Herniorrhaphy Study for Opioid Elimination
- Conditions
- Analgesia
- Interventions
- Registration Number
- NCT03907176
- Lead Sponsor
- Heron Therapeutics
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 115
- 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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cohort 1 HTX-011 HTX-011; Ibuprofen and Acetaminophen (regimen 1) Cohort 1 Luer lock applicator HTX-011; Ibuprofen and Acetaminophen (regimen 1) Cohort 2 HTX-011 HTX-011; Ibuprofen and Acetaminophen (regimen 2) Cohort 2 Luer lock applicator HTX-011; Ibuprofen and Acetaminophen (regimen 2) Cohort 1 Ibuprofen HTX-011; Ibuprofen and Acetaminophen (regimen 1) Cohort 1 Acetaminophen HTX-011; Ibuprofen and Acetaminophen (regimen 1) Cohort 2 Acetaminophen HTX-011; Ibuprofen and Acetaminophen (regimen 2) Cohort 2 Ibuprofen HTX-011; Ibuprofen and Acetaminophen (regimen 2)
- Primary Outcome Measures
Name Time Method Proportion of subjects who do not receive an opioid prescription at discharge through the day 15 visit Discharge through Day 15
- Secondary Outcome Measures
Name Time Method Proportion of subjects who do not receive a postdischarge opioid prescription, through the Day 15 visit. Postdischarge through Day 15 Number of oxycodone pills taken between discharge and the Day 15 visit Postdischarge through Day 15 Proportion of subjects who do not receive an opioid prescription at discharge At discharge Pain intensity scores at the time of discharge At discharge Mean TSQM-9 scores Day 15 plus or minus 2 days
Trial Locations
- Locations (29)
Cleveland Clinic
🇺🇸Cleveland, Ohio, United States
UPMC Shadyside Hospital
🇺🇸Pittsburgh, Pennsylvania, United States
UPMC Passavant
🇺🇸Pittsburgh, Pennsylvania, United States
Stony Brook University Hospital
🇺🇸Stony Brook, New York, United States
Rutgers - New Jersey Medical School
🇺🇸Newark, New Jersey, United States
Cleveland Clinic Fairview
🇺🇸Cleveland, Ohio, United States
The Ohio State University Wexner Medical Center - University Hospital
🇺🇸Columbus, Ohio, United States
Midwest Clinical Research Center, LLC
🇺🇸Dayton, Ohio, United States
Summit Medical Group Oregon-Bend Memorial Clinic
🇺🇸Bend, Oregon, United States
University of Louisville Hospital
🇺🇸Louisville, Kentucky, United States
Plano Surgical Hospital
🇺🇸Plano, Texas, United States
Montefiore Hutchinson Campus
🇺🇸Bronx, New York, United States
JBR Clinical Research
🇺🇸Draper, Utah, United States
Washington University School of Medicine
🇺🇸Saint Louis, Missouri, United States
Hermann Drive Surgical Hospital
🇺🇸Houston, Texas, United States
Houston Methodist Hospital
🇺🇸Houston, Texas, United States
M3 Emerging Medical Research, LLC
🇺🇸Durham, North Carolina, United States
Endeavor Clinical Trials, LLC
🇺🇸San Antonio, Texas, United States
Sharp Grossmont Hospital
🇺🇸La Mesa, California, United States
Professional Health Care of Pinellas
🇺🇸Saint Petersburg, Florida, United States
Horizon Clinical Research
🇺🇸La Mesa, California, United States
Anaheim Clinical Trials, LLC
🇺🇸Anaheim, California, United States
University of California, Irvine Medical Center
🇺🇸Orange, California, United States
Parkview Community Hospital
🇺🇸Riverside, California, United States
Yale University School of Medicine
🇺🇸New Haven, Connecticut, United States
Medical Research of Westchester, Inc
🇺🇸Miami, Florida, United States
Baylor University Medical Center
🇺🇸Dallas, Texas, United States
Thomas Jefferson University Hospital
🇺🇸Philadelphia, Pennsylvania, United States
Penn Presbyterian Medical Center
🇺🇸Philadelphia, Pennsylvania, United States