A Safety and Efficacy Study of SABER®-Bupivacaine for Pain Following Hernia Repair
Condition: Postoperative Pain; Hernia; Surgery
MeSH terms: Hernia
Intervention: SABER-Bupivacaine; SABER-Bupivacaine; SABER-Placebo
Intervention description: Injectable Extended Release Solution; 2.5 mL SABER-Bupivacaine/Once; Injectable Extended Release Solution; 5.0 mL SABER-Bupivacaine/Once; Injectable Solution; 2.5 or 5.0 mL SABER-Placebo/Once
Intervention MeSH terms: Bupivacaine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 124.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Post-operative pain; hernia surgery; opioid

Summary:

      This is a research study testing SABER-Bupivacaine (an experimental pain-relieving
      medication). SABER-Bupivacaine is designed to continuously deliver bupivacaine, a common
      local anesthetic, for a few days in order to treat local post-surgical pain. This study is
      testing SABER-Bupivacaine in people having surgery to repair a hernia.

      The purpose of the study is to measure and compare the safety (side effects), tolerability
      (ability to tolerate), and efficacy (how well it works) of two different volumes of
      SABER-Bupivacaine with SABER-Placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males and females, 18 to 65 years of age, scheduled for hernia repair surgery

          -  Patients must be in good health prior to study participation

          -  Patients must have blood pressure within normal range or with Stage 1 high blood
             pressure

          -  Male and female patients must agree to use medically acceptable method of
             contraception throughout the entire trial period and for 1 week after the trial is
             completed

          -  Patients must refrain from strenuous activities and avoid changes to prescribed
             exercise levels throughout the course of the trial

          -  Ability to read, understand, communicate, and voluntarily sign the informed consent
             form prior to any trial specific procedures

        Exclusion Criteria:

          -  Patients with previous abdominal surgery scar tissue

          -  Patients with clinically significant abnormalities of any body system unrelated to the
             disease under study

          -  Connective tissue disorders

          -  Patients who are pregnant or lactating

          -  Current or regular use of analgesic medication for other indications

          -  Patients with current or regular use of antidepressants or monoamine oxidase
             inhibitors at screening

          -  Use of any drugs or medication that may interfere with the study and its results

          -  Patients with known hypersensitivity to the study drugs or their components

          -  Patients with known or suspected alcohol abuse or illicit drug use

          -  Participation in another clinical trial at the same time or within 30 days of this
             trial

          -  Patient is unwilling to comply with the study procedures