Pacira Pharmaceuticals, Inc. has announced results of an independent, physician-initiated study that reinforce the positive impact of an EXPAREL-based pain management regimen on reducing postsurgical complications associated with opioid use. The data, presented at the American College of Surgeons (ACS) Clinical Congress, found that patients treated with EXPAREL experienced statistically significantly lower rates of urinary retention, respiratory depression and fall risk compared to their counterparts who received the previous standard of care (SOC).

"Owed largely to their potency, opioids have been the cornerstone of postsurgical pain management despite inherent risks and side effects which can delay the recovery process and pose substantial patient safety issues," said Jay Redan, M.D., FACS, Medical Director of Minimally Invasive General Surgery at Florida Hospital Celebration Health and the study's lead investigator. "Our findings suggest that including EXPAREL in a multimodal analgesic regimen can reduce the occurrence of opioid-related adverse events, and is associated with statistically significant reductions in urinary retention, respiratory depression and risk of falls after surgery."

The study evaluated 82 patients undergoing open ventral hernia repair or laparoscopic colon resection, all of whom were treated by Dr. Redan. Thirty-seven patients received the SOC: intravenous hydromorphone or morphine with or without epidurals and/or IV acetaminophen. The other 45 patients received infiltration with EXPAREL in addition to the SOC. Key findings include:

Patients in the EXPAREL group experienced statistically significant reductions in the incidence of:

Urinary retention (0% in the EXPAREL group vs 10.8% in the SOC group; P<0.05)

Respiratory depression (2.2% in the EXPAREL group vs 21.6% in the SOC group; P<0.05)

Use of EXPAREL resulted in a statistically significant reduction (P<0.001) in the amount of patients classified as being "high-risk" for falls (8.4% in the EXPAREL group vs 16% in the SOC group) and an increase in patients classified as being "low-risk" for falls (48.7% in the EXPAREL vs 37.6% in the SOC group), according to the Morse Fall Scale designed to predict falls, and assess and address risk factors contributing to fall risk.

"Our ability to demonstrate the measurable impact of adding EXPAREL to our postsurgical pain management protocol played a major role in driving formulary acceptance of the product and increasing adoption across various surgical disciplines," added Dr. Redan. "Based on my data and clinical experience, adopting a low-opioid strategy using EXPAREL not only reduces ORAEs and improves the patient recovery process, but has the potential to positively impact institutional efficiencies and economics as well as patient outcomes."

EXPAREL is indicated for single-dose administration into the surgical site to produce postsurgical analgesia.