Clinical trial NCT04189783: 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
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Retroperitoneal Sarcoma
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2019-12-06
Enrollment: 113
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Initial discharge prescription oral morphine equivalents (OME)
timeFrame: At time of discharge (median of 9 days)
Secondary outcomes:
measure: Proportion of patients with zero discharge prescription OME
timeFrame: At time of discharge (median of 9 days)
measure: Patient reported outcomes for gastrointestinal surgery
timeFrame: Up to 12 months post surgery
measure: Daily inpatient pain scores
timeFrame: At time of discharge (median of 9 days)
measure: Total length of stay
timeFrame: At time of discharge (median of 9 days)
measure: 30-day total OME
timeFrame: At 30 days after discharge
measure: Initial discharge pain prescription dosage/size
timeFrame: At time of discharge (median of 9 days)
measure: Number of postoperative days until zero opioid use
timeFrame: Up to 12 months post surgery
measure: Opioid use at 30 days
timeFrame: At 30 days post surgery
measure: Opioid use at 3 months
timeFrame: At 3 months post surgery
measure: Opioid use at 12 months
timeFrame: At 12 months post surgery
measure: MDASI-GI at 30 days
timeFrame: At 30 days post surgery
measure: MDASI-GI at 3 months
timeFrame: At 3 months post surgery
measure: MDASI-GI at 12 months
timeFrame: At 12 months post surgery
measure: Patients free of opioid use
timeFrame: At 3 months post surgery
measure: Patients free of opioid use
timeFrame: Up to 1 year post surgery
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Christopher Scally
role: PRINCIPAL_INVESTIGATOR
References: