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

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.