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Randomized, Double Blind, Controlled Trial of Two Methods of Postoperative Pain Management Following Free Transverse Rectus Abdominous Musculocutaneous (TRAM) Flap for Breast Reconstruction

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Trial Information

Randomized, Double Blind, Controlled Trial of Two Methods of Postoperative Pain Management Following Free Transverse Rectus Abdominous Musculocutaneous (TRAM) Flap for Breast Reconstruction

Inadequate control of surgical pain after free TRAM procedures may lead to complications and
delay recovery time. This could lead to a longer stay in the hospital. The standard care
for pain after a free TRAM procedure has been with drugs that are anesthetics.
Unfortunately, these anesthetics are not long lasting and usually require the use of opioids
(morphine or hydromorphone) to control "break-through" pain. A continuous delivery of local
anesthetic to the wound site may provide better control of pain and decrease the need for
the use of opioids. This may decrease the length of the hospital stay as well as other side
effects associated with the treatment of pain.

Before the study, you will be asked questions about your health, your age, and about any
allergies you may have. Women who are able to have children must have a negative blood
pregnancy test. You will have already been scheduled to undergo a free TRAM flap procedure.

During free TRAM flap procedure, you will have two "soaker catheters" placed by the surgeon
directly into the surgical site. The catheters are flexible tubes which will allow pain
medicine (or saline) to be delivered directly to the donor wound site which is the abdominal
site from where the tissue for breast reconstruction is taken. A small pump (On-Q pump)
will be connected to the catheter to deliver a constant flow of pain medicine (or saline)
for up to 5 days. The On-Q pump is completely portable and can be attached to your hospital
gown to allow for movement.

You will be randomly assigned (as in the toss of a coin) to one of two groups. Participants
in the first group will have the On-Q pump filled with saline. Participants in the other
group will have the On-Q pump filled with bupivicaine.

Participants in both groups will receive IVPCA, which is the standard of care for pain
relief. The IVPCA will be placed on PRN mode which means you will be able to press a button
to deliver pain medication whenever you feel pain.

You will be asked questions about your pain and your recovery process every 6 hours while
you are awake for up to 5 days. You will also be asked to fill out a questionnaire about
pain once a day during treatment. It should take around 10 minutes to complete the

The catheters will be removed after 5 days of treatment (or your last day in the hospital,
whichever is sooner) by one of the surgeons that participated in the surgery

During the study, if you experience any intolerable side effects or your doctor feels it is
in your best interest to stop treatment, you will be taken off the study and other treatment
options will be discussed with you.

This is an investigational study. The On-Q device, PCA, and bupivicaine are FDA approved
and commercially available. Up to 60 participants will take part in this study (30 in each
group). All will be enrolled at UTMDACC.

This protocol is partially funded by a research grant from the I-Flow Corporation.

Inclusion Criteria:

- Patients with or undergoing unilateral elective free TRAM flap for breast
reconstruction, immediate or delayed, with or without a surgical revision of the
contralateral breast for asymmetry.

- American Society of Anesthesiology Physical Status I - III patients.

- Patients has given voluntary written informed consent before performance of any
study-related procedure.

Exclusion Criteria:

- Patients undergoing bilateral TRAM flap reconstruction.

- Patients with a prior allergic reaction to Marcaine (bupivacaine) or other amide
local anesthetics.

- Patients with a prior allergic reaction to Morphine and Hydromorphone.

- Patients undergoing any other unrelated surgical procedure to the breast

- Patient refusal to participate.

- Patient required major abdominal surgery within four weeks prior to enrollment.

- Patients being treated for chronic pain or using daily intake of opioid analgesics.

- Patients with a history of abuse of recreational drugs or alcohol.

- Patients with any laboratory values or underlying disease, which in the
investigator's opinion would preclude them from participation in the trial,
specifically: (A) significant liver dysfunction (eg. bilirubin, AST and/or ALT >1.5
times the upper limit of normal value (B) cardiac conduction defects noted by history
or on the pre-op screening EKG.

- Pregnant or breast feeding.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

Total Postoperative Opioid Use by Patient

Outcome Time Frame:

Measurements performed and recorded every 6 hours while patient is hospitalized.

Safety Issue:


Principal Investigator

Charles E. Butler, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center


United States: Institutional Review Board

Study ID:




Start Date:

December 2003

Completion Date:

June 2008

Related Keywords:

  • Breast Cancer
  • Breast Cancer
  • On-Q Pain Relief System
  • Transverse Rectus Abdominous Myocutaneous
  • Breast Reconstruction
  • TRAM flap
  • Bupivicaine
  • Pain Management
  • Breast Neoplasms



U.T.M.D. Anderson Cancer Center Houston, Texas  77030