Total Knee Arthroplasty (TKA) Study of HTX-011 in an Multimodal Analgesic Regimen (MMA) Regimen
Condition: Analgesia
Intervention: HTX-011; Ibuprofen; Acetaminophen; Celecoxib; +/- Bupivacaine HCl; Luer Lock Applicator; HTX-011
Intervention description: Dual-acting local anesthetic. Dose 1.; NSAID.; Analgesic.; NSAID.; Local anesthetic.; Applicator for instillation.; Dual-acting local anesthetic. Dose 2.
Intervention MeSH terms: Acetaminophen; Ibuprofen; Celecoxib; Bupivacaine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 116.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: total knee arthroplasty; postoperative pain; multimodal analgesia

Summary:

      Phase 3b, open-label single-arm study in which all subjects receive HTX-011 as part of a
      scheduled non-opioid MMA regimen.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Is scheduled to undergo primary unilateral TKA under spinal anesthesia.

          -  Has not previously undergone TKA in either knee.

          -  Has an American Society of Anesthesiologists (ASA) Physical Status of I, II, or III.

          -  Is able to walk at least 20 feet with optional use of a 4-legged walker for balance.

          -  Female subjects are eligible only if not pregnant, not lactating, not planning to
             become pregnant during the study, sterile; or is at least 2 years post-menopausal; or
             is in a monogamous relationship with a partner who is surgically sterile; or using
             acceptable contraceptives.

        Exclusion Criteria:

          -  Has a planned concurrent surgical procedure.

          -  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.

          -  Using or expected to use Factor IX Complex or anti-inhibitor coagulant concentrates
             during the study.

          -  Has known or suspected daily use of opioids for 7 or more consecutive days within the
             previous 6 months.

          -  Has taken NSAIDs within 10 days prior to the scheduled surgery with the exception of
             subjects on low-dose (≤100 mg) daily acetylsalicylic acid for cardioprotection.

          -  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 been administered any local anesthetic within 72 hours 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.

          -  Received an investigational product or device in a clinical trial within 30 days or
             within 5 elimination half lives.

          -  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.

          -  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.

          -  Is currently undergoing treatment for hepatitis B, hepatitis C, or HIV.

          -  Has uncontrolled anxiety, psychiatric, or neurological disorder that, in the opinion
             of the Investigator, might interfere with study assessments.

          -  Has acquired defective color vision or acute gastrointestinal ulcers, either of which
             could interfere with scheduled study medications.

          -  Has any chronic neuromuscular deficit of either femoral nerve function or thigh
             musculature.

          -  Has any chronic condition or disease that would compromise neurological or vascular
             assessments.

          -  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 undergone 3 or more surgeries within 12 months.

          -  Has a body mass index (BMI) >39 kg/m2.