bupivacaine effectiveness and safety in saber® trial

Conditions: Postoperative Pain; Abdominal Surgery

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of systemic steroids, anticonvulsants, antiepileptics, antidepressants, or monoamine oxidase inhibitors, who cannot be withdrawn from these medications * patients with current or regular use of drugs known to significantly prolong the qtc interval * patients with known hypersensitivity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

Keywords: postoperative pain post-operative pain opioid laparoscopic surgery bupivacaine local anesthetic