Nerve Block for Sarcoma Pain Management After Surgery
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a new method to manage pain after surgery for patients with retroperitoneal sarcoma, a type of cancer in the abdominal area. The researchers aim to determine if a numbing medication, liposomal bupivacaine, can reduce the need for opioid painkillers, which often carry addictive potential. Two groups are tested: one receives the standard single injection, while the other gets a second injection a few days later. Suitable candidates for this trial are those undergoing open surgery to remove sarcoma with curative intent and currently following a specific pain management plan. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to potentially groundbreaking pain management strategies.
Do I need to stop my current medications for the trial?
The trial protocol does not specify if you need to stop your current medications. It focuses on using a numbing medication to reduce opioid use after surgery.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that liposomal bupivacaine, a type of pain relief medication, is generally safe. In studies comparing it to regular bupivacaine, liposomal bupivacaine was well-tolerated, with no major side effects linked to it. Patients using it reported slightly less pain than those using the regular version.
Another study found that all doses of liposomal bupivacaine were safe, with no significant unwanted side effects. This medication is already approved for use during surgeries to help manage pain, indicating that its safety is well understood.
In the current trial, both groups will receive this medication, with one group getting an extra dose after surgery. Based on previous research, participants can expect it to be well-tolerated.12345Why are researchers excited about this trial's treatment?
Researchers are excited about the use of liposomal bupivacaine for sarcoma pain management because it offers a longer-lasting pain relief compared to traditional bupivacaine. Liposomal bupivacaine is formulated to release the medication slowly, which can reduce the need for opioids after surgery, minimizing the risk of addiction and side effects. Additionally, the trial is exploring a second injection on day 4 after surgery, which could provide extended pain control and further enhance patient comfort during recovery.
What evidence suggests that liposomal bupivacaine is effective for reducing opioid use after sarcoma surgery?
Research has shown that liposomal bupivacaine might reduce the need for opioid painkillers after surgery. Some studies suggest it provides longer-lasting pain relief, potentially leading to less opioid use. However, not all research agrees; some studies find it may not significantly improve pain control compared to other treatments or even a placebo. In this trial, participants in one arm will receive a second injection of liposomal bupivacaine on day 4 after surgery, which might better manage pain and reduce opioid use.15678
Who Is on the Research Team?
Christopher P. Scally
Principal Investigator
M.D. Anderson Cancer Center
Are You a Good Fit for This Trial?
This trial is for patients having elective open surgery to remove retroperitoneal sarcoma, who would normally receive pain management with a QL block and IV-PCA. It's not for those expected to be discharged within 4 days post-surgery or with a history of substance abuse.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Patients receive standard of care liposomal bupivacaine injection before and during surgery, with non-opioids and opioids at days 0-3 after surgery. Arm II receives an additional injection on day 4.
Follow-up
Participants are monitored for opioid use and recovery at 1, 3, and 12 months post-surgery.
What Are the Treatments Tested in This Trial?
Interventions
- Liposomal Bupivacaine
- Quadratus Lumborum Block
Find a Clinic Near You
Who Is Running the Clinical Trial?
M.D. Anderson Cancer Center
Lead Sponsor
National Cancer Institute (NCI)
Collaborator