Trial Outcomes & Findings for Repeat or Single Quadratus Lumborum Block for the Reduction of Opioid Prescriptions After Surgery in Retroperitoneal Sarcoma Patients ("RESQU-SARC" Trial) (NCT NCT04189783)

NCT ID: NCT04189783

Last Updated: 2026-01-23

Results Overview

After sarcoma surgery, our historical discharge opioid prescription was a median of 300mg oral morphine equivalents (OME) in 2016-2018, with 5% patients discharged opioid-free. The primary objective of this study was to compare 2 novel opioid-reduction bundles to increase the proportion of opioid-free patients.

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

PHASE2

Target enrollment

113 participants

Primary outcome timeframe

At time of discharge (median of 9 days)

Results posted on

2026-01-23

Participant Flow

84 patients underwent resection, with 43 Arm-1 (Usual care) patients and 41 Arm-2 (2nd QL-block).

29 participants were excluded from the study before assignment to arms due to screen failure, aborted surgery, discharged before 4 days after surgery or opioids free at 3rd day after surgery.

Participant milestones

Participant milestones
Measure
Arm 1, Control Arm (Usual Care)
Arm 1 was a novel bundle (single block, 3 non-opioids, 5x-multiplier).
Arm 2, Experimental Arm (2nd QL-Block)
Arm 2 was the Arm 1 plus 2nd QL-block on POD4
Overall Study
STARTED
43
41
Overall Study
COMPLETED
43
41
Overall Study
NOT COMPLETED
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Repeat or Single Quadratus Lumborum Block for the Reduction of Opioid Prescriptions After Surgery in Retroperitoneal Sarcoma Patients ("RESQU-SARC" Trial)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Arm 1, Control Arm (Usual Care)
n=43 Participants
Arm 1 was a novel bundle (single block, 3 non-opioids, 5x-multiplier).
Arm 2, Experimental Arm (2nd QL-Block)
n=41 Participants
Arm 2 was the Arm 1 plus 2nd QL-block on POD4
Total
n=84 Participants
Total of all reporting groups
Age, Categorical
<=18 years
0 Participants
n=270 Participants
0 Participants
n=4 Participants
0 Participants
n=9 Participants
Age, Categorical
Between 18 and 65 years
27 Participants
n=270 Participants
27 Participants
n=4 Participants
54 Participants
n=9 Participants
Age, Categorical
>=65 years
16 Participants
n=270 Participants
14 Participants
n=4 Participants
30 Participants
n=9 Participants
Age, Continuous
57 years
STANDARD_DEVIATION 13.3 • n=270 Participants
60 years
STANDARD_DEVIATION 12.7 • n=4 Participants
58 years
STANDARD_DEVIATION 13.0 • n=9 Participants
Sex: Female, Male
Female
15 Participants
n=270 Participants
17 Participants
n=4 Participants
32 Participants
n=9 Participants
Sex: Female, Male
Male
28 Participants
n=270 Participants
24 Participants
n=4 Participants
52 Participants
n=9 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
7 Participants
n=270 Participants
5 Participants
n=4 Participants
12 Participants
n=9 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
36 Participants
n=270 Participants
34 Participants
n=4 Participants
70 Participants
n=9 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=270 Participants
2 Participants
n=4 Participants
2 Participants
n=9 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=270 Participants
0 Participants
n=4 Participants
0 Participants
n=9 Participants
Race (NIH/OMB)
Asian
1 Participants
n=270 Participants
4 Participants
n=4 Participants
5 Participants
n=9 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=270 Participants
0 Participants
n=4 Participants
0 Participants
n=9 Participants
Race (NIH/OMB)
Black or African American
3 Participants
n=270 Participants
0 Participants
n=4 Participants
3 Participants
n=9 Participants
Race (NIH/OMB)
White
37 Participants
n=270 Participants
36 Participants
n=4 Participants
73 Participants
n=9 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=270 Participants
0 Participants
n=4 Participants
0 Participants
n=9 Participants
Race (NIH/OMB)
Unknown or Not Reported
2 Participants
n=270 Participants
1 Participants
n=4 Participants
3 Participants
n=9 Participants
Region of Enrollment
United States
43 participants
n=270 Participants
41 participants
n=4 Participants
84 participants
n=9 Participants

PRIMARY outcome

Timeframe: At time of discharge (median of 9 days)

After sarcoma surgery, our historical discharge opioid prescription was a median of 300mg oral morphine equivalents (OME) in 2016-2018, with 5% patients discharged opioid-free. The primary objective of this study was to compare 2 novel opioid-reduction bundles to increase the proportion of opioid-free patients.

Outcome measures

Outcome measures
Measure
Arm 1, Control Arm (Usual Care)
n=43 Participants
Arm 1 was a novel bundle (single block, 3 non-opioids, 5x-multiplier).
Arm 2, Experimental Arm (2nd QL-Block)
n=41 Participants
Arm 2 was the Arm 1 plus 2nd QL-block on POD4
Initial Discharge Prescription Oral Morphine Equivalents (OME)
50 mg of Oral Morphine Equivalents (OME)
Standard Deviation 444
25 mg of Oral Morphine Equivalents (OME)
Standard Deviation 342

SECONDARY outcome

Timeframe: At time of discharge (median of 9 days)

Comparing the rate of opioid free patients at discharge between the 2 Arms

Outcome measures

Outcome measures
Measure
Arm 1, Control Arm (Usual Care)
n=43 Participants
Arm 1 was a novel bundle (single block, 3 non-opioids, 5x-multiplier).
Arm 2, Experimental Arm (2nd QL-Block)
n=41 Participants
Arm 2 was the Arm 1 plus 2nd QL-block on POD4
Proportion of Participants With Discharge Prescription OME = Zero
14 Participants
19 Participants

SECONDARY outcome

Timeframe: Scores at discharge and 1 month after the surgery

Compare the scores based on MDASI-GI between the 2 Arms. Score from 0 to 10 to define participant feelings with 0 for none and 10 for worst.

Outcome measures

Outcome measures
Measure
Arm 1, Control Arm (Usual Care)
n=43 Participants
Arm 1 was a novel bundle (single block, 3 non-opioids, 5x-multiplier).
Arm 2, Experimental Arm (2nd QL-Block)
n=41 Participants
Arm 2 was the Arm 1 plus 2nd QL-block on POD4
Participant Reported Outcomes for Gastrointestinal Surgery- MD Anderson Symptom Inventory (MDASI-GI) at Discharge and 1 Month After Surgery.
Pain score at discharge
5 score on a scale
Standard Deviation 3
4 score on a scale
Standard Deviation 2
Participant Reported Outcomes for Gastrointestinal Surgery- MD Anderson Symptom Inventory (MDASI-GI) at Discharge and 1 Month After Surgery.
Pain score at 1 month
3 score on a scale
Standard Deviation 2
3 score on a scale
Standard Deviation 3
Participant Reported Outcomes for Gastrointestinal Surgery- MD Anderson Symptom Inventory (MDASI-GI) at Discharge and 1 Month After Surgery.
General activity interference at discharge
5 score on a scale
Standard Deviation 3
4 score on a scale
Standard Deviation 3
Participant Reported Outcomes for Gastrointestinal Surgery- MD Anderson Symptom Inventory (MDASI-GI) at Discharge and 1 Month After Surgery.
General activity interference at 1 month
3 score on a scale
Standard Deviation 2
3 score on a scale
Standard Deviation 3
Participant Reported Outcomes for Gastrointestinal Surgery- MD Anderson Symptom Inventory (MDASI-GI) at Discharge and 1 Month After Surgery.
Interference with enjoyment of life at discharge
4 score on a scale
Standard Deviation 3
3 score on a scale
Standard Deviation 3
Participant Reported Outcomes for Gastrointestinal Surgery- MD Anderson Symptom Inventory (MDASI-GI) at Discharge and 1 Month After Surgery.
Interference with enjoyment of life at 1 month
2 score on a scale
Standard Deviation 2
3 score on a scale
Standard Deviation 3

Adverse Events

Arm 1, Control Arm (Usual Care)

Serious events: 9 serious events
Other events: 6 other events
Deaths: 6 deaths

Arm 2, Experimental Arm (2nd QL-Block)

Serious events: 10 serious events
Other events: 7 other events
Deaths: 2 deaths

Serious adverse events

Serious adverse events
Measure
Arm 1, Control Arm (Usual Care)
n=43 participants at risk
Arm 1 was a novel bundle (single block, 3 non-opioids, 5x-multiplier).
Arm 2, Experimental Arm (2nd QL-Block)
n=41 participants at risk
Arm 2 was the Arm 1 plus 2nd QL-block on POD4
Blood and lymphatic system disorders
Anemia requiring transfusion
0.00%
0/43 • Approximately 3 years, 5 months
All surgical complications for 90 days after the surgery were recorded. They were all unrelated to the QL-Block. Eight patients died during the study, and they were all unrelated to the QL-Block.
2.4%
1/41 • Approximately 3 years, 5 months
All surgical complications for 90 days after the surgery were recorded. They were all unrelated to the QL-Block. Eight patients died during the study, and they were all unrelated to the QL-Block.
Renal and urinary disorders
Bladder leak requiring drain placement
2.3%
1/43 • Approximately 3 years, 5 months
All surgical complications for 90 days after the surgery were recorded. They were all unrelated to the QL-Block. Eight patients died during the study, and they were all unrelated to the QL-Block.
0.00%
0/41 • Approximately 3 years, 5 months
All surgical complications for 90 days after the surgery were recorded. They were all unrelated to the QL-Block. Eight patients died during the study, and they were all unrelated to the QL-Block.
Gastrointestinal disorders
Delayed gastric emptying requiring percutaneous gastrostomy tube
0.00%
0/43 • Approximately 3 years, 5 months
All surgical complications for 90 days after the surgery were recorded. They were all unrelated to the QL-Block. Eight patients died during the study, and they were all unrelated to the QL-Block.
2.4%
1/41 • Approximately 3 years, 5 months
All surgical complications for 90 days after the surgery were recorded. They were all unrelated to the QL-Block. Eight patients died during the study, and they were all unrelated to the QL-Block.
Gastrointestinal disorders
Diarrhea requiring readmission
2.3%
1/43 • Approximately 3 years, 5 months
All surgical complications for 90 days after the surgery were recorded. They were all unrelated to the QL-Block. Eight patients died during the study, and they were all unrelated to the QL-Block.
0.00%
0/41 • Approximately 3 years, 5 months
All surgical complications for 90 days after the surgery were recorded. They were all unrelated to the QL-Block. Eight patients died during the study, and they were all unrelated to the QL-Block.
Infections and infestations
Intra-abdominal abscess/sepsis requiring emergent reoperation
0.00%
0/43 • Approximately 3 years, 5 months
All surgical complications for 90 days after the surgery were recorded. They were all unrelated to the QL-Block. Eight patients died during the study, and they were all unrelated to the QL-Block.
2.4%
1/41 • Approximately 3 years, 5 months
All surgical complications for 90 days after the surgery were recorded. They were all unrelated to the QL-Block. Eight patients died during the study, and they were all unrelated to the QL-Block.
Hepatobiliary disorders
Pancreatic leak requiring drainage
2.3%
1/43 • Approximately 3 years, 5 months
All surgical complications for 90 days after the surgery were recorded. They were all unrelated to the QL-Block. Eight patients died during the study, and they were all unrelated to the QL-Block.
0.00%
0/41 • Approximately 3 years, 5 months
All surgical complications for 90 days after the surgery were recorded. They were all unrelated to the QL-Block. Eight patients died during the study, and they were all unrelated to the QL-Block.
Hepatobiliary disorders
Pancreatic leak requiring IR drain
2.3%
1/43 • Approximately 3 years, 5 months
All surgical complications for 90 days after the surgery were recorded. They were all unrelated to the QL-Block. Eight patients died during the study, and they were all unrelated to the QL-Block.
0.00%
0/41 • Approximately 3 years, 5 months
All surgical complications for 90 days after the surgery were recorded. They were all unrelated to the QL-Block. Eight patients died during the study, and they were all unrelated to the QL-Block.
Gastrointestinal disorders
Partial small bowel obstruction
0.00%
0/43 • Approximately 3 years, 5 months
All surgical complications for 90 days after the surgery were recorded. They were all unrelated to the QL-Block. Eight patients died during the study, and they were all unrelated to the QL-Block.
2.4%
1/41 • Approximately 3 years, 5 months
All surgical complications for 90 days after the surgery were recorded. They were all unrelated to the QL-Block. Eight patients died during the study, and they were all unrelated to the QL-Block.
Gastrointestinal disorders
Pleural effusin
2.3%
1/43 • Approximately 3 years, 5 months
All surgical complications for 90 days after the surgery were recorded. They were all unrelated to the QL-Block. Eight patients died during the study, and they were all unrelated to the QL-Block.
0.00%
0/41 • Approximately 3 years, 5 months
All surgical complications for 90 days after the surgery were recorded. They were all unrelated to the QL-Block. Eight patients died during the study, and they were all unrelated to the QL-Block.
Blood and lymphatic system disorders
Postoperative hemorrhage requiring reintervention
2.3%
1/43 • Approximately 3 years, 5 months
All surgical complications for 90 days after the surgery were recorded. They were all unrelated to the QL-Block. Eight patients died during the study, and they were all unrelated to the QL-Block.
0.00%
0/41 • Approximately 3 years, 5 months
All surgical complications for 90 days after the surgery were recorded. They were all unrelated to the QL-Block. Eight patients died during the study, and they were all unrelated to the QL-Block.
Infections and infestations
Postoperative infection requiring re-intervention
0.00%
0/43 • Approximately 3 years, 5 months
All surgical complications for 90 days after the surgery were recorded. They were all unrelated to the QL-Block. Eight patients died during the study, and they were all unrelated to the QL-Block.
4.9%
2/41 • Approximately 3 years, 5 months
All surgical complications for 90 days after the surgery were recorded. They were all unrelated to the QL-Block. Eight patients died during the study, and they were all unrelated to the QL-Block.
Gastrointestinal disorders
Postoperative small bowel obstruction
0.00%
0/43 • Approximately 3 years, 5 months
All surgical complications for 90 days after the surgery were recorded. They were all unrelated to the QL-Block. Eight patients died during the study, and they were all unrelated to the QL-Block.
2.4%
1/41 • Approximately 3 years, 5 months
All surgical complications for 90 days after the surgery were recorded. They were all unrelated to the QL-Block. Eight patients died during the study, and they were all unrelated to the QL-Block.
Renal and urinary disorders
Renal Obstruction requiring percutaneous nephrostomy
2.3%
1/43 • Approximately 3 years, 5 months
All surgical complications for 90 days after the surgery were recorded. They were all unrelated to the QL-Block. Eight patients died during the study, and they were all unrelated to the QL-Block.
0.00%
0/41 • Approximately 3 years, 5 months
All surgical complications for 90 days after the surgery were recorded. They were all unrelated to the QL-Block. Eight patients died during the study, and they were all unrelated to the QL-Block.
Gastrointestinal disorders
Small bowel obstruction; intra-abdominal abscess
0.00%
0/43 • Approximately 3 years, 5 months
All surgical complications for 90 days after the surgery were recorded. They were all unrelated to the QL-Block. Eight patients died during the study, and they were all unrelated to the QL-Block.
2.4%
1/41 • Approximately 3 years, 5 months
All surgical complications for 90 days after the surgery were recorded. They were all unrelated to the QL-Block. Eight patients died during the study, and they were all unrelated to the QL-Block.
Renal and urinary disorders
Ureteral obstruction requiring stent placement
4.7%
2/43 • Approximately 3 years, 5 months
All surgical complications for 90 days after the surgery were recorded. They were all unrelated to the QL-Block. Eight patients died during the study, and they were all unrelated to the QL-Block.
0.00%
0/41 • Approximately 3 years, 5 months
All surgical complications for 90 days after the surgery were recorded. They were all unrelated to the QL-Block. Eight patients died during the study, and they were all unrelated to the QL-Block.
Infections and infestations
UTI treated with antibiotics
0.00%
0/43 • Approximately 3 years, 5 months
All surgical complications for 90 days after the surgery were recorded. They were all unrelated to the QL-Block. Eight patients died during the study, and they were all unrelated to the QL-Block.
2.4%
1/41 • Approximately 3 years, 5 months
All surgical complications for 90 days after the surgery were recorded. They were all unrelated to the QL-Block. Eight patients died during the study, and they were all unrelated to the QL-Block.
Surgical and medical procedures
Wound dehiscence requiring repeat operation
0.00%
0/43 • Approximately 3 years, 5 months
All surgical complications for 90 days after the surgery were recorded. They were all unrelated to the QL-Block. Eight patients died during the study, and they were all unrelated to the QL-Block.
2.4%
1/41 • Approximately 3 years, 5 months
All surgical complications for 90 days after the surgery were recorded. They were all unrelated to the QL-Block. Eight patients died during the study, and they were all unrelated to the QL-Block.

Other adverse events

Other adverse events
Measure
Arm 1, Control Arm (Usual Care)
n=43 participants at risk
Arm 1 was a novel bundle (single block, 3 non-opioids, 5x-multiplier).
Arm 2, Experimental Arm (2nd QL-Block)
n=41 participants at risk
Arm 2 was the Arm 1 plus 2nd QL-block on POD4
Renal and urinary disorders
AKI
0.00%
0/43 • Approximately 3 years, 5 months
All surgical complications for 90 days after the surgery were recorded. They were all unrelated to the QL-Block. Eight patients died during the study, and they were all unrelated to the QL-Block.
2.4%
1/41 • Approximately 3 years, 5 months
All surgical complications for 90 days after the surgery were recorded. They were all unrelated to the QL-Block. Eight patients died during the study, and they were all unrelated to the QL-Block.
Blood and lymphatic system disorders
Chyle leak requiring JP drain
2.3%
1/43 • Approximately 3 years, 5 months
All surgical complications for 90 days after the surgery were recorded. They were all unrelated to the QL-Block. Eight patients died during the study, and they were all unrelated to the QL-Block.
0.00%
0/41 • Approximately 3 years, 5 months
All surgical complications for 90 days after the surgery were recorded. They were all unrelated to the QL-Block. Eight patients died during the study, and they were all unrelated to the QL-Block.
Gastrointestinal disorders
Constipation, resolved w miralax
0.00%
0/43 • Approximately 3 years, 5 months
All surgical complications for 90 days after the surgery were recorded. They were all unrelated to the QL-Block. Eight patients died during the study, and they were all unrelated to the QL-Block.
2.4%
1/41 • Approximately 3 years, 5 months
All surgical complications for 90 days after the surgery were recorded. They were all unrelated to the QL-Block. Eight patients died during the study, and they were all unrelated to the QL-Block.
General disorders
DVT treated with anticoagulation
2.3%
1/43 • Approximately 3 years, 5 months
All surgical complications for 90 days after the surgery were recorded. They were all unrelated to the QL-Block. Eight patients died during the study, and they were all unrelated to the QL-Block.
0.00%
0/41 • Approximately 3 years, 5 months
All surgical complications for 90 days after the surgery were recorded. They were all unrelated to the QL-Block. Eight patients died during the study, and they were all unrelated to the QL-Block.
Gastrointestinal disorders
Ileus
0.00%
0/43 • Approximately 3 years, 5 months
All surgical complications for 90 days after the surgery were recorded. They were all unrelated to the QL-Block. Eight patients died during the study, and they were all unrelated to the QL-Block.
2.4%
1/41 • Approximately 3 years, 5 months
All surgical complications for 90 days after the surgery were recorded. They were all unrelated to the QL-Block. Eight patients died during the study, and they were all unrelated to the QL-Block.
Gastrointestinal disorders
Prolonged ileus requiring NG placement and TPN
2.3%
1/43 • Approximately 3 years, 5 months
All surgical complications for 90 days after the surgery were recorded. They were all unrelated to the QL-Block. Eight patients died during the study, and they were all unrelated to the QL-Block.
0.00%
0/41 • Approximately 3 years, 5 months
All surgical complications for 90 days after the surgery were recorded. They were all unrelated to the QL-Block. Eight patients died during the study, and they were all unrelated to the QL-Block.
Infections and infestations
SSI requiring wound vac therapy
0.00%
0/43 • Approximately 3 years, 5 months
All surgical complications for 90 days after the surgery were recorded. They were all unrelated to the QL-Block. Eight patients died during the study, and they were all unrelated to the QL-Block.
2.4%
1/41 • Approximately 3 years, 5 months
All surgical complications for 90 days after the surgery were recorded. They were all unrelated to the QL-Block. Eight patients died during the study, and they were all unrelated to the QL-Block.
Infections and infestations
SSI, resolved w keflex
2.3%
1/43 • Approximately 3 years, 5 months
All surgical complications for 90 days after the surgery were recorded. They were all unrelated to the QL-Block. Eight patients died during the study, and they were all unrelated to the QL-Block.
2.4%
1/41 • Approximately 3 years, 5 months
All surgical complications for 90 days after the surgery were recorded. They were all unrelated to the QL-Block. Eight patients died during the study, and they were all unrelated to the QL-Block.
Infections and infestations
Superficial surgical infection
2.3%
1/43 • Approximately 3 years, 5 months
All surgical complications for 90 days after the surgery were recorded. They were all unrelated to the QL-Block. Eight patients died during the study, and they were all unrelated to the QL-Block.
2.4%
1/41 • Approximately 3 years, 5 months
All surgical complications for 90 days after the surgery were recorded. They were all unrelated to the QL-Block. Eight patients died during the study, and they were all unrelated to the QL-Block.
Infections and infestations
Urinary Tract Infection
2.3%
1/43 • Approximately 3 years, 5 months
All surgical complications for 90 days after the surgery were recorded. They were all unrelated to the QL-Block. Eight patients died during the study, and they were all unrelated to the QL-Block.
0.00%
0/41 • Approximately 3 years, 5 months
All surgical complications for 90 days after the surgery were recorded. They were all unrelated to the QL-Block. Eight patients died during the study, and they were all unrelated to the QL-Block.
Infections and infestations
UTI treated with antibiotics
0.00%
0/43 • Approximately 3 years, 5 months
All surgical complications for 90 days after the surgery were recorded. They were all unrelated to the QL-Block. Eight patients died during the study, and they were all unrelated to the QL-Block.
2.4%
1/41 • Approximately 3 years, 5 months
All surgical complications for 90 days after the surgery were recorded. They were all unrelated to the QL-Block. Eight patients died during the study, and they were all unrelated to the QL-Block.

Additional Information

Christopher Scally, MD

The University of Texas MD Anderson Cancer Center

Phone: (281) 682-3314

Results disclosure agreements

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