Clinical Study Finds That McKinley Medical’s Accufuser Basal + Bolus Operation Offers Significant Advantages for Post-Operative Pain

-- The investigation was initiated to determine the efficacy and benefits of local anesthetic infused via an interscalene perineural catheter

-- The study is available to view at : www.mckinleymed.com
 
Denver, Colorado – August 11, 2003 – The University of Florida College of Medicine performed a randomized, double-blind, placebo-controlled clinical study to determine the effectiveness of continuous interscalene brachial plexus block for postoperative pain control at home using McKinley Medical’s Accufuser ambulatory infusion system.  The study concluded that a pump that provides a basal infusion as well as patient-controlled bolus dosing – also called patient-controlled regional anesthesia (PCRA) – provides equivalent or superior analgesia with less medication consumption compared to continuous infusion or bolus-dosing alone.  Led by Dr. Brian M. Ilfeld, M.D., the study was published in the April issue of Anesthesia and Analgesia.
 
This first-of-its-kind investigation, conducted in a randomized, double-blind manner, was focused on determining how to better control pain at home after shoulder surgery.  Research shows that more than 40% of ambulatory patients undergoing orthopedic procedures experience moderate to severe postoperative pain, whereas a single-injection peripheral nerve block provides 12-15 hours of analgesia after upper-extremity procedures.  A continuous interscalene perineural infusion of local anesthetic extends analgesia in hospitalized patients for equal to or more than five days.
 
In this study, 20 patients received either 0.2% ropivacaine or sterile saline 0.9% at a rate of 8 mL/hr with a 2-mL patient-controlled bolus available every 15 minutes using the Accufuser.  The researchers determined that a 50% reduction in pain scores would be clinically significant.  Of the 10 patients receiving ropivacaine, only 6 required ≤ 1 opioid tablet during their infusion, whereas all patients receiving the saline infusion required ≥ 4 opioid tablets by the evening of day of surgery.  Correspondingly, patients receiving ropivacaine experienced significantly fewer side effects or sleep disturbances compared to the saline group.  As a result, 90% of the ropivacaine patients stated that they would repeat this analgesic method.
 
“ This study is unique, since until the availability of the Accufuser, only electronic pumps have been able to provide this type of therapy,” said Randy Hoffman, President of McKinley Medical.  The authors concluded that “PCRA is important for ambulatory patients because the infusion may be tailored to provide minimal basal rate to maximize infusion duration, yet allow bolus dosing for break-through pain and before physical therapy.”
 
McKinley Medical supports this research and future studies to substantiate that regional anesthesia techniques in combination with a device that provides both basal and bolus dosing will benefit at-home patients.
 
About McKinley Medical
McKinley Medical, LLLP, is an infusion technology company that offers innovative solutions designed to meet the growing needs of the worldwide healthcare market for high quality drug delivery. With operations in the United States and Europe, McKinley is dedicated to providing its customers with exceptionally precise and cost-effective solutions for infusion therapy and pain management. McKinley pain-management systems are leaders in the rapidly emerging markets of orthopedics and general surgery.
 
McKinley's products have simple operating features designed for patient use, while at the same time offering uncompromised clinical benefits. McKinley Medical is seeking business opportunities and partners for its products worldwide. McKinley Medical is managed by The Broe Group, a diversified company which provides management expertise, business intelligence, and financing options. 

Media Contact:
Tom Henley
Dir. of Communications
303-398-0342
thenley@broe.com