Ignite Creation Date:
2024-05-06 @ 2:00 PM
Last Modification Date:
2024-10-26 @ 1:23 PM
Study NCT ID:
NCT04189783
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-05-08
First Post:
2019-12-03
Brief Title:
Repeat or Single Quadratus Lumborum Block for the Reduction of Opioid Prescriptions After Surgery in Retroperitoneal Sarcoma Patients RESQU-SARC Trial
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
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
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2019-07564 | REGISTRY | None | None |
| 2019-0780 | OTHER | M D Anderson Cancer Center | None |