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

NCT02523443 | Active Not Recruiting Phase 3

• 1 other identifier: 15-148
• Study Type: interventional
• Target: 231
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Liver Cancer; Pain Management

Keywords

Epidural Analgesia; Intravenous Patient Controlled; 15-148

Outcome Measures

Primary Outcomes (1)

• ability to detect a 2-point NRS scale difference

  The primary endpoint assesses differences in pain control between PCEA and IV PCA after a "get up and go" test performed on POD2 during pain rounds, evaluated using a NRS pain score.

  1 year

Study Arms (2)

IV PCA after surgery

ACTIVE COMPARATOR

general anesthesia with post-operative IV PCA with a standard demand pump

Other: IV PCA

PCEA during and after surgery

EXPERIMENTAL

general anesthesia with post-operative thoracic epidural analgesia with a standard demand pump

Other: PCEA

Interventions

IV PCA OTHER

Patients undergoing IV PCA for pain control will have intravenous (IV) analgesia provided through a demand pump started in the recovery room.

IV PCA after surgery

PCEA OTHER

Patients in this group will have the epidural catheter placed by the anesthesia pain service team in the pre-surgical center (PSC) as performed routinely at MSKCC. The epidural will be used intra-operatively at the end of liver resection phase of the surgical procedure, once the specimen has been extracted, and continued subsequently in the post-operative phase for pain management.

PCEA during and after surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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)

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead

Study Sites (3)

Memorial Sloan Kettering Cancer Center (Consent Only)

Basking Ridge, New Jersey, United States

Location

Memorial Sloan Kettering Cancer Center @ Commack (Consent Only)

Commack, New York, 11725, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10021, United States

Location

Related Links

• Memorial Sloan Kettering Cancer Center

MeSH Terms

Conditions

Liver Neoplasms; Agnosia

Interventions

Analgesia, Patient-Controlled

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Liver Diseases; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Analgesia; Anesthesia and Analgesia

Study Officials

• Vittoria Arslan-Carlon, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2015
• First Posted: August 14, 2015
• Study Start: August 1, 2015
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: July 22, 2025

Record last verified: 2025-07

Locations

US (3)