Retroperitoneal Sarcoma
Conditions
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.
Interventions
DRUGLiposomal Bupivacaine
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
DRUGQuadratus Lumborum Block
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
OTHERQuestionnaire Administration
Ancillary studies
Sponsors
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Initial Discharge Prescription Oral Morphine Equivalents (OME) | At time of discharge (median of 9 days) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Participants With Discharge Prescription OME = Zero | At time of discharge (median of 9 days) | Comparing the rate of opioid free patients at discharge between the 2 Arms |
| Participant Reported Outcomes for Gastrointestinal Surgery- MD Anderson Symptom Inventory (MDASI-GI) at Discharge and 1 Month After Surgery. | Scores at discharge and 1 month after the 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORChristopher Scally
M.D. Anderson Cancer Center
Participant flow
Recruitment details
84 patients underwent resection, with 43 Arm-1 (Usual care) patients and 41 Arm-2 (2nd QL-block).
Pre-assignment details
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.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 30 Participants |
| Age, Categorical Between 18 and 65 years | 54 Participants |
| Age, Continuous | 57 years STANDARD_DEVIATION 13.3 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 7 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 34 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 4 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 73 Participants |
| Region of Enrollment United States | 41 participants |
| Sex: Female, Male Female | 32 Participants |
| Sex: Female, Male Male | 28 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 6 / 43 | 2 / 41 |
| other Total, other adverse events | 6 / 43 | 7 / 41 |
| serious Total, serious adverse events | 9 / 43 | 10 / 41 |
Outcome results
None listed