Pain Management Following TRAM Flap for Breast Reconstruction
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||Randomized, Double Blind, Controlled Trial of Two Methods of Postoperative Pain Management Following Free Transverse Rectus Abdominous Musculocutaneous (TRAM) Flap for Breast Reconstruction|
- Total Postoperative Opioid Use by Patient [ Time Frame: Measurements performed and recorded every 6 hours while patient is hospitalized. ] [ Designated as safety issue: No ]
|Study Start Date:||December 2003|
|Study Completion Date:||June 2008|
|Primary Completion Date:||June 2006 (Final data collection date for primary outcome measure)|
Experimental: On-Q pump with Saline
On-Q Pump with Saline
On-Q Pain Pump filled with Saline. The On-Q pump will be connected to the catheter to deliver a constant flow of saline for up to 5 days.
Experimental: On-Q Pump with Bupivicaine
On-Q Pump with bupivicaine
On-Q Pain Pump filled with 0.375% Bupivicaine through two catheters at a total rate of 4 cc/hr over 111 hours. The On-Q pump will be connected to the catheter to deliver a constant flow of Bupivicaine for up to 5 days.
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 questionnaire.
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 The University of Texas (UT) MD Anderson Cancer Center (MDACC).
This protocol is partially funded by a research grant from the I-Flow Corporation.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00500565
|United States, Texas|
|U.T.M.D. Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Charles E. Butler, MD||M.D. Anderson Cancer Center|