Category: Professional Posters
Purpose: HTX-011, an extended-release dual-acting local anesthetic containing bupivacaine and meloxicam in a Biochronomer polymer, has enabled over 90% of patients to be opioid-free after herniorrhaphy when used as the foundation of a non-opioid multimodal analgesia (MMA) regimen in a prior study. This MMA regimen included over-the-counter ibuprofen and acetaminophen. Patients were required to remain in the facility for 72 hours postoperatively. Here, we present Part 1 of a Phase 3b open-label study evaluating 2 HTX-011-based postoperative non-opioid MMA regimens following herniorrhaphy in a real-world setting in which patients were discharged 2-3 hours following surgery.
Methods: In this study in patients undergoing open inguinal herniorrhaphy, patients were randomly assigned (1:1) to 1 of 2 parallel cohorts evaluating 2 non-opioid MMA regimens. All patients received preoperative oral ibuprofen 400 mg and oral acetaminophen 1 g, and intraoperative HTX-011 300 mg/9 mg (bupivacaine/meloxicam). After surgery, patients were instructed to follow their assigned postoperative non-opioid MMA regimen consisting of oral ibuprofen 600 mg every 6 hours plus oral acetaminophen 1 g every 6 hours alternating every 3 hours (Cohort 1) or taken together (Cohort 2) for 5 days; after Day 6, patients could continue their MMA regimen as needed. Patients were discharged per institution’s practice and followed up on Days 15 and 29. Patients who had a numeric rating score (NRS) pain intensity score ≥6 or who received a postoperative opioid before discharge, were provided with a prescription for oxycodone (ten 5-mg pills). The primary endpoint was the proportion of patients who do not receive an opioid prescription through Day 15. Secondary endpoints included the proportion of patients receiving an opioid prescription at discharge or postdischarge through Day 15, number of oxycodone pills taken between discharge and Day 15, pain intensity scores at discharge, number of patient-initiated callbacks, mean total Treatment Satisfaction Questionnaire for Medication score, and safety.
Results: A total of 93 patients from Part 1 were included in this analysis; the average time to discharge was 2.4 hours, reflective of the real-world setting. The majority of patients (89% in Cohort 1 and 94% in Cohort 2) were discharged without an opioid prescription. No patient discharged without an opioid prescription called back to request an opioid prescription. Of the 8 patients provided with an opioid prescription, only 2 from Cohort 1 and 1 from Cohort 2 took any oxycodone pills between discharge and Day 15. Through Day 15, only 1 of these 8 patients initiated a callback for an opioid prescription refill. Mean pain scores at discharge were mild (NRS < 4) in both cohorts. Patients indicated an overall high satisfaction in all 3 domains (effectiveness, convenience, and global satisfaction) with both MMA regimens. Similar to previous studies, there were no new safety signals associated with the use of ibuprofen and acetaminophen with HTX-011, including no evidence of nonsteroidal anti-inflammatory drug-related cardiovascular, gastrointestinal, or renal toxicity.
Conclusion: In this real-world setting, the use of HTX-011 as the foundation of a non-opioid MMA regimen enabled 91% of patients to be discharged without an opioid prescription and remain opioid-free in the postoperative recovery period following herniorrhaphy. The decrease in opioid use was not accompanied by an increase in patient-initiated callbacks. Both MMA regimens, alternating and concurrent administration, were effective and had similarly high levels of patient satisfaction. HTX-011 used together with ibuprofen and acetaminophen was well tolerated. HTX-011 as the foundation of a non-opioid MMA regimen may eliminate or reduce the need for opioids following herniorrhaphy.