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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Retroperitoneal Sarcoma

Intervention / Treatment
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* Drug: Liposomal Bupivacaine
* Drug: Quadratus Lumborum Block
* Other: Questionnaire Administration


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Arm I (liposomal bupivacaine)<br>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<br>* 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<br>* Other names: Exparel;Drug: Quadratus Lumborum Block<br>* 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<br>* Other names: QL Block;Other: Questionnaire Administration<br>* Ancillary studies<br>|
| Experimental: Arm II (liposomal bupivacaine)<br>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<br>* 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<br>* Other names: Exparel;Drug: Quadratus Lumborum Block<br>* 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<br>* Other names: QL Block;Other: Questionnaire Administration<br>* Ancillary studies<br>|

What is the study measuring?
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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 |