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
| Autor: | John Fanikos, Roy G. Soto, Gregory B. Hammer, Neel Mehta, Jia Hu, Jay Redan, Harold S. Minkowitz |
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| Rok vydání: | 2021 |
| Předmět: |
Bupivacaine
Multimodal analgesia business.industry Opioid Acetaminophen Postoperative pain HTX-011 Regimen Opioid-free Anesthesiology and Pain Medicine Patient satisfaction Anesthesia medicine Hernia repair Neurology (clinical) Medical prescription Bupivacaine hydrochloride business Oxycodone Original Research medicine.drug |
| Zdroj: | Pain and Therapy |
| ISSN: | 2193-651X 2193-8237 |
| DOI: | 10.1007/s40122-021-00289-2 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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