Bupivacaine Effectiveness and Safety in SABER® Trial
Condition: Postoperative Pain; Abdominal Surgery
MeSH terms: Pain, Postoperative
Intervention: SABER-Bupivacaine; Bupivacaine HCl; SABER-Placebo
Intervention description: Injectable Extended Release Solution; SABER-Bupivacaine /Once; Injectable Solution; Bupivacaine HCl /Once; Injectable Solution; SABER-Placebo/Once
Intervention MeSH terms: Bupivacaine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 331.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Postoperative pain; Post-operative pain; Opioid; Laparoscopic surgery; Bupivacaine; Local anesthetic

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.

      The purpose of this study is to investigate safety (side effects) associated with the use of
      SABER-Bupivacaine and how well it works in reducing pain and opioid-related side effects
      following various kinds of abdominal surgeries.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients must be able to read and understand the consent form, provide written
             consent, complete trial-related procedures, and communicate with the trial staff

          -  Males and females, 18 years of age and older scheduled to undergo elective general
             abdominal surgery

          -  Patients must be healthy or have only mild systemic disease

          -  BMI < 45

          -  Patients must have ECG wave form within normal limits

          -  Female and male patients must agree to use medically acceptable method of
             contraception throughout the entire trial period and for 1 week after the trial
             participation is completed

        Exclusion Criteria:

          -  Patients who are pregnant or lactating

          -  Patients undergoing emergency surgery (unless full consent is obtained and all
             screening procedures are completed prior to surgery)

          -  Significant concomitant surgical procedure

          -  History of multiple prior laparotomy procedures

          -  Cancer with known metastases pre-operatively, which are suspected to impact
             post-operative recovery or pain

          -  Planned formation of stoma during surgery or plans to undergo another laparotomy
             procedure within 30 days post-operatively

          -  Pre-operative evidence of sepsis or septic shock

          -  Pre-operative evaluation that suggests a surgery may preclude full closure of the
             incision(s)

          -  Patients with current or regular use of systemic steroids, anticonvulsants,
             antiepileptics, antidepressants, or monoamine oxidase inhibitors, who cannot be
             withdrawn from these medications

          -  Patients with current or regular use of drugs known to significantly prolong the QTc
             interval

          -  Patients with known hypersensitivity to local anesthetic agents of the amide type
             (e.g. lidocaine, bupivacaine)

          -  Patients with known hypersensitivity to morphine

          -  Patients with conditions contraindicated for use of opioids

          -  Patients with atrial fibrillation/flutter or other non-sinus rhythm (including paced
             rhythm); left bundle branch block (LBBB); or the following conditions: right bundle
             branch block (RBBB) in presence of a cardiac disease, significant cardiomyopathy, and
             myocardial infarction within last 6 months

          -  Patients with a serum creatinine level two times more than the local laboratory normal
             limit

          -  Patients who have received greater than 600 mg morphine equivalent daily dose for
             three or more days per week in the month prior to the surgical procedure

          -  Patients who are currently being treated with methadone, or history of methadone use
             within the previous 6 months

          -  Patients with known or suspected abuse of opioids or other illicit drugs

          -  Patients with known or suspected alcohol abuse

          -  Participation in another clinical trial at the same time or within 30 days of this
             trial

          -  Patients who, in the Investigator's opinion, should not participate in the trial or
             may not be capable of following the trial schedule for any reason