Herniorrhaphy Study for Opioid Elimination

NCT03907176 | Completed Phase 3 FDA Drug FDA Device

• 1 other identifier: HTX-011-304
• Study Type: interventional
• Target: 115
• Locations: 1 country
• Sites: 30

Brief Summary

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.

Conditions

Analgesia

Keywords

inguinal hernia; hernia; hernia surgery; postoperative pain; herniorrhaphy; multimodal analgesia

Outcome Measures

Primary Outcomes (1)

• Proportion of subjects who do not receive an opioid prescription at discharge through the day 15 visit

  Discharge through Day 15

Secondary Outcomes (5)

• 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

Study Arms (2)

Cohort 1

EXPERIMENTAL

HTX-011; Ibuprofen and Acetaminophen (regimen 1)

Drug: HTX-011; Device: Luer lock applicator; Drug: Ibuprofen; Drug: Acetaminophen

Cohort 2

EXPERIMENTAL

HTX-011; Ibuprofen and Acetaminophen (regimen 2)

Drug: HTX-011; Device: Luer lock applicator; Drug: Ibuprofen; Drug: Acetaminophen

Interventions

HTX-011 DRUG

300 mg

Cohort 1; Cohort 2

Luer lock applicator DEVICE

Applicator for instillation

Cohort 1; Cohort 2

Ibuprofen DRUG

600 mg

Cohort 1; Cohort 2

Acetaminophen DRUG

1 g

Cohort 1; Cohort 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Heron Therapeutics: lead

Study Sites (30)

Anaheim Clinical Trials, LLC

Anaheim, California, 92801, United States

Location

Horizon Clinical Research

La Mesa, California, 91942, United States

Location

Sharp Grossmont Hospital

La Mesa, California, 91942, United States

Location

University of California, Irvine Medical Center

Orange, California, 92868, United States

Location

Parkview Community Hospital

Riverside, California, 92503, United States

Location

Yale University School of Medicine

New Haven, Connecticut, 06510, United States

Location

Medical Research of Westchester, Inc

Miami, Florida, 33144, United States

Location

Professional Health Care of Pinellas

St. Petersburg, Florida, 33713, United States

Location

University of Louisville Hospital

Louisville, Kentucky, 40202, United States

Location

Baylor University Medical Center

Dallas, Missouri, 75246, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Rutgers - New Jersey Medical School

Newark, New Jersey, 07103, United States

Location

Stony Brook University Hospital

Stony Brook, New York, 11794, United States

Location

Montefiore Hutchinson Campus

The Bronx, New York, 10461, United States

Location

M3 Emerging Medical Research, LLC

Durham, North Carolina, 27704, United States

Location

Cleveland Clinic Fairview

Cleveland, Ohio, 44111, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

The Ohio State University Wexner Medical Center - University Hospital

Columbus, Ohio, 43210, United States

Location

Midwest Clinical Research Center, LLC

Dayton, Ohio, 45417, United States

Location

Summit Medical Group Oregon-Bend Memorial Clinic

Bend, Oregon, 97701, United States

Location

Penn Presbyterian Medical Center

Philadelphia, Pennsylvania, 19104, United States

Location

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107, United States

Location

UPMC Shadyside Hospital

Pittsburgh, Pennsylvania, 15232, United States

Location

UPMC Passavant

Pittsburgh, Pennsylvania, 15237, United States

Location

Baylor University Medical Center

Dallas, Texas, 75246, United States

Location

Hermann Drive Surgical Hospital

Houston, Texas, 77004, United States

Location

Houston Methodist Hospital

Houston, Texas, 77030, United States

Location

Plano Surgical Hospital

Plano, Texas, 75093, United States

Location

Endeavor Clinical Trials, LLC

San Antonio, Texas, 78229, United States

Location

JBR Clinical Research

Draper, Utah, 84020, United States

Location

MeSH Terms

Conditions

Agnosia; Hernia, Inguinal; Hernia; Pain, Postoperative

Interventions

Ibuprofen; Acetaminophen

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hernia, Abdominal; Pathological Conditions, Anatomical; Postoperative Complications; Pathologic Processes; Pain

Intervention Hierarchy (Ancestors)

Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Acetanilides; Anilides; Amides; Aniline Compounds; Amines

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: In Part 1, subjects who meet the Screening eligibility criteria (Section 4.1) will be randomized to one of the 2 parallel cohorts. In Part 2, prior to surgery, the Investigator will select for the subject one of the 2 postoperative MMA regimens, based on Investigator and/or subject preference.

Study Record Dates

• First Submitted: April 5, 2019
• First Posted: April 8, 2019
• Study Start: April 5, 2019
• Primary Completion: October 25, 2021
• Study Completion: November 22, 2021
• Last Updated: February 21, 2022

Record last verified: 2022-02

Locations

US (30)