Phase 2B Upper Extremity Nerve Block Study
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Intervention: HTX-011; Bupivacaine HCl without epinephrine; Saline Placebo
Intervention description: HTX-011 (bupivacaine/meloxicam) via nerve block or instillation.; Bupivacaine HCl without epinephrine, 50 mg via nerve block.; Saline placebo via nerve block.
Intervention MeSH terms: Epinephrine; Bupivacaine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 243.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a Phase 2B, randomized, assessor-blind, active- and saline placebo-controlled,
      multicenter study in subjects undergoing augmentation mammoplasty to evaluate the analgesic
      efficacy, safety, and pharmacokinetics (PK) of HTX-011 when administered via
      ultrasound-guided lateral and medial pectoral nerve block before surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Is scheduled to undergo primary bilateral submuscular augmentation mammoplasty with
             saline or silicone smooth implants with a volume of 300 to 500 cc, inclusive. Note:
             textured implants are not allowed.

          -  Has an American Society of Anesthesiologists Physical Status of I, II, or III.

          -  Subjects are eligible only if not pregnant, not lactating, not planning to become
             pregnant during the study, sterile; or using acceptable contraceptives.

        Exclusion Criteria:

          -  Has a planned concurrent surgical procedure.

          -  Has a planned reconstructive procedure status post breast cancer therapy.

          -  Has a 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 medication.

          -  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 scheduled surgery.

          -  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 other than to treat an AE that occurs after signing the ICF or for
             pretreatment prior to a needle placement.

          -  Has initiated treatment with any of the following medications within 1 month prior to
             study drug administration or is taking any of these medications to control pain:
             selective serotonin reuptake inhibitors (SSRIs), selective norepinephrine reuptake
             inhibitors (SNRIs), gabapentin, pregabalin, duloxetine, or cyclooxygenase-2 (COX-2)
             inhibitors. (Note: If a subject is taking one of these medications for a reason other
             than pain control, she must be on a stable scheduled dose [ie, not "as needed"] for at
             least 1 month prior to study drug administration.) Anxiolytics prior to surgery are
             permitted, if necessary.

          -  Has a medical condition 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 a known history of Hepatitis B, Hepatitis C, or human immunodeficiency virus
             (HIV).

          -  Has uncontrolled anxiety, psychiatric, or neurological disorder that might interfere
             with study assessments

          -  Has any chronic neuromuscular deficit of either pectoral nerve function or
             arm/shoulder/truncal 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 non-metastatic 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. Note: Subjects with a positive drug
             screen who are taking an allowed, prescribed medication that is known to result in a
             positive drug test (eg, amphetamine and dextroamphetamine for
             attention-deficit/hyperactivity disorder, benzodiazepine for anxiety disorder) may be
             eligible for participation in the study. Subjects taking medical marijuana are not
             allowed to participate in the study.

          -  Received an investigational product or device in a clinical trial within 30 days or
             within 5 elimination half lives.

          -  Has undergone 3 or more surgeries in 12 months.

          -  Has a body mass index (BMI) >35 kg/m2.