Evaluation of the Efficacy and Safety of HTX-011 for Postoperative Analgesia Following Abdominoplasty Surgery
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Intervention: HTX-011B; Placebo; HTX-011A; HTX-002; Bupivicaine HCl
Intervention description: HTX- 011B (bupivacaine/meloxicam) via injection; Saline placebo via injection; HTX- 011A (bupivacaine/meloxicam) via injection; HTX-002 via combination; Bupivacaine HCl via injection
Intervention MeSH terms: Bupivacaine
Phase: Phase 2
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 277.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      A Phase 2, Randomized, Controlled Evaluation of the Efficacy and Safety of HTX-011 or HTX-002
      for Post-Operative Analgesia Following Abdominoplasty Surgery
    

Eligibility criteria:

        Inclusion Criteria:

        Subjects must meet all of the following criteria to be considered eligible to participate
        in the study:

          1. Be scheduled to undergo abdominoplasty surgery that is amenable to treatment with a
             long acting local anesthetic as per the anesthesia protocol

          2. Be American Society of Anesthesiology (ASA) physical Class I or II

          3. Subjects 18 years of age or older

          4. Have clinical laboratory values that are within normal limits (WNL); subjects with
             AST/ALT < 3 x ULN, and/or creatinine < 2 x ULN are acceptable.

          5. Have a body mass index ≤ 30 kg/m2

          6. Female subjects are eligible only if all of the following apply:

               -  Not pregnant (female subject of child bearing potential must have a negative
                  serum pregnancy tests at screening and negative urine pregnancy test before
                  surgery)

               -  Not lactating

               -  Not planning to become pregnant during the study

               -  Be surgically sterile; or at least two years post-menopausal; or have a
                  monogamous partner who is surgically sterile; or is 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

          7. 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

          8. Does NOT have, as determined by the investigator or the study's medical monitor, a
             history or clinical manifestations of significant renal, hepatic, cardiovascular,
             metabolic, neurologic, psychiatric, or other condition that would preclude
             participation in the study

          9. Must be able to understand study procedures and be willing to comply and give informed
             consent for the conduct of all study procedures, using an IRB approved consent

        Exclusion Criteria:

        Subjects who meet any of the following criteria will be excluded from participating in the
        study:

          1. Have a contraindication or be allergic to any medication to be used during the trial
             period

          2. Have another painful physical condition that, in the opinion of the investigator, may
             confound the assessments of post-operative pain

          3. Have a history of migraine or frequent headaches, seizures, or are currently taking
             anticonvulsants

          4. 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
             surgery

          5. Previous abdominal surgery, as determined by the investigator, that would preclude
             participation in the study

          6. Subjects that require liposuction as part of the abdominoplasty procedure in Part A of
             the protocol

          7. Subjects that are to have ancillary procedures performed during the abdominoplasty
             surgery that are unrelated to the abdominal area (breast reduction, breast
             augmentation, etc.)

          8. Subjects unable to discontinue medications that have not been at a stable dose for at
             least 14 days prior to the scheduled abdominoplasty procedure and before dosing with
             investigational product

          9. Subjects taking the following medications; anticonvulsants, sedatives (including
             benzodiazepines) corticosteroids (by any means of administration), nonsteroidal
             anti-inflammatory drugs (NSAIDS) within 24 hours of study drug dosing, morphine,
             monoamine oxidase inhibitors (MAOIs), tricyclic antidepressants (TCAs), neuroleptics,
             or serotonin-norepinephrine reuptake inhibitors (SNRIs). Gabapentin and pregabalin are
             not permitted

         10. Have a known or suspected history of alcohol or drug abuse

         11. Have positive results on the alcohol breath test indicative of alcohol abuse or urine
             drug screen indicative of illicit drug use (unless results can be explained by a
             current prescription or acceptable over-the-counter medication at screening as
             determined by the investigator). The urine drug screen prior to surgery must be
             negative

         12. Have evidence of a clinically significant 12-lead ECG abnormality according to the
             judgment of the investigator

         13. Have received any investigational product within 30 days before start of study

         14. Have previously received HTX-011 in clinical trials

         15. Experiences a clinically significant event during surgery prior to the administration
             of the investigational product (e.g., excessive bleeding, hemodynamic instability)
             that would render the subject medically unstable, complicate their post-surgical
             course, or significantly increase the risk of study drug administration as per the
             judgment of the investigator. This will result in the subject being reported as
             randomized, not treated.

         16. Subjects with sleep apnea or are on home continuous positive airway pressure (CPAP)

         17. Subjects who are receiving oxygen therapy at the time of screening