Herniorrhaphy Study for Opioid Elimination

Overview

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.

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: July 2021

Interventions

  • Drug: HTX-011
    • 300 mg
  • Device: Luer lock applicator
    • Applicator for instillation
  • Drug: Ibuprofen
    • 600 mg
  • Drug: Acetaminophen
    • 1 g

Arms, Groups and Cohorts

  • Experimental: Cohort 1
    • HTX-011; Ibuprofen and Acetaminophen (regimen 1)
  • Experimental: Cohort 2
    • HTX-011; Ibuprofen and Acetaminophen (regimen 2)

Clinical Trial Outcome Measures

Primary Measures

  • Proportion of subjects who do not receive an opioid prescription at discharge through the day 15 visit
    • Time Frame: Discharge through Day 15

Secondary Measures

  • Proportion of subjects who do not receive an opioid prescription at discharge
    • Time Frame: At discharge
  • Proportion of subjects who do not receive a postdischarge opioid prescription, through the Day 15 visit.
    • Time Frame: Postdischarge through Day 15
  • Pain intensity scores at the time of discharge
    • Time Frame: At discharge
  • Number of oxycodone pills taken between discharge and the Day 15 visit
    • Time Frame: Postdischarge through Day 15
  • Mean TSQM-9 scores
    • Time Frame: Day 15 plus or minus 2 days

Participating in This Clinical Trial

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 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. – Has uncontrolled anxiety, psychiatric, or neurological disorder. – 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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Heron Therapeutics
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Contact(s)
    • Chris Storgard, MD, (858) 251-4452, cstorgard@herontx.com

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