Sustained-release analgesic significantly reduced postop pain from TKA

A Phase II study on a single intraoperative administration of an analgesic in patients who underwent total knee arthroplasty (TKA) showed that the drug effectively and safely controlled moderate-to-severe postoperative pain for more than 72 hours.

Researchers reported the findings this weekend on Exparel (DepoBupivacaine, Pacira Pharmaceuticals Inc.) at the Biennial World Congress of the International College of Surgeons in Vienna.

Kenneth W. Bramlett, MD, of the orthopedic department at West Alabama Research in Birmingham, Ala., concluded that Exparel significantly reduced postoperative pain, decreased the use of opioids and allowed some patients to avoid the use of opioids altogether.

“Exparel effectively controlled moderate to severe pain for more than 72 hours, with better relief achieved with higher doses and a dose-dependent effect in both analgesia and reduction in opioid rescue,” he said in a press release.

Bramlett said Exparel’s efficacy was statistically significant against bupivacaine, the gold standard of local anesthetics. “Exparel may provide safe and effective, prolonged pain relief and an opioid-sparing alternative to currently available local analgesics,” he said in the press release.

Exaparel is a novel long-acting, sustained-release formulation of bupivacaine HCL, a local anesthetic widely used for treating postoperative pain, he said in the press release.

The multicenter, double-blind, randomized Phase II study used a parallel-group, active-control format to evaluate the efficacy and safety of Exaparel for prolonged postoperative analgesia. Either a single intraoperative administration of Exaparel or active control (bupivacaine) was given via local infiltration to 103 adult patients undergoing TKA in five centers across the United States and Europe.

In the press release, Bramlett said there was a statistically significant reduction in pain in patients who received 450 mg of Exaparel versus bupivacaine at the end of general anesthesia (5.0 vs. 7.0 pain intensity, respectively). Pain intensity was also lower in the Exaparel group than in the bupivacaine group during activity at all postoperative intervals evaluated.

Use of Exaparel (450 mg) also significantly decreased the use of opioid rescue medications throughout the entire evaluation period, plus postoperative nausea and vomiting occurrence was 40% lower in the Exaparel group compared to the active control group, according to the press release.