Herniorrhaphy Study for Opioid Elimination

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Analgesia

Intervention / Treatment
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* Drug: HTX-011
* Device: Luer lock applicator
* Drug: Ibuprofen
* Drug: Acetaminophen


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: In Part 1, subjects who meet the Screening eligibility criteria (Section 4.1) will be randomized to one of the 2 parallel cohorts. In Part 2, prior to surgery, the Investigator will select for the subject one of the 2 postoperative MMA regimens, based on Investigator and/or subject preference.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort 1<br>HTX-011; Ibuprofen and Acetaminophen (regimen 1) | Drug: HTX-011<br>* 300 mg<br>Device: Luer lock applicator<br>* Applicator for instillation<br>Drug: Ibuprofen<br>* 600 mg<br>Drug: Acetaminophen<br>* 1 g<br>|
| Experimental: Cohort 2<br>HTX-011; Ibuprofen and Acetaminophen (regimen 2) | Drug: HTX-011<br>* 300 mg<br>Device: Luer lock applicator<br>* Applicator for instillation<br>Drug: Ibuprofen<br>* 600 mg<br>Drug: Acetaminophen<br>* 1 g<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of subjects who do not receive an opioid prescription at discharge through the day 15 visit |  | Discharge through Day 15 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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inguinal hernia, hernia, hernia surgery, postoperative pain, herniorrhaphy, multimodal analgesia