A Pilot Study to Investigate the Safety, Efficacy, Pharmacokinetics and Bioavailability of HTX-011, HTX-002, or HTX-009 Administered Via Injection and/or Topical Application Following Unilateral Open Inguinal Herniorrhaphy
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Intervention: HTX-011; Placebo; HTX-002; Bupivacaine HCI (Marcaine); HTX-011A; HTX-011B; HTX-009
Intervention description: HTX-011 (bupivacaine/meloxicam) by injection.; Saline placebo by injection.; HTX-002, by injection or instillation (pooled).; Bupivacaine HCI (Marcaine) by injection.; HTX-011A (bupivacaine/meloxicam) by injection.; HTX-011B (bupivacaine/meloxicam) by injection, instillation or combination.; HTX-009 by injection and instillation (combination).
Intervention MeSH terms: Bupivacaine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 463.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      A Phase 2, Randomized, Pilot Study to Investigate the Safety, Efficacy, Pharmacokinetics and
      Bioavailability of HTX-011, HTX-002, or HTX-009 Administered Via Injection and/or Topical
      Application Following Unilateral Open Inguinal Herniorrhaphy
    

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:

             Not pregnant (female subject of child bearing potential must have a negative serum
             pregnancy test 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 and for 30 days
                  from completion of the study

             Male:

             o 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.

          3. Plan to undergo a unilateral inguinal herniorrhaphy

          4. Have the ability and be willing to comply with the study procedures

          5. 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 should they participate in the
             trial

          4. Have American Society of Anesthesiologists (ASA) Physical Status classification system
             category 4 or greater (Appendix E)

          5. Have clinically significant renal or hepatic abnormalities (defined as an AST or ALT >
             3x ULN, creatinine > 2x ULN)

          6. Have another painful condition that may confound pain assessments

          7. Have another surgery planned within 30 days of procedure, or presents with bilateral
             or recurrent inguinal hernia, other hernia presentations, or hernias with large
             scrotal component that would be difficult to reduce surgically

          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
             surgery

         10. Subjects with documented sleep apnea or are on home continuous positive airway
             pressure (CPAP)

         11. Female subjects who are pregnant (positive pregnancy test at screening or on the day
             of surgery)

         12. Subjects who are receiving oxygen therapy at the time of screening

         13. Have participated in a clinical trial within 30 days of planned surgery

         14. Have a body mass index (BMI) > 39 kg/m2