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 (Estimated): 106
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Christopher Scally; Phone Number: 713-792-6940; Email: cpscally@mdanderson.org

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)	Will perform two-sample t-test to compare the mean doses of discharge prescription OME between the two groups. In addition, multiple linear regression analysis will be carried out to assess the difference between the two arms after adjusting for the stratification factors and other patient characteristics at baseline.	At time of discharge (median of 9 days)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patients with zero discharge prescription OME	Logistic regression analyses will be performed.	At time of discharge (median of 9 days)
Patient reported outcomes for gastrointestinal surgery	Will be captured using MD Anderson Symptom Inventory-Gastrointestinal (MDASI-GI).	Up to 12 months post surgery
Daily inpatient pain scores	Linear mixed model will be used for continuous outcomes such as daily inpatient pain scores.	At time of discharge (median of 9 days)
Total length of stay	Will perform two-sample t-test to compare the total length of stay between the two groups. In addition, multiple linear regression analysis will be carried out to assess the difference between the two arms after adjusting for the stratification factors and other patient characteristics at baseline.	At time of discharge (median of 9 days)
30-day total OME	Will perform two-sample t-test to compare the 30-day total OME between the two groups. In addition, multiple linear regression analysis will be carried out to assess the difference between the two arms after adjusting for the stratification factors and other patient characteristics at baseline.	At 30 days after discharge
Initial discharge pain prescription dosage/size	Will perform two-sample t-test to compare the initial discharge pain prescription dosage/size between the two groups. In addition, multiple linear regression analysis will be carried out to assess the difference between the two arms after adjusting for the stratification factors and other patient characteristics at baseline.	At time of discharge (median of 9 days)
Number of postoperative days until zero opioid use	Will perform two-sample t-test to compare the number of postoperative days until zero opioid use between the two groups. In addition, multiple linear regression analysis will be carried out to assess the difference between the two arms after adjusting for the stratification factors and other patient characteristics at baseline.	Up to 12 months post surgery
Opioid use at 30 days	Logistic regression analyses will be performed.	At 30 days post surgery
Opioid use at 3 months	Logistic regression analyses will be performed.	At 3 months post surgery
Opioid use at 12 months	Logistic regression analyses will be performed.	At 12 months post surgery
MDASI-GI at 30 days		At 30 days post surgery
MDASI-GI at 3 months		At 3 months post surgery
MDASI-GI at 12 months		At 12 months post surgery
Patients free of opioid use		At 3 months post surgery
Patients free of opioid use		Up to 1 year post 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

• University of Texas MD Anderson Cancer Center Website

Study record dates

Study Major Dates

• Study Start (Actual): June 8, 2020
• Primary Completion (Estimated): December 31, 2023
• Study Completion (Estimated): December 31, 2023

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): September 14, 2023
• Last Update Submitted That Met QC Criteria: September 12, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Sarcoma; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Bupivacaine
• Other Study ID Numbers: 2019-0780 (Other Identifier: M D Anderson Cancer Center); P30CA016672 (U.S. NIH Grant/Contract); 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