Postoperative PainPhase 3BESSTNCT01052012
Bupivacaine Effectiveness and Safety in SABER® Trial
A Phase 3 study testing SABER-Bupivacaine and Bupivacaine HCl in people with Postoperative Pain and Abdominal Surgery, run by Durect at 26 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Pain, Abdominal Surgery
- What is being tested?
- SABER-Bupivacaine and Bupivacaine HCl
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 331 participants
- Where
- 26 sitesin 3 countries
- Study dates
- Dec 2009to Sep 2011
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 21Show fewer
- 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 locations and contacts
26 sites in 3 countries.
26 sites in 3 countries
United States22 sites
DURECT Study Site
Arcadia, California, 91007
DURECT Study Site
Birmingham, Alabama, 35209
DURECT Study Site
Boston, Massachusetts, 02135
DURECT Study Site
Columbus, Ohio, 43210
DURECT Study Site
Duluth, Minnesota, 55805
DURECT Study Site
Durham, North Carolina, 27710
DURECT Study Site
Florence, Alabama, 35630
DURECT Study Site
Fontana, California, 92335
DURECT Study Site
Hershey, Pennsylvania, 17033
DURECT Study Site
Houston, Texas, 77024
DURECT Study Site
Indianapolis, Indiana, 46206
DURECT Study Site
Laguna Hills, California, 92653
DURECT Study Site
Mobile, Alabama, 36608
DURECT Study Site
Mobile, Alabama, 36617
DURECT Study Site
Montgomery, Alabama, 36106
DURECT Study Site
New York, New York, 10016
DURECT Study Site
Pasadena, California, 91105
DURECT Study Site
Powder Springs, Georgia, 30127
DURECT Study Site
Sheffield, Alabama, 35660
DURECT Study Site
Tampa, Florida, 33606
DURECT Study Site
Temple, Texas, 77375
DURECT Study Site
Troy, Michigan, 48085
Australia3 sites
DURECT Study Site
Box Hill, Victoria, 3128
DURECT Study Site
Ringwood East, Victoria, 3135
DURECT Study Site
Woodville South, South Australia, 5011
About this study
Official title: Bupivacaine Effectiveness and Safety in SABER Trial (BESST)
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.
- Conditions
- Postoperative Pain, Abdominal Surgery
- Being tested
- SABER-Bupivacaine, Bupivacaine HCl, SABER-Placebo
- Keywords
- Postoperative pain, Post-operative pain, Opioid, Laparoscopic surgery, Bupivacaine, Local anesthetic
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SABER-BupivacaineDrug
Also called POSIMIR® bupivacaine solution
Injectable Extended Release Solution; SABER-Bupivacaine /Once
Bupivacaine HClDrug
Injectable Solution; Bupivacaine HCl /Once
SABER-PlaceboDrug
Injectable Solution; SABER-Placebo/Once
| Study group | Role | What they receive |
|---|---|---|
| Active: SABER-Bupivacaine | Experimental | SABER-Bupivacaine Receives: Drug: SABER-Bupivacaine |
| Comparator: Bupivacaine HCl | Active comparator | Bupivacaine HCl Receives: Drug: Bupivacaine HCl |
| Placebo: SABER-Placebo | Placebo comparator | SABER-Placebo Receives: Drug: SABER-Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 0-72 hours post dose
Secondary outcomes (7)
Mean Pain Intensity on Movement
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.
Measured: 0 to 48 hours post-dose
Total Morphine-equivalent Dose
Total morphine-equivalent dose during 0-48 hours post dose.
Measured: 0-48 hours post dose
Proportion (Percent) of Patients Who Have Evidence of a Wound Infection
From Surgical Wound Healing and Local Tissue Condition Evaluation
Measured: 0 to 14 days post-dose (Visits 3 and 4)
Time-to-first Use of Opioid Rescue Medication
Measured: 0 to 14 days post-dose (Time from extubation until first opioid use)
Number (Incidence) of Participants With Opioid-related Side Effects
AEs include: nausea, vomiting, constipation, dizziness, somnolence, urinary retention, respiratory depression
Measured: 0 to 30 days post-dose
Pain Intensity at Rest AUC During 0-72 Hours Post Dose
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.
Measured: 0-72 hours post dose
Mean Pain Intensity at Rest AUC During 0-48 Hours Post Dose
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.
Measured: 0-48 hours post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2010 (estimated)
- Study startDec 2009
- Primary completionSep 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 331 participants (actual)
Sponsor and investigators
- Lead sponsor
- Durect
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Nycomed, Hospira, now a wholly owned subsidiary of Pfizer
- Responsible party
- Sponsor
- Investigators
- Dmitri Lissin, MD, Study director, Durect
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01052012
- Sponsor's protocol ID
- C803-025
- Acronym
- BESST
- Status last verified
- May 2021
- First submitted
- 18 Jan 2010
- Last updated
- 1 Jun 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bupivacaine Effectiveness and Safety in SABER Trial (BESST)
- ClinicalTrials.gov ID
- NCT01052012
- Acronym / sponsor ID
- BESST / C803-025
- Conditions
- Postoperative Pain, Abdominal Surgery
- Keywords
- Postoperative pain, Post-operative pain, Opioid, Laparoscopic surgery, Bupivacaine, Local anesthetic
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 331 participants (actual)
- Lead sponsor
- DurectIndustry (pharma, biotech, devices)
- Collaborators
- Nycomed, Hospira, now a wholly owned subsidiary of Pfizer
- Study start
- Dec 2009
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 20 Jan 2010 (estimated)
- Results
- Posted 1 Jun 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Active: SABER-Bupivacaine | Experimental | Drug: SABER-BupivacaineSABER-Bupivacaine |
| Comparator: Bupivacaine HCl | Active comparator | Drug: Bupivacaine HClBupivacaine HCl |
| Placebo: SABER-Placebo | Placebo comparator | Drug: SABER-PlaceboSABER-Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (21 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SABER-BupivacaineAlso: POSIMIR® bupivacaine solutionInjectable Extended Release Solution; SABER-Bupivacaine /Once | Drug | Active: SABER-Bupivacaine |
| Bupivacaine HClInjectable Solution; Bupivacaine HCl /Once | Drug | Comparator: Bupivacaine HCl |
| SABER-PlaceboInjectable Solution; SABER-Placebo/Once | Drug | Placebo: SABER-Placebo |
Primary outcome
Mean Pain Intensity on Movement
Time frame: 0 to 72 hours post-dose
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.
Supplemental Opioid Use
Time frame: 0-72 hours post dose
Total morphine-equivalent dose during 0-72 hours post dose. Median values were presented because data was not normally distributed.
7 secondary outcomes
Mean Pain Intensity on Movement
Time frame: 0 to 48 hours post-dose
Total Morphine-equivalent Dose
Time frame: 0-48 hours post dose
Proportion (Percent) of Patients Who Have Evidence of a Wound Infection
Time frame: 0 to 14 days post-dose (Visits 3 and 4)
Time-to-first Use of Opioid Rescue Medication
Time frame: 0 to 14 days post-dose (Time from extubation until first opioid use)
Number (Incidence) of Participants With Opioid-related Side Effects
Time frame: 0 to 30 days post-dose
Pain Intensity at Rest AUC During 0-72 Hours Post Dose
Time frame: 0-72 hours post dose
Mean Pain Intensity at Rest AUC During 0-48 Hours Post Dose
Time frame: 0-48 hours post dose
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dmitri Lissin, MD study director
Durect
26 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing SABER-Bupivacaine and Bupivacaine HCl in people with Postoperative Pain and Abdominal Surgery, run by Durect at 26 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 sites in United States, Australia, New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Jun 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Pain Intensity on Movement (time frame: 0 to 72 hours post-dose). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2021.