Evaluation of the Efficacy and Safety of Locally Administered HTX-011 for Postoperative Analgesia Following Bunionectomy
Condition: Postoperative Pain; Bunions
MeSH terms: Bunion; Pain, Postoperative
Intervention: HTX-011A; Saline Placebo; HTX-011B; HTX-002; Bupivacaine HCl; HTX-009
Intervention description: HTX-011A (bupivacaine/meloxicam), via injection.; Saline placebo via injection.; HTX-011B (bupivacaine/meloxicam), via injection or instillation.; HTX-002, via injection.; Bupivacaine HCI, via injection.; HTX-009, via injection.
Intervention MeSH terms: Bupivacaine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 430.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Analgesia; Bunionectomy

Summary:

      A Phase 2, Randomized, Controlled, Multicenter, Evaluation of the Efficacy and Safety of
      Locally Administered HTX-011 for Postoperative Analgesia Following Bunionectomy
    

Eligibility criteria:

        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

        Exclusion Criteria:

          1. Unwilling to sign informed consent or not willing or able to complete all study
             procedures

          2. Have a contraindication or be allergic to any medication to be used during the trial
             period

          3. Have clinically significant cardiac abnormalities that, in the opinion of the
             investigator, would pose a health risk to the subject

          4. Have American Society of Anesthesiologists (ASA) Physical Status classification system
             category ≥4

          5. Have clinically significant renal or hepatic abnormalities: for example, AST or ALT >
             3x ULN, creatinine > 2x ULN

          6. Have another pre-existing painful condition that may confound pain assessments

          7. Have another surgery planned within 30 days of procedure

          8. Have a known or suspected history of alcohol or drug abuse, or a positive drug screen

          9. Currently taking analgesics for a chronically painful condition, or has taken long
             acting opioids within 3 days of surgery, or taken any opioids within 24 hours of
             scheduled surgery for this study

         10. Subjects with documented sleep apnea or are on home continuous positive airway
             pressure (CPAP)

         11. Subjects who are receiving oxygen therapy at the time of screening

         12. Have participated in a clinical trial within 30 days of planned surgery