A Multi-surgery Assessment of ZYNRELEF (HTX-011), AMAZE.

Inclusion Criteria:

• Has American Society of Anesthesiologists (ASA) Physical Status of I, II, or III.
• Is scheduled to undergo a unilateral Total Shoulder Arthroplasty.

Exclusion Criteria:

• Is undergoing a revision surgery.
• Has a known or suspected history of hypersensitivity or clinically significantidiosyncratic 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 ofsevere 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 ofthe Investigator.
• Has been administered immediate-release bupivacaine HCl within 5 days prior to thescheduled surgery, or a modified-release bupivacaine product within 14 days prior tothe scheduled surgery.
• Has initiated treatment with any of the following medications within 1 month prior tostudy drug administration: selective serotonin reuptake inhibitors, selectivenorepinephrine reuptake inhibitors, gabapentin, pregabalin, duloxetine, orcyclooxygenase-2 inhibitors.
• Has been administered systemic steroids within 5 half-lives or 10 days prior to thescheduled surgery (whichever is longer).
• Has a known or suspected history of drug abuse, a positive drug screen (except forcannabinoids) on the day of surgery, or a history of alcohol abuse within the past 5years.
• Suspected or confirmed active coronavirus disease 2019 (COVID-19) infection.
• Had a malignancy in the last year, with the exception of nonmetastatic basal cell orsquamous 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 diagnosticprocedures (eg, colonoscopy).
• Has a body mass index (BMI) >40 kg/m2.