Herniorrhaphy Study for Opioid Elimination

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.

Study Overview

• Status: Completed
• Conditions: Analgesia
• Intervention / Treatment: Device: Luer lock applicator; Drug: HTX-011; Drug: Acetaminophen; Drug: Ibuprofen

• Study Type: Interventional
• Enrollment (Actual): 115
• Phase: Phase 3

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort 1; HTX-011; Ibuprofen and Acetaminophen (regimen 1)	Device: Luer lock applicator; Applicator for instillation; Drug: HTX-011; 300 mg; Drug: Acetaminophen; 1 g; Drug: Ibuprofen; 600 mg
Experimental: Cohort 2; HTX-011; Ibuprofen and Acetaminophen (regimen 2)	Device: Luer lock applicator; Applicator for instillation; Drug: HTX-011; 300 mg; Drug: Acetaminophen; 1 g; Drug: Ibuprofen; 600 mg

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Heron Therapeutics

Study record dates

Study Major Dates

• Study Start (Actual): April 5, 2019
• Primary Completion (Actual): October 25, 2021
• Study Completion (Actual): November 22, 2021

Study Registration Dates

• First Submitted: April 5, 2019
• First Submitted That Met QC Criteria: April 5, 2019
• First Posted (Actual): April 8, 2019

Study Record Updates

• Last Update Posted (Actual): February 21, 2022
• Last Update Submitted That Met QC Criteria: February 17, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: hernia; postoperative pain; inguinal hernia; multimodal analgesia; herniorrhaphy; hernia surgery
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Antipyretics; Acetaminophen; Ibuprofen
• Other Study ID Numbers: HTX-011-304

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: Yes