Repeat or Single Quadratus Lumborum Block for the Reduction of Opioid Prescriptions After Surgery in Retroperitoneal Sarcoma Patients ("RESQU-SARC" Trial)

  • STATUS
    Recruiting
  • End date
    Dec 31, 2023
  • participants needed
    106
  • sponsor
    M.D. Anderson Cancer Center
Updated on 4 October 2022

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.

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.

Details
Condition Retroperitoneal Sarcoma
Treatment questionnaire administration, Liposomal bupivacaine, Quadratus lumborum block
Clinical Study IdentifierNCT04189783
SponsorM.D. Anderson Cancer Center
Last Modified on4 October 2022

Eligibility

Yes No Not Sure

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
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