Trial of Thoracic Epidural Analgesia Versus Four-Quadrant Transversus Abdominus Plane Block in Oncologic Open Liver Surgery

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. This is done because no one knows if one study group is better, the
same, or worse than the other group. You will have an equal chance of being in either group.

- If you are in Group 1, you will receive transversus abdominus plane block.

- If you are in Group 2, you will receive epidural pain management.

Length of Study Participation:

Researchers want to provide the best pain control possible. If at any time you are having
intolerable side effects or if the medication is not working, the pain medication or epidural
insertion will be switched to other methods.

Your participation in the pain medication part of the study will be over after Day 6, or at
the time of discharge from the hospital if sooner than Day 6. Your participation in the
recovery questionnaire part of the study will be over after Month 6.

Group 1:

For the transversus abdominus plane block, after anesthesia is started and you are asleep, a
long-acting (2-3 day) local anesthetic medicine will be injected in 4 areas of your belly
wall to numb the nerves that supply the area of your incision/wound. Ultrasound imaging will
be used to safely direct the injections to the proper location.

After surgery, your doctor will monitor your pain levels and will give you additional oral
and intravenous (IV) drugs as needed to keep you comfortable. You may ask the study staff for
information about how the drugs are given and their risks.

Group 2:

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

After surgery, your doctor will monitor your pain levels and will give you additional oral
drugs and drugs by vein as needed to keep you comfortable. You may ask the study staff for
information about how the drugs are given and their risks. Your blood pressure will be
checked as often as the doctor thinks is needed, and you will be closely monitored when you
begin to sit up, stand up, and walk after surgery.

Both Groups:

You will sign a separate consent form that explains the surgery and its risks in detail. You
will also sign a separate consent for the catheter placement.

After Surgery:

After your surgery, you will recover in the Post-Anesthesia Care Unit (PACU). 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 an
overnight recovery suite or will be moved to a regular post-surgical recovery floor room,
where your recovery will be watched.

If you are in Group 2, your epidural will be checked every day to make sure that it is
working and that there are no problems with the area around your epidural site. 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 on a scale of 0-10. When you
first come out of surgery, this pain rating will happen about every hour. 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 nurse's
routine checks.

Questionnaires:

Before your surgery, you will fill out questionnaires about pain and your quality of life.
The surgery team will also check your strength, balance and thinking. These questionnaires
and tests should take about 15 minutes to complete.

Every other day after surgery (Day 1 through Day 6), 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 10 minutes each time.

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.

After you are discharged from the hospital, when you return for scheduled clinic visits
within the first 8 weeks after surgery, researchers will again check your strength, balance
and thinking. This should take about 10 minutes to complete per visit.

Participation in this study will not increase the number of postoperative visits that are
scheduled.

Researchers will also ask you to complete questionnaires about your recovery and quality of
life every other week for 6 weeks and then monthly for 4 months. You will complete these
questionnaires for the final time at Month 6. These can be done verbally at the time of
clinic visits, over the phone, electronically by email, or on a smartphone or computer. These
will take about 10 minutes each time.

Inclusion Criteria:

1. Patients undergoing open liver resection without bowel resection/anastomosis for
malignancy at MD Anderson Cancer Center

2. Patients must be 18 years of age or older. There is no upper age limit.

3. Patients must sign a study-specific consent form.

4. Adequate coagulation function within 30 days of surgery, defined as: Platelets >/=
100,000/ml International Normalized Ratio (INR) Thromboplastin Time (aPTT)
5. Patients must have no fever or evidence of infection or other coexisting medical
condition that would preclude epidural placement.

Exclusion Criteria:

1. Evidence of severe uncontrolled systemic disease or other comorbidity that precludes
liver surgery.

2. History of chronic narcotic use, defined as 30 days or more of preoperative daily
narcotic use, measured from the date of surgery.

3. Anaphylaxis to local anesthetics or narcotics.

4. Previous or current neurologic disease affecting the lower hemithorax or below.

5. Major open abdominal/thoracic surgery in the previous 30 days under general
anesthesia.

6. Technical contraindications to epidural placement: previous thoracic spinal surgery or
local skin or soft tissue infection at proposed site for epidural insertion

7. Use of therapeutic anticoagulation within 5 days of surgery (not including venous
thromboembolism prophylaxis)

8. Known bleeding diathesis or coagulopathy

9. Psychiatric (untreated or poorly controlled schizophrenia, major depression, or
bipolar disorder), or communication (language) barrier that would preclude accurate
assessment of postoperative pain and/or ability to answer questionnaires (need to be
able to read, comprehend, and answer questions)

10. Inability to comply with study and/or follow-up procedures

11. Patient refusal to participate in randomization

12. Pregnant women are excluded from this study; women of childbearing potential (defined
as those who have not undergone defined as those who have not undergone a hysterectomy
or who have not been postmenopausal for at least 12 consecutive months) must agree to
practice adequate contraception and to refrain from breast-feeding, as specified in
the informed consent.

13. Patients with obvious unresectable disease prior to signing informed consent.

14. Patients with previous ventral hernia repair, cosmetic abdominoplasty or anterior
abdominal wall reconstruction.