Pain Management Following TRAM Flap for Breast Reconstruction
NCT ID: NCT00500565
Last Updated: 2013-10-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
61 participants
INTERVENTIONAL
2003-12-31
2008-06-30
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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On-Q pump with Saline
On-Q Pump with Saline
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.
On-Q Pump with Bupivicaine
On-Q Pump with bupivicaine
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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 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 reconstruction.
* 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.
ALL
No
Sponsors
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I-Flow
INDUSTRY
M.D. Anderson Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Charles E. Butler, MD
Role: PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center
Locations
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U.T.M.D. Anderson Cancer Center
Houston, Texas, United States
Countries
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Related Links
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UT MD Anderson Cancer Center website
Other Identifiers
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ID03-0046
Identifier Type: -
Identifier Source: org_study_id