Can an epidural pump beat IV painkillers after liver surgery?
NCT ID NCT02523443
First seen Jul 22, 2026 · Last updated Jul 23, 2026 · Updated 1 time
Summary
This trial compares two ways to control pain after open liver surgery: an epidural pump that delivers pain medicine near the spine, versus a standard IV pump. About 230 adults having elective open liver resection will be randomly assigned to one method. The goal is to see which approach provides better pain relief, especially during movement, in the days after surgery.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- patient-controlled epidural analgesia (PCEA) compared to intravenous patient-controlled analgesia (IV PCA)
- What this could lead to
- If PCEA proves better, it could become the preferred method for managing pain after liver surgery, improving recovery and mobility.
- What could go wrong
- This is a single trial at one center, and epidurals carry risks like infection or bleeding. Results may not apply to all patients or hospitals.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 231 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2015
- Expected to finish
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Aug 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Adults (age 18 years or older) who are able to provide informed consent. * Patients undergoing open elective liver resection for primary liver pathology (benign or malignant) or secondary metastatic liver disease, including patients undergoing concomitant surgical procedures (such as colorectal resection or debulking procedures), with no contraindication to the insertion of an epidural catheter (localized infection, septicemia, or pre-operative coagulopathy). Exclusion Criteria: * Patients with a history of documented anaphylaxis or contraindication to any of the study medications or standardized intra-operative medications. These include dilaudid, fentanyl, and bupivacaine. * Patients with pain at rest or with movement measured by NRS \>2. * Patients receiving high dose opioids on a chronic basis (greater than or equivalent to 60mg of morphine per day). * Patients with severe chronic obstructive pulmonary disease (COPD) defined as an FEV1 \<50%. * Patients with significant cognitive impairment or documented psychologic impairment. * Contraindication to epidural catheter placement including bleeding diathesis (essential thrombocythemia, idiopathic thrombocytopenic purpura, von Willebrand disease, and hemophilia A or B), neurological dysfunction (multiple sclerosis, subacute myelo-opticoneuropathy or preexisting lower limb neurological deficit), prior extensive spinal surgery or major spinal deformity, pre-operative use of anti-coagulant with planned use of therapeutic dose of anti-coagulant in post-operatively, documented pre-operative coagulopathy (INR greater than 1.3 not on Coumadin or PTT greater than 42), platelets less than 100,000/μL, or evidence of infection at potential epidural site. * Cirrhotic patients. When incidentally discovered intra-operatively, patients will be excluded from the study and replaced, but will be followed for primary and secondary endpoints. * Patients with poor performance status preoperatively such that they are unable to walk up two flights of stairs. * Patients taking any opioid agonist/antagonist medication (i.e. Buprenorphine)
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Memorial Sloan Kettering Cancer Center
New York, New York, 10021, United States
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Memorial Sloan Kettering Cancer Center (Consent Only)
Basking Ridge, New Jersey, United States
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Memorial Sloan Kettering Cancer Center @ Commack (Consent Only)
Commack, New York, 11725, United States
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