Bunionectomy Study for Postoperative Analgesia (EPOCH 1)
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Intervention: HTX-011; Saline Placebo; Bupivacaine HCl; Luer-lock applicator; Vial access device
Intervention description: HTX 011 (bupivacaine/meloxicam), 60 mg/1.8 mg by instillation; Saline placebo by instillation; Bupivacaine HCl without epinephrine, 50 mg by injection; Applicator for instillation; Device for withdrawal of drug product
Intervention MeSH terms: Bupivacaine
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 412.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: bunion; bunionectomy; bunion surgery; postoperative pain

Summary:

      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 bunionectomy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Is scheduled to undergo a primary unilateral, distal, first metatarsal bunionectomy
             with osteotomy and internal fixation under regional 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:

          -  Has had a contralateral foot bunionectomy in the past 3 months.

          -  Has a planned concurrent surgical procedure (eg, bilateral bunionectomy or collateral
             procedures on the surgical foot).

          -  Has other 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 at least 10 days prior to the scheduled surgery.

          -  Has taken opioids within 24 hours prior to the scheduled surgery (3 days for
             long-acting).

          -  Has been administered bupivacaine within 5 days prior to the scheduled surgery.

          -  Has initiated treatment with 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. Subjects taking medical marijuana are not allowed to
             participate in the 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.