Wound Infiltration With Liposomal Bupivacaine vs. Standard Wound Infiltration With Bupivacaine in Patient's Undergoing Open Gynecologic Surgery on an Enhanced Recovery Pathway

Study Arms and Drug Administration:

If you are found to be eligible to take part in this study, you will be randomly assigned (as
in the flip of a coin) to 1 of 2 study arms:

- If you are in Arm 1, you will receive bupivacaine only.

- If you are in Arm 2, you will receive a combination of liposomal bupivacaine and
bupivacaine.

You will have an equal (50/50) chance of being assigned to either group. You will not know
what you are receiving. However, the study staff will know what you are receiving.

In both cases, the drug(s) will be injected into your skin and tissue at the end of your
surgery, right before the wound is closed.

Study Data Collection:

Every day while you are in the hospital recovering from surgery, you will be asked questions
about pain, any side effects you may be having, symptoms, and opioid use.

Within 30 days after you leave the hospital, you may also be called and asked about side
effects you may be having. If you are called, this call should last about 10-15 minutes. This
information may also be collected during a routinely scheduled clinic visit and from the
medical record.

Three (3) and 7 days after you leave the hospital, and then 1 time every week after that for
a total of 8 weeks, you will be called or emailed and asked questions about any symptoms you
may be having. If you are called, each call should last about 10-15 minutes.

If you are also enrolled on the study BS99-094 "Measuring the Symptom Distress of Cancer
Patients: Development of a New Assessment System," information from your participation in
this study may also be collected and used in that study.

Length of Study:

Your participation on this study will be over 8 weeks after you leave the hospital.

This is an investigational study. Both bupivacaine and liposomal bupivacaine are FDA approved
and commercially available. It is investigational to compare the 2 drugs.

Up to 200 participants will be enrolled in this study. All will take part at MD Anderson.

Inclusion Criteria:

1. Undergoing an exploratory laparotomy for suspected gynecologic cancer, which includes
metastatic disease from neoplasia originating in other organs

2. Planned participation in the Gynecologic Enhanced Recovery Pathway

3. Female 18 years of age or older

4. Patient must be able to read and speak English

5. Consents to being part of a randomized, single-blinded study

6. Patient has physical and mental capabilities to take part in study

7. Bilirubin less than or equal to 1.5 x upper limit of the normal range (ULN); Serum
Glutamic Oxaloacetic Transaminase (SGOT) and Serum Glutamic-Pyruvic Transaminase
(SGPT)
8. If the patient is of childbearing potential, the patient must have a negative blood or
urine pregnancy test within 14 days of surgical treatment on study

Exclusion Criteria:

1. Sensitivity to amide-type local anesthetics

2. Patients on long-acting opioid medications, or scheduled (four or more times a day for
seven or more days) short-acting opioid medications within the last 30 days

3. Emergency surgery of any type that does not allow for proper time for protocol review
by the patient

4. Surgery that involves known/anticipated resection of anterior abdominal wall with
plastic surgery reconstruction

5. Patients undergoing pelvic exenteration

6. Patients undergoing known/anticipated anterior abdominal wall hernia repairs

7. Patients weighing <50 kg