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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2019-07564 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 2019-0780 | Other Identifier | M D Anderson Cancer Center |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I (liposomal bupivacaine) | Active Comparator | 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. |
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| Arm II (liposomal bupivacaine) | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Liposomal Bupivacaine | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | At time of discharge (median of 9 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Participants With Discharge Prescription OME = Zero | Comparing the rate of opioid free patients at discharge between the 2 Arms | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christopher Scally | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| M D Anderson Cancer Center | Houston | Texas | 77030 | United States |
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| Label | URL |
|---|---|
| M D Anderson Cancer Center | View source |
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29 participants were excluded from the study before assignment to arms due to screen failure, aborted surgery, discharged before 4 days after surgery or opioids free at 3rd day after surgery.
84 patients underwent resection, with 43 Arm-1 (Usual care) patients and 41 Arm-2 (2nd QL-block).
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm 1, Control Arm (Usual Care) | Arm 1 was a novel bundle (single block, 3 non-opioids, 5x-multiplier). |
| FG001 | Arm 2, Experimental Arm (2nd QL-Block) | Arm 2 was the Arm 1 plus 2nd QL-block on POD4 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 30, 2021 |
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| Quadratus Lumborum Block | Drug | 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 |
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| Questionnaire Administration | Other | Ancillary studies |
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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. |
| Scores at discharge and 1 month after the surgery |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm 1, Control Arm (Usual Care) | Arm 1 was a novel bundle (single block, 3 non-opioids, 5x-multiplier). |
| BG001 | Arm 2, Experimental Arm (2nd QL-Block) | Arm 2 was the Arm 1 plus 2nd QL-block on POD4 |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Median | Standard Deviation | mg of Oral Morphine Equivalents (OME) | At time of discharge (median of 9 days) |
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| Secondary | Proportion of Participants With Discharge Prescription OME = Zero | Comparing the rate of opioid free patients at discharge between the 2 Arms | Posted | Count of Participants | Participants | At time of discharge (median of 9 days) |
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| Secondary | 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. | Posted | Median | Standard Deviation | score on a scale | Scores at discharge and 1 month after the surgery |
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Approximately 3 years, 5 months
All surgical complications for 90 days after the surgery were recorded. They were all unrelated to the QL-Block. Eight patients died during the study, and they were all unrelated to the QL-Block.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Arm 1, Control Arm (Usual Care) | Arm 1 was a novel bundle (single block, 3 non-opioids, 5x-multiplier). | 6 | 43 | 9 | 43 | 6 | 43 |
| EG001 | Arm 2, Experimental Arm (2nd QL-Block) | Arm 2 was the Arm 1 plus 2nd QL-block on POD4 | 2 | 41 | 10 | 41 | 7 | 41 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia requiring transfusion | Blood and lymphatic system disorders | ACCORDION scale | Systematic Assessment |
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| Bladder leak requiring drain placement | Renal and urinary disorders | ACCORDION scale | Systematic Assessment |
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| Delayed gastric emptying requiring percutaneous gastrostomy tube | Gastrointestinal disorders | ACCORDION scale | Systematic Assessment |
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| Diarrhea requiring readmission | Gastrointestinal disorders | ACCORDION scale | Systematic Assessment |
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| Intra-abdominal abscess/sepsis requiring emergent reoperation | Infections and infestations | ACCORDION scale | Systematic Assessment |
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| Pancreatic leak requiring drainage | Hepatobiliary disorders | ACCORDION scale | Systematic Assessment |
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| Pancreatic leak requiring IR drain | Hepatobiliary disorders | ACCORDION scale | Systematic Assessment |
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| Partial small bowel obstruction | Gastrointestinal disorders | ACCORDION scale | Systematic Assessment |
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| Pleural effusin | Gastrointestinal disorders | ACCORDION scale | Systematic Assessment |
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| Postoperative hemorrhage requiring reintervention | Blood and lymphatic system disorders | ACCORDION scale | Systematic Assessment |
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| Postoperative infection requiring re-intervention | Infections and infestations | ACCORDION scale | Systematic Assessment |
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| Postoperative small bowel obstruction | Gastrointestinal disorders | ACCORDION scale | Systematic Assessment |
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| Renal Obstruction requiring percutaneous nephrostomy | Renal and urinary disorders | ACCORDION scale | Systematic Assessment |
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| Small bowel obstruction; intra-abdominal abscess | Gastrointestinal disorders | ACCORDION scale | Systematic Assessment |
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| Ureteral obstruction requiring stent placement | Renal and urinary disorders | ACCORDION scale | Systematic Assessment |
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| UTI treated with antibiotics | Infections and infestations | ACCORDION scale | Systematic Assessment |
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| Wound dehiscence requiring repeat operation | Surgical and medical procedures | ACCORDION scale | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| AKI | Renal and urinary disorders | ACCORDION scale | Systematic Assessment |
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| Chyle leak requiring JP drain | Blood and lymphatic system disorders | ACCORDION scale | Systematic Assessment |
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| Constipation, resolved w miralax | Gastrointestinal disorders | ACCORDION scale | Systematic Assessment |
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| DVT treated with anticoagulation | General disorders | ACCORDION scale | Systematic Assessment |
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| Ileus | Gastrointestinal disorders | ACCORDION scale | Systematic Assessment |
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| Prolonged ileus requiring NG placement and TPN | Gastrointestinal disorders | ACCORDION scale | Systematic Assessment |
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| SSI requiring wound vac therapy | Infections and infestations | ACCORDION scale | Systematic Assessment |
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| SSI, resolved w keflex | Infections and infestations | ACCORDION scale | Systematic Assessment |
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| Superficial surgical infection | Infections and infestations | ACCORDION scale | Systematic Assessment |
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| Urinary Tract Infection | Infections and infestations | ACCORDION scale | Systematic Assessment |
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| UTI treated with antibiotics | Infections and infestations | ACCORDION scale | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Christopher Scally, MD | The University of Texas MD Anderson Cancer Center | (281) 682-3314 | cpscally@mdanderson.org |
| Sep 23, 2025 |
| Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 6, 2022 | Oct 24, 2024 | ICF_000.pdf |
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| >=65 years |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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