Bupivacaine Effectiveness and Safety in SABER® Trial

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of systemic steroids, anticonvulsants, antiepileptics, antidepressants, or monoamine oxidase inhibitors, who cannot be withdrawn from these medications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