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

NCT04189783 | Active Not Recruiting Phase 2 Results DMC FDA Drug

• 2 other identifiers: 2019-0780NCI-2019-07564
• Study Type: interventional
• Target: 113
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Retroperitoneal Sarcoma

Outcome Measures

Primary Outcomes (1)

• 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.

  At time of discharge (median of 9 days)

Secondary Outcomes (2)

• Proportion of Participants With Discharge Prescription OME = Zero

  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.

  Scores at discharge and 1 month after the surgery

Study Arms (2)

Arm I (liposomal bupivacaine)

ACTIVE COMPARATOR

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

Arm II (liposomal bupivacaine)

EXPERIMENTAL

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

Interventions

Liposomal Bupivacaine DRUG

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

Arm I (liposomal bupivacaine); Arm II (liposomal bupivacaine)

Quadratus Lumborum Block DRUG

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

Arm I (liposomal bupivacaine); Arm II (liposomal bupivacaine)

Questionnaire Administration OTHER

Ancillary studies

Arm I (liposomal bupivacaine); Arm II (liposomal bupivacaine)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing elective open sarcoma resection for potentially curative intent who would otherwise be treated with quadratus lumborum (QL) block + intravenous-patient controlled analgesia (IV-PCA) converted to oral pain medications (meds) (non-narcotic bundle + opioid pain pill)

You may not qualify if:

• Patients with current or past substance (drug or alcohol) abuse disorder
• Laparoscopic or minimally invasive surgery
• Cases in which anticipated discharge is on or before postoperative day 4

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• M D Anderson Cancer Center

Results Point of Contact

• Title: Christopher Scally, MD
• Organization: The University of Texas MD Anderson Cancer Center

cpscally@mdanderson.org

(281) 682-3314

Study Officials

• Christopher Scally

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2019
• First Posted: December 6, 2019
• Study Start: June 8, 2020
• Primary Completion: October 26, 2024
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 14, 2026
• Results First Posted: January 23, 2026

Record last verified: 2026-04

Locations

US (1)