Herniorrhaphy Study for Opioid Elimination

Analgesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03907176
• Other study ID #: HTX-011-304
• Status: Completed
• Phase: Phase 3
• Start date: April 5, 2019
• Est. completion date: November 22, 2021

Study information

• Verified date: February 2022
• Source: Heron Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 115
• Est. completion date: November 22, 2021
• Est. primary completion date: October 25, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Analgesia

Intervention

Drug:
• HTX-011
300 mg

Device:
• Luer lock applicator
Applicator for instillation

Drug:
• Ibuprofen
600 mg
• Acetaminophen
1 g

Locations

Country	Name	City	State
United States	Anaheim Clinical Trials, LLC	Anaheim	California
United States	Summit Medical Group Oregon-Bend Memorial Clinic	Bend	Oregon
United States	Montefiore Hutchinson Campus	Bronx	New York
United States	Cleveland Clinic	Cleveland	Ohio
United States	Cleveland Clinic Fairview	Cleveland	Ohio
United States	The Ohio State University Wexner Medical Center - University Hospital	Columbus	Ohio
United States	Baylor University Medical Center	Dallas	Missouri
United States	Baylor University Medical Center	Dallas	Texas
United States	Midwest Clinical Research Center, LLC	Dayton	Ohio
United States	JBR Clinical Research	Draper	Utah
United States	M3 Emerging Medical Research, LLC	Durham	North Carolina
United States	Hermann Drive Surgical Hospital	Houston	Texas
United States	Houston Methodist Hospital	Houston	Texas
United States	Horizon Clinical Research	La Mesa	California
United States	Sharp Grossmont Hospital	La Mesa	California
United States	University of Louisville Hospital	Louisville	Kentucky
United States	Medical Research of Westchester, Inc	Miami	Florida
United States	Yale University School of Medicine	New Haven	Connecticut
United States	Rutgers - New Jersey Medical School	Newark	New Jersey
United States	University of California, Irvine Medical Center	Orange	California
United States	Penn Presbyterian Medical Center	Philadelphia	Pennsylvania
United States	Thomas Jefferson University Hospital	Philadelphia	Pennsylvania
United States	UPMC Passavant	Pittsburgh	Pennsylvania
United States	UPMC Shadyside Hospital	Pittsburgh	Pennsylvania
United States	Plano Surgical Hospital	Plano	Texas
United States	Parkview Community Hospital	Riverside	California
United States	Washington University School of Medicine	Saint Louis	Missouri
United States	Professional Health Care of Pinellas	Saint Petersburg	Florida
United States	Endeavor Clinical Trials, LLC	San Antonio	Texas
United States	Stony Brook University Hospital	Stony Brook	New York

Sponsors (1)

Lead Sponsor	Collaborator
Heron Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

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