Trial reportHernia : the journal of hernias and abdominal wall surgery2019
HTX-011 reduced pain intensity and opioid consumption versus bupivacaine HCl in herniorrhaphy: results from the phase 3 EPOCH 2 study.
Trial report in Hernia : the journal of hernias and abdominal wall surgery, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT03237481 (A Phase 3, Randomized, Double Blind, Saline Placebo and Active Controlled, Multicenter Study of HTX 011 Via Local Administration for Postoperative Analgesia and Decreased Opioid Use Following Unilateral Open Inguinal Herniorrhaphy), which is not on this map. Cited by 22 papers, 1 of them a synthesis that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Phase 3, Randomized, Double Blind, Saline Placebo and Active Controlled, Multicenter Study of HTX 011 Via Local Administration for Postoperative Analgesia and Decreased Opioid Use Following Unilateral Open Inguinal Herniorrhaphy
Who cites it
22 citing papers in PubMed, 1 synthesis or guideline pooled it, 49 citations in OpenAlex.
- Pooled it
- HTX-011 in Combination with Multimodal Analgesic Regimen Minimized Severe Pain and Opioid Use after Total Knee Arthroplasty in an Open-Label Study.The journal of knee surgery · 2023Trial
- Sustained-release local anesthetics: advances in drug delivery systems for prolonged postoperative analgesia.Anesthesia and pain medicine · 2026Review
- Applications of micro/nano drug delivery systems in cancer pain management.Bioactive materials · 2026Review
- Use of Zynrelef (bupivacaine and meloxicam) to eliminate the need for opioids in laparoscopic pre-peritoneal inguinal hernia repairs.Surgical endoscopy · 2026Article
- Local Delivery of Non-opioid Analgesic Microparticles to Modulate Post-surgical Pain.Pharmaceutical research · 2025Article
- Drugs in Development to Manage Acute Pain.Drugs · 2025Review
- A carrier-free long-acting ropivacaine formulation using methylprednisolone sodium succinate as a dual-functional adjuvant.Theranostics · 2025Article
- Recent advances in local anesthetic drug delivery systems based on natural polymers.Frontiers in bioengineering and biotechnology · 2025Review
- Nanotechnology in Pain Management.Pharmaceutics · 2024Review
- Extended Release of Bupivacaine from Temperature-Responsive PNDJ Hydrogels Improves Postoperative Weight-Bearing in Rabbits Following Knee Surgery.Pharmaceuticals (Basel, Switzerland) · 2024Article
- Nanotechnology for Pain Management.Journal of clinical medicine · 2024Review
- Initial Experience with Bupivacaine-Meloxicam Extended Formulation (ZynrelefJournal of pain management and therapeutic care · 2024Article
- Peripheral Regional Anesthesia Using Local Anesthetics: Old Wine in New Bottles?Journal of clinical medicine · 2023Review
- Safety and Efficacy of ZynrelefJournal of pain & relief · 2023Article
- Combination anesthetic therapy: co-delivery of ropivacaine and meloxicam using transcriptional transactivator peptide modified nanostructured lipid carriersDrug delivery · 2022Article
- Novel Local Anesthetics in Clinical Practice: Pharmacologic Considerations and Potential Roles for the Future.Anesthesiology and pain medicine · 2022Review
- 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 and therapy · 2021Article
- Review
- Nanotherapeutic-directed approaches to analgesia.Trends in pharmacological sciences · 2021Review
Corrections and comments
- Erratum issued
Authors and funding
6 authors at 6 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeCurrently available local anesthetics have not demonstrated sufficient analgesia beyond 12-24 h postoperatively. The purpose of the study was to assess the safety and efficacy of HTX-011 (bupivacaine and meloxicam in Biochronomer
methodsA phase 3, randomized, double-blind, active-controlled multi-center study (EPOCH 2; NCT03237481) in subjects undergoing unilateral open inguinal herniorrhaphy with mesh placement was performed. Subjects randomly received a single intraoperative dose of HTX-011, immediate-release bupivacaine HCl, or saline placebo prior to closure.
resultsThe study evaluated 418 subjects, and the primary and all key secondary efficacy endpoints were in favor of HTX-011. HTX-011 reduced mean pain intensity by 23% versus placebo (primary endpoint; p < 0.001) and by 21% versus bupivacaine HCl (p < 0.001) with significant reductions in the number of patients experiencing severe pain. Opioid consumption over 72 h was reduced by 38% versus placebo (p < 0.001) and 25% versus bupivacaine HCl (p = 0.024). Overall, 51% of HTX-011 subjects were opioid-free through 72 h (versus 22% for placebo [p < 0.001] and 40% for bupivacaine HCl [p = 0.049]). HTX-011 was generally well-tolerated with fewer opioid-related adverse events reported compared to the bupivacaine HCl and placebo and no evidence of local anesthetic systemic toxicity.
conclusionsHTX-011 demonstrated significant improvement in postoperative pain control and a clinically meaningful reduction in opioid consumption when compared to the most widely used local anesthetic, bupivacaine HCl.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.