Clinical trial NCT03907176: Herniorrhaphy Study for Opioid Elimination
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Analgesia
Keywords: inguinal hernia
hernia
hernia surgery
postoperative pain
herniorrhaphy
multimodal analgesia
Lead sponsor: Heron Therapeutics
Sponsor class: INDUSTRY
First posted: 2019-04-08
Enrollment: 115
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Proportion of subjects who do not receive an opioid prescription at discharge through the day 15 visit
timeFrame: Discharge through Day 15
Secondary outcomes:
measure: Proportion of subjects who do not receive an opioid prescription at discharge
timeFrame: At discharge
measure: Proportion of subjects who do not receive a postdischarge opioid prescription, through the Day 15 visit.
timeFrame: Postdischarge through Day 15
measure: Pain intensity scores at the time of discharge
timeFrame: At discharge
measure: Number of oxycodone pills taken between discharge and the Day 15 visit
timeFrame: Postdischarge through Day 15
measure: Mean TSQM-9 scores
timeFrame: Day 15 plus or minus 2 days
Other outcomes:
Locations:
city: Anaheim
country: United States
facility: Anaheim Clinical Trials, LLC
state: California
city: La Mesa
country: United States
facility: Horizon Clinical Research
state: California
city: La Mesa
country: United States
facility: Sharp Grossmont Hospital
state: California
city: Orange
country: United States
facility: University of California, Irvine Medical Center
state: California
city: Riverside
country: United States
facility: Parkview Community Hospital
state: California
city: New Haven
country: United States
facility: Yale University School of Medicine
state: Connecticut
city: Miami
country: United States
facility: Medical Research of Westchester, Inc
state: Florida
city: Saint Petersburg
country: United States
facility: Professional Health Care of Pinellas
state: Florida
city: Louisville
country: United States
facility: University of Louisville Hospital
state: Kentucky
city: Dallas
country: United States
facility: Baylor University Medical Center
state: Missouri
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Newark
country: United States
facility: Rutgers - New Jersey Medical School
state: New Jersey
city: Bronx
country: United States
facility: Montefiore Hutchinson Campus
state: New York
city: Stony Brook
country: United States
facility: Stony Brook University Hospital
state: New York
city: Durham
country: United States
facility: M3 Emerging Medical Research, LLC
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic Fairview
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Columbus
country: United States
facility: The Ohio State University Wexner Medical Center - University Hospital
state: Ohio
city: Dayton
country: United States
facility: Midwest Clinical Research Center, LLC
state: Ohio
city: Bend
country: United States
facility: Summit Medical Group Oregon-Bend Memorial Clinic
state: Oregon
city: Philadelphia
country: United States
facility: Penn Presbyterian Medical Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: Thomas Jefferson University Hospital
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPMC Shadyside Hospital
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPMC Passavant
state: Pennsylvania
city: Dallas
country: United States
facility: Baylor University Medical Center
state: Texas
city: Houston
country: United States
facility: Hermann Drive Surgical Hospital
state: Texas
city: Houston
country: United States
facility: Houston Methodist Hospital
state: Texas
city: Plano
country: United States
facility: Plano Surgical Hospital
state: Texas
city: San Antonio
country: United States
facility: Endeavor Clinical Trials, LLC
state: Texas
city: Draper
country: United States
facility: JBR Clinical Research
state: Utah
Study officials:
References: