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Study of Post-Herniorrhaphy Non-opioid MMA Regimens

8. mai 2026 oppdatert av: 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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

209

Fase

  • Fase 3

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Ikke-randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Enhet: Luer lock applikator
Applikator for instillasjon
Legemiddel: Paracetamol
1 g
Legemiddel: Ibuprofen
600 mg
Legemiddel: HTX-011
300 mg bupivacaine/9 mg meloxicam
Andre navn:
  • ZYNRELEF
Eksperimentell: 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.
Enhet: Luer lock applikator
Applikator for instillasjon
Legemiddel: Paracetamol
1 g
Legemiddel: Ibuprofen
600 mg
Legemiddel: HTX-011
300 mg bupivacaine/9 mg meloxicam
Andre navn:
  • ZYNRELEF

Hva måler studien?

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
Tiltaksbeskrivelse
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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Heron Therapeutics

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

4. april 2019

Primær fullføring (Faktiske)

25. oktober 2021

Studiet fullført (Faktiske)

22. november 2021

Datoer for studieregistrering

Først innsendt

5. april 2019

Først innsendt som oppfylte QC-kriteriene

5. april 2019

Først lagt ut (Faktiske)

8. april 2019

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

4. juni 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

8. mai 2026

Sist bekreftet

1. mai 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • HTX-011-304

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

UBESLUTTE

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Ja

Studerer et amerikansk FDA-regulert enhetsprodukt

Ja

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