Clinical trial NCT01052012: Bupivacaine Effectiveness and Safety in SABER® Trial
Official title: Bupivacaine Effectiveness and Safety in SABER Trial (BESST)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Postoperative Pain
Abdominal Surgery
Keywords: Postoperative pain
Post-operative pain
Opioid
Laparoscopic surgery
Bupivacaine
Local anesthetic
Lead sponsor: Durect
Sponsor class: INDUSTRY
Collaborators: name: Nycomed
name: Hospira, now a wholly owned subsidiary of Pfizer
First posted: 2010-01-20
Enrollment: 331
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

Primary outcomes:
measure: Mean Pain Intensity on Movement
timeFrame: 0 to 72 hours post-dose
measure: Supplemental Opioid Use
timeFrame: 0-72 hours post dose
Secondary outcomes:
measure: Mean Pain Intensity on Movement
timeFrame: 0 to 48 hours post-dose
measure: Total Morphine-equivalent Dose
timeFrame: 0-48 hours post dose
measure: Proportion (Percent) of Patients Who Have Evidence of a Wound Infection
timeFrame: 0 to 14 days post-dose (Visits 3 and 4)
measure: Time-to-first Use of Opioid Rescue Medication
timeFrame: 0 to 14 days post-dose (Time from extubation until first opioid use)
measure: Number (Incidence) of Participants With Opioid-related Side Effects
timeFrame: 0 to 30 days post-dose
measure: Pain Intensity at Rest AUC During 0-72 Hours Post Dose
timeFrame: 0-72 hours post dose
measure: Mean Pain Intensity at Rest AUC During 0-48 Hours Post Dose
timeFrame: 0-48 hours post dose
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: DURECT Study Site
state: Alabama
city: Florence
country: United States
facility: DURECT Study Site
state: Alabama
city: Mobile
country: United States
facility: DURECT Study Site
state: Alabama
city: Mobile
country: United States
facility: DURECT Study Site
state: Alabama
city: Montgomery
country: United States
facility: DURECT Study Site
state: Alabama
city: Sheffield
country: United States
facility: DURECT Study Site
state: Alabama
city: Arcadia
country: United States
facility: DURECT Study Site
state: California
city: Fontana
country: United States
facility: DURECT Study Site
state: California
city: Laguna Hills
country: United States
facility: DURECT Study Site
state: California
city: Pasadena
country: United States
facility: DURECT Study Site
state: California
city: Tampa
country: United States
facility: DURECT Study Site
state: Florida
city: Powder Springs
country: United States
facility: DURECT Study Site
state: Georgia
city: Indianapolis
country: United States
facility: DURECT Study Site
state: Indiana
city: Boston
country: United States
facility: DURECT Study Site
state: Massachusetts
city: Troy
country: United States
facility: DURECT Study Site
state: Michigan
city: Duluth
country: United States
facility: DURECT Study Site
state: Minnesota
city: New York
country: United States
facility: DURECT Study Site
state: New York
city: Durham
country: United States
facility: DURECT Study Site
state: North Carolina
city: Columbus
country: United States
facility: DURECT Study Site
state: Ohio
city: Hershey
country: United States
facility: DURECT Study Site
state: Pennsylvania
city: Houston
country: United States
facility: DURECT Study Site
state: Texas
city: Temple
country: United States
facility: DURECT Study Site
state: Texas
city: Woodville South
country: Australia
facility: DURECT Study Site
state: South Australia
city: Box Hill
country: Australia
facility: DURECT Study Site
state: Victoria
city: Ringwood East
country: Australia
facility: DURECT Study Site
state: Victoria
city: Christchurch
country: New Zealand
facility: DURECT Study Site
Study officials:
affiliation: Durect
name: Dmitri Lissin, MD
role: STUDY_DIRECTOR
References: