Study of Post-Herniorrhaphy Non-opioid MMA Regimens

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: Acetaminophen; Drug: Ibuprofen; Drug: HTX-011

• Study Type: Interventional
• Enrollment (Actual): 209
• 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
    • St. 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
    • St 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
    • Stony Brook, New York, United States, 11794
      • Stony Brook University Hospital
    • The Bronx, New York, United States, 10461
      • Montefiore Hutchinson Campus
  • 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

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 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 .

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: 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.	Device: Luer lock applicator; Applicator for instillation; Drug: Acetaminophen; 1 g; Drug: Ibuprofen; 600 mg; Drug: HTX-011; 300 mg bupivacaine/9 mg meloxicam; Other Names: ZYNRELEF
Experimental: 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.	Device: Luer lock applicator; Applicator for instillation; Drug: Acetaminophen; 1 g; Drug: Ibuprofen; 600 mg; Drug: HTX-011; 300 mg bupivacaine/9 mg meloxicam; Other Names: ZYNRELEF

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Proportion of Subjects Who do Not Receive an Opioid Prescription Through the Day 15 Visit	Through Day 15

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of Subjects Who do Not Receive an Opioid Prescription 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.		Postdischarge through Day 15
Pain Intensity Scores at the Time of 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		Postdischarge through Day 15
Mean TSQM-9 Scores	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

Collaborators and Investigators

• Sponsor: Heron Therapeutics

Study record dates

Study Major Dates

• Study Start (Actual): April 4, 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): June 4, 2026
• Last Update Submitted That Met QC Criteria: May 8, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: hernia; postoperative pain; inguinal hernia; multimodal analgesia; herniorrhaphy; hernia surgery
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Anatomical; Neurobehavioral Manifestations; Hernia, Abdominal; Perceptual Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain, Postoperative; Hernia; Hernia, Inguinal; Agnosia; Organic Chemicals; Carboxylic Acids; Anilides; Amides; Aniline Compounds; Amines; Acetanilides; Acids, Carbocyclic; Phenylpropionates; Acetaminophen; Ibuprofen; bupivacaine-meloxicam drug combination
• 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