Opioid-Free Recovery After Hernia Repair with HTX-011 as the Foundation of a Non-Opioid, Multimodal Analgesia Regimen in a Real-World Setting: A Randomized, Open-Label Study

Abstract

Introduction: Helping Opioid Prescription Elimination (HOPE) is a project designed to provide surgeons with practical, real-world solutions to effectively manage postoperative pain and eliminate the need for opioids using HTX-011 (extended-release bupivacaine/low-dose meloxicam). In phase 3 herniorrhaphy and bunionectomy studies, HTX-011 without multimodal analgesia (MMA) was superior to bupivacaine hydrochloride in reducing pain and opioid consumption. Here, we examine the HOPE Hernia-1 study, which was designed to compare alternating ibuprofen/acetaminophen with concurrent use as part of an HTX-011-based non-opioid MMA regimen in patients undergoing herniorrhaphy and to evaluate the effectiveness of a personalized opioid prescription algorithm.

Methods: Patients undergoing outpatient open inguinal herniorrhaphy with intraoperative administration of HTX-011 (300 mg bupivacaine/9 mg meloxicam) were randomly assigned to receive a scheduled oral regimen of ibuprofen plus acetaminophen, either taken together every 6 hours or alternating every 3 hours, for 5 days following surgery, while awake. Based on the opioid prescription algorithm evaluated here, patients could receive an oxycodone prescription upon discharge only if they had a numeric rating scale pain score of ≥ 6 at discharge and/or had received a postoperative rescue opioid.

Results: The majority of patients did not require an opioid prescription through 2 weeks following surgery, and this was similar between cohorts (alternating MMA, 89.1%; concurrent MMA, 93.6%). Patient satisfaction was high for both regimens, and 95% of patients had an opioid-free recovery. No patient discharged without a prescription called back to request one. Treatment was well tolerated, without evidence of nonsteroidal anti-inflammatory drug-related toxicity.

Conclusions: HTX-011, used with over-the-counter products ibuprofen/acetaminophen and personalized opioid prescription algorithm in a real-world environment, has the potential to reduce opioid use and opioid prescriptions after herniorrhaphy without compromising patient satisfaction.

Trial registration: ClinicalTrials.gov, NCT03237481.

Keywords: HTX-011; Hernia repair; Multimodal analgesia; Opioid; Opioid-free; Postoperative pain.

© 2021. The Author(s).

Figures

Fig. 1

HOPE Hernia-1 study design. *While patient is awake. APAP acetaminophen, HOPE Helping Opioid Prescription Elimination, IBU ibuprofen, q6h every 6 hours, MMA multimodal analgesia, NRS Numeric Rating Scale of pain intensity, TSQM-9 Treatment Satisfaction Questionnaire for Medication (9-question)

Fig. 2

Patient disposition

Fig. 3

Postoperative opioid utilization. MMA multimodal analgesia, OTC over-the-counter. Alternating MMA, ibuprofen 600 mg and acetaminophen 1 g, one or the other every 3 hours, while awake, for 5 days. Concurrent MMA, ibuprofen 600 mg and acetaminophen 1 g, together every 6 hours, while awake, for 5 days