← Back to Search

Pain Management Techniques for Liver Surgery

Phase 3

Recruiting

Led By Timothy E. Newhook, MD

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 open liver resection without bowel resection/anastomosis for malignancy at MD Anderson Cancer Center

Patients must have no fever or evidence of infection or other coexisting medical condition that would preclude epidural placement

Must not have

Evidence of severe uncontrolled systemic disease or other comorbidity that precludes liver surgery

Technical contraindications to epidural placement: previous thoracic spinal surgery or local skin or soft tissue infection at proposed site for epidural insertion

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

All Individual Drugs Already Approved

Approved for 10 Other Conditions

No Placebo-Only Group

Pivotal Trial

Summary

This trial will compare two different types of pain relief during liver surgery to see which works better.

Who is the study for?

This trial is for patients scheduled for open liver surgery at MD Anderson Cancer Center, without bowel resection. They must have normal blood clotting measures, no fever or infections that would interfere with epidural placement, and not be on chronic narcotics. Pregnant women or those unable to follow the study are excluded.

What is being tested?

The study compares thoracic epidural analgesia and four-quadrant transversus abdominus plane block to see which method better reduces pain after liver surgery. The goal is to determine if one leads to quicker and more complete recovery.

What are the potential side effects?

Potential side effects may include discomfort at the injection site, low blood pressure due to the epidural, nausea, itching from narcotics like fentanyl or hydromorphone hydrochloride, and rare risks of nerve damage.

Eligibility Criteria

Inclusion Criteria

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

Select...

I am having liver surgery for cancer without bowel surgery at MD Anderson.

Select...

I don't have a fever, infection, or condition that prevents epidural use.

Exclusion Criteria

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

Select...

I have a severe illness that makes liver surgery too risky for me.

Select...

I have not had previous thoracic spinal surgery or skin infections where an epidural would be placed.

Select...

I have had surgery before for a hernia, tummy tuck, or to rebuild my belly wall.

Select...

I have a nerve condition affecting my lower chest or below.

Select...

I have not had major surgery in my abdomen or chest area in the last 30 days.

Select...

I do not want to be randomly assigned to a treatment group.

Select...

My disease cannot be removed with surgery.

Select...

I am not pregnant and agree to use birth control and not breastfeed if I can have children.

Select...

I have a bleeding disorder.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Total length of inpatient stay

Secondary study objectives

Complication rates secondary to the analgesic regimen

Early post-operative pain control

Measures of functional recovery

+1 more

Other study objectives

Biologic inflammatory markers

Compliance with ordering and delivery of Enhanced Recovery After Surgery program elements

Cost of perioperative care

+2 more

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Approved for 10 Other Conditions

This treatment demonstrated efficacy for 10 other conditions.

No Placebo-Only Group

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

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Arm II (TAP)Experimental Treatment4 Interventions

Patients undergo placement of ultrasound-guided, four-quadrant transversus abdominus plane block. Patients receive plain bupivacaine and liposomal bupivacaine via TAP block.

Group II: Arm I (TAE)Experimental Treatment5 Interventions

Patients undergo placement of thoracic epidural catheter before surgery. Patients receive hydromorphone hydrochloride and bupivacaine via thoracic epidural catheter every 10 minutes or 3 hours as needed. Patients may receive fentanyl and bupivacaine or plain bupivacaine via thoracic epidural catheter.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Bupivacaine

FDA approved

Fentanyl

FDA approved

Implanted Medical Device

2019

Completed Early Phase 1

~80