Evaluation of the Efficacy and Safety of Locally Administered HTX-011 for Postoperative Analgesia Following Bunionectomy

Inclusion Criteria

• •1. Be male or female 18 years of age or older
• •2. Female subjects are eligible only if all of the following apply:
• •1. Not pregnant (female subject of child bearing potential must have a negative serum pregnancy test at screening and negative urine pregnancy test before surgery)
• •2. Not lactating
• •3. Not planning to become pregnant while participating in the study
• •4. Be surgically sterile; or be at least two years post-menopausal; or have a monogamous partner who is surgically sterile; or be practicing double-barrier contraception; or practicing abstinence (must agree to use double-barrier contraception in the event of sexual activity); or using an insertable, injectable, transdermal, or combination oral contraceptive approved by the FDA for greater than 2 months prior to screening visits and commits to the use of an acceptable form of birth control for the duration of the study and for 30 days from completion of the study
• •3. Male subjects must be surgically sterile (biologically or surgically) or commit to the use of a reliable method of birth control for the duration of the study until at least 1 week after the administration of study medication
• •4. Be scheduled to undergo a primary unilateral first metatarsal bunionectomy repair, without collateral procedures, under regional anesthesia
• •5. Subject has not had a contralateral bunionectomy in the non-study foot in the past 3 months
• •6. Have the ability and be willing to comply with the study procedures.
• •7. Must be able to understand study procedures and give informed consent for the conduct for all study procedures, using an IRB approved consent form