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

Harold Minkowitz; Roy Soto; John Fanikos; Gregory B Hammer; Neel Mehta; Jia Hu; Jay Redan

doi:10.1007/s40122-021-00289-2

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

Pain Ther. 2021 Dec;10(2):1295-1308. doi: 10.1007/s40122-021-00289-2. Epub 2021 Jul 27.

Authors

Harold Minkowitz¹, Roy Soto², John Fanikos³, Gregory B Hammer⁴, Neel Mehta⁵, Jia Hu⁶, Jay Redan⁷

Affiliations

¹ HD Research Group, 4801 Bissonnet St, Bellaire, TX, 77401, USA. harold@minkowitzmd.com.
² Beaumont Health System, 3601 W 13 Mile Rd, Royal Oak, MI, USA.
³ Brigham and Women's Hospital, 75 Francis St, Boston, MA, 02115, USA.
⁴ Stanford University School of Medicine, 291 Campus Drive, Stanford, CA, 94305, USA.
⁵ Weill Cornell Pain Medicine Center, 1300 York Avenue, New York, NY, 10065, USA.
⁶ Heron Therapeutics, Inc., 4242 Campus Point Court Suite 200, San Diego, CA, 92121, USA.
⁷ AdventHealth Celebration, 400 Celebration Place, Celebration, FL, 34747, USA.

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.

Associated data

ClinicalTrials.gov/NCT03237481