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



Status:Recruiting
Conditions:Liver Cancer, Cancer, Cancer, Chronic Pain, Post-Surgical Pain
Therapuetic Areas:Musculoskeletal, Oncology
Healthy:No
Age Range:18 - Any
Updated:10/19/2018
Start Date:August 2015
End Date:August 2019
Contact:Vittoria Arslan-Carlon, MD
Phone:212-639-2680

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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

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.


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.
We found this trial at
2
sites
Basking Ridge, New Jersey
Principal Investigator: Vittoria Arslan-Carlon, MD
Phone: 212-639-3226
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1275 York Ave
New York, New York 10021
(212) 639-2000
Principal Investigator: Vittoria Arslan-Carlon, MD
Phone: 212-639-2680
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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New York, NY
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