Treatments and/or Procedures

Study Criteria

Inclusion Criteria:

  -  Has American Society of Anesthesiologists (ASA) Physical Status of I, II, or III.

  -  Is scheduled to undergo a unilateral Total Shoulder Arthroplasty (TSA) or
     abdominoplasty.

Exclusion Criteria:

  -  Is undergoing a revision surgery.

  -  Has a known or suspected history of hypersensitivity or clinically significant
     idiosyncratic reaction to bupivacaine (or other local anesthetics), NSAIDs,
     acetaminophen, oxycodone, morphine, or hydromorphone.

  -  History of severe allergic reaction to aspirin or other NSAIDs, or known history of
     severe gastrointestinal adverse reactions associated with NSAID use

  -  Has taken meloxicam within 10 days prior to the scheduled surgery, or any NSAID within
     24 hours prior to the scheduled surgery, with the exception of subjects on low-dose
     (≤100 mg) daily acetylsalicylic acid for cardioprotection

  -  Opioid use for most days within the last 3 months prior to Screening in the opinion of
     the Investigator.

  -  Has been administered immediate-release bupivacaine HCl within 5 days prior to the
     scheduled surgery, or a modified-release bupivacaine product within 14 days prior to
     the scheduled surgery.

  -  Has initiated treatment with any of the following medications within 1 month prior to
     study drug administration: selective serotonin reuptake inhibitors, selective
     norepinephrine reuptake inhibitors, gabapentin, pregabalin, duloxetine, or
     cyclooxygenase-2 inhibitors.

  -  Has been administered systemic steroids within 5 half-lives or 10 days prior to the
     scheduled surgery (whichever is longer).

  -  Has a known or suspected history of drug abuse, a positive drug screen (except for
     cannabinoids) on the day of surgery, or a history of alcohol abuse within the past 5
     years.

  -  Suspected or confirmed active coronavirus disease 2019 (COVID-19) infection

  -  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, other than for diagnostic
     procedures (eg, colonoscopy).

  -  Has a body mass index (BMI) >40 kg/m2.

  -  Had undergone prior abdominoplasty or major abdominal wall surgery.