Background and aims HTX-011 is a novel, dual-acting, extended-release local anesthetic comprising bupivacaine and low-dose meloxicam in a Biochronomer® polymer. In a phase 3 herniorrhaphy study, HTX-011 alone provided superior pain relief and resulted in more opioid-free subjects through 72 hours than placebo or bupivacaine hydrochloride. This follow-on study evaluates HTX-011 as the foundation of a non-opioid multimodal analgesic (MMA) regimen following herniorrhaphy.
Methods This open-label study enrolled subjects undergoing open inguinal herniorrhaphy into two sequential cohorts. In both cohorts, subjects received acetaminophen 1000mg preoperatively, HTX-011 300mg/9mg (bupivacaine/meloxicam) intraoperatively via needle-free application, and postoperative scheduled MMA regimen of alternating oral acetaminophen 1000mg and oral ibuprofen 600mg, every 6 hours. Cohort 2 subjects also received intraoperative intravenous ketorolac. Prespecified endpoints included the proportion of opioid-free subjects and subjects in severe pain (numeric rating scale [NRS] ≥7 on a 0–10 scale) at any time through 72 hours.
Results 63 subjects were enrolled. Mean pain scores never rose above mild pain (NRS <4) through 72 hours. the proportion of subjects who experienced severe pain was low (17.5%) and more than 90% of subjects remained opioid-free through 72 hours. the addition of intravenous ketorolac did not demonstrate additional pain relief or reduction in opioid use. HTX-011 and the MMA regimen were well-tolerated; there was no evidence of non-steroidal anti-inflammatory drug-related toxicities.
Conclusions The use of HTX-011 as the foundation of a non-opioid MMA regimen is safe and resulted in a low proportion of subjects who experienced severe pain, enabling a high proportion of subjects to be opioid-free following herniorrhaphy.
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