Nerve Block for Sarcoma Pain Management After Surgery

Overseen By Christopher Scally

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: Substance abuse, Laparoscopic surgery, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 3

Duration: 1 week

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. ^{1 2 3 4 5}

Why 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. ^{1 5 6 7 8}

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

I am having surgery to remove a sarcoma and will be given specific pain management.

Exclusion Criteria

I am having or had a surgery with small cuts.

Cases in which anticipated discharge is on or before postoperative day 4

You have struggled with drug or alcohol addiction in the past or currently.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

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.

1 week

Daily visits during hospital stay

Follow-up

Participants are monitored for opioid use and recovery at 1, 3, and 12 months post-surgery.

12 months

3 visits (in-person or virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Liposomal Bupivacaine
• Quadratus Lumborum Block

Trial Overview

The study is testing if giving a repeat injection of liposomal bupivacaine (a numbing medication) as part of the QL block can reduce opioid prescriptions after surgery, potentially decreasing long-term use and addiction risks.

How Is the Trial Designed?

Group I: Arm II (liposomal bupivacaine) Experimental Treatment 3 Interventions

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.

Group II: Arm I (liposomal bupivacaine) Active Control 3 Interventions

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.

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

The ultrasound-guided quadratus lumborum (QL) block provided significantly longer postoperative analgesia (approximately 545 minutes) compared to the ilioinguinal-iliohypogastric (IIIH) nerve block and local wound infiltration (approximately 351 minutes), indicating its superior efficacy for pain management after unilateral inguinal surgeries.

Patients receiving the QL block reported lower pain scores and required less additional analgesics, along with higher satisfaction scores (3.93 vs. 3.4), highlighting the benefits of this technique in enhancing patient comfort and reducing medication needs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ultrasound-guided quadratus lumborum block versus ilioinguinal-iliohypogastric nerve block with wound infiltration for postoperative analgesia in unilateral inguinal surgeries: A randomised controlled trial. Yadav, M., Agrawal, M., Bansal, P., et al.[2023]

Bilateral quadratus lumborum (QL) block provided significant pain relief for a 43-year-old woman after uterine artery embolization, reducing her pain score from 8/10 to 3/10 within an hour and maintaining low pain levels (2-3/10) for 24 hours without the need for additional analgesics.

The study suggests that QL block could be a highly effective alternative for managing acute postoperative pain after uterine artery embolization, potentially reducing reliance on opioids and improving patient comfort.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quadratus lumborum block in management of severe pain after uterine artery embolization. Ben-David, B., Kaligozhin, Z., Viderman, D.[2019]

Citations

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clinicaltrials.gov

clinicaltrials.gov/study/NCT03867188?id=%22NCT03867188%22&rank=1

Liposomal Bupivacaine (Exparel) in Sarcomas | ...

These results are expected to have a significant positive impact; allowing for a reduction in narcotic pain medication usage and its associated side effects ...

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pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/33372949/

Clinical Effectiveness of Liposomal Bupivacaine ...

Ninety-two percent of trials (11 of 12) suggested a peripheral nerve block with unencapsulated bupivacaine provides superior analgesia to infiltrated liposomal ...

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jamanetwork.com

jamanetwork.com/journals/jamanetworkopen/fullarticle/2777506

Standard vs Liposomal Bupivacaine for Postoperative Pain ...

Liposomal bupivacaine did not provide improved pain control and did not reduce adjunctive opioid use compared with conventional bupivacaine formulation over 3 ...

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journalofsurgicalresearch.com

journalofsurgicalresearch.com/article/S0022-4804(21)00124-4/abstract

The Efficacy of Liposomal Bupivacaine for Opioid and Pain ...

Liposomal bupivacaine did not demonstrate significant pain relief compared to placebo or active agents in 74.58% of RCTs. Of the studies ...

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withpower.com

withpower.com/clinical-trials/using-exparel

Top Treatment for Exparel Clinical Trials | Power

Based on prior experience, prolonged analgesia after liposomal bupivacaine injection is safe, and may help reduce perioperative opioid consumption and decrease ...

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pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC3772762/

Liposomal extended-release bupivacaine for postsurgical ...

The cumulative pain intensity score was found to be lower in patients using EXPAREL® than in patients using bupivacaine HCl (283 versus 329, P = 0.039). The ...

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exparel.com

exparel.com/

Postsurgical Pain Relief | EXPAREL® (bupivacaine liposome ...

EXPAREL is a non-opioid injection given by your doctor during surgery to help manage pain. Please see full Prescribing Information and Important Safety ...

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frontiersin.org

frontiersin.org/journals/pharmacology/articles/10.3389/fphar.2014.00090/full

Safety of liposome extended-release bupivacaine for ...

All the doses of DepoFoam bupivacaine and bupivacaine HCl were reported to be well tolerated and safe. No significant AEs were attributed to the study drug, and ...