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.
ACTIVE_NOT_RECRUITING
PHASE2
113 participants
At time of discharge (median of 9 days)
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
| 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
| 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
| 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
| 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 surgeryCompare 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
| 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)
Arm 2, Experimental Arm (2nd QL-Block)
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
| 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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place