Trial Information

Randomized Controlled Trial of Postoperative Thoracic Epidural Analgesia Versus Intravenous Patient Controlled Analgesia (3:1) in Patients Undergoing Liver and/or Pancreatic Resection

Study Groups:

If you agree to take part in this study, you will be randomly assigned (as in the flip of a
coin) to 1 of 2 groups. For every participant assigned to Group 1, 3 participants will be
assigned to Group 2. This means you are 3 times more likely to be assigned to Group 2 than
you are to Group 1.

- Group 1 will receive IV pain management.

- Group 2 will receive epidural pain management.

Group 1:

IV pain management will be given through a needle in your arm. This needle will be placed
when you are either in the holding area or in the operating room. You will have this needle
placed no matter if you take part in this study or not. The needle is used to give drugs
and manage fluids during surgery.

After surgery, your doctor will set the limit for the highest dose of pain medication that
you can receive at any time, but you will be able to use a hand-held button to adjust your
drug according to the level of pain you may be having.

If your pain is not well controlled, the study staff may decide you can be switched to Group
2 if it seems to be in your best interest.

Group 2:

Epidural pain management will be given through a needle inserted into the space between the
covering of your spinal cord and the cord itself. This area is full of fluid and is called
the epidural region. The needle will be placed before your surgery, either in the holding
area or in the operating room by the doctor that gives your anesthesia.

If your epidural does not work, the study staff may decide you can be switched to Group 1 if
it seems to be in your best interest.

Both Groups:

During your surgery, you will have a catheter (sterile flexible tube) placed in an artery.
This catheter will be used to provide additional fluid and blood support and to monitor you
during surgery. Your doctor will explain this procedure to you in more detail, and you will
be required to sign a separate consent form.

During surgery, blood (about 1 tablespoon) will be drawn before you receive anesthesia.
This blood will be drawn using one of the IV lines that you already have in place for your
surgery. This blood will be tested to look for certain proteins called cytokines that may
help researchers to understand how your body is responding to pain and how pain is affecting
the healing process.

You will be asked to sign a separate consent form that describes the surgery and its risks
in detail. The study staff will also tell you about the standard pain medications, how they
will be given, and the possible risks.

After Surgery:

After your surgery, you will go to the Post-Anesthesia Care Unit (PACU) for recovery. You
will have a physical exam to check your recovery. Your vital signs will also be measured.
You will be asked how you are feeling. Your doctor(s) will decide whether you will go from
the PACU to the intensive care unit (ICU), overnight recovery suite, or will be moved to a
regular post-surgical recovery floor room, where your recovery will be watched.

On Days 1, 3, and 5 after your surgery, blood (about 1 tablespoon) will be drawn for
cytokine testing. This blood will be drawn along with the other routine blood work that you
will have after your surgery.

If you are in Group 2, a member of the MD Anderson Pain Service will check your epidural
site every day to make sure that it is working and that there are no problems with the area
around your epidural. A nurse will also check during each shift (about every 8-10 hours) to
see how well you are able to move and how the epidural is affecting your feeling in the area
it is supposed to be working in.

In both groups, you will be asked to rate your level of pain management on a scale of 0-10.
When you first come out of surgery, this pain rating will happen about every hour. Your
pain will also be rated about every hour if you are assigned to the surgical ICU. When you
get to your room (overnight recovery or surgical floor), it will happen about every 4 hours.
You can use your call bell to let a nurse know if your pain is intolerable between the
nurses checks.

Questionnaires:

Before your surgery, you will fill out questionnaires about the pain and your quality of
life. This should take about 20 minutes to complete.

From the day after surgery (Day 1) through Day 5, you will also be asked to fill out
questionnaires about your recovery and any side effects and symptoms you may be having from
the pain medication. This will take about 20-40 minutes.

While you are in the hospital, you will be asked to answer some questions that will measure
how quickly you recover from the sedation used during your surgery. Each shift (about every
8-10 hours), a nurse will ask you questions to find out how quickly you are recovering from
anesthesia.

:The pain medication or epidural insertion will be stopped early if you are having
intolerable side effects or if the medication is not working.

Your participation in the study will be over after Day 5.

This is an investigational study. IV pain management and epidural pain management are FDA
approved and commercially available. Randomly assigning you to a type of pain management
and comparing the treatments is being done for research purposes only.

Up to 200 patients will be enrolled in this study. All will be enrolled at MD Anderson.