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Study of Post-Herniorrhaphy Non-opioid MMA Regimens

8. maj 2026 opdateret af: Heron Therapeutics

A Phase 3b, Randomized, Open-Label Study of HTX-011 as the Foundation of a Non-opioid, Multimodal Analgesic Regimen to Decrease Opioid Use Following Unilateral Open Inguinal Herniorrhaphy

This is a Phase 3b, open-label study to assess postoperative opioid use in subjects undergoing unilateral open inguinal herniorrhaphy with intraoperative administration of HTX-011 and a postoperative non-opioid multimodal analgesic (MMA) regimen. The study will be conducted in 2 sequential parts: Part 1 is randomized and Part 2 is Investigator's preference for MMA regimen.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

209

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • California
      • Anaheim, California, Forenede Stater, 92801
        • Anaheim Clinical Trials, LLC
      • La Mesa, California, Forenede Stater, 91942
        • Sharp Grossmont Hospital
      • La Mesa, California, Forenede Stater, 91942
        • Horizon Clinical Research
      • Orange, California, Forenede Stater, 92868
        • University of California, Irvine Medical Center
      • Riverside, California, Forenede Stater, 92503
        • Parkview Community Hospital
    • Connecticut
      • New Haven, Connecticut, Forenede Stater, 06510
        • Yale University School of Medicine
    • Florida
      • Miami, Florida, Forenede Stater, 33144
        • Medical Research of Westchester, Inc
      • St. Petersburg, Florida, Forenede Stater, 33713
        • Professional Health Care of Pinellas
    • Kentucky
      • Louisville, Kentucky, Forenede Stater, 40202
        • University of Louisville Hospital
    • Missouri
      • Dallas, Missouri, Forenede Stater, 75246
        • Baylor University Medical Center
      • St Louis, Missouri, Forenede Stater, 63110
        • Washington University School of Medicine
    • New Jersey
      • Newark, New Jersey, Forenede Stater, 07103
        • Rutgers - New Jersey Medical School
    • New York
      • Stony Brook, New York, Forenede Stater, 11794
        • Stony Brook University Hospital
      • The Bronx, New York, Forenede Stater, 10461
        • Montefiore Hutchinson Campus
    • North Carolina
      • Durham, North Carolina, Forenede Stater, 27704
        • M3 Emerging Medical Research, LLC
    • Ohio
      • Cleveland, Ohio, Forenede Stater, 44195
        • Cleveland Clinic
      • Cleveland, Ohio, Forenede Stater, 44111
        • Cleveland Clinic Fairview
      • Columbus, Ohio, Forenede Stater, 43210
        • The Ohio State University Wexner Medical Center - University Hospital
      • Dayton, Ohio, Forenede Stater, 45417
        • Midwest Clinical Research Center, LLC
    • Oregon
      • Bend, Oregon, Forenede Stater, 97701
        • Summit Medical Group Oregon-Bend Memorial Clinic
    • Pennsylvania
      • Philadelphia, Pennsylvania, Forenede Stater, 19107
        • Thomas Jefferson University Hospital
      • Philadelphia, Pennsylvania, Forenede Stater, 19104
        • Penn Presbyterian Medical Center
      • Pittsburgh, Pennsylvania, Forenede Stater, 15232
        • UPMC Shadyside Hospital
      • Pittsburgh, Pennsylvania, Forenede Stater, 15237
        • UPMC Passavant
    • Texas
      • Dallas, Texas, Forenede Stater, 75246
        • Baylor University Medical Center
      • Houston, Texas, Forenede Stater, 77030
        • Houston Methodist Hospital
      • Houston, Texas, Forenede Stater, 77004
        • Hermann Drive Surgical Hospital
      • Plano, Texas, Forenede Stater, 75093
        • Plano Surgical Hospital
      • San Antonio, Texas, Forenede Stater, 78229
        • Endeavor Clinical Trials, LLC
    • Utah
      • Draper, Utah, Forenede Stater, 84020
        • JBR Clinical Research

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Beskrivelse

Inclusion Criteria:

  • Is scheduled and medically fit to undergo an elective unilateral open inguinal herniorrhaphy with mesh under deep sedation or general anesthesia; no neuraxial technique (eg, no spinal or epidural).
  • Has an American Society of Anesthesiologists (ASA) Physical Status of I, II, or III.
  • Female subjects are eligible only if not pregnant, not lactating, not planning to become pregnant during the study, sterile; or using acceptable contraceptives.

Exclusion Criteria:

  • Has a planned concurrent surgical procedure (eg, bilateral herniorrhaphy).
  • Has a pre-existing concurrent acute or chronic painful physical/restrictive condition expected to require analgesic treatment in the postoperative period for pain.
  • Has a contraindication or a known or suspected history of hypersensitivity or clinically significant idiosyncratic reaction to required study medications.
  • Part 1 only: Has known or suspected daily use of opioids for 7 or more consecutive days within the previous 6 months. Part 2 only: Has known or suspected history of persistent opioid use, defined as daily, or almost daily, use of opioids for a period of at least 30 days within the previous 6 months.
  • Has taken any opioids within 24 hours prior to the scheduled surgery.
  • Has a known or suspected history of drug abuse, has a positive drug screen on the day of surgery, consumes 3 or more alcoholic drinks every day, or has a recent history of alcohol abuse.
  • Has a medical condition such that, in the opinion of the Investigator, participating in the study would pose a health risk to the subject or confound the postoperative assessments .

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Ikke-randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: HTX-011 + Alternating MMA Regimen
HTX-011 (bupivacaine/meloxicam), 300 mg/9 mg via instillation; non-opioid multimodal analgesic (MMA) regimen of ibuprofen and acetaminophen, alternating (one or the other every 3 hours), while awake.
Enhed: Luer lock applikator
Applikator til inddrypning
Medicin: Acetaminophen
1 g
Medicin: Ibuprofen
600 mg
Medicin: HTX-011
300 mg bupivacaine/9 mg meloxicam
Andre navne:
  • ZYNRELEF
Eksperimentel: HTX-011 + Concurrent MMA Regimen
HTX-011 (bupivacaine/meloxicam), 300 mg/9 mg via instillation; non-opioid multimodal analgesic (MMA) regimen of ibuprofen and acetaminophen, together every 6 hours, while awake.
Enhed: Luer lock applikator
Applikator til inddrypning
Medicin: Acetaminophen
1 g
Medicin: Ibuprofen
600 mg
Medicin: HTX-011
300 mg bupivacaine/9 mg meloxicam
Andre navne:
  • ZYNRELEF

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Proportion of Subjects Who do Not Receive an Opioid Prescription Through the Day 15 Visit
Tidsramme: Through Day 15
Through Day 15

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Proportion of Subjects Who do Not Receive an Opioid Prescription at Discharge
Tidsramme: At discharge
Proportion of subjects who do not receive an opioid prescription at discharge (between 2 and 3 hours after surgery on average).
At discharge
Proportion of Subjects Who do Not Receive a Postdischarge Opioid Prescription, Through the Day 15 Visit.
Tidsramme: Postdischarge through Day 15
Postdischarge through Day 15
Pain Intensity Scores at the Time of Discharge
Tidsramme: At discharge
Pain intensity scores were assessed at discharge (between 2 and 3 hours after surgery on average) using an 11-point Numeric Rating Scale (NRS) (0-10) where 0 represents "no pain" and 10 represents "worst pain imaginable". NRS scores are recorded with activity (NRS-A), sitting up from a resting position.
At discharge
Number of Oxycodone Pills Taken Between Discharge and the Day 15 Visit
Tidsramme: Postdischarge through Day 15
Postdischarge through Day 15
Mean TSQM-9 Scores
Tidsramme: Day 15 plus or minus 2 days
The TSQM-9 contains 9 items which make up the Effectiveness, Convenience, and Global Satisfaction domains; each domain includes 3 items. Scores for each domain were computed by adding the TSQM items in each domain and then transforming the composite score into a value ranging from 0 to 100, with higher scores indicating higher satisfaction.
Day 15 plus or minus 2 days

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Heron Therapeutics

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

4. april 2019

Primær færdiggørelse (Faktiske)

25. oktober 2021

Studieafslutning (Faktiske)

22. november 2021

Datoer for studieregistrering

Først indsendt

5. april 2019

Først indsendt, der opfyldte QC-kriterier

5. april 2019

Først opslået (Faktiske)

8. april 2019

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

4. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

8. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • HTX-011-304

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

UBESLUTET

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ja

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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