Ropivacaine 0.2% Pre-Filled Dispenser for the Treatment of Postsurgical Pain in Patients Undergoing Cesarean Delivery

Inclusion Criteria:

- Complete the informed consent process as documented by a signed informed consent form
(ICF).

- Be in generally good health and classified as either PS-1 or PS-2 by the American
Society of Anesthetists (ASA) Physical Status Classification System.

- Have a single birth pregnancy. Can be parous or nulliparous.

- Be scheduled for a Cesarean Delivery

- Subjects undergoing emergency Cesarean Delivery will not be eligible for participation
in this study.

- In the event a subject signs the ICF (but has not been randomized), has a C section
planned and then has an emergency C section delivery, this subject will be considered
a screen failure.

- In the unlikely event a subject signs the ICF and is randomized into the study, has a
C section planned and then has an emergency C section delivery, this subject will
continue in the study as planned.

- Be willing to complete the pain assessments according to the protocol and return to
clinic as scheduled, as needed.

Exclusion Criteria:

- Have an uncontrolled medical condition, serious intercurrent illness, clinically
significant general health condition, or extenuating circumstance that may
significantly decrease study compliance or otherwise preclude their participation in
the study.

- Have a clinically significant abnormal electrocardiogram (ECG) at screening as
determined by the Investigator.

- Have a history of any medical condition or surgical procedure that would alter the
absorption, distribution, metabolism, or excretion of ropivacaine.

- Have, in the opinion of the investigator, a clinically significant abnormality in
their clinical laboratory values (urinalysis, hematology and chemistry) at screening.

- Have made a donation (standard donation amount or more) of blood or blood products
(with the exception of plasma as noted below) within 56 days prior to Day 1.

- Weigh greater than 100 kg (220 lbs).

- Have made a plasma donation within 7 days prior to Day -1.

- Have a known allergy or hypersensitivity to anesthetics (eg. Ropivacaine),
acetaminophen, or non-steroidal anti inflammatory drugs (NSAIDs, eg, ibuprofen or
naproxen, ketorolac).

- Not be able or willing to discontinue the prohibited medications listed below within
the allotted time before surgery and throughout the duration of their participation in
the study.

- monoamine oxidase inhibitors (MAOIs) within the past 30 days

- anticonvulsants, tricyclic antidepressants (TCAs), neuroleptics,
serotonin-norepinephrine reuptake inhibitors (SNRIs), as well as selective
serotonin reuptake inhibitors (SSRIs) (unless SSRIs have been prescribed for
depression and/or anxiety and subjects have been on a stable dose for at least 30
days prior to the screening visit);

- Corticosteroids: Oral and injectable corticosteroids must be discontinued 3
months prior to surgery; nasal, inhaled and topical corticosteroids will be
allowed;

- Use concurrent therapy that could interfere with the evaluation of efficacy or safety
parameters in the opinion of the investigator (eg, any drugs, in the investigator's
opinion, that may exert significant analgesic properties), except for rescue
medications.

- Have a history of seizures or history of serious head injury.

- Must not be a member of a vulnerable population as defined by the Code of Federal
Regulations Title 45, Part 46, Delivery 46.111(b), including but not limited to
employees (temporary, part-time, full-time, etc.) or a family member of the research
staff conducting the study, or of the Sponsor, or of the Clinical Research
Organization.

- Have previously participated in a clinical trial using ropivacaine.

- Have a history of major mental illness that in the opinion of the Investigator may
affect the ability of the subject to participate in the study. Institutionalized
subjects will not be eligible for participation.