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

113 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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.

What data supports the effectiveness of the treatment for sarcoma pain management after surgery?

The research shows that the quadratus lumborum (QL) block, which is part of the treatment, is effective in providing pain relief after abdominal surgeries, such as cesarean delivery and inguinal surgeries. This suggests it may also help manage pain after sarcoma surgery. ^{1 2 3 4 5}

Is the nerve block using liposomal bupivacaine generally safe for humans?

Research shows that liposomal bupivacaine used in nerve blocks, like the quadratus lumborum block, is generally safe for humans, with similar side effects to standard bupivacaine, except for a higher need for metoclopramide (a medication for nausea) in some cases. ^{1 4 6 7 8}

How does the nerve block treatment for sarcoma pain management after surgery differ from other treatments?

The nerve block treatment for sarcoma pain management after surgery is unique because it involves regional anesthesia, which can reduce pain levels and stabilize blood pressure, potentially leading to less blood loss during surgery. This approach is different from other treatments like isolated limb perfusion with drugs or ethanol adjuvant therapy, which focus on tumor control rather than pain management. ^{9 10 11 12 13}

Research Team

Christopher P. Scally

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Liposomal bupivacaine addition versus standard bupivacaine alone for colorectal surgery: a randomized controlled trial. [2021]

2. India 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. [2023]

3. China pubmed.ncbi.nlm.nih.gov

Effect of Subcostal Anterior Quadratus Lumborum Block vs. Oblique Subcostal Transversus Abdominis Plane Block after Laparoscopic Radical Gastrectomy. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

A novel ultrasound-guided lateral quadratus lumborum block in dogs: a comparative cadaveric study of two approaches. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

The Analgesic Effect of Ultrasound-Guided Quadratus Lumborum Block After Cesarean Delivery: A Randomized Clinical Trial. [2018]

6. Nepal pubmed.ncbi.nlm.nih.gov

USG Guided Quadaratus Lumburoum Block and Low Dose Spinal Anesthesia in Abdominal Surgeries. [2021]

7. Japan pubmed.ncbi.nlm.nih.gov

Ultrasound-guided quadratus lumborum block in pediatrics: trans-muscular versus intra-muscular approach. [2021]

8. England pubmed.ncbi.nlm.nih.gov

Quadratus lumborum block in management of severe pain after uterine artery embolization. [2019]

9. United States pubmed.ncbi.nlm.nih.gov

Treatment of soft tissue and bone sarcomas: review of studies at the National Cancer Institute. [2013]

10. United States pubmed.ncbi.nlm.nih.gov

TNFalpha-based isolated perfusion for limb-threatening soft tissue sarcomas: state of the art and future trends. [2019]

11. Switzerland pubmed.ncbi.nlm.nih.gov

The Use of Regional Anesthesia to Reduce Blood Loss in Isolated Limb Perfusion (ILP)-A Novel Approach. [2023]

12. Switzerland pubmed.ncbi.nlm.nih.gov

Anti-Tumor Effect and Neurotoxicity of Ethanol Adjuvant Therapy after Surgery of a Soft Tissue Sarcoma. [2023]

13. United States pubmed.ncbi.nlm.nih.gov

Isolated limb perfusion with tumor necrosis factor and melphalan prevents amputation in patients with multiple sarcomas in arm or leg. [2022]