Bupivacaine Effectiveness and Safety in SABER® Trial
BESST
1 other identifier
interventional
331
3 countries
26
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 postoperative-pain
Started Dec 2009
Typical duration for phase_3 postoperative-pain
26 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2009
CompletedFirst Submitted
Initial submission to the registry
January 18, 2010
CompletedFirst Posted
Study publicly available on registry
January 20, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2011
CompletedResults Posted
Study results publicly available
June 1, 2021
CompletedJune 1, 2021
May 1, 2021
1.8 years
January 18, 2010
February 24, 2021
May 6, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Mean Pain Intensity on Movement
Mean pain intensity on movement AUC (time-normalized AUC) during the period 0 to 72 hours post-dose. Pain intensity was assessed with a standard 0 to 10 numeric rating scale (NRS), where no pain at all was rated as 0 and the worst pain imaginable was rated as 10. The AUC is computed for each patient using the standard trapezoidal rule and normalised by dividing by the time interval over which it is computed. This normalisation converts the AUC to the natural pain scale (NRS 0-10) to allow for better translation of the clinical treatment effect magnitude.
0 to 72 hours post-dose
Supplemental Opioid Use
Total morphine-equivalent dose during 0-72 hours post dose. Median values were presented because data was not normally distributed.
0-72 hours post dose
Secondary Outcomes (7)
Mean Pain Intensity on Movement
0 to 48 hours post-dose
Total Morphine-equivalent Dose
0-48 hours post dose
Proportion (Percent) of Patients Who Have Evidence of a Wound Infection
0 to 14 days post-dose (Visits 3 and 4)
Time-to-first Use of Opioid Rescue Medication
0 to 14 days post-dose (Time from extubation until first opioid use)
Number (Incidence) of Participants With Opioid-related Side Effects
0 to 30 days post-dose
- +2 more secondary outcomes
Study Arms (3)
Active: SABER-Bupivacaine
EXPERIMENTALSABER-Bupivacaine
Comparator: Bupivacaine HCl
ACTIVE COMPARATORBupivacaine HCl
Placebo: SABER-Placebo
PLACEBO COMPARATORSABER-Placebo
Interventions
Injectable Extended Release Solution; SABER-Bupivacaine /Once
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +6 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Durectlead
- Nycomedcollaborator
- Hospira, now a wholly owned subsidiary of Pfizercollaborator
Study Sites (26)
DURECT Study Site
Birmingham, Alabama, 35209, United States
DURECT Study Site
Florence, Alabama, 35630, United States
DURECT Study Site
Mobile, Alabama, 36608, United States
DURECT Study Site
Mobile, Alabama, 36617, United States
DURECT Study Site
Montgomery, Alabama, 36106, United States
DURECT Study Site
Sheffield, Alabama, 35660, United States
DURECT Study Site
Arcadia, California, 91007, United States
DURECT Study Site
Fontana, California, 92335, United States
DURECT Study Site
Laguna Hills, California, 92653, United States
DURECT Study Site
Pasadena, California, 91105, United States
DURECT Study Site
Tampa, Florida, 33606, United States
DURECT Study Site
Powder Springs, Georgia, 30127, United States
DURECT Study Site
Indianapolis, Indiana, 46206, United States
DURECT Study Site
Boston, Massachusetts, 02135, United States
DURECT Study Site
Troy, Michigan, 48085, United States
DURECT Study Site
Duluth, Minnesota, 55805, United States
DURECT Study Site
New York, New York, 10016, United States
DURECT Study Site
Durham, North Carolina, 27710, United States
DURECT Study Site
Columbus, Ohio, 43210, United States
DURECT Study Site
Hershey, Pennsylvania, 17033, United States
DURECT Study Site
Houston, Texas, 77024, United States
DURECT Study Site
Temple, Texas, 77375, United States
DURECT Study Site
Woodville South, South Australia, 5011, Australia
DURECT Study Site
Box Hill, Victoria, 3128, Australia
DURECT Study Site
Ringwood East, Victoria, 3135, Australia
DURECT Study Site
Christchurch, 8022, New Zealand
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Deborah Scott
- Organization
- Durect Corporation
Study Officials
- STUDY DIRECTOR
Dmitri Lissin, MD
Durect
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 18, 2010
First Posted
January 20, 2010
Study Start
December 1, 2009
Primary Completion
September 1, 2011
Study Completion
September 1, 2011
Last Updated
June 1, 2021
Results First Posted
June 1, 2021
Record last verified: 2021-05