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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 1 year post surgery

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 1 year post surgery

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 1 year post surgery

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 year post surgery for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Initial discharge prescription oral morphine equivalents (OME)

Secondary outcome measures

30-day total OME

Daily inpatient pain scores

Initial discharge pain prescription dosage/size

+11 more

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

~820

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor

2,971 Previous Clinical Trials

1,787,103 Total Patients Enrolled

National Cancer Institute (NCI)NIH

13,658 Previous Clinical Trials

40,924,376 Total Patients Enrolled

3 Trials studying Retroperitoneal Sarcoma

133 Patients Enrolled for Retroperitoneal Sarcoma

Christopher ScallyPrincipal InvestigatorM.D. Anderson Cancer Center

Media Library

Liposomal Bupivacaine Clinical Trial Eligibility Overview. Trial Name: NCT04189783 — Phase 2

Retroperitoneal Sarcoma Research Study Groups: Arm I (liposomal bupivacaine), Arm II (liposomal bupivacaine)

Retroperitoneal Sarcoma Clinical Trial 2023: Liposomal Bupivacaine Highlights & Side Effects. Trial Name: NCT04189783 — Phase 2

Liposomal Bupivacaine 2023 Treatment Timeline for Medical Study. Trial Name: NCT04189783 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What syndromes or conditions does Quadratus Lumborum Block help to alleviate?

"The Quadratus Lumborum Block is a medical procedure that is typically used to treat permphigus. It can also be used as an intervention for acute nonspecific tenosynovitis, general anesthesia, and lupus erythematosus cell."

Answered by AI

How many research subjects are being accepted into this trial?

"That is correct, according to the listing on clinicaltrials.gov this study is still searching for participants. The trial was first posted on June 8th 2020 and has been updated as recently as July 5th 2022. They are looking for a total of 106 patients from 1 locations."

Answered by AI

Is there a risk of serious side effects from Quadratus Lumborum Block?

"Because this is a phase 2 trial, meaning that while there are data supporting safety, there are no such data for efficacy, our team at Power has estimated the safety of Quadratus Lumborum Block to be a 2."

Answered by AI

Are participants still being recruited for this experiment?

"As of today, this clinical trial is still recruiting patients. The posting for the study went up on 6/8/2020 and the most recent edit was made on 7/5/2022 according to clinicaltrials.gov."

Answered by AI

Does literature exist on Quadratus Lumborum Blockage procedures?

"There are a total of 124 ongoing studies investigating Quadratus Lumborum Block with 21 currently in Phase 3. The majority of these trials are located in Philadelphia, however, there are a total of 169 locations running studies for this treatment across the United States."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Repeat or Single Quadratus Lumborum Block for the Reduction of Opioid Prescriptions After Surgery in Retroperitoneal Sarcoma Patients ("RESQU-SARC" Trial)

2020. "Repeat or Single Quadratus Lumborum Block for the Reduction of Opioid Prescriptions After Surgery in Retroperitoneal Sarcoma Patients ("RESQU-SARC" Trial)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04189783.

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