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NCT02523443Active, not recruitingPhase 3

Patient Controlled Epidural Analgesia Versus Intravenous Patient Controlled Analgesia for Post-Operative Pain Control in Patients Undergoing Elective Liver Resection

A Prospective Randomized Controlled Clinical Trial of Patient Controlled Epidural Analgesia Versus Intravenous Patient Controlled Analgesia for Post-Operative Pain Control in Patients Undergoing Elective Open Liver Resection

Source: ClinicalTrials.gov · Last updated 15 Sept 2026

Brief summary (registry, in English)

The purpose of this study is to learn whether patient-controlled epidural analgesia (PCEA) is a better method for managing pain after liver resection compared to patient-controlled analgesia (IV PCA). Currently, the standard pain control method for liver resection patients is IV PCA. There is not enough data on how epidural (PCEA) relieves pain and movement on a day to day basis after liver resection.

Status (registry)
Active, not recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
231 (estimated)
First submitted
12 Aug 2015
Start date
1 Aug 2015
Primary completion date
31 Aug 2027
Lead sponsor
Memorial Sloan Kettering Cancer Center
NCT number
NCT02523443

What you commit to

  • Study type: Interventional · Phase 3
  • Planned participants: 231
  • From 1 Aug 2015 to the primary completion date, 31 Aug 2027
  • 3 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Patients receiving high dose opioids on a chronic basis (greater than or equivalent to 60mg of morphine per day).
  • Patients taking any opioid agonist/antagonist medication (i.e. Buprenorphine)

Other illness

  • 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 severe chronic obstructive pulmonary disease (COPD) defined as an FEV1 \<50%.
  • Patients with significant cognitive impairment or documented psychologic impairment.

Lab values

  • 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.

Other

  • Patients with pain at rest or with movement measured by NRS \>2.
  • 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.

Who the study is looking for

  • 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).

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (3)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Memorial Sloan Kettering Cancer Center (Consent Only)
Coordinator of this site? Confirm its status
Basking RidgeUnited StatesUnknown status
Memorial Sloan Kettering Cancer Center @ Commack (Consent Only)
Coordinator of this site? Confirm its status
CommackUnited StatesUnknown status
Memorial Sloan-Kettering Cancer Center
Coordinator of this site? Confirm its status
New YorkUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.