Phase 2 Herniorrhaphy Study for Opioid Elimination
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Intervention: HTX-011; Luer lock applicator; Vial access device; Ibuprofen; Acetaminophen; Ketorolac
Intervention description: 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.; Intraoperative IV ketorolac.
Intervention MeSH terms: Acetaminophen; Ibuprofen; Ketorolac
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Enrollment: 63.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: inguinal hernia; hernia; hernia surgery; postoperative pain; herniorrhaphy

Summary:

      This is a Phase 2, open-label study in subjects undergoing unilateral open inguinal
      herniorrhaphy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  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.

        Exclusion Criteria:

          -  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.

          -  Had a malignancy in the last year, with the exception of nonmetastatic basal cell or
             squamous cell carcinoma of the skin or localized carcinoma in situ of the cervix.

          -  Has a known or suspected history of drug abuse, a positive drug screen on the day of
             surgery, or a recent history of alcohol abuse. Note: Subjects with a positive drug
             screen who are taking an allowed, prescribed medication that is known to result in a
             positive drug test (eg, amphetamine and dextroamphetamine for
             attention-deficit/hyperactivity disorder, benzodiazepine for anxiety disorder) may be
             eligible for participation in the study at the discretion of the Sponsor. Subjects
             taking any marijuana (medical or recreational) are not allowed to participate in the
             study.

          -  Previously participated in an HTX-011 study.

          -  Received an investigational product or device in a clinical trial within 30 days or
             within 5 elimination half-lives.

          -  Has undergone 3 or more surgeries within 12 months.

          -  Has a body mass index (BMI) >39 kg/m2.