Phase 3 Herniorrhaphy Study for Postoperative Analgesia (EPOCH 2)
Public ClinicalTrials.gov record NCT03237481. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 3, Randomized, Double Blind, Saline Placebo and Active Controlled, Multicenter Study of HTX 011 Via Local Administration for Postoperative Analgesia and Decreased Opioid Use Following Unilateral Open Inguinal Herniorrhaphy
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This is a Phase 3, randomized, double-blind, saline placebo- and active-controlled, multicenter study to evaluate the analgesic efficacy and safety of HTX 011 administered via local administration into the surgical site in subjects undergoing unilateral open inguinal herniorrhaphy.
Study identification
- NCT ID
- NCT03237481
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 418 participants
Conditions and interventions
Conditions
Interventions
- HTX-011 Drug
- Bupivacaine HCl Drug
- Saline placebo Drug
- Luer-lock applicator Device
- Vial access device Device
Drug · Device
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jul 31, 2017 (Actual)
- Primary completion
- Dec 22, 2017 (Actual)
- Completion
- Jan 16, 2018 (Actual)
- Last update posted
- Mar 2, 2026
2017 – 2018
United States locations
- U.S. sites
- 22
- U.S. states
- 10
- U.S. cities
- 21
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Eliza Coffee Memorial Hospital | Florence | Alabama | 35630 | — |
| Shoals Medical Trials, Inc. | Sheffield | Alabama | 35660 | — |
| Arizona Research Center | Phoenix | Arizona | 85053 | — |
| Anaheim Clinical Trials, LLC | Anaheim | California | 92801 | — |
| Trovare Clinical Research, Inc. | Bakersfield | California | 93301 | — |
| Alliance Research Centers | Laguna Hills | California | 92653 | — |
| Lotus Clinical Research, LLC | Pasadena | California | 91105 | — |
| HD Research Corp | Riverside | California | 92503 | — |
| American Institute of Research | Whittier | California | 90603 | — |
| Yale University School of Medicine | New Haven | Connecticut | 06511 | — |
| Cornerstone Research Institute, LLC | Longwood | Florida | 32750 | — |
| Park Place Surgery Center | Maitland | Florida | 32751 | — |
| University of Miami | Miami | Florida | 33136 | — |
| St. Louis Clinical Trials | St Louis | Missouri | 63141 | — |
| eStudySite | Las Vegas | Nevada | 89109 | — |
| Midwest Clinical Research | Dayton | Ohio | 45417 | — |
| Hermann Drive Surgical Hospital | Houston | Texas | 77004 | — |
| Westside Surgical Hospital | Houston | Texas | 77027 | — |
| Plano Surgical Hospital | Plano | Texas | 75093 | — |
| Endeavor Clinical Trials, P.A. | San Antonio | Texas | 78229 | — |
| EPIC Medical Research, LLC | Murray | Utah | 84123 | — |
| Jean Brown Research | Salt Lake City | Utah | 84124 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 2 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03237481, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Mar 2, 2026 · Synced Oct 21, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03237481 live on ClinicalTrials.gov.