Bupivacaine Effectiveness and Safety in SABER® Trial

• Status: Completed
• Trial end date: 2011-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Durect
• Collaborators: Hospira, Inc.; Hospira, now a wholly owned subsidiary of Pfizer; Nycomed
• Treatments: Bupivacaine

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of systemic steroids, anticonvulsants, antiepileptics, antidepressants, or monoamine oxidase inhibitors, who cannot be withdrawn from these medications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