Pacira Pharmaceuticals, Inc. has announced results of an independent, physician-initiated study designed to evaluate the difference in postsurgical pain and opioid consumption between patients who received EXPAREL versus a multi-drug analgesic cocktail for pain management following total knee arthroplasty (TKA). The data, presented at the annual meeting of the American Association of Hip and Knee Surgeons (AAHKS), found that patients treated with EXPAREL reported significantly lower patient-perceived pain scores and morphine sulfate equivalence consumption, and reported higher satisfaction with pain control and overall experience, compared with patients who received the multi-drug analgesic cocktail.
"A majority of patients who undergo total knee arthroplasty report dissatisfaction with overall pain control and side effects associated with narcotic medications, so there is clearly a need for a more effective and better-tolerated pain management option," said Mark A. Snyder, M.D., director of the Orthopaedic Center of Excellence at Good Samaritan Hospital in Cincinnati. "Our study found that EXPAREL not only provided effective pain control, but also reduced opioid load and improved the patient's overall experience. In addition, we found that EXPAREL eliminated the incidence of post-operative falls, a serious patient safety risk resulting from muscle weakness associated with nerve blocks and prolonged indwelling pain catheters, and confusion or disorientation caused by opioids."
The double-blind, randomized clinical study evaluated 70 TKA patients who were randomly assigned to receive either a periarticular injection with EXPAREL or a multi-drug analgesic cocktail (ketorolac, morphine, epinephrine and ropivacaine) for postsurgical analgesia.
Key findings showed that compared to patients who received the multi-drug analgesic cocktail, patients who received EXPAREL reported:
- Significantly lower pain levels on post-op day one (p<.05 and post-op day two>
- Significantly lower total morphine equivalency consumption in the PACU (p<.01 and by post-op day two>
- Higher satisfaction in pain control (p<.001 and overall experience>
- Significantly fewer adverse events (p<.01>
"The patient-perceived pain scores and high satisfaction ratings we observed suggest that EXPAREL may be a comparably effective, yet far better tolerated pain management solution than continuous femoral nerve blocks, which require catheters to deliver extended analgesia," added Dr. Snyder. "While larger studies are needed to drive a shift in current practice guidelines, our data and previously reported physician-led studies indicate that EXPAREL should play a vital role in the pain management paradigm for orthopedic procedures."
EXPAREL is indicated for single-dose administration into the surgical site to produce postsurgical analgesia.
EXPAREL (bupivacaine liposome injectable suspension) is indicated for single-dose infiltration into the surgical site to produce postsurgical analgesia. The product combines bupivacaine with DepoFoam, a proven product delivery technology that delivers medication over a desired time period. EXPAREL represents the first and only multivesicular liposome local anesthetic that can be utilized in the peri- or postsurgical setting in the same fashion as current local anesthetics. By utilizing the DepoFoam platform, a single dose of EXPAREL delivers bupivacaine over time, providing significant reductions in cumulative pain scores with a 45% decrease in opioid consumption; the clinical benefit of the opioid reduction was not demonstrated. Additional information is available at www.EXPAREL.com.