Evidence map›Paper›PMID 34318438›Full record

ArticlePain and therapy2021

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

Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in Pain and therapy, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. 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 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
1.3field-weighted citation impact, top 21% of its field
1 · What the graph read from 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.

2 · The registry

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.

NCT03237481 phase3completednot on this map

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

TypeinterventionalSponsorHeron TherapeuticsRan2017 to 2018Enrolled418ConditionsPostoperative PainArmsHTX-011, Bupivacaine HCl, Saline placebo, Luer-lock applicator, Vial access device
3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 8 citations in OpenAlex.

  1. Article
  2. Initial Experience with Bupivacaine-Meloxicam Extended Formulation (ZynrelefJournal of pain management and therapeutic care · 2024
    Article
  3. Article
  4. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors at 6 institutions in 1 country.

Harold MinkowitzHD Research Group, 4801 Bissonnet St, Bellaire, TX, 77401, USA. harold@minkowitzmd.com.
Roy SotoBeaumont Health System, 3601 W 13 Mile Rd, Royal Oak, MI, USA.
John FanikosBrigham and Women's Hospital, 75 Francis St, Boston, MA, 02115, USA.
Gregory B HammerStanford University School of Medicine, 291 Campus Drive, Stanford, CA, 94305, USA.
Neel MehtaWeill Cornell Pain Medicine Center, 1300 York Avenue, New York, NY, 10065, USA.
Jia HuHeron Therapeutics, Inc., 4242 Campus Point Court Suite 200, San Diego, CA, 92121, USA.
Jay RedanAdventHealth Celebration, 400 Celebration Place, Celebration, FL, 34747, USA.
AdventHealth Celebration · USBeaumont Health · USBrigham and Women's Hospital · USCornell University · USHeron Therapeutics (United States) · USStanford University · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionHelping 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.

methodsPatients 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.

resultsThe 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.

conclusionsHTX-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 registrationClinicalTrials.gov, NCT03237481.

Indexed as

Hernia repairHTX-011Multimodal analgesiaOpioidOpioid-freePostoperative pain

Identifiers

PMID34318438
PMCPMC8586395
OpenAlexW3184471572

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

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.