Bupivacaine Effectiveness and Safety in SABER™ Trial

Condition(s) targeted: Postoperative Pain; Abdominal Surgery

Intervention: SABER™-Bupivacaine (Drug); Bupivacaine HCl (Drug); SABER™-Placebo (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Durect

Official(s) and/or principal investigator(s):
Dmitri Lissin, MD, Study Director, Affiliation: Durect Corporation

Overall contact:
Chris Ambrose, BA, MA, Phone: 408-777-1417, Ext: 7484, Email: chris.ambrose@durect.com

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.

Official title: Bupivacaine Effectiveness and Safety in SABER™ Trial (BESST)

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome:

Pain intensity on movement

Supplemental opioid use

Secondary outcome:

Pain intensity at rest

Time-to-first use of opioid supplemental pain medication

Incidence of opioid-related side effects

Mean scores on the Recovery Index-49

Modified Post-Anesthetic Discharge Scoring System score

Treatment satisfaction

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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 diseasePatients must be healthy

or have only mild systemic disease

- BMI < 45

- Patients must have ECG wave form within normal limits

- Female 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

- 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 at screening

- 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); right bundle branch block (RBBB); known cardiomyopathy or prior myocardial infarction

- 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

Chris Ambrose, BA, MA, Phone: 408-777-1417, Ext: 7484, Email: chris.ambrose@durect.com

DURECT Study Site, Christchurch 8022, New Zealand; Recruiting

DURECT Study Site, Florence, Alabama 35630, United States; Recruiting

DURECT Study Site, Mobile, Alabama 36617, United States; Not yet recruiting

DURECT Study Site, Sheffield, Alabama 35660, United States; Recruiting

DURECT Study Site, Arcadia, California 91007, United States; Recruiting

DURECT Study Site, Fontana, California 92335, United States; Recruiting

DURECT Study Site, Laguna Hills, California 92653, United States; Recruiting

DURECT Study Site, Pasadena, California 91105, United States; Recruiting

DURECT Study Site, Tampa, Florida 33606, United States; Recruiting

DURECT Study Site, Indianapolis, Indiana 46206, United States; Recruiting

DURECT Study Site, Durham, North Carolina 27710, United States; Not yet recruiting

DURECT Study Site, Columbus, Ohio 43210, United States; Recruiting

DURECT Study Site, Hershey, Pennsylvania 17033, United States; Not yet recruiting

DURECT Study Site, Houston, Texas 77024, United States; Recruiting

DURECT Study Site, Temple, Texas 77375, United States; Recruiting

DURECT Study Site, Box Hill, Victoria 3128, Australia; Recruiting

DURECT Study Site, Ringwood East, Victoria 3135, Australia; Recruiting

Starting date: December 2009
Last updated: October 4, 2010