Bupivacaine Effectiveness and Safety in SABER® Trial (BESST)

Durect

Status and phase: Completed; Phase 3

Conditions: Postoperative Pain; Abdominal Surgery

Treatments: Drug: SABER-Bupivacaine; Drug: SABER-Placebo; Drug: Bupivacaine HCl

Study type: Interventional

Funder types: Industry

Identifiers

NCT01052012

C803-025

Details and patient eligibility

About

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.

Enrollment: 331 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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of systemic steroids, anticonvulsants, antiepileptics, antidepressants, or monoamine oxidase inhibitors, who cannot be withdrawn from these medications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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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331 participants in 3 patient groups, including a placebo group

Active: SABER-Bupivacaine

Experimental group

Description:

SABER-Bupivacaine

Treatment:

Drug: SABER-Bupivacaine

Comparator: Bupivacaine HCl

Active Comparator group

Description:

Bupivacaine HCl

Treatment:

Drug: Bupivacaine HCl

Placebo: SABER-Placebo

Placebo Comparator group

Description:

SABER-Placebo

Treatment:

Drug: SABER-Placebo