Repeat or Single Quadratus Lumborum Block for the Reduction of Opioid Prescriptions After Surgery in Retroperitoneal Sarcoma Patients ("RESQU-SARC" Trial)
Primary Purpose
Retroperitoneal Sarcoma
Status
Active
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Liposomal Bupivacaine
Quadratus Lumborum Block
Questionnaire Administration
Sponsored by
About this trial
This is an interventional supportive care trial for Retroperitoneal Sarcoma
Eligibility Criteria
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
Sites / Locations
- M D Anderson Cancer Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Arm I (liposomal bupivacaine)
Arm II (liposomal bupivacaine)
Arm Description
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 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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Proportion of patients with zero discharge prescription OME
Logistic regression analyses will be performed.
Patient reported outcomes for gastrointestinal surgery
Will be captured using MD Anderson Symptom Inventory-Gastrointestinal (MDASI-GI).
Daily inpatient pain scores
Linear mixed model will be used for continuous outcomes such as daily inpatient pain scores.
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.
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.
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.
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.
Opioid use at 30 days
Logistic regression analyses will be performed.
Opioid use at 3 months
Logistic regression analyses will be performed.
Opioid use at 12 months
Logistic regression analyses will be performed.
MDASI-GI at 30 days
MDASI-GI at 3 months
MDASI-GI at 12 months
Patients free of opioid use
Patients free of opioid use
Full Information
NCT ID
NCT04189783
First Posted
December 3, 2019
Last Updated
September 12, 2023
Sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT04189783
Brief Title
Repeat or Single Quadratus Lumborum Block for the Reduction of Opioid Prescriptions After Surgery in Retroperitoneal Sarcoma Patients ("RESQU-SARC" Trial)
Official Title
Randomized Controlled Trial of Repeat vs. Single Quadratus Lumborum Block to Reduce Opioid Prescriptions After Open Resection of Retroperitoneal Sarcoma ("RESQU-SARC" Trial)
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 8, 2020 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Retroperitoneal Sarcoma
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
106 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Arm I (liposomal bupivacaine)
Arm Type
Active Comparator
Arm Description
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 Title
Arm II (liposomal bupivacaine)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Liposomal Bupivacaine
Other Intervention Name(s)
Bupivacaine Liposome Injectable Suspension, Exparel
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Quadratus Lumborum Block
Other Intervention Name(s)
QL Block
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Questionnaire Administration
Intervention Description
Ancillary studies
Primary Outcome Measure Information:
Title
Initial discharge prescription oral morphine equivalents (OME)
Description
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.
Time Frame
At time of discharge (median of 9 days)
Secondary Outcome Measure Information:
Title
Proportion of patients with zero discharge prescription OME
Description
Logistic regression analyses will be performed.
Time Frame
At time of discharge (median of 9 days)
Title
Patient reported outcomes for gastrointestinal surgery
Description
Will be captured using MD Anderson Symptom Inventory-Gastrointestinal (MDASI-GI).
Time Frame
Up to 12 months post surgery
Title
Daily inpatient pain scores
Description
Linear mixed model will be used for continuous outcomes such as daily inpatient pain scores.
Time Frame
At time of discharge (median of 9 days)
Title
Total length of stay
Description
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.
Time Frame
At time of discharge (median of 9 days)
Title
30-day total OME
Description
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.
Time Frame
At 30 days after discharge
Title
Initial discharge pain prescription dosage/size
Description
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.
Time Frame
At time of discharge (median of 9 days)
Title
Number of postoperative days until zero opioid use
Description
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.
Time Frame
Up to 12 months post surgery
Title
Opioid use at 30 days
Description
Logistic regression analyses will be performed.
Time Frame
At 30 days post surgery
Title
Opioid use at 3 months
Description
Logistic regression analyses will be performed.
Time Frame
At 3 months post surgery
Title
Opioid use at 12 months
Description
Logistic regression analyses will be performed.
Time Frame
At 12 months post surgery
Title
MDASI-GI at 30 days
Time Frame
At 30 days post surgery
Title
MDASI-GI at 3 months
Time Frame
At 3 months post surgery
Title
MDASI-GI at 12 months
Time Frame
At 12 months post surgery
Title
Patients free of opioid use
Time Frame
At 3 months post surgery
Title
Patients free of opioid use
Time Frame
Up to 1 year post surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher Scally
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
M D Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
12. IPD Sharing Statement
Links:
URL
http://www.mdanderson.org
Description
University of Texas MD Anderson Cancer Center Website
Learn more about this trial
Repeat or Single Quadratus Lumborum Block for the Reduction of Opioid Prescriptions After Surgery in Retroperitoneal Sarcoma Patients ("RESQU-SARC" Trial)
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