Exparel Reduces Need for Opioids Following Surgery for Gynecologic Malignancies

Reducing or eliminating the need for opioids following major surgery for gynecologic malignancies is becoming increasingly possible, according to results from a new study.

The study showed that in a population of nearly 200 women, Exparel (bupivacaine liposome injectable suspension) was similarly effective in reducing pain compared with bupivacaine HCL, but reduced ileus, nausea and the need for patient-controlled analgesia and rescue IV opioid use.

“Basically, it means patients need less narcotics and still have the same pain scores,” said Sean C. Dowdy, professor and chair, Division of Gynecologic Surgery at the Mayo Clinic College of Medicine.

The study, which was conducted at the Mayo Clinic in Rochester, Minnesota, looked at patients undergoing staging laparotomy (72 patients; hysterectomy, lymphadenectomy and omentectomy) or complex cytoreductive surgery (121 patients; staging laparotomy with extensive cytoreduction). Researchers compared the recoveries of women receiving Exparel via injection with those who received bupivacaine HCL. Cumulative pain scores (CPS) were monitored for 48 hours.

“What we did here was rather than randomize, we just made a practice change and compared the results to what we were doing before,” Dowdy said.

In the complex cytoreductive group, pain scores were no different between patients treated with Exparel and bupivacaine HCL at 24 and 48 hours. Among those treated with Exparel, usage of oral morphine equivalents was lower through 24 hours (30 vs 54 mg), 48 hours (38 vs 83 mg) and the remaining length of stay (62 vs 101 mg).

The proportion of patients who were “opioid- and tramadol-free,” according to the study’s abstract, was higher in the Exparel cohort at 24 hours (19 vs 12 percent), 48 hours (40 vs 28 percent) and remaining length of stay (39 vs 26 percent).

Nausea after surgery occurred less frequently among those receiving Exparel at 24 hours (25 vs 61 percent) and 48 hours (30 vs 56 percent). Ileus rate, too, was lower (12 vs 22 percent).

Injection with Exparel also reduced the need for IV rescue opioids (28.9 vs 55.6 percent) and patient-controlled analgesia (4.1 vs 33.3 percent). Hospital stays were reduced by three or four days among patients receiving Exparel, according to Dowdy.

In addition to the physical benefits of Exparel, researchers found no statistically significant difference in cost. Average 30-day adjusted total costs were $31,562 and $33,498 for Exparel and bupivacaine HCL, respectively. Pharmacy costs were $2,575 and $3,007, respectively.

Today, using Exparel for women undergoing surgeries for gynecological malignancies is common practice for Dowdy and his team, but he says that a belief that Exparel is more expensive than bupivacaine HCL is preventing other doctors from doing the same.

“There’s the perception that the cost is higher because it is more expensive than [bupivacaine HCL], but with this [study], we showed that it is cost neutral, which is important,” he said.

Those benefits come, in part, due to the fact that Exparel has a much longer half-life than bupivacaine HCL. The former lasts about eight hours, while the latter lasts about 48 hours, according to Dowdy.

Results from this study may have an effect that goes beyond one subset of patients. Dowdy expects Exparel to continue to be tested in randomized trials and possibly gain approval outside the United States.