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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT01052012
Registration number
NCT01052012
Ethics application status
Date submitted
18/01/2010
Date registered
20/01/2010
Date last updated
1/06/2021
Titles & IDs
Public title
Bupivacaine Effectiveness and Safety in SABER® Trial
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Scientific title
Bupivacaine Effectiveness and Safety in SABER Trial (BESST)
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Secondary ID [1]
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C803-025
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Universal Trial Number (UTN)
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Trial acronym
BESST
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Postoperative Pain
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Abdominal Surgery
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - SABER-Bupivacaine
Treatment: Drugs - Bupivacaine HCl
Treatment: Drugs - SABER-Placebo
Experimental: Active: SABER-Bupivacaine - SABER-Bupivacaine
Active Comparator: Comparator: Bupivacaine HCl - Bupivacaine HCl
Placebo Comparator: Placebo: SABER-Placebo - SABER-Placebo
Treatment: Drugs: SABER-Bupivacaine
Injectable Extended Release Solution; SABER-Bupivacaine /Once
Treatment: Drugs: Bupivacaine HCl
Injectable Solution; Bupivacaine HCl /Once
Treatment: Drugs: SABER-Placebo
Injectable Solution; SABER-Placebo/Once
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Mean Pain Intensity on Movement
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Assessment method [1]
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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.
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Timepoint [1]
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0 to 72 hours post-dose
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Primary outcome [2]
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Supplemental Opioid Use
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Assessment method [2]
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Total morphine-equivalent dose during 0-72 hours post dose. Median values were presented because data was not normally distributed.
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Timepoint [2]
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0-72 hours post dose
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Secondary outcome [1]
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Mean Pain Intensity on Movement
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Assessment method [1]
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Mean pain intensity on movement AUC (time-normalized AUC) during the period 0 to 48 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.
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Timepoint [1]
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0 to 48 hours post-dose
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Secondary outcome [2]
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Total Morphine-equivalent Dose
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Assessment method [2]
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Total morphine-equivalent dose during 0-48 hours post dose.
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Timepoint [2]
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0-48 hours post dose
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Secondary outcome [3]
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Proportion (Percent) of Patients Who Have Evidence of a Wound Infection
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Assessment method [3]
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From Surgical Wound Healing and Local Tissue Condition Evaluation
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Timepoint [3]
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0 to 14 days post-dose (Visits 3 and 4)
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Secondary outcome [4]
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Time-to-first Use of Opioid Rescue Medication
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Assessment method [4]
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Timepoint [4]
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0 to 14 days post-dose (Time from extubation until first opioid use)
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Secondary outcome [5]
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Number (Incidence) of Participants With Opioid-related Side Effects
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Assessment method [5]
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AEs include: nausea, vomiting, constipation, dizziness, somnolence, urinary retention, respiratory depression
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Timepoint [5]
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0 to 30 days post-dose
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Secondary outcome [6]
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Pain Intensity at Rest AUC During 0-72 Hours Post Dose
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Assessment method [6]
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Mean pain intensity at rest 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.
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Timepoint [6]
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0-72 hours post dose
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Secondary outcome [7]
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Mean Pain Intensity at Rest AUC During 0-48 Hours Post Dose
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Assessment method [7]
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Mean pain intensity at rest AUC during the period 0 to 48 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.
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Timepoint [7]
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0-48 hours post dose
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Eligibility
Key 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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/12/2009
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/09/2011
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Sample size
Target
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Accrual to date
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Final
331
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Recruitment in Australia
Recruitment state(s)
SA,VIC
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Recruitment hospital [1]
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DURECT Study Site - Woodville South
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Recruitment hospital [2]
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DURECT Study Site - Box Hill
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Recruitment hospital [3]
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DURECT Study Site - Ringwood East
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Recruitment postcode(s) [1]
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5011 - Woodville South
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Recruitment postcode(s) [2]
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3128 - Box Hill
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Recruitment postcode(s) [3]
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3135 - Ringwood East
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Alabama
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Country [2]
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United States of America
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State/province [2]
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California
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Country [3]
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United States of America
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State/province [3]
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Florida
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Country [4]
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United States of America
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State/province [4]
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Georgia
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Country [5]
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United States of America
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State/province [5]
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Indiana
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Country [6]
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United States of America
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State/province [6]
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Massachusetts
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Country [7]
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United States of America
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State/province [7]
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Michigan
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Country [8]
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United States of America
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State/province [8]
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Minnesota
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Country [9]
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United States of America
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State/province [9]
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New York
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Country [10]
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United States of America
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State/province [10]
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North Carolina
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Country [11]
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United States of America
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State/province [11]
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Ohio
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Country [12]
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United States of America
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State/province [12]
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Pennsylvania
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Country [13]
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United States of America
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State/province [13]
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Texas
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Country [14]
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New Zealand
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State/province [14]
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Christchurch
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Durect
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Address
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Country
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Other collaborator category [1]
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Commercial sector/Industry
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Name [1]
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Nycomed
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Address [1]
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Country [1]
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Other collaborator category [2]
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Commercial sector/Industry
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Name [2]
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Hospira, now a wholly owned subsidiary of Pfizer
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Address [2]
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Country [2]
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01052012
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dmitri Lissin, MD
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Address
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Durect
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01052012
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