Repeat or Single Quadratus Lumborum Block for the Reduction of Opioid Prescriptions After Surgery in Retroperitoneal Sarcoma Patients ("RESQU-SARC" Trial)
- Conditions
- Retroperitoneal Sarcoma
- Interventions
- Registration Number
- NCT04189783
- Lead Sponsor
- M.D. Anderson Cancer Center
- 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.
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 113
- 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)
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm I (liposomal bupivacaine) 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. Arm II (liposomal bupivacaine) 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. Arm I (liposomal bupivacaine) Questionnaire Administration 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 (liposomal bupivacaine) Quadratus Lumborum Block 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. Arm II (liposomal bupivacaine) Questionnaire Administration 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. Arm I (liposomal bupivacaine) Quadratus Lumborum Block 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.
- Primary Outcome Measures
Name Time Method Initial discharge prescription oral morphine equivalents (OME) At time of discharge (median of 9 days) 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.
- Secondary Outcome Measures
Name Time Method Patient reported outcomes for gastrointestinal surgery Up to 12 months post surgery Will be captured using MD Anderson Symptom Inventory-Gastrointestinal (MDASI-GI).
Daily inpatient pain scores At time of discharge (median of 9 days) Linear mixed model will be used for continuous outcomes such as daily inpatient pain scores.
30-day total OME At 30 days after discharge 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.
Number of postoperative days until zero opioid use Up to 12 months post surgery 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.
Opioid use at 30 days At 30 days post surgery Logistic regression analyses will be performed.
Opioid use at 3 months At 3 months post surgery Logistic regression analyses will be performed.
Proportion of patients with zero discharge prescription OME At time of discharge (median of 9 days) Logistic regression analyses will be performed.
Total length of stay At time of discharge (median of 9 days) 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.
Initial discharge pain prescription dosage/size At time of discharge (median of 9 days) 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.
Patients free of opioid use Up to 1 year post surgery MDASI-GI at 12 months 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 Opioid use at 12 months At 12 months post surgery Logistic regression analyses will be performed.
Trial Locations
- Locations (1)
M D Anderson Cancer Center
🇺🇸Houston, Texas, United States