A Phase 2 interventional study of Liposomal Bupivacaine and Quadratus Lumborum Block in Retroperitoneal Sarcoma, sponsored by M.D. Anderson Cancer Center. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-07.
Sponsored by M.D. Anderson Cancer Center · Phase 2, Interventional, and Supportive care
This phase II trial studies how well a repeat or single liposomal bupivacaine injection (quadratus lumborum block) works in reducing opioid prescriptions after surgery in patients with retroperitoneal sarcoma. Liposomal bupivacaine is a numbing medication. Giving a second injection block may decrease dependency on opioid medications for pain relief after surgery and prevent long-term use and addiction.
PRIMARY OBJECTIVE:
I. To use a pragmatic phase II randomized controlled trial to compare two standardized bundles of usual care for postoperative pain management to reduce the initial discharge prescription opioid volume.
SECONDARY OBJECTIVE:
I. To assess which pragmatic arm improves aspects of postoperative recovery including 30-day, 3-month, and 1-year opioid use, patient symptom inventory at those time points, hospital measures including length of stay and inpatient pain scores.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive standard of care liposomal bupivacaine injection before and during surgery and standard of care non-opioids and opioids at days 0-3 after surgery in the absence of unacceptable toxicity.
ARM II: Patients receive standard of care liposomal bupivacaine injection before and during surgery and standard of care non-opioids and opioids at days 0-3 after surgery in the absence of unacceptable toxicity. Patients then receive a second liposomal bupivacaine injection on day 4 after surgery.
After completion of study treatment, patients are followed up at 1, 3, and 12 months after the surgery.
M.D. Anderson Cancer Center is the lead sponsor of 2,999 studies on the registry; 581 are open to participants now.
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Exclusion Criteria:
Patients receive standard of care liposomal bupivacaine injection before and during surgery and standard of care non-opioids and opioids at days 0-3 after surgery in the absence of unacceptable toxicity.
Drug: Liposomal Bupivacaine · Drug: Quadratus Lumborum Block · Other: Questionnaire Administration
Patients receive standard of care liposomal bupivacaine injection before and during surgery and standard of care non-opioids and opioids at days 0-3 after surgery in the absence of unacceptable toxicity. Patients then receive a second liposomal bupivacaine injection on day 4 after surgery.
Drug: Liposomal Bupivacaine · Drug: Quadratus Lumborum Block · Other: Questionnaire Administration
Patients receive standard of care liposomal bupivacaine injection before and during surgery, followed by standard of care non-opioids and opioids at days 0-3 after surgery in the absence of unacceptable toxicity
Also known as: Bupivacaine Liposome Injectable Suspension, Exparel
Patients receive standard of care liposomal bupivacaine injection before and during surgery, followed by standard of care non-opioids and opioids at days 0-3 after surgery in the absence of unacceptable toxicity. Patients receive a second liposomal bupivacaine injection ("RESQU" block) on day 4 after surgery
Also known as: QL Block
Ancillary studies
Initial Discharge Prescription Oral Morphine Equivalents (OME)
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.
Time frame: At time of discharge (median of 9 days)
Proportion of Participants With Discharge Prescription OME = Zero
Comparing the rate of opioid free patients at discharge between the 2 Arms
Time frame: At time of discharge (median of 9 days)
Participant Reported Outcomes for Gastrointestinal Surgery- MD Anderson Symptom Inventory (MDASI-GI) at Discharge and 1 Month After 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.
Time frame: Scores at discharge and 1 month after the surgery
84 patients underwent resection, with 43 Arm-1 (Usual care) patients and 41 Arm-2 (2nd QL-block).
| Milestone | Arm 1, Control Arm (Usual Care) | Arm 2, Experimental Arm (2nd QL-Block) |
|---|---|---|
| Started | 43 | 41 |
| Completed | 43 | 41 |
| Not completed | 0 | 0 |
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.
| mg of Oral Morphine Equivalents (OME) | Arm 1, Control Arm (Usual Care) | Arm 2, Experimental Arm (2nd QL-Block) |
|---|---|---|
| Initial Discharge Prescription Oral Morphine Equivalents (OME) | 50 ± 444 | 25 ± 342 |
Comparing the rate of opioid free patients at discharge between the 2 Arms
| Participants | Arm 1, Control Arm (Usual Care) | Arm 2, Experimental Arm (2nd QL-Block) |
|---|---|---|
| Proportion of Participants With Discharge Prescription OME = Zero | 14 | 19 |
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.
| score on a scale | Arm 1, Control Arm (Usual Care) | Arm 2, Experimental Arm (2nd QL-Block) |
|---|---|---|
| Pain score at discharge | 5 ± 3 | 4 ± 2 |
| Pain score at 1 month | 3 ± 2 | 3 ± 3 |
| General activity interference at discharge | 5 ± 3 | 4 ± 3 |
| General activity interference at 1 month | 3 ± 2 | 3 ± 3 |
| Interference with enjoyment of life at discharge | 4 ± 3 | 3 ± 3 |
| Interference with enjoyment of life at 1 month | 2 ± 2 | 3 ± 3 |
Collected over Approximately 3 years, 5 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Arm 1, Control Arm (Usual Care) | 6/43 (14%) | 9/43 (20.9%) | 6/43 (14%) |
| Arm 2, Experimental Arm (2nd QL-Block) | 2/41 (4.9%) | 10/41 (24.4%) | 7/41 (17.1%) |
| Event | Arm 1, Control Arm (Usual Care) | Arm 2, Experimental Arm (2nd QL-Block) |
|---|---|---|
| Postoperative infection requiring re-interventionInfections and infestations | 0/43 | 2/41 |
| Ureteral obstruction requiring stent placementRenal and urinary disorders | 2/43 | 0/41 |
| Anemia requiring transfusionBlood and lymphatic system disorders | 0/43 | 1/41 |
| Delayed gastric emptying requiring percutaneous gastrostomy tubeGastrointestinal disorders | 0/43 | 1/41 |
| Intra-abdominal abscess/sepsis requiring emergent reoperationInfections and infestations | 0/43 | 1/41 |
| Partial small bowel obstructionGastrointestinal disorders | 0/43 | 1/41 |
| Postoperative small bowel obstructionGastrointestinal disorders | 0/43 | 1/41 |
| Small bowel obstruction; intra-abdominal abscessGastrointestinal disorders | 0/43 | 1/41 |
| UTI treated with antibioticsInfections and infestations | 0/43 | 1/41 |
| Wound dehiscence requiring repeat operationSurgical and medical procedures | 0/43 | 1/41 |
| Event | Arm 1, Control Arm (Usual Care) | Arm 2, Experimental Arm (2nd QL-Block) |
|---|---|---|
| AKIRenal and urinary disorders | 0/43 | 1/41 |
| Constipation, resolved w miralaxGastrointestinal disorders | 0/43 | 1/41 |
| IleusGastrointestinal disorders | 0/43 | 1/41 |
| SSI requiring wound vac therapyInfections and infestations | 0/43 | 1/41 |
| SSI, resolved w keflexInfections and infestations | 1/43 | 1/41 |
| Superficial surgical infectionInfections and infestations | 1/43 | 1/41 |
| UTI treated with antibioticsInfections and infestations | 0/43 | 1/41 |
| Chyle leak requiring JP drainBlood and lymphatic system disorders | 1/43 | 0/41 |
| DVT treated with anticoagulationGeneral disorders | 1/43 | 0/41 |
| Prolonged ileus requiring NG placement and TPNGastrointestinal disorders | 1/43 | 0/41 |
| Age, Categorical(Participants) | Arm 1, Control Arm (Usual Care) | Arm 2, Experimental Arm (2nd QL-Block) | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 27 | 27 | 54 |
| >=65 years | 16 | 14 | 30 |
| Age, Continuous(years) | Arm 1, Control Arm (Usual Care) | Arm 2, Experimental Arm (2nd QL-Block) | Total |
|---|---|---|---|
| Mean | 57 ± 13.3 | 60 ± 12.7 | 58 ± 13.0 |
| Sex: Female, Male(Participants) | Arm 1, Control Arm (Usual Care) | Arm 2, Experimental Arm (2nd QL-Block) | Total |
|---|---|---|---|
| Female | 15 | 17 | 32 |
| Male | 28 | 24 | 52 |
| Ethnicity (NIH/OMB)(Participants) | Arm 1, Control Arm (Usual Care) | Arm 2, Experimental Arm (2nd QL-Block) | Total |
|---|---|---|---|
| Hispanic or Latino | 7 | 5 | 12 |
| Not Hispanic or Latino | 36 | 34 | 70 |
| Unknown or Not Reported | 0 | 2 | 2 |
| Race (NIH/OMB)(Participants) | Arm 1, Control Arm (Usual Care) | Arm 2, Experimental Arm (2nd QL-Block) | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 1 | 4 | 5 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 3 | 0 | 3 |
| White | 37 | 36 | 73 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 2 | 1 | 3 |
| Region of Enrollment(participants) | Arm 1, Control Arm (Usual Care) | Arm 2, Experimental Arm (2nd QL-Block) | Total |
|---|---|---|---|
| United States | 43 | 41 | 84 |
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