Posters
Welcome to the AHS 2020 ePoster Session. Please scroll down to view all of the submitted posters or press Control-F to search. To view the poster and its abstract, click on the poster image. Many posters also have a brief audio introduction which can be played by going to the bottom of the poster screen.
P042: HTX-011 WITH ALTERNATING OR CONCURRENTLY ADMINISTERED IBUPROFEN AND ACETAMINOPHEN AFTER HERNIORRHAPHY IN A REAL-WORLD SETTING: EFFECTIVE PAIN MANAGEMENT, REDUCTION IN OPIOID PRESCRIPTIONS, AND HIGH PATIENT SATISFACTION
Neil Singla1; Jia Hu2; Harold Minkowitz3; John Fanikos4; Jay Redan5; 1Lotus Clinical Research LLC; 2Heron Therapeutics, Inc.; 3HD Research LLC; 4Brigham and Women's Hospital; 5AdventHealth Celebration
Introduction: HTX-011 is an extended-release, dual-acting local anesthetic (DALA) containing bupivacaine and low-dose meloxicam. A prior phase 2 study demonstrated that ≥90% of patients remained opioid-free through 72 hours after herniorrhaphy with HTX-011 + scheduled non-opioid multimodal analgesia (MMA; alternating acetaminophen and ibuprofen every 3 hours [q3h]). It is unknown whether it is more effective to schedule acetaminophen and ibuprofen in an alternating or concurrent manner. This real-world, open-label phase 3b study (NCT03907176) evaluated effectiveness and patient satisfaction after herniorrhaphy in patients receiving HTX-011 randomized to receive concurrent or alternating postoperative acetaminophen and ibuprofen.
Methods: All patients underwent open inguinal herniorrhaphy with mesh and received a single intraoperative dose of HTX-011 (300 mg bupivacaine/9 mg meloxicam) administered needle-free into the surgical site. Patients were preoperatively randomized 1:1. In one cohort (alternating MMA), patients received postoperative oral ibuprofen 600 mg and 3 hours later received oral acetaminophen 1000 mg, alternating so patients received an analgesic every 3 hours while awake. In the other cohort (concurrent MMA), patients received oral ibuprofen 600 mg and oral acetaminophen 1000 mg taken together q6h while awake. All patients were discharged per site practice and instructed to follow their assigned MMA regimen for 5 days. Patients with a numeric rating scale (NRS) pain score ≥6 at discharge or who received a postoperative opioid before discharge were eligible to receive a prescription for oxycodone at discharge. Postoperative prescribing of opioids, opioid use after discharge, and patient callbacks for additional analgesics were monitored. To measure treatment satisfaction, patients completed the Treatment Satisfaction Questionnaire for Medication (TSQM-9) 2 weeks after surgery. The TSQM-9 consists of 9 questions covering 3 domains: effectiveness, convenience, and global satisfaction.
Results: Ninety-three patients (alternating MMA, n=46; concurrent MMA, n=47) were included; mean time to discharge was 2.4 hours. Most patients were discharged without an opioid prescription (alternating vs concurrent MMA, 89% vs 94%), and most of these patients remained opioid-free through day 15 (91% vs 98%). None of the patients discharged without an opioid prescription called back to request additional analgesia. No meaningful differences in patient-reported outcomes (TSQM-9) were observed between cohorts: most patients were satisfied, very satisfied, or extremely satisfied with symptom relief (alternating vs concurrent MMA, 91% vs 92%); found their regimen convenient, very convenient, or extremely convenient (89 vs 96%); and were satisfied, very satisfied, or extremely satisfied with their treatment (93% vs 91%). Mean global satisfaction domain scores were 85.6 (on a 0-100 scale) with alternating MMA and 82.1 with concurrent MMA. No new safety signals or meaningful differences between cohorts were observed with the addition of ibuprofen and acetaminophen to HTX-011.
Conclusions: Intraoperative HTX-011 as the foundation of a scheduled non-opioid MMA regimen with concurrent or alternating oral ibuprofen and acetaminophen effectively minimized the need for opioids after herniorrhaphy. No meaningful differences were observed between the 2 MMA regimens; both regimens were well tolerated and had similarly high levels of patient-reported satisfaction, effectiveness, and convenience. HTX-011 with an over-the-counter scheduled non-opioid MMA regimen may allow for opioid-free herniorrhaphy recovery.
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