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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
113
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 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
Ancillary studies
M D Anderson Cancer Center
Houston, Texas, United States
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
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