Study of Post-Herniorrhaphy Non-opioid MMA Regimens
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
1 other identifier
interventional
209
1 country
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Apr 2019
Typical duration for phase_3
30 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 4, 2019
CompletedFirst Submitted
Initial submission to the registry
April 5, 2019
CompletedFirst Posted
Study publicly available on registry
April 8, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 25, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
November 22, 2021
CompletedResults Posted
Study results publicly available
June 4, 2026
CompletedJune 4, 2026
May 1, 2026
2.6 years
April 5, 2019
June 8, 2023
May 8, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Proportion of Subjects Who do Not Receive an Opioid Prescription Through the Day 15 Visit
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)
HTX-011 + Alternating MMA Regimen
EXPERIMENTALHTX-011 (bupivacaine/meloxicam), 300 mg/9 mg via instillation; non-opioid multimodal analgesic (MMA) regimen of ibuprofen and acetaminophen, alternating (one or the other every 3 hours), while awake.
HTX-011 + Concurrent MMA Regimen
EXPERIMENTALHTX-011 (bupivacaine/meloxicam), 300 mg/9 mg via instillation; non-opioid multimodal analgesic (MMA) regimen of ibuprofen and acetaminophen, together every 6 hours, while awake.
Interventions
300 mg bupivacaine/9 mg meloxicam
Applicator for instillation
Eligibility Criteria
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 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.
- 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 .
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (30)
Anaheim Clinical Trials, LLC
Anaheim, California, 92801, United States
Horizon Clinical Research
La Mesa, California, 91942, United States
Sharp Grossmont Hospital
La Mesa, California, 91942, United States
University of California, Irvine Medical Center
Orange, California, 92868, United States
Parkview Community Hospital
Riverside, California, 92503, United States
Yale University School of Medicine
New Haven, Connecticut, 06510, United States
Medical Research of Westchester, Inc
Miami, Florida, 33144, United States
Professional Health Care of Pinellas
St. Petersburg, Florida, 33713, United States
University of Louisville Hospital
Louisville, Kentucky, 40202, United States
Baylor University Medical Center
Dallas, Missouri, 75246, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Rutgers - New Jersey Medical School
Newark, New Jersey, 07103, United States
Stony Brook University Hospital
Stony Brook, New York, 11794, United States
Montefiore Hutchinson Campus
The Bronx, New York, 10461, United States
M3 Emerging Medical Research, LLC
Durham, North Carolina, 27704, United States
Cleveland Clinic Fairview
Cleveland, Ohio, 44111, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
The Ohio State University Wexner Medical Center - University Hospital
Columbus, Ohio, 43210, United States
Midwest Clinical Research Center, LLC
Dayton, Ohio, 45417, United States
Summit Medical Group Oregon-Bend Memorial Clinic
Bend, Oregon, 97701, United States
Penn Presbyterian Medical Center
Philadelphia, Pennsylvania, 19104, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107, United States
UPMC Shadyside Hospital
Pittsburgh, Pennsylvania, 15232, United States
UPMC Passavant
Pittsburgh, Pennsylvania, 15237, United States
Baylor University Medical Center
Dallas, Texas, 75246, United States
Hermann Drive Surgical Hospital
Houston, Texas, 77004, United States
Houston Methodist Hospital
Houston, Texas, 77030, United States
Plano Surgical Hospital
Plano, Texas, 75093, United States
Endeavor Clinical Trials, LLC
San Antonio, Texas, 78229, United States
JBR Clinical Research
Draper, Utah, 84020, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Tricia Mulford
- Organization
- Heron Therapeutics, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 5, 2019
First Posted
April 8, 2019
Study Start
April 4, 2019
Primary Completion
October 25, 2021
Study Completion
November 22, 2021
Last Updated
June 4, 2026
Results First Posted
June 4, 2026
Record last verified: 2026-05