Emerging Data

Emerging Data

Disclosures: Tirotta reports being a paid consultant for and receiving research funding from Pacira BioSciences Inc.
October 13, 2021
2 min read
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Exparel may be safe for pediatric patients undergoing spine, cardiac surgeries

Disclosures: Tirotta reports being a paid consultant for and receiving research funding from Pacira BioSciences Inc.
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Published results showed Exparel may be safe in patients aged 6 to younger than 17 years undergoing spine or cardiac surgery.

Christopher F. Tirotta, MD, and colleagues categorized patients into two age groups, including patients aged 12 to younger than 17 years undergoing spine surgery (age group 1) and patients aged 6 to younger than 12 years undergoing either spine or cardiac surgery (age group 2). Researchers randomly assigned patients in age group 1 to receive either 4 mg/kg of Exparel (bupivacaine liposome injectable suspension, Pacira BioSciences Inc.; n=16) or 2 mg/kg of bupivacaine hydrochloride (n=15) via local infiltration at the end of spine surgery. All 23 patients in age group 2 received 4 mg/kg of bupivacaine liposome injectable suspension via local infiltration at the end of spine (n=2) or cardiac surgery (n=21).

Analysis of pharmacokinetics

Researchers analyzed the pharmacokinetics of bupivacaine liposome injectable suspension, including area under the plasma concentration-time curve, maximum plasma concentration, time to maximum plasma concentration, apparent elimination half-life, apparent clearance and apparent volume of distribution, as the primary objective and safety of bupivacaine liposome injectable suspension as the secondary outcome.

Results showed patients in age group 1 who received bupivacaine liposome injectable suspension had a lower mean maximum plasma concentration vs. patients who received bupivacaine hydrochloride.

Researchers found patients in age group 2 had a mean maximum plasma concentration of 320 ng/mL for spine surgery and of 447 ng/mL for cardiac surgery. Patients in age group 2 who underwent cardiac surgery experienced a later occurrence of median time to maximum plasma concentration compared with patients who underwent spine surgery, according to results.

Mild, moderate adverse events

Researchers noted a comparable incidence of adverse events between patients who received bupivacaine liposome injectable suspension and those who received bupivacaine hydrochloride in age group 1.

Results showed 100% and 31% of patients undergoing spine and cardiac surgery, respectively, in age group 2 experienced adverse events. In general, researchers found the adverse events to be mild or moderate, with no discontinuations due to adverse events or deaths.

“Traditionally, clinicians seeking pain control in pediatric patients have been forced to choose between opioids or traditional local anesthetics that require the use of cumbersome catheters or pumps to provide the duration of pain control needed in historically painful surgical procedures,” Tirotta, chief of anesthesiology at Nicklaus Children’s Hospital and lead author of the study, said in a press release from Pacira BioSciences Inc. “The results from this study demonstrate the excellent safety profile of Exparel, which provides prolonged pain control and offers versatility of administration without many of the unwanted side effects that often come with opioids.”

Reference:

Pacira announces publication of phase 3 study of Exparel infiltration in pediatric patients undergoing spinal or cardiac surgeries. https://investor.pacira.com/news-releases/news-release-details/pacira-announces-publication-phase-3-study-exparel-infiltration. Published Sept. 21, 2021. Accessed Sept. 24, 2021.