Phase 2 Herniorrhaphy Study for Opioid Elimination
A Phase 2, Open-Label Study of HTX 011 in a Multimodal Analgesic Regimen for Decreased Opioid Use Following Unilateral Open Inguinal Herniorrhaphy
1 other identifier
interventional
63
1 country
5
Brief Summary
This is a Phase 2, open-label study in subjects undergoing unilateral open inguinal herniorrhaphy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 postoperative-pain
Started Oct 2018
Shorter than P25 for phase_2 postoperative-pain
5 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
First Submitted
Initial submission to the registry
October 1, 2018
CompletedStudy Start
First participant enrolled
October 1, 2018
CompletedFirst Posted
Study publicly available on registry
October 4, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 20, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 15, 2018
CompletedResults Posted
Study results publicly available
July 2, 2021
CompletedMarch 2, 2026
February 1, 2026
2 months
October 1, 2018
June 11, 2021
February 10, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Subjects Receiving no Opioid Rescue
72 hours
Secondary Outcomes (4)
Total Postoperative Opioid Consumption (in IV Morphine Milligram Equivalents [IV MME])
72 hours
Percentge of Subjects Receiving no Opioid Rescue
0-24 hours, 24-48 hours, 24-72 hours, 48-72 hours
Percentge of Subjects Receiving no Opioid Rescue
Day 28
Percentge of Subjects in Severe Pain With Numeric Rating Scale (NRS-R; Windowed Worst Observation Carried Forward) of Pain Intensity Scores >7 on a Scale of 0-10 at Any Point. NRS-R for Pain Where 0 Equals no Pain and 10 Equals Worst Pain Imaginable.
72 hours
Study Arms (2)
Cohort 1: HTX-011 + MMA Regimen
EXPERIMENTALHTX-011 (bupivacaine/meloxicam), 300 mg/9 mg via instillation; non-opioid multimodal analgesic (MMA) regimen.
Cohort 2: HTX-011 + MMA Regimen + Ketorolac
EXPERIMENTALHTX-011 (bupivacaine/meloxicam), 300 mg/9 mg via instillation; non-opioid multimodal analgesic (MMA) regimen and IV ketorolac.
Interventions
HTX-011 (bupivacaine/meloxicam), 300 mg/ 9 mg via instillation.
Applicator for instillation.
Device for withdrawal of drug product.
Ibuprofen, 600 mg.
Acetaminophen, 1 g.
Eligibility Criteria
You may qualify if:
- Is scheduled to undergo a unilateral open inguinal herniorrhaphy with mesh under general anesthesia.
- Has an American Society of Anesthesiologists 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:
- Had any prior inguinal hernia repair except as a child (less than 6 years of age).
- 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.
- Has known or suspected daily use of opioids for 7 or more consecutive days within the previous 6 months.
- Has taken any NSAIDs within least 10 days prior to the scheduled surgery.
- Has taken long-acting opioids within 3 days prior to the scheduled surgery.
- Has taken any opioids within 24 hours prior to the scheduled surgery.
- Has been administered bupivacaine within 5 days prior to the scheduled surgery.
- Has been administered any local anesthetic within 72 hours prior to the scheduled surgery.
- Has initiated treatment with study medications within 1 month prior to study drug administration that can impact pain control.
- Has been administered systemic steroids within 5 half-lives or 10 days prior to administration of study drug.
- 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.
- As per subject history and/or medical records, has active infection or is currently undergoing treatment for Hepatitis B, Hepatitis C, or human immunodeficiency virus (HIV).
- Has uncontrolled anxiety, psychiatric, or neurological disorder.
- +6 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
Anaheim Clinical Trials, LLC
Anaheim, California, 92801, United States
Lotus Clinical Research, LLC
Pasadena, California, 91105, United States
JBR Clinical Research
Draper, Utah, 84020, United States
JBR Clinical Research
Murray, Utah, 84107, United States
JBR Clinical Research
Salt Lake City, Utah, 84124, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Tricia Mulford
- Organization
- Heron Therapeutics, Inc.
Study Officials
- STUDY CHAIR
Neil Singla, MD
Lotus Clinical Research, LLC
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 1, 2018
First Posted
October 4, 2018
Study Start
October 1, 2018
Primary Completion
November 20, 2018
Study Completion
December 15, 2018
Last Updated
March 2, 2026
Results First Posted
July 2, 2021
Record last verified: 2026-02