Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
115 participants
INTERVENTIONAL
2019-04-05
2021-11-22
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Phase 2 Herniorrhaphy Study for Opioid Elimination
NCT03695367
A Phase 2, Randomized, Double-Blind, Dose Escalation Study in Postoperative Pain Open Inguinal Herniorrhaphy
NCT05080959
No Opioids vs. Minimal Opioids Following Inguinal Hernia Repair
NCT05929937
A Trial of HR18034 in Inguinal Hernia Repair
NCT04551924
Multimodal Pain Therapy After Hernia Repair
NCT03792295
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Cohort 1
HTX-011; Ibuprofen and Acetaminophen (regimen 1)
HTX-011
300 mg
Luer lock applicator
Applicator for instillation
Ibuprofen
600 mg
Acetaminophen
1 g
Cohort 2
HTX-011; Ibuprofen and Acetaminophen (regimen 2)
HTX-011
300 mg
Luer lock applicator
Applicator for instillation
Ibuprofen
600 mg
Acetaminophen
1 g
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
HTX-011
300 mg
Luer lock applicator
Applicator for instillation
Ibuprofen
600 mg
Acetaminophen
1 g
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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 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.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Heron Therapeutics
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Anaheim Clinical Trials, LLC
Anaheim, California, United States
Horizon Clinical Research
La Mesa, California, United States
Sharp Grossmont Hospital
La Mesa, 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
Professional Health Care of Pinellas
St. Petersburg, Florida, United States
University of Louisville Hospital
Louisville, Kentucky, United States
Baylor University Medical Center
Dallas, Missouri, United States
Washington University School of Medicine
St Louis, Missouri, United States
Rutgers - New Jersey Medical School
Newark, New Jersey, United States
Stony Brook University Hospital
Stony Brook, New York, United States
Montefiore Hutchinson Campus
The Bronx, New York, United States
M3 Emerging Medical Research, LLC
Durham, North Carolina, United States
Cleveland Clinic Fairview
Cleveland, Ohio, United States
Cleveland Clinic
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
Penn Presbyterian Medical Center
Philadelphia, Pennsylvania, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States
UPMC Shadyside Hospital
Pittsburgh, Pennsylvania, United States
UPMC Passavant
Pittsburgh, Pennsylvania, United States
Baylor University Medical Center
Dallas, Texas, United States
Hermann Drive Surgical Hospital
Houston, Texas, United States
Houston Methodist Hospital
Houston, Texas, United States
Plano Surgical Hospital
Plano, Texas, United States
Endeavor Clinical Trials, LLC
San Antonio, Texas, United States
JBR Clinical Research
Draper, Utah, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
HTX-011-304
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.