-steroidal anti-inflammatory drugs, and dexamethasone	Standard Medical Management n=6 Participants Subjects will receive Intervention: Procedure: Standard Medical Management as needed. Standard Medical Management: Standard medical management typically includes perioperative multimodal analgesia utilizing acetaminophen, opioids, non-steroidal anti-inflammatory drugs, and dexamethasone
Time in PACU	66.63 minutes Standard Deviation 28.58	64.33 minutes Standard Deviation 26.82

SECONDARY outcome

Timeframe: 72 hours

Total postoperative time until discharge.

Outcome measures

Measure	QLB + Medical Management n=8 Participants Subjects will undergo Intervention: Procedure/Surgery: Quadratus Lumborum Block and receive Intervention: Procedure: Standard Medical Management as needed. Quadratus Lumborum Block: 30 mL of .25% bupivacaine with 2.5mcg/mL epinephrine will ne injected on both sides of the mid-abdomen posterior to the mid-axillary line. Standard Medical Management: Standard medical management typically includes perioperative multimodal analgesia utilizing acetaminophen, opioids, non-steroidal anti-inflammatory drugs, and dexamethasone	Standard Medical Management n=5 Participants Subjects will receive Intervention: Procedure: Standard Medical Management as needed. Standard Medical Management: Standard medical management typically includes perioperative multimodal analgesia utilizing acetaminophen, opioids, non-steroidal anti-inflammatory drugs, and dexamethasone
Postoperative Time to Discharge	66.625 hours Standard Deviation 28.58	66.60 hours Standard Deviation 26.82

SECONDARY outcome

Timeframe: 12 hours

Population: This question was not asked by the clinical team at 12 hours and therefore, no data can be entered for this aim.

For patients that underwent QLB, numbness to ice will be assessed by filling a plastic glove with ice water and systematically assessing numbness to cold in the thoracic and lumbar dermatomes by comparing these sites with a reference point.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 hours

Patient will be questioned to assess if they have nausea in PACU.

Outcome measures

Measure	QLB + Medical Management n=8 Participants Subjects will undergo Intervention: Procedure/Surgery: Quadratus Lumborum Block and receive Intervention: Procedure: Standard Medical Management as needed. Quadratus Lumborum Block: 30 mL of .25% bupivacaine with 2.5mcg/mL epinephrine will ne injected on both sides of the mid-abdomen posterior to the mid-axillary line. Standard Medical Management: Standard medical management typically includes perioperative multimodal analgesia utilizing acetaminophen, opioids, non-steroidal anti-inflammatory drugs, and dexamethasone	Standard Medical Management n=5 Participants Subjects will receive Intervention: Procedure: Standard Medical Management as needed. Standard Medical Management: Standard medical management typically includes perioperative multimodal analgesia utilizing acetaminophen, opioids, non-steroidal anti-inflammatory drugs, and dexamethasone
Number of Participants Who Report Nausea in PACU	2 Participants	0 Participants

SECONDARY outcome

Timeframe: 12 hours

Population: This secondary aim was not asked/followed up by the PI and therefore, the subjects were not asked this question and no data was collected for either time point.

Total consumption of antiemetics on POD 0 and in PACU.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: POD1, POD2, POD7

Population: Data was not collected from all participants.

Patient will be questioned to assess if they had nausea necessitating treatment on POD 1, 2, and 7

Outcome measures

Measure	QLB + Medical Management n=5 Participants Subjects will undergo Intervention: Procedure/Surgery: Quadratus Lumborum Block and receive Intervention: Procedure: Standard Medical Management as needed. Quadratus Lumborum Block: 30 mL of .25% bupivacaine with 2.5mcg/mL epinephrine will ne injected on both sides of the mid-abdomen posterior to the mid-axillary line. Standard Medical Management: Standard medical management typically includes perioperative multimodal analgesia utilizing acetaminophen, opioids, non-steroidal anti-inflammatory drugs, and dexamethasone	Standard Medical Management n=4 Participants Subjects will receive Intervention: Procedure: Standard Medical Management as needed. Standard Medical Management: Standard medical management typically includes perioperative multimodal analgesia utilizing acetaminophen, opioids, non-steroidal anti-inflammatory drugs, and dexamethasone
Number of Participants With Presence of Nausea Necessitating Treatment POD 1	5 Participants	4 Participants
Number of Participants With Presence of Nausea Necessitating Treatment POD 2	0 Participants	0 Participants
Number of Participants With Presence of Nausea Necessitating Treatment POD 7	0 Participants	0 Participants

SECONDARY outcome

Timeframe: POD1, POD2, POD7

Population: Not all participants responded to the survey question.

Satisfaction with perioperative care on POD 1, 2, and 7 measured by a Numerical Rating Scale (0-10) with 0 representing no satisfaction and 10 representing high satisfaction.

Outcome measures

Measure	QLB + Medical Management n=7 Participants Subjects will undergo Intervention: Procedure/Surgery: Quadratus Lumborum Block and receive Intervention: Procedure: Standard Medical Management as needed. Quadratus Lumborum Block: 30 mL of .25% bupivacaine with 2.5mcg/mL epinephrine will ne injected on both sides of the mid-abdomen posterior to the mid-axillary line. Standard Medical Management: Standard medical management typically includes perioperative multimodal analgesia utilizing acetaminophen, opioids, non-steroidal anti-inflammatory drugs, and dexamethasone	Standard Medical Management n=5 Participants Subjects will receive Intervention: Procedure: Standard Medical Management as needed. Standard Medical Management: Standard medical management typically includes perioperative multimodal analgesia utilizing acetaminophen, opioids, non-steroidal anti-inflammatory drugs, and dexamethasone
Rating of Satisfaction With Perioperative Care Rating of Satisfaction with perioperative care POD 1	8.60 score on a scale Standard Deviation 0.97	9.20 score on a scale Standard Deviation 1.14
Rating of Satisfaction With Perioperative Care Rating of Satisfaction with perioperative care POD 2	8.83 score on a scale Standard Deviation 0.96	9.17 score on a scale Standard Deviation 1.91
Rating of Satisfaction With Perioperative Care Rating of Satisfaction with perioperative care POD 7	9.21 score on a scale Standard Deviation 1.096	8.61 score on a scale Standard Deviation 1.768

SECONDARY outcome

Timeframe: 12 hours

Total consumption of Non-Opioid Analgesics in the PACU.

Outcome measures

Measure	QLB + Medical Management n=8 Participants Subjects will undergo Intervention: Procedure/Surgery: Quadratus Lumborum Block and receive Intervention: Procedure: Standard Medical Management as needed. Quadratus Lumborum Block: 30 mL of .25% bupivacaine with 2.5mcg/mL epinephrine will ne injected on both sides of the mid-abdomen posterior to the mid-axillary line. Standard Medical Management: Standard medical management typically includes perioperative multimodal analgesia utilizing acetaminophen, opioids, non-steroidal anti-inflammatory drugs, and dexamethasone	Standard Medical Management n=6 Participants Subjects will receive Intervention: Procedure: Standard Medical Management as needed. Standard Medical Management: Standard medical management typically includes perioperative multimodal analgesia utilizing acetaminophen, opioids, non-steroidal anti-inflammatory drugs, and dexamethasone
Total Non-Opioid Analgesic Consumption in PACU: Measured in Milligrams Ketorolac	0 milligrams Standard Deviation 0	5 milligrams Standard Deviation 12.25
Total Non-Opioid Analgesic Consumption in PACU: Measured in Milligrams lidocaine in mg	0 milligrams Standard Deviation 0	0 milligrams Standard Deviation 0
Total Non-Opioid Analgesic Consumption in PACU: Measured in Milligrams acetaminophen in mg	235.71 milligrams Standard Deviation 415.04	333.33 milligrams Standard Deviation 440.17

SECONDARY outcome

Timeframe: 6 hours

This measure describes the amount, in milliliters, of non-opioid analgesics administered in the Operating Room.

Outcome measures

Measure	QLB + Medical Management n=8 Participants Subjects will undergo Intervention: Procedure/Surgery: Quadratus Lumborum Block and receive Intervention: Procedure: Standard Medical Management as needed. Quadratus Lumborum Block: 30 mL of .25% bupivacaine with 2.5mcg/mL epinephrine will ne injected on both sides of the mid-abdomen posterior to the mid-axillary line. Standard Medical Management: Standard medical management typically includes perioperative multimodal analgesia utilizing acetaminophen, opioids, non-steroidal anti-inflammatory drugs, and dexamethasone	Standard Medical Management n=6 Participants Subjects will receive Intervention: Procedure: Standard Medical Management as needed. Standard Medical Management: Standard medical management typically includes perioperative multimodal analgesia utilizing acetaminophen, opioids, non-steroidal anti-inflammatory drugs, and dexamethasone
Additional Analgesics in Milliliters Administered in the Operating Room	0 milliliters Standard Deviation 0	15.00 milliliters Standard Deviation 16.43

SECONDARY outcome

Timeframe: 6 hours

This measure describes the amount, in milligrams, of non-opioid analgesics administered in the Operating Room.

Outcome measures

Measure	QLB + Medical Management n=8 Participants Subjects will undergo Intervention: Procedure/Surgery: Quadratus Lumborum Block and receive Intervention: Procedure: Standard Medical Management as needed. Quadratus Lumborum Block: 30 mL of .25% bupivacaine with 2.5mcg/mL epinephrine will ne injected on both sides of the mid-abdomen posterior to the mid-axillary line. Standard Medical Management: Standard medical management typically includes perioperative multimodal analgesia utilizing acetaminophen, opioids, non-steroidal anti-inflammatory drugs, and dexamethasone	Standard Medical Management n=6 Participants Subjects will receive Intervention: Procedure: Standard Medical Management as needed. Standard Medical Management: Standard medical management typically includes perioperative multimodal analgesia utilizing acetaminophen, opioids, non-steroidal anti-inflammatory drugs, and dexamethasone
Additional Analgesics in Milligrams Administered in the Operating Room Ketorolac	8.57 milligrams Standard Deviation 8.02	2.50 milligrams Standard Deviation 6.12
Additional Analgesics in Milligrams Administered in the Operating Room Acetaminophen	166.67 milligrams Standard Deviation 408.25	0 milligrams Standard Deviation 0
Additional Analgesics in Milligrams Administered in the Operating Room Propofol	0.00 milligrams Standard Deviation 0.00	28.33 milligrams Standard Deviation 69.40
Additional Analgesics in Milligrams Administered in the Operating Room lidocaine	17.50 milligrams Standard Deviation 36.15	20.00 milligrams Standard Deviation 40.00

Adverse Events

QLB + Medical Management

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Standard Medical Management

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	QLB + Medical Management n=8 participants at risk Subjects will undergo Intervention: Procedure/Surgery: Quadratus Lumborum Block and receive Intervention: Procedure: Standard Medical Management as needed. Quadratus Lumborum Block: 30 mL of .25% bupivacaine with 2.5mcg/mL epinephrine will ne injected on both sides of the mid-abdomen posterior to the mid-axillary line. Standard Medical Management: Standard medical management typically includes perioperative multimodal analgesia utilizing acetaminophen, opioids, non-steroidal anti-inflammatory drugs, and dexamethasone	Standard Medical Management n=6 participants at risk Subjects will receive Intervention: Procedure: Standard Medical Management as needed. Standard Medical Management: Standard medical management typically includes perioperative multimodal analgesia utilizing acetaminophen, opioids, non-steroidal anti-inflammatory drugs, and dexamethasone
General disorders incision site bleeding	0.00% 0/8 • up to Post-operative day 7 (POD7)	16.7% 1/6 • Number of events 1 • up to Post-operative day 7 (POD7)
General disorders tiredness	0.00% 0/8 • up to Post-operative day 7 (POD7)	16.7% 1/6 • Number of events 1 • up to Post-operative day 7 (POD7)

Additional Information

Dr Kristin Bevil

University of Wisconsin-Madison

Phone: 6082638100

Email: kbevil@wisc.edu

Results disclosure agreements

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