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Study of ON-Q pain relief device begins.
2003 OCT 2 - (NewsRx.com & NewsRx.net) -- I-Flow Corp. (IFLO) announced that the University of Texas M. D. Anderson Cancer Center has commenced a study with the ON-Q Post-operative Pain Relief System in women undergoing breast reconstruction surgery.
The goal of this randomized study, to involve 60 women, is to measure the potential benefits of this device to help patients return to their normal lives faster while reducing narcotics intake following surgery. The study will be conducted with I-Flow's ON-Q, a continuous, nonnarcotic, surgical-site pain relief device.
This study will be led by Charles E. Butler, MD, director of the Plastic Surgery Clinic at M. D. Anderson Cancer Center in collaboration with Alicia Kowalski, MD, assistant professor in anesthesiology at M. D. Anderson.
All patients in the study will undergo a TRAM Flap, a surgical method using the body's own tissues to reconstruct the breast following a mastectomy, and will receive an ON-Q pump. Half of the ON-Q pumps will be filled with a local anesthetic to be delivered to the surgical site and the other half will be filled with a placebo of saline. In all cases, patients will be given the standard pain medications delivered through a patient controlled analgesia (PCA) device in addition to ON-Q and will be continuously graded on a standard pain scale to determine comfort level.
All of the patients will be evaluated on the amount of narcotics necessary to alleviate their pain and the pace of their overall recovery, for example, the length of their hospital stay.
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Source: HighBeam Research, Study of ON-Q pain relief device begins.