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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Total length of inpatient stay
Secondary outcome measures
Complication rates secondary to the analgesic regimen
Early post-operative pain control
Measures of functional recovery
+1 moreOther outcome measures
Biologic inflammatory markers
Compliance with ordering and delivery of Enhanced Recovery After Surgery program elements
Cost of perioperative care
+2 moreTrial 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
Implanted Medical Device
2019
Completed Early Phase 1
~80
Bupivacaine
FDA approved
Questionnaire
2014
Completed Phase 2
~20020
Bupivacaine
FDA approved
Fentanyl
FDA approved
Hydromorphone
FDA approved
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,973 Previous Clinical Trials
1,789,250 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,665 Previous Clinical Trials
40,925,758 Total Patients Enrolled
Timothy E. Newhook, MDPrincipal InvestigatorM.D. Anderson Cancer Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have used narcotics daily for 30 days or more before my surgery.I have a severe illness that makes liver surgery too risky for me.I have not had previous thoracic spinal surgery or skin infections where an epidural would be placed.I have had surgery before for a hernia, tummy tuck, or to rebuild my belly wall.I am having liver surgery for cancer without bowel surgery at MD Anderson.My blood clotting time is normal.I don't have a fever, infection, or condition that prevents epidural use.I have a nerve condition affecting my lower chest or below.I have not had major surgery in my abdomen or chest area in the last 30 days.I do not want to be randomly assigned to a treatment group.My disease cannot be removed with surgery.I am not pregnant and agree to use birth control and not breastfeed if I can have children.I have a bleeding disorder.I haven't used blood thinners for treatment within 5 days before surgery.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Arm I (TAE)
- Group 2: Arm II (TAP)
Awards:
This trial has 4 awards, including:- Approved for 10 Other Conditions - This treatment demonstrated efficacy for 10 other conditions.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Could you please list off any other research that has been conducted with Hydromorphone Hydrochloride?
"As of now, 171 research studies related to Hydromorphone Hydrochloride are ongoing with 33 of those in Phase 3. Many trials for Hydromorphone Hydrochloride take place in Germantown, Tennessee; however, there are a total of 251 locations running these sorts of experiments."
Answered by AI
Has the FDA cleared hydromorphone hydrochloride for public use?
"There is some evidence supporting the efficacy of Hydromorphone Hydrochloride, as this is a Phase 3 trial. Furthermore, multiple rounds of data support its safety; thus, it receives a score of 3."
Answered by AI
For what purpose is Hydromorphone Hydrochloride generally given to patients?
"Hydromorphone Hydrochloride is often given to patients suffering from permphigus. Additionally, it has shown efficacy in treating acute nonspecific tenosynovitis, lupus erythematosus cell, and as a general anesthetic."
Answered by AI
What is the upper limit for patients taking part in this experiment?
"That is correct. The clinicaltrials.gov website indicates that the study sponsor is actively looking for enrollees. This research was first made public on October 4th, 2017 and received its most recent update on July 29th, 2021. Currently, 96 individuals are needed to participate at a single site."
Answered by AI
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