← Back to Search

Nerve Block for Sarcoma Pain Management After Surgery

Phase 2

Waitlist Available

Led By Christopher Scally

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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)

Be older than 18 years old

Must not have

Laparoscopic or minimally invasive surgery

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at 12 months post surgery

Awards & highlights

No Placebo-Only Group

Summary

This trial looks at whether giving a second injection of a numbing medication can reduce the amount of opioids patients need for pain relief after surgery, and prevent long-term addiction.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Possible side effects may include reactions at the injection site, such as pain or discomfort, potential nerve damage, low blood pressure, nausea, and constipation typically associated with numbing medications.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am having or had a surgery with small cuts.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 12 months post surgery

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at 12 months post surgery

This trial's timeline: 3 weeks for screening, Varies for treatment, and at 12 months post surgery for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Initial discharge prescription oral morphine equivalents (OME)

Secondary study objectives

30-day total OME

Daily inpatient pain scores

Initial discharge pain prescription dosage/size

+7 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm II (liposomal bupivacaine)Experimental Treatment3 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 Control3 Interventions

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Liposomal Bupivacaine

2016

Completed Phase 4

~1540

Quadratus Lumborum Block

2020

Completed Phase 2