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

Retroperitoneal Sarcoma Clinical 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)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04189783
• Other study ID #: 2019-0780
• Secondary ID: NCI-2019-0756420
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: June 8, 2020
• Est. completion date: December 31, 2024

Study information

• Verified date: May 2024
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 113
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Retroperitoneal Sarcoma
• Sarcoma

Intervention

Drug:
• Liposomal 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
• Quadratus 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

Other:
• Questionnaire Administration
Ancillary studies

Locations

Country	Name	City	State
United States	M D Anderson Cancer Center	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	At time of discharge (median of 9 days)
Secondary	Proportion of patients with zero discharge prescription OME	Logistic regression analyses will be performed.	At time of discharge (median of 9 days)
Secondary	Patient reported outcomes for gastrointestinal surgery	Will be captured using MD Anderson Symptom Inventory-Gastrointestinal (MDASI-GI).	Up to 12 months post surgery
Secondary	Daily inpatient pain scores	Linear mixed model will be used for continuous outcomes such as daily inpatient pain scores.	At time of discharge (median of 9 days)
Secondary	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.	At time of discharge (median of 9 days)
Secondary	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.	At 30 days after discharge
Secondary	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.	At time of discharge (median of 9 days)
Secondary	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.	Up to 12 months post surgery
Secondary	Opioid use at 30 days	Logistic regression analyses will be performed.	At 30 days post surgery
Secondary	Opioid use at 3 months	Logistic regression analyses will be performed.	At 3 months post surgery
Secondary	Opioid use at 12 months	Logistic regression analyses will be performed.	At 12 months post surgery
Secondary	MDASI-GI at 30 days		At 30 days post surgery
Secondary	MDASI-GI at 3 months		At 3 months post surgery
Secondary	MDASI-GI at 12 months		At 12 months post surgery
Secondary	Patients free of opioid use		At 3 months post surgery
Secondary	Patients free of opioid use		Up to 1 year post surgery

External Links

•   M D Anderson Cancer Center