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

Randomized Controlled Trial of Repeat vs. Single Quadratus Lumborum Block to Reduce Opioid Prescriptions After Open Resection of Retroperitoneal Sarcoma ("RESQU-SARC" Trial)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Retroperitoneal Sarcoma
• Intervention / Treatment: Other: Questionnaire Administration; Drug: Liposomal Bupivacaine; Drug: Quadratus Lumborum Block

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 113
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • M D Anderson Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Arm I (liposomal bupivacaine); 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.	Other: Questionnaire Administration; Ancillary studies; Drug: Liposomal Bupivacaine; 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; Other Names: Exparel; Bupivacaine Liposome Injectable Suspension; Drug: Quadratus Lumborum Block; 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; Other Names: QL Block
Experimental: Arm II (liposomal bupivacaine); 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.	Other: Questionnaire Administration; Ancillary studies; Drug: Liposomal Bupivacaine; 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; Other Names: Exparel; Bupivacaine Liposome Injectable Suspension; Drug: Quadratus Lumborum Block; 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; Other Names: QL Block

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of Participants With Discharge Prescription OME = Zero	Comparing the rate of opioid free patients at discharge between the 2 Arms	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.	Scores at discharge and 1 month after the surgery

Collaborators and Investigators

• Sponsor: M.D. Anderson Cancer Center
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Christopher Scally, M.D. Anderson Cancer Center

Publications and helpful links

Helpful Links

• M D Anderson Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): June 8, 2020
• Primary Completion (Actual): October 26, 2024
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: December 3, 2019
• First Submitted That Met QC Criteria: December 4, 2019
• First Posted (Actual): December 6, 2019

Study Record Updates

• Last Update Posted (Actual): April 14, 2026
• Last Update Submitted That Met QC Criteria: April 10, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Histologic Type; Neoplasms, Connective and Soft Tissue; Sarcoma; Physiological Effects of Drugs; Peripheral Nervous System Agents; Anesthetics, Local; Anesthetics; Central Nervous System Depressants; Sensory System Agents; Bupivacaine
• Other Study ID Numbers: 2019-0780 (Other Identifier: M D Anderson Cancer Center); NCI-2019-07564 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No