HTX-011 Administration Study in Planned Caesarean Section Procedure

Exclusion Criteria

• •Has planned to breastfeed her neonate at any time during the 28-day period after HTX-011 administration.
• •Has had a prior full-term pregnancy with unsuccessful breast milk expression.
• •Has a planned concurrent surgical procedure.
• •Has a contraindication or a known or suspected history of hypersensitivity or clinically significant idiosyncratic reaction to required study medications.
• •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 been administered systemic steroids within 5 half-lives or 10 days prior to administration of study drug.
• •Has initiated treatment with study medications within 1 month prior to study drug administration that can impact pain control.
• •Has taken any NSAIDs within least 10 days prior to the scheduled surgery.
• •Has current significant placental abnormality/complications including, but not limited to, placenta previa or placenta accreta.
• •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.
• •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.
• •Previously participated in an HTX-011 study.
• •Received an investigational product or device in a clinical trial within 30 days or within 5 elimination half-lives.
• •Weight is \<50 kg at the time of Screening visit.
• •In the Investigator's judgment, subject is likely to have been morbidly obese prior to her pregnancy.